冬天来了，春天还会远吗？｜研发客临床年会暨ChinaTrials14精粹

<br/></p><p style="white-space: normal;box-sizing: border-box;text-align: left;line-height: 1.75em;margin-bottom: 8px;margin-left: 8px;margin-right: 8px;"><strong><span style="letter-spacing: 0.5px;text-align: justify;font-size: 15px;color: rgb(0, 122, 170);"><br/></span></strong></p><p style="white-space: normal;box-sizing: border-box;text-align: left;line-height: 1.75em;margin-bottom: 8px;margin-left: 8px;margin-right: 8px;"><span style="letter-spacing: 0.5px;text-align: justify;">第六届研发客临床年会暨ChinaTrials14最后一天的议题围绕行业大时代、企业如何“过冬”、以患者为中心的临床研究和CDE单臂与联合用药技术指导原则等话题进行了干货满满的研讨。</span><span style="letter-spacing: 0.5px;text-align: justify;">话题虽依旧深重，但“冬天”来了，“春天”还会远吗？</span><span style="letter-spacing: 0.5px;text-align: justify;">与会嘉宾已纷纷憧憬着春回大地、行业复苏的日子了。</span><span style="letter-spacing: 0.5px;text-align: justify;"/></p></section></section><p style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;"><br/></p><section style="font-size: 16px;text-align: center;margin-left: 8px;margin-right: 8px;"><img class="rich_pages wxw-img" data-backh="375" data-backw="562" data-galleryid="" data-ratio="0.666875" data-s="300,640" src="https://zfz-oss.oss-cn-hangzhou.aliyuncs.com/temp/ac8dbb9e9f47ccf819ec42fe93178a36.jpeg" data-type="png" data-w="1600" style="width: 100%;height: auto;"/></section><p style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><span style="color: rgb(0, 122, 170);"><strong><span style="color: rgb(0, 122, 170);letter-spacing: 0.5px;font-size: 15px;">大会主持人研发客总裁、出版人 戴佳凌</span></strong></span></p><p style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;"><span style="letter-spacing: 0.5px;font-family: Optima-Regular, PingFangTC-light;"><br/></span></p><section style="font-size: 16px;text-align: center;margin-left: 8px;margin-right: 8px;"><img class="rich_pages wxw-img" data-galleryid="" data-ratio="0.6673773987206824" data-s="300,640" src="https://zfz-oss.oss-cn-hangzhou.aliyuncs.com/temp/b02bf0dcd7ee1ff8de4e5dd0d953d854.png" data-type="png" data-w="1876" style=""/></section><p style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><span style="color: rgb(0, 122, 170);"><strong><span style="color: rgb(0, 122, 170);letter-spacing: 0.5px;font-size: 15px;">ChinaTrials年度研发客和L.E.K.咨询临床开发报告主管合伙人  曾凡凡博士</span></strong></span></p><p style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;"><br/></p><section style="font-size: 16px;box-sizing: border-box;"><section powered-by="xiumi.us" style="font-family: PingFangSC-light;box-sizing: border-box;"><p style="white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;"><span style="letter-spacing: 0.5px;">艾意凯咨询（L.E.K.）咨询临床开发报告主管合伙人曾凡凡博士介绍了新鲜出炉的研发客联合L.E.K. Consulting、ChinaTrials推出的《中国临床试验高质量发展调研报告》。曾凡凡说，2/3的行业高管受访者认为当下的挑战是短期的，长期的临床需求不会改变。</span><span style="letter-spacing: 0.5px;color: rgb(0, 122, 170);"><strong>未来中国临床试验的增速将超过过往，满足更多患者需求。</strong></span></p></section></section><p style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;"><br/></p><p style="font-size: 16px;text-align: center;"><img class="rich_pages wxw-img" data-galleryid="" data-ratio="0.5625" data-s="300,640" src="https://zfz-oss.oss-cn-hangzhou.aliyuncs.com/temp/a73ec616d43504f8cb6aadd08d4db0d7.png" data-type="png" data-w="832" style=""/></p><p style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;"><br/></p><section style="font-size: 16px;box-sizing: border-box;"><section powered-by="xiumi.us" style="font-family: PingFangSC-light;box-sizing: border-box;"><p style="white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;"><span style="letter-spacing: 0.5px;">具体体现在四大趋势：首先，中国生物制药公司将开发更具创新性疗法，“超过800家公司有5-10个1类新药正在研发，但靶点过于集中；同质化产品商业潜力有限，融资压力大，监管对其提出更高要求。”曾凡凡说 ，未来企业关注新模式、技术平台和开发目标，预计会有更多差异化药物诞生。其次，企业将更早思考建立商业化能力，“过去，肿瘤药是最热的领域，未来，商业回报会成为考量的关键因素。”第三，人工智能手段将全面应用于临床试验，智能和数字化工具将产生革命性影响。最后是中国生物制药和跨国公司的研发战略具有双向追求。跨国公司加大中国早期试验的比例，从过去在华建立研发中心到现在通过许可引进和孵化加强与中国初创团队合作。而本土大小公司纷纷走出海外，制定MRCT战略。“公司要确定海外国家或地区的优先次序，建立海外团队，与主流监管机构积极沟通。相信通过双向融合，中国的创新成果不断在全球展现实力。”曾凡凡说。</span></p></section></section><p style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;margin-bottom: 0px;"><br/></p><section arial="" break-word="" gb="" neue="" normal="" rgb="" sans="" sans-serif="" sc="" style="font-size: 16px;margin-bottom: 0px;outline: 0px;max-width: 100%;box-sizing: border-box;color: rgb(34, 34, 34);font-family: system-ui, -apple-system, " system-ui="" ui="" yahei=""><section powered-by="xiumi.us" style="margin-top: 10px;margin-bottom: 10px;outline: 0px;max-width: 100%;box-sizing: border-box;text-align: left;justify-content: flex-start;display: flex;flex-flow: row nowrap;overflow-wrap: break-word !important;"><section style="padding: 20px;outline: 0px;max-width: 100%;box-sizing: border-box;display: inline-block;width: 661px;vertical-align: top;background-color: rgb(243, 243, 243);align-self: flex-start;flex: 0 0 auto;overflow-wrap: break-word !important;"><section powered-by="xiumi.us" style="outline: 0px;max-width: 100%;box-sizing: border-box;font-size: 17px;color: rgb(49, 46, 45);letter-spacing: 0px;text-align: justify;font-family: PingFangSC-light;overflow-wrap: break-word !important;"><p style="outline: 0px;max-width: 100%;box-sizing: border-box;text-align: left;overflow-wrap: break-word !important;"><span style="outline: 0px;max-width: 100%;color: rgb(255, 104, 39);letter-spacing: 0.5px;font-size: 17px;box-sizing: border-box !important;overflow-wrap: break-word !important;"><strong style="outline: 0px;max-width: 100%;box-sizing: border-box;overflow-wrap: break-word !important;"><span style="color: rgb(255, 104, 39);font-size: 17px;outline: 0px;max-width: 100%;font-family: Optima-Regular, PingFangTC-light;box-sizing: border-box !important;overflow-wrap: break-word !important;">行业领袖未雨绸缪</span></strong></span></p></section></section></section></section><section powered-by="xiumi.us" style="font-size: 16px;margin-bottom: 0px;outline: 0px;max-width: 100%;box-sizing: border-box;color: rgb(34, 34, 34);letter-spacing: 0.544px;white-space: normal;background-color: rgb(255, 255, 255);font-family: PingFangSC-light;overflow-wrap: break-word !important;"><section style="outline: 0px;max-width: 100%;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;overflow-wrap: break-word !important;"><br/></section></section><section style="font-size: 16px;box-sizing: border-box;"><section powered-by="xiumi.us" style="font-family: PingFangSC-light;box-sizing: border-box;"><p style="white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;"><span style="letter-spacing: 0.5px;">在第一个讨论环节中，基石药业首席执行官杨建新提纲挈领的设计了3个问题 。他第一个问题是当下中国的CEO们最担心什么?</span></p></section></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;margin-bottom: 0px;"><span style="letter-spacing: 0.5px;"/></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;"><span style="font-family: Optima-Regular, PingFangTC-light;box-sizing: border-box;letter-spacing: 0.5px;"><br/></span></section><section style="font-size: 16px;text-align: center;margin-left: 8px;margin-right: 8px;"><img class="rich_pages wxw-img" data-galleryid="" data-ratio="0.7157772621809745" data-s="300,640" src="https://zfz-oss.oss-cn-hangzhou.aliyuncs.com/temp/78f1fd51325cb60960d1516972a1145b.png" data-type="png" data-w="1724" style=""/></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><span style="color: rgb(0, 122, 170);"><strong><span style="color: rgb(0, 122, 170);letter-spacing: 0.5px;font-size: 15px;">基石药业首席执行官 杨建新博士</span></strong></span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;"><br/></section><section style="font-size: 16px;text-align: center;margin-left: 8px;margin-right: 8px;"><img class="rich_pages wxw-img" data-galleryid="" data-ratio="0.631578947368421" data-s="300,640" src="https://zfz-oss.oss-cn-hangzhou.aliyuncs.com/temp/a6b4196b64b10ade6a09a4b72a68085a.png" data-type="png" data-w="1900" style=""/></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><span style="color: rgb(0, 122, 170);"><strong><span style="color: rgb(0, 122, 170);letter-spacing: 0.5px;font-size: 15px;">本专场与会嘉宾</span></strong></span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;"><br/></section><section style="font-size: 16px;text-align: center;margin-left: 8px;margin-right: 8px;"><img class="rich_pages wxw-img" data-galleryid="" data-ratio="0.6670190274841438" data-s="300,640" src="https://zfz-oss.oss-cn-hangzhou.aliyuncs.com/temp/81ddfc9ed1cb4190c6fb4702489400bb.png" data-type="png" data-w="1892" style=""/></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><span style="color: rgb(0, 122, 170);"><strong><span style="color: rgb(0, 122, 170);letter-spacing: 0.5px;font-size: 15px;">岸迈生物科技首席医学官 彭彬博士</span></strong></span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;"><span style="font-family: Optima-Regular, PingFangTC-light;box-sizing: border-box;letter-spacing: 0.5px;"><br style="box-sizing: border-box;"/></span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;"><span style="letter-spacing: 0.5px;"/></section><section style="font-size: 16px;box-sizing: border-box;"><section powered-by="xiumi.us" style="font-family: PingFangSC-light;box-sizing: border-box;"><p style="white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;"><span style="letter-spacing: 0.5px;">岸迈生物科技首席医学官彭彬博士说，全球行业迎来寒冬，投资人观望的态度导致以研发驱动的生物技术公司压力巨大。</span><span style="letter-spacing: 0.5px;color: rgb(0, 122, 170);"><strong style="box-sizing: border-box;">新药研发九死一生，期待投资人有更长远的眼光</strong></span><span style="letter-spacing: 0.5px;">。此时的艰难时光考验投资人和生物技术公司的执着与定力。为了应对，小公司要过“紧日子”。目前岸迈生物所有项目都是in-house研发，同时开展MRCT以最大化节省开支。</span></p></section></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;"><span style="letter-spacing: 0.5px;"/></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;"><span style="font-family: Optima-Regular, PingFangTC-light;box-sizing: border-box;letter-spacing: 0.5px;"> </span></section><section style="font-size: 16px;text-align: center;margin-left: 8px;margin-right: 8px;"><img class="rich_pages wxw-img" data-galleryid="" data-ratio="0.6786492374727668" data-s="300,640" src="https://zfz-oss.oss-cn-hangzhou.aliyuncs.com/temp/e04aa8eb014bf4704bcb6061aa40def1.png" data-type="png" data-w="1836" style=""/></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><span style="color: rgb(0, 122, 170);"><strong><span style="color: rgb(0, 122, 170);letter-spacing: 0.5px;font-size: 15px;">和记黄埔医药执行副总裁、研发负责人及首席医学官(中国)  石明博士</span></strong></span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;"><span style="font-family: Optima-Regular, PingFangTC-light;box-sizing: border-box;letter-spacing: 0.5px;"><br style="box-sizing: border-box;"/></span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;"><span style="letter-spacing: 0.5px;"/></section><section style="font-size: 16px;box-sizing: border-box;"><section powered-by="xiumi.us" style="font-family: PingFangSC-light;box-sizing: border-box;"><p style="white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;"><span style="letter-spacing: 0.5px;">和记黄埔医药执行副总裁、研发负责人及首席医学官(中国) 石明博士介绍该公司主要集中在肿瘤和自身免疫领域，已有三款肿瘤药物上市，虽然现金流充足，但依然要快速而稳健的发展，加紧国际化和差异化布局，大力推进晚期临床产品上市，将重点放在商业化阶段。“</span><span style="letter-spacing: 0.5px;color: rgb(0, 122, 170);"><strong style="box-sizing: border-box;">在寒冬下我们不但要生存，还要成为profitable的制药公司</strong></span><span style="letter-spacing: 0.5px;">。”石明说。</span></p></section></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;"><span style="letter-spacing: 0.5px;"/></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;"><br/></section><section style="font-size: 16px;text-align: center;margin-left: 8px;margin-right: 8px;"><strong><img class="rich_pages wxw-img" data-galleryid="" data-ratio="0.6724324324324324" data-s="300,640" src="https://zfz-oss.oss-cn-hangzhou.aliyuncs.com/temp/7c5826f6fca1cc5bca81bb9c621bebe4.png" data-type="png" data-w="1850" style=""/></strong></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><span style="color: rgb(0, 122, 170);"><strong><span style="color: rgb(0, 122, 170);letter-spacing: 0.5px;font-size: 15px;">来凯医药执行董事兼首席科学官 顾祥巨博士（左一）</span></strong></span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;"><span style="font-family: Optima-Regular, PingFangTC-light;box-sizing: border-box;letter-spacing: 0.5px;"><br style="box-sizing: border-box;"/></span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><span style="letter-spacing: 0.5px;">来凯医药执行董事兼首席科学官顾祥巨博士认为，基于自主研发能力，来凯医药正对研发管线中14款创新候产品深耕和优化，并积极与大公司合作推进研发和商业化进度。“</span><span style="letter-spacing: 0.5px;color: rgb(0, 122, 170);"><strong>希望寒冬尽快度过</strong></span><span style="letter-spacing: 0.5px;">。”顾祥巨说。</span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;"><span style="font-family: Optima-Regular, PingFangTC-light;box-sizing: border-box;letter-spacing: 0.5px;"><br/></span></section><section style="font-size: 16px;text-align: center;margin-left: 8px;margin-right: 8px;"><img class="rich_pages wxw-img" data-galleryid="" data-ratio="0.70261066969353" data-s="300,640" src="https://zfz-oss.oss-cn-hangzhou.aliyuncs.com/temp/287b5b012a4e3929554c564bffe68520.png" data-type="png" data-w="1762" style=""/></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><span style="color: rgb(0, 122, 170);"><strong><span style="color: rgb(0, 122, 170);letter-spacing: 0.5px;font-size: 15px;">英派药业首席医学官 谢志逸博士</span></strong></span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;"><span style="font-size: 15px;"><strong><span style="font-size: 15px;font-family: Optima-Regular, PingFangTC-light;box-sizing: border-box;letter-spacing: 0.5px;color: rgb(0, 122, 170);"><br/></span></strong></span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><span style="letter-spacing: 0.5px;">英派药业首席医学官谢志逸博士认为，寒冬下融资越发艰难，</span><span style="letter-spacing: 0.5px;color: rgb(0, 122, 170);"><strong>英派药业要重新选择研发重点，将资源转移到最具前景的项目</strong></span><span style="letter-spacing: 0.5px;">；对靶点的探索可精雕细选，将早期研究做深；而制剂优化可放在次要位置。该公司两款PAPR抑制剂已在III期临床阶段，会全力推进其NDA和商业化。</span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;"><span style="font-family: Optima-Regular, PingFangTC-light;box-sizing: border-box;letter-spacing: 0.5px;"><br style="box-sizing: border-box;"/></span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><span style="letter-spacing: 0.5px;">杨建新博士介绍说，基石药业已上市4款药物。根据半年报，公司现金余额为11亿元，研发费用2.2亿元左右，目前正全力推进商业化，加之有产品对外授权里程碑收入，同时关闭在其苏州的工厂、保留核心生产人员。“</span><span style="letter-spacing: 0.5px;color: rgb(0, 122, 170);"><strong>在寒冬下，基石药业已备好粮仓</strong></span><span style="letter-spacing: 0.5px;">。”杨建新博士说。</span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;"><span style="font-family: Optima-Regular, PingFangTC-light;box-sizing: border-box;letter-spacing: 0.5px;"><br style="box-sizing: border-box;"/></span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><span style="letter-spacing: 0.5px;">杨博士的第二个问题是，一旦春回大地，行业复苏，各公司如何布局和规划？彭彬认为，该公司是国内较早一批开发双抗平台的创新公司，“正所谓单抗看靶点，双抗看平台”。在该平台上各种靶点和产品竞相开发出来，而</span><span style="letter-spacing: 0.5px;color: rgb(0, 122, 170);"><strong>岸迈生物始终坚定不移的坚持双抗的核心技术与创新</strong></span><span style="letter-spacing: 0.5px;">。</span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;"><span style="font-family: Optima-Regular, PingFangTC-light;box-sizing: border-box;letter-spacing: 0.5px;"><br style="box-sizing: border-box;"/></span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><span style="color: rgb(0, 122, 170);"><strong><span style="letter-spacing: 0.5px;">石明说和记黄埔的战略分三步走</span></strong></span><span style="letter-spacing: 0.5px;">，短期要推进具有商业潜力的晚期阶段产品，中期要有创新项目布局，加强创新，长期则要有国际化视野。和记黄埔在肿瘤药领域具有优势，未来虽然会布局大分子，但仍会结合自身小分子药物的优势或发展ADC研发。</span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;"><span style="font-family: Optima-Regular, PingFangTC-light;box-sizing: border-box;letter-spacing: 0.5px;"><br style="box-sizing: border-box;"/></span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><span style="letter-spacing: 0.5px;">而来凯医药则长期坚持在肿瘤 、肝纤维化和罕见病药物领域里创新。</span><span style="letter-spacing: 0.5px;color: rgb(0, 122, 170);"><strong>顾祥巨说在春天到来之前，正好能让研发人员冷静思考、修炼内功</strong></span><span style="letter-spacing: 0.5px;">；加强早期发现能力，把基础科研做扎实。</span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;"><span style="font-family: Optima-Regular, PingFangTC-light;box-sizing: border-box;letter-spacing: 0.5px;"><br style="box-sizing: border-box;"/></span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><span style="letter-spacing: 0.5px;">谢志逸则从公司管理角度计划了在春天来临前要做的事儿。“优秀的人员要极力保留；完善公司管理制度和SOP及电子系统；加强基础研究、转化研究、生物标志物的发展；优化新分子化合物的PK/PD研究。正所谓冬藏春生，一旦春暖花开，</span><span style="letter-spacing: 0.5px;color: rgb(0, 122, 170);"><strong>英派药业会全速前进</strong></span><span style="letter-spacing: 0.5px;">。”</span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;"><span style="font-family: Optima-Regular, PingFangTC-light;box-sizing: border-box;letter-spacing: 0.5px;"><br style="box-sizing: border-box;"/></span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><span style="letter-spacing: 0.5px;">杨建新则再一次强调要开源节流，包括优化企业架构，减少外包服务。把省下来的钱做好早期研究，</span><span style="letter-spacing: 0.5px;color: rgb(0, 122, 170);"><strong>项目不求多，但求高质量</strong></span><span style="letter-spacing: 0.5px;">。</span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;"><span style="font-family: Optima-Regular, PingFangTC-light;box-sizing: border-box;letter-spacing: 0.5px;"><br style="box-sizing: border-box;"/></span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><span style="letter-spacing: 0.5px;">本专场最后一个问题是未来5~10年，中国Biotech公司发展趋势如何？彭彬认为目前的中国生物技术行业像极了美国90年代的情景，涌现出多家具有创新活力、非常灵活的生物技术公司，未来他们有望转变为在全球有影响力的大药厂。不过也必将大浪淘沙，只有真正具有创新性的公司才能站在世人面前。</span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;margin-bottom: 0px;"><br style="box-sizing: border-box;"/></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><span style="letter-spacing: 0.5px;">石明说，十年前中国只能参加跨国公司III期注册试验。现在，研发局面非常可喜。从药监局药审中心到行业再到临床研究中心，都在积极打造创新生态环境，开展高质量的临床试验。在CAR-T、抗体、ADC、细胞基因治疗方面已紧跟世界趋势。<span style="font-family: PingFangSC-light;font-size: 16px;letter-spacing: 0.5px;">石</span><span style="font-family: PingFangSC-light;font-size: 16px;letter-spacing: 0.5px;">明希望</span></span><span style="letter-spacing: 0.5px;color: rgb(0, 122, 170);"><strong>国内高校的基础科研也能充分发展</strong></span><span style="letter-spacing: 0.5px;">，像美国那样有学院的老师出来创业，把更多的基础创新转化到工业界。</span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><span style="letter-spacing: 0.5px;"/></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><span style="letter-spacing: 0.5px;"><span style="font-family: PingFangSC-light;font-size: 16px;letter-spacing: 0.5px;"><br/></span></span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><span style="letter-spacing: 0.5px;"><span style="font-family: PingFangSC-light;font-size: 16px;letter-spacing: 0.5px;">谢</span><span style="font-family: PingFangSC-light;font-size: 16px;letter-spacing: 0.5px;">志</span><span style="font-family: PingFangSC-light;font-size: 16px;letter-spacing: 0.5px;">逸认为，</span></span><span style="color: rgb(0, 122, 170);"><strong><span style="letter-spacing: 0.5px;">地缘政治对生物医药行业的影响不大</span></strong></span><span style="letter-spacing: 0.5px;">。受患者需求驱动，这一领域始终是最具活力的行业。期待未来5-10年真正的创新越来越多，世界级大公司能从中国出来，生态系统也愈发成熟，本土兼并合作会更多发生在国内制药行业。</span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><span style="letter-spacing: 0.5px;"/></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;"><span style="font-family: Optima-Regular, PingFangTC-light;box-sizing: border-box;letter-spacing: 0.5px;"><br style="box-sizing: border-box;"/></span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><span style="letter-spacing: 0.5px;">杨建新回答观众“行业什么时候复苏”时说，回看每一次经济衰退都有其周期，</span><span style="letter-spacing: 0.5px;color: rgb(0, 122, 170);"><strong>当资本情绪最悲观最下挫之时，便是行业反弹之时</strong></span><span style="letter-spacing: 0.5px;">。从美国近日数据显示，美国10月CPI同比增长7.7%，较9月8.2%的增幅回落0.5个百分点，透露出美国通胀降温的信号，美国及全球金融市场将为之反弹。</span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;"><span style="font-family: Optima-Regular, PingFangTC-light;box-sizing: border-box;letter-spacing: 0.5px;"><br style="box-sizing: border-box;"/></span></section><section arial="" break-word="" gb="" neue="" rgb="" sans="" sans-serif="" sc="" style="font-size: 16px;margin-right: 8px;margin-bottom: 0px;margin-left: 8px;white-space: normal;outline: 0px;max-width: 100%;box-sizing: border-box;color: rgb(34, 34, 34);font-family: system-ui, -apple-system, " system-ui="" ui="" yahei=""><section powered-by="xiumi.us" style="margin-top: 10px;margin-bottom: 10px;outline: 0px;max-width: 100%;box-sizing: border-box;text-align: left;justify-content: flex-start;display: flex;flex-flow: row nowrap;overflow-wrap: break-word !important;"><section style="padding: 20px;outline: 0px;max-width: 100%;box-sizing: border-box;display: inline-block;width: 661px;vertical-align: top;background-color: rgb(243, 243, 243);align-self: flex-start;flex: 0 0 auto;overflow-wrap: break-word !important;"><section powered-by="xiumi.us" style="outline: 0px;max-width: 100%;box-sizing: border-box;font-size: 17px;color: rgb(49, 46, 45);letter-spacing: 0px;text-align: justify;font-family: PingFangSC-light;overflow-wrap: break-word !important;"><p style="outline: 0px;max-width: 100%;box-sizing: border-box;text-align: left;overflow-wrap: break-word !important;"><span style="font-size: 17px;"><strong><span style="color: rgb(255, 104, 39);font-size: 17px;font-family: Optima-Regular, PingFangTC-light;letter-spacing: 0.5px;text-align: justify;">细胞治疗药物临床开发的经验教训</span></strong></span></p></section></section></section></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;"><br/></section><section style="font-size: 16px;text-align: center;margin-left: 8px;margin-right: 8px;"><img class="rich_pages wxw-img" data-galleryid="" data-ratio="0.6705632306057385" data-s="300,640" src="https://zfz-oss.oss-cn-hangzhou.aliyuncs.com/temp/32d4bb8355b55fa51f91920f815e2dd6.png" data-type="png" data-w="1882" style=""/></section><p style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><span style="color: rgb(0, 122, 170);"><strong><span style="color: rgb(0, 122, 170);letter-spacing: 0.5px;font-size: 15px;">图为瑞金医院主任医师，血液科糜坚青教授（线上左一）、北京大学肿瘤医院淋巴瘤内科主任医师应志涛博士（线上图中）、药明巨诺临床开发副总裁秦耘博士（线上右一）以及药明巨诺联合创始人、董事长兼首席执行官李怡平博士（现场左一）、传奇生物临床开发副总载罗永鑫博士（现场右一）</span></strong></span></p><section style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;"><span style="font-family: Optima-Regular, PingFangTC-light;box-sizing: border-box;letter-spacing: 0.5px;"> </span></section><section style="font-size: 16px;box-sizing: border-box;"><section powered-by="xiumi.us" style="font-family: PingFangSC-light;box-sizing: border-box;"><p style="white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;"><span style="letter-spacing: 0.5px;">近几年来，CAR-T疗法成为多种血液肿瘤，如白血病、淋巴瘤、多发性骨髓瘤最火的抗肿瘤手段之一。全球7款已获批CAR-T疗法获批上市。中国已上市的CAR-T疗法有2款：Yescarta（阿基仑赛）、Relma-cel（瑞基奥仑赛）。</span></p></section></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;margin-bottom: 0px;"><span style="letter-spacing: 0.5px;"/></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;"><span style="font-family: Optima-Regular, PingFangTC-light;box-sizing: border-box;letter-spacing: 0.5px;"><br style="box-sizing: border-box;"/></span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><span style="letter-spacing: 0.5px;">瑞金医院主任医师、血液科糜坚青教授分享了他开展细胞治疗产品临床试验的体会。糜教授认为，首先</span><span style="letter-spacing: 0.5px;color: rgb(0, 122, 170);"><strong>要选择疗效较好的产品给病人带来获益</strong></span><span style="letter-spacing: 0.5px;">；其次在CAR-T领域，临床试验需尽早开展，越早采集患者T细胞越好，因为越到末线病人，细胞质量越差，不利于自体CART细胞免疫治疗；第三，研究者要在保证安全的基础上，尽早发起IIT，让病人长期获益。谈到经验教训，糜教授认为要关注患者不良反应，不能强行开展试验，一定要综合评估受试者的健康情况才决定能否让他参加研究。</span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;margin-bottom: 0px;"><span style="letter-spacing: 0.5px;"> </span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><span style="letter-spacing: 0.5px;">北京大学肿瘤医院淋巴瘤内科主任医师应志涛博士认为，细胞治疗是颠覆性疗法，在血液瘤已发挥很好的疗效。该院在2013-2014年开始接触细胞治疗产品，全面了解了注册临床试验。谈及感悟，</span><span style="letter-spacing: 0.5px;color: rgb(0, 122, 170);"><strong>应志涛医师说需关注各种细节，慢慢积累了不良反应的经验</strong></span><span style="letter-spacing: 0.5px;">。例如，在什么情况下使用激素等，而保障病人安全是临床试验的重中之重。</span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;"><span style="font-family: Optima-Regular, PingFangTC-light;box-sizing: border-box;letter-spacing: 0.5px;"> </span></section><section style="font-size: 16px;text-align: center;margin-left: 8px;margin-right: 8px;"><img class="rich_pages wxw-img" data-backh="385" data-backw="562" data-galleryid="" data-ratio="0.6843853820598007" data-s="300,640" src="https://zfz-oss.oss-cn-hangzhou.aliyuncs.com/temp/de1602762c9d3ef4825333479536fa53.png" data-type="png" data-w="1806" style="width: 100%;height: auto;"/></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><span style="color: rgb(0, 122, 170);"><strong><span style="color: rgb(0, 122, 170);letter-spacing: 0.5px;font-size: 15px;">主持人药明巨诺联合创始人、董事长兼首席执行官 李怡平博士</span></strong></span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;"><span style="font-family: Optima-Regular, PingFangTC-light;box-sizing: border-box;letter-spacing: 0.5px;"> </span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><span style="letter-spacing: 0.5px;">当主持人药明巨诺联合创始人、董事长兼首席执行官李怡平问到未来血液瘤还有哪些有潜力的新靶点，两位研究者认为，CD19和CD20是淋巴瘤治疗非常重要的靶点，目前还没有其他靶点在这一领域能超越。双靶点双免疫治疗是CAR-T未来方向。除此之外，他们看好针对白血病的</span><span style="letter-spacing: 0.5px;color: rgb(0, 122, 170);"><strong>GRP78</strong></span><span style="letter-spacing: 0.5px;">，在体外实验中，针对该靶点的CAR-T疗法表现出了对急性髓性白血病癌细胞的杀伤作用。另外，还有</span><span style="letter-spacing: 0.5px;color: rgb(0, 122, 170);"><strong>BCMA</strong></span><span style="letter-spacing: 0.5px;">，目前在高达60%~70%的多发性骨髓瘤患者中均能发现BCMA的高表达。而无论何种靶点，CAR-T的质量控制要解决，各靶点的临床试验也要尽早开展。</span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;"><span style="font-family: Optima-Regular, PingFangTC-light;box-sizing: border-box;letter-spacing: 0.5px;"> </span></section><section style="font-size: 16px;text-align: center;margin-left: 8px;margin-right: 8px;"><img class="rich_pages wxw-img" data-galleryid="" data-ratio="0.5801282051282052" data-s="300,640" src="https://zfz-oss.oss-cn-hangzhou.aliyuncs.com/temp/a0d665c24e58b78e6897a5dc68e545b4.png" data-type="png" data-w="1872" style=""/></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><span style="color: rgb(0, 122, 170);"><strong><span style="color: rgb(0, 122, 170);letter-spacing: 0.5px;font-size: 15px;">传奇生物临床开发副总载 罗永鑫博士</span></strong></span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;"><span style="font-family: Optima-Regular, PingFangTC-light;box-sizing: border-box;letter-spacing: 0.5px;"> </span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><span style="letter-spacing: 0.5px;">传奇生物的西达基奥仑赛（cilta-cel）已在美国、欧盟和日本获批上市。该公司临床开发副总载罗永鑫博士分享了经验和“踩过的坑”。她说，CAR-T是极为创新的治疗手段，刚开始大家都没有经验，不论是试验设计还是临床运营，申办方需要跟研究者紧密配合。对一些特殊情况，例如研究者发现，有些患者注射了一针以后疗效较好，此时大家热情高涨，入组很快，但患者能否符合CAR细胞回输条件，仍需跟研究者探讨而不是激进的入组患者。国家药监局药审中心（CDE）不断出台与细胞治疗产品相关的指南，按药品思路进行监管审评，药厂也要与时俱进。</span><span style="letter-spacing: 0.5px;color: rgb(0, 122, 170);"><strong>对于计划出海的中国企业，全球开发策略要根据疾病分布越早制定越好</strong></span><span style="letter-spacing: 0.5px;">。要及早建立中美产地，跟中美监管部门申报，少走弯路。未来希望美国FDA和中国CDE能同步接受对方的CMC和临床数据。</span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><span style="letter-spacing: 0.5px;"> </span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><span style="letter-spacing: 0.5px;">药明巨诺临床开发副总裁秦耘从细胞产品生命周期管理分享了经验。企业要对自身的产品从靶点到结构都需要非常了解，需要研究在某个靶点中还有哪些适应症可以挖掘。此外，要广泛与研究者开展IIT。</span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><span style="letter-spacing: 0.5px;"><br/></span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><span style="letter-spacing: 0.5px;">对于CAR-T等细胞产品在实体瘤的应用前景，与会学者认为，实体瘤和血液瘤具有差异。实体瘤表达靶点较少，且没有清晰的靶点，加之肿瘤抑制性和肿瘤微环境等因素，</span><span style="letter-spacing: 0.5px;color: rgb(0, 122, 170);"><strong>因此细胞治疗产品在实体瘤中还未获得像血液瘤那样的疗效</strong></span><span style="letter-spacing: 0.5px;">。相信随着借助平台技术，精选病人，精调靶点及改善T细胞功能，未来细胞治疗产品在实体瘤方向的应用可期，且已有一些公司针对CAR-T在实体瘤中进行研发。</span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;margin-bottom: 0px;"><span style="letter-spacing: 0.5px;"> </span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><span style="letter-spacing: 0.5px;">与会嘉宾还围绕IIT在我国的发展建言献策，认为要尽快制定法规，令IIT与注册临床研究能够衔接，只要研究质量保证，IIT的数据能应为注册所接受。李总补充认为，除了上述环节，细胞治疗产品的生产环节也很重要，需要在细化生产工艺上及早制定策略，病人安全性是首要考量。</span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><span style="letter-spacing: 0.5px;"> </span></section><section arial="" break-word="" gb="" neue="" rgb="" sans="" sans-serif="" sc="" style="font-size: 16px;margin-right: 8px;margin-bottom: 0px;margin-left: 8px;white-space: normal;outline: 0px;max-width: 100%;box-sizing: border-box;color: rgb(34, 34, 34);font-family: system-ui, -apple-system, " system-ui="" ui="" yahei=""><section powered-by="xiumi.us" style="margin-top: 10px;margin-bottom: 10px;outline: 0px;max-width: 100%;box-sizing: border-box;text-align: left;justify-content: flex-start;display: flex;flex-flow: row nowrap;overflow-wrap: break-word !important;"><section style="padding: 20px;outline: 0px;max-width: 100%;box-sizing: border-box;display: inline-block;width: 661px;vertical-align: top;background-color: rgb(243, 243, 243);align-self: flex-start;flex: 0 0 auto;overflow-wrap: break-word !important;"><section powered-by="xiumi.us" style="outline: 0px;max-width: 100%;box-sizing: border-box;font-size: 17px;color: rgb(49, 46, 45);letter-spacing: 0px;text-align: justify;font-family: PingFangSC-light;overflow-wrap: break-word !important;"><p style="outline: 0px;max-width: 100%;box-sizing: border-box;text-align: left;overflow-wrap: break-word !important;"><span style="font-size: 17px;"><strong><span style="font-size: 17px;font-family: Optima-Regular, PingFangTC-light;letter-spacing: 0.5px;text-align: justify;color: rgb(255, 104, 39);">如何驾驭驾驭资本市场和风险投资</span></strong></span></p></section></section></section></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;"><br/></section><section style="font-size: 16px;text-align: center;margin-left: 8px;margin-right: 8px;"><img class="rich_pages wxw-img" data-galleryid="" data-ratio="0.6695557963163596" data-s="300,640" src="https://zfz-oss.oss-cn-hangzhou.aliyuncs.com/temp/4da984624a63de6e438606da84787b3c.png" data-type="png" data-w="1846" style=""/></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><span style="color: rgb(0, 122, 170);"><strong><span style="color: rgb(0, 122, 170);letter-spacing: 0.5px;font-size: 15px;">本专场与会嘉宾</span></strong></span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;"><br/></section><section style="font-size: 16px;text-align: center;margin-left: 8px;margin-right: 8px;"><img class="rich_pages wxw-img" data-galleryid="" data-ratio="0.6721132897603486" data-s="300,640" src="https://zfz-oss.oss-cn-hangzhou.aliyuncs.com/temp/9480b312b34c2b60e5c01442e1e37573.png" data-type="png" data-w="1836" style=""/></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><span style="color: rgb(0, 122, 170);"><strong><span style="color: rgb(0, 122, 170);letter-spacing: 0.5px;font-size: 15px;">维昇药业业务拓展副总裁呙毅博士主持讨论了在当前环境下如何驾驭资本市场和风险投资。</span></strong></span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;"><span style="font-family: Optima-Regular, PingFangTC-light;box-sizing: border-box;letter-spacing: 0.5px;"> </span></section><section style="font-size: 16px;text-align: left;margin-left: 8px;margin-right: 8px;"><strong><img class="rich_pages wxw-img" data-galleryid="" data-ratio="0.6732673267326733" data-s="300,640" src="https://zfz-oss.oss-cn-hangzhou.aliyuncs.com/temp/952f6eb0ed465272973f8262fdd152e7.png" data-type="png" data-w="1818" style=""/></strong><span style="color: rgb(0, 122, 170);"><strong><span style="color: rgb(0, 122, 170);letter-spacing: 0.5px;font-size: 15px;">鼎丰生科资本合伙人 钱晶博士</span></strong></span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;"><span style="font-family: Optima-Regular, PingFangTC-light;box-sizing: border-box;letter-spacing: 0.5px;"> </span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><span style="letter-spacing: 0.5px;">鼎丰生科资本合伙人钱晶梳理了4种投融资渠道和模式。对于初创公司，早期阶段的公司可进行财务投资（如A轮，B轮等）；接近晚期或上市阶段的公司可与银行之间有更多融资机会；还有战略投资人，包括引入境外投资机构；第四种是向政府融资，包括与厂房和产品相关的合作。</span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;"><span style="font-family: Optima-Regular, PingFangTC-light;box-sizing: border-box;letter-spacing: 0.5px;"> </span></section><section style="font-size: 16px;text-align: center;margin-left: 8px;margin-right: 8px;"><span style="color: rgb(0, 122, 170);"><strong><img class="rich_pages wxw-img" data-galleryid="" data-ratio="0.6813186813186813" data-s="300,640" src="https://zfz-oss.oss-cn-hangzhou.aliyuncs.com/temp/c0c2f82878c9e3c63584e713895c333e.png" data-type="png" data-w="1820" style=""/></strong></span></section><section style="font-size: 16px;text-align: left;margin-left: 8px;margin-right: 8px;box-sizing: border-box;margin-bottom: 0px;"><span style="color: rgb(0, 122, 170);"><strong><span style="color: rgb(0, 122, 170);letter-spacing: 0.5px;font-size: 15px;">亚虹医药科技董事长&amp;首席执行官 潘柯博士</span></strong></span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;"><span style="font-family: Optima-Regular, PingFangTC-light;box-sizing: border-box;letter-spacing: 0.5px;"> </span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><span style="letter-spacing: 0.5px;">专注于泌尿生殖系统肿瘤的创新药上市公司亚虹医药科技董事长&amp;首席执行官潘柯建议在形势艰难时，用“小步快跑”的方式融资，先获取一小部分金额的资金（如1000万），让企业快速运转起来，增加一些临床数据，就能增加估值。要趁现阶段冷静思考，优化战略级别和次序，加大研发体系、管理体系、技术能力建设，随时等待时机好转。“</span><span style="letter-spacing: 0.5px;color: rgb(0, 122, 170);"><strong>越是艰难时，企业掌门人一定要担起责任，增强企业凝聚力，鼓舞士气，永不放弃</strong></span><span style="letter-spacing: 0.5px;">。”潘柯说。</span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;"><span style="font-family: Optima-Regular, PingFangTC-light;box-sizing: border-box;letter-spacing: 0.5px;"> </span></section><section style="font-size: 16px;text-align: center;margin-left: 8px;margin-right: 8px;"><img class="rich_pages wxw-img" data-galleryid="" data-ratio="0.6713362068965517" data-s="300,640" src="https://zfz-oss.oss-cn-hangzhou.aliyuncs.com/temp/3be63d9b65a657ccc7963ec7b8600adc.png" data-type="png" data-w="1856" style=""/></section><section style="font-size: 16px;text-align: left;margin-left: 8px;margin-right: 8px;box-sizing: border-box;margin-bottom: 0px;"><span style="color: rgb(0, 122, 170);"><strong><span style="color: rgb(0, 122, 170);letter-spacing: 0.5px;font-size: 15px;">瑞石生物医药创始人&amp;首席执行官 王敏博士</span></strong></span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;"><span style="font-family: Optima-Regular, PingFangTC-light;box-sizing: border-box;letter-spacing: 0.5px;"><br style="box-sizing: border-box;"/></span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><span style="letter-spacing: 0.5px;">瑞石生物医药创始人&amp;首席执行官王敏博士感慨说，5年前行业景气时，投资人纷至沓来，而现在门可罗雀，投资变得十分审慎。生物技术公司需要深耕细作和加强能力建设。作为CEO要清晰思考公司独特定位，长远规划，才能获得投资人青睐。她鼓励业内同道在资金和资源有限的情况下，也要做出伟大的药物。“</span><span style="letter-spacing: 0.5px;color: rgb(0, 122, 170);"><strong>创业是始于造福患者的梦想，要不忘初心，充满信心；基于创新，成于实战，谁能调整转变得快谁就有胜出的机会</strong></span><span style="letter-spacing: 0.5px;">。”王敏说。</span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;"><span style="font-family: Optima-Regular, PingFangTC-light;box-sizing: border-box;letter-spacing: 0.5px;"> </span></section><section style="font-size: 16px;text-align: center;margin-left: 8px;margin-right: 8px;"><img class="rich_pages wxw-img" data-galleryid="" data-ratio="0.6702586206896551" data-s="300,640" src="https://zfz-oss.oss-cn-hangzhou.aliyuncs.com/temp/25085676840751614fca9ef77f4d4d93.png" data-type="png" data-w="1856" style=""/></section><section style="font-size: 16px;text-align: left;margin-left: 8px;margin-right: 8px;box-sizing: border-box;margin-bottom: 0px;"><span style="color: rgb(0, 122, 170);"><strong><span style="color: rgb(0, 122, 170);letter-spacing: 0.5px;font-size: 15px;">烨辉医药科技董事长&amp;首席执行官 华烨博士</span></strong></span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;"><span style="font-family: Optima-Regular, PingFangTC-light;box-sizing: border-box;letter-spacing: 0.5px;"> </span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><span style="letter-spacing: 0.5px;">华烨博士读千秋史册谈古论今。他认为创新不能突飞猛进，要做有价值添补竞争力具有临床需求的产品，在寒冬中做短小精干以设计型为主的公司，练好内功。如果公司没有生存价值，大势已去，就要像项羽一样愿赌服输——对投资人和员工负责。“</span><span style="letter-spacing: 0.5px;color: rgb(0, 122, 170);"><strong>相信有春暖花开的一天</strong></span><span style="letter-spacing: 0.5px;">。”华烨博士说。</span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><br style="box-sizing: border-box;"/></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><span style="letter-spacing: 0.5px;">钱晶认为回望历史上每一次重大经济危机，人类似乎都会出现反应过度的情况。她认为既不能盲目乐观也不能过于悲观。“如果从哲学层面而言，只有过好每一个当下，</span><span style="letter-spacing: 0.5px;color: rgb(0, 122, 170);"><strong>专注于做好眼前的事情，尊重自己的内心</strong></span><span style="letter-spacing: 0.5px;">。抱持最好的希望，做最坏的打算，希望拐点会在不久的将来出现。”钱晶说。</span></section><section style="font-size: 16px;margin-right: 8px;margin-bottom: 0px;margin-left: 8px;white-space: normal;box-sizing: border-box;line-height: 1.75em;"><span style="font-family: Optima-Regular, PingFangTC-light;box-sizing: border-box;letter-spacing: 0.5px;"> </span></section><section arial="" break-word="" gb="" neue="" rgb="" sans="" sans-serif="" sc="" style="font-size: 16px;margin-right: 8px;margin-bottom: 0px;margin-left: 8px;white-space: normal;outline: 0px;max-width: 100%;box-sizing: border-box;color: rgb(34, 34, 34);font-family: system-ui, -apple-system, " system-ui="" ui="" yahei=""><section powered-by="xiumi.us" style="margin-top: 10px;margin-bottom: 10px;outline: 0px;max-width: 100%;box-sizing: border-box;text-align: left;justify-content: flex-start;display: flex;flex-flow: row nowrap;overflow-wrap: break-word !important;"><section style="padding: 20px;outline: 0px;max-width: 100%;box-sizing: border-box;display: inline-block;width: 661px;vertical-align: top;background-color: rgb(243, 243, 243);align-self: flex-start;flex: 0 0 auto;overflow-wrap: break-word !important;"><section powered-by="xiumi.us" style="outline: 0px;max-width: 100%;box-sizing: border-box;font-size: 17px;color: rgb(49, 46, 45);letter-spacing: 0px;text-align: justify;font-family: PingFangSC-light;overflow-wrap: break-word !important;"><p style="outline: 0px;max-width: 100%;box-sizing: border-box;text-align: left;overflow-wrap: break-word !important;"><span style="font-size: 17px;"><strong><span style="font-size: 17px;font-family: Optima-Regular, PingFangTC-light;letter-spacing: 0.5px;text-align: justify;color: rgb(255, 104, 39);">以患者为中心的临床试验时代到来</span></strong></span></p></section></section></section></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;"><br/></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><span style="letter-spacing: 0.5px;">在下午环节里，来自患者组织、研究机构、申办方（药厂、CRO）、主要研究者的代表进行了交流。</span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;"><span style="font-family: Optima-Regular, PingFangTC-light;box-sizing: border-box;letter-spacing: 0.5px;"><br style="box-sizing: border-box;"/></span></section><section style="font-size: 16px;text-align: left;margin-left: 8px;margin-right: 8px;"><img class="rich_pages wxw-img" data-galleryid="" data-ratio="0.6123535676251332" data-s="300,640" src="https://zfz-oss.oss-cn-hangzhou.aliyuncs.com/temp/e60f1d36d812965519d35fdd1071972e.png" data-type="png" data-w="1878" style=""/><span style="color: rgb(0, 122, 170);"><strong><span style="color: rgb(0, 122, 170);letter-spacing: 0.5px;font-size: 15px;">中山大学附属肿瘤医院中国抗癌协会医学伦理学专业委员会教授&amp;主任委员 洪明晃教授</span></strong></span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;"><span style="font-family: Optima-Regular, PingFangTC-light;box-sizing: border-box;letter-spacing: 0.5px;"><br style="box-sizing: border-box;"/></span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><span style="letter-spacing: 0.5px;">中山大学附属肿瘤医院中国抗癌协会医学伦理学专业委员会教授&amp;主任委员洪明晃教授长期关注受试者保护，他首次带来了落实“两办文件”和“以患者为中心”指导原则下企业应履行的伦理责任。2022年3月20日，中共中央办公厅，国务院办公厅印发《关于加强科技伦理治理的意见》，该意见规定从事生命科学、医学等科技活动的医疗卫生机构和企业等，如果研究涉及科技伦理敏感领域，应设立科技伦理审查委员会。</span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;"><span style="font-family: Optima-Regular, PingFangTC-light;box-sizing: border-box;letter-spacing: 0.5px;"><br/></span></section><section style="font-size: 16px;text-align: center;margin-left: 8px;margin-right: 8px;"><img class="rich_pages wxw-img" data-galleryid="" data-ratio="0.5813397129186603" data-s="300,640" src="https://zfz-oss.oss-cn-hangzhou.aliyuncs.com/temp/c578d9a51ab945760f4da3070693fa22.png" data-type="png" data-w="836" style=""/></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;"><br/></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><span style="letter-spacing: 0.5px;">“研究机构设立伦理委员会已是普遍和必要的做法，在企业中建设伦理却是新鲜概念。”洪教授说。 而企业伦理（Enterprise Ethics）是涉及企业研发、经营中的伦理问题、伦理责任和伦理治理。其在主要职责在于伦理审查、伦理建议、伦理监督和伦理培训。具体任务包括科研项目和数据收集进行伦理审查、对涉及医疗检测或医学处理的项目进行伦理初审，对收集的信息数据，在处理、传输、使用中的隐私保护伦理监督，对受试者出现的不良事件，进行伦理监督，对企业发展提出伦理建议。 </span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;"><span style="font-family: Optima-Regular, PingFangTC-light;box-sizing: border-box;letter-spacing: 0.5px;"><br style="box-sizing: border-box;"/></span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><span style="letter-spacing: 0.5px;">最终，“员工的道德素养可转化为企业的伦理责任，</span><span style="letter-spacing: 0.5px;color: rgb(0, 122, 170);"><strong>一方面为社会提供优质产品，另一方面诚信经营，有利于打造百年老店</strong></span><span style="letter-spacing: 0.5px;">。“不过，国内企业尚无建立伦理机构，大多数是以安全委员会的形式存在，但企业的伦理建设和治理势在必行。  </span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;"><span style="font-family: Optima-Regular, PingFangTC-light;box-sizing: border-box;letter-spacing: 0.5px;"><br/></span></section><section style="font-size: 16px;text-align: center;margin-left: 8px;margin-right: 8px;"><img class="rich_pages wxw-img" data-galleryid="" data-ratio="0.6779846659364732" data-s="300,640" src="https://zfz-oss.oss-cn-hangzhou.aliyuncs.com/temp/9dabb5c415c73aaecb1765cf949bc0ad.png" data-type="png" data-w="1826" style=""/></section><section style="font-size: 16px;text-align: left;margin-left: 8px;margin-right: 8px;box-sizing: border-box;margin-bottom: 0px;"><span style="color: rgb(0, 122, 170);"><strong><span style="color: rgb(0, 122, 170);letter-spacing: 0.5px;font-size: 15px;">复旦大学附属肿瘤医院 I期临床研究病房行政主任 张剑教授</span></strong></span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;"><span style="font-family: Optima-Regular, PingFangTC-light;box-sizing: border-box;letter-spacing: 0.5px;"><br style="box-sizing: border-box;"/></span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><span style="letter-spacing: 0.5px;">复旦大学附属肿瘤医院 I期临床研究病房行政主任张剑教授从研究者的视角如何解读了以患者为中心的临床试验设计。今年以来，CDE同时发布3个“以患者为中心”的指导原则。“现在，把患者意见和参与整合进临床研究全流程成为临床研究成功的必要条件，但非充分条件。”</span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><br style="box-sizing: border-box;"/></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><span style="letter-spacing: 0.5px;">张教授说，</span><span style="letter-spacing: 0.5px;color: rgb(0, 122, 170);"><strong>以患者为中心的临床试验是指患者从过去产生试验数据的被动的受试者，转变为研究人员的积极合作伙伴，全程深度参与临床试验</strong></span><span style="letter-spacing: 0.5px;">。在设计，实施，结果总结，发表全流程的各个阶段钧发挥作用。张教授说，作为研究者，不应仅关注试验药物对于患者的生存时长、客观指标的改善，还要关心患者身心感受、功能状态和生存状态的获益。最终，用可以使用基于临床结局评估（clinical outcome assessment, COA）的有效性评价方法，在临床试验中收集患者体验数据。他解释了COA的定义，这是一种重要的用于评价患者感受和生存状态的评估工具，包括患者报告结局（PRO），医生报告结局（ClinRO）等。具体可以参考CDE刚出台的《以患者为中心的临床试验获益-风险评估知道原则（征求意见稿）》。在试验方案制定、研究实施、结果报告于分享方面见以下流程图。</span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;"><span style="font-family: Optima-Regular, PingFangTC-light;box-sizing: border-box;letter-spacing: 0.5px;"><br/></span></section><section style="font-size: 16px;text-align: center;margin-left: 8px;margin-right: 8px;"><img class="rich_pages wxw-img" data-galleryid="" data-ratio="0.375" data-s="300,640" src="https://zfz-oss.oss-cn-hangzhou.aliyuncs.com/temp/ec654bda0992dddba5be0759655636ce.png" data-type="png" data-w="832" style=""/></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;"><br/></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><span style="letter-spacing: 0.5px;">在以患者崛起的时代，受试者参加试验也关注临床研究终点。OS仍是终点“金标准”， PFS是近年来新出现的一个临床疗效评价指标，应挖掘替代终点、次要终点更多的临床意义，帮助指导临床实践。免疫相关不良反应是安全性的重要议题，研究也应考虑患者生活质量，采用兼顾疗效、安全性、生活质量等多个维度的评估量表，用以综合评估临床方案。</span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><br style="box-sizing: border-box;"/></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><span style="letter-spacing: 0.5px;">在未来，张剑教授说，基于症状评估的终点PRO在审评和临床研究中会越来越重要。以乳腺癌为例，介绍了PRO定义及在肿瘤患者中的意义，在肿瘤患者中收集PRO数据，能提供无法从其他指标或终点中获得的临床重要信息。因此，中国PRO的发展进一步推动了乳腺癌的健康管理（见下图）。</span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;"><img class="rich_pages wxw-img" data-galleryid="" data-ratio="0.5625" data-s="300,640" src="https://zfz-oss.oss-cn-hangzhou.aliyuncs.com/temp/726acb9a90f60957306ee6628d406d4e.png" data-type="png" data-w="832" style="font-size: 16px;text-align: center;white-space: normal;"/></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><span style="letter-spacing: 0.5px;">在ASCO推荐中，PRO已成为各分子分型转移性乳腺癌临床终点设计的终点之一（见下图）。</span></section><p style="font-size: 16px;text-align: center;"><img class="rich_pages wxw-img" data-galleryid="" data-ratio="0.5504807692307693" data-s="300,640" src="https://zfz-oss.oss-cn-hangzhou.aliyuncs.com/temp/72578fc5f95a1e0d9bd33f9d007895d1.png" data-type="png" data-w="832" style=""/></p><section style="font-size: 16px;text-align: center;margin-left: 8px;margin-right: 8px;"><br/></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><span style="letter-spacing: 0.5px;">最后，他以CDE指南中的一段进行总结，现阶段，落实以患者为中心的临床试验设计还存在一定困难。患者的意见能否被充分表达且被采纳的环境尚未成熟，需逐步推进，实现符合中国国情的以患者为中心的临床试验设计。</span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;margin-bottom: 0px;"><span style="letter-spacing: 0.5px;"> </span></section><section style="font-size: 16px;text-align: center;margin-left: 8px;margin-right: 8px;"><img class="rich_pages wxw-img" data-galleryid="" data-ratio="0.6904231625835189" data-s="300,640" src="https://zfz-oss.oss-cn-hangzhou.aliyuncs.com/temp/021b8dca7f940b2ca7db00cfe6fff6cb.png" data-type="png" data-w="1796" style=""/></section><section style="font-size: 16px;text-align: left;margin-left: 8px;margin-right: 8px;box-sizing: border-box;margin-bottom: 0px;"><span style="color: rgb(0, 122, 170);"><strong><span style="color: rgb(0, 122, 170);letter-spacing: 0.5px;font-size: 15px;">罗氏中国临床运营负责人 王皓博士</span></strong></span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;"><br/></section><section style="font-size: 16px;text-align: center;margin-left: 8px;margin-right: 8px;"><img class="rich_pages wxw-img" data-galleryid="" data-ratio="0.6698615548455804" data-s="300,640" src="https://zfz-oss.oss-cn-hangzhou.aliyuncs.com/temp/da46e8e3bb76bb9b0bc17bb7bc7eb118.png" data-type="png" data-w="1878" style=""/></section><section style="font-size: 16px;text-align: left;margin-left: 8px;margin-right: 8px;box-sizing: border-box;margin-bottom: 0px;"><span style="color: rgb(0, 122, 170);"><strong><span style="color: rgb(0, 122, 170);letter-spacing: 0.5px;font-size: 15px;">本专场讨论嘉宾</span></strong></span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;"><span style="font-family: Optima-Regular, PingFangTC-light;box-sizing: border-box;letter-spacing: 0.5px;"><br style="box-sizing: border-box;"/></span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><span style="letter-spacing: 0.5px;">罗氏中国临床运营负责人王皓主持了小组讨论。广州市红棉肿瘤和罕见病公益基金会副理事长顾洪飞本身是一名淋巴瘤患者，他创立了中国唯一的淋巴瘤患者在线交流社区“淋巴瘤之家”，志在帮病友一起闯难关。</span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;"><span style="font-family: Optima-Regular, PingFangTC-light;box-sizing: border-box;letter-spacing: 0.5px;"><br/></span></section><section style="font-size: 16px;text-align: center;margin-left: 8px;margin-right: 8px;"><img class="rich_pages wxw-img" data-galleryid="" data-ratio="0.7412333736396615" data-s="300,640" src="https://zfz-oss.oss-cn-hangzhou.aliyuncs.com/temp/a0d3640a1b2326a324c3dc1902b8dc15.png" data-type="png" data-w="1654" style=""/></section><section style="font-size: 16px;text-align: left;margin-left: 8px;margin-right: 8px;box-sizing: border-box;margin-bottom: 0px;"><span style="color: rgb(0, 122, 170);"><strong><span style="color: rgb(0, 122, 170);letter-spacing: 0.5px;font-size: 15px;">广州市红棉肿瘤和罕见病公益基金会副理事长 顾洪飞</span></strong></span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;"><span style="font-family: Optima-Regular, PingFangTC-light;box-sizing: border-box;letter-spacing: 0.5px;"><br/></span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><span style="letter-spacing: 0.5px;">对临床试验，他指出，受试者入组时仍有非必要检查，如申办方欲收集肿瘤基因变异的数据，要求病人重新活检，这是一种有创检查，且令肿瘤进展快速的病人错过参加试验的机会。他建议申办方在设计入排标准时，要与患者沟通方决定是否是必要检查。</span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><br style="box-sizing: border-box;"/></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><span style="letter-spacing: 0.5px;">他进而说，一些新技术的试验入组条件非常严格，如乙肝患者参与CAR-T临床试验机会较少；CT、核磁共振检查流程冗长，仍以医院流程为中心而非以疾病的紧迫性为中心；对于不良反应研究者要与患者积极沟通，受试者更需要研究者的关心关注；临床试验过程中产生的报销和赔付仍然较慢。“以上细节如能改进，能更好体现以患者为中心的临床试验。”洪飞说。为了提高自身的专业度，</span><span style="letter-spacing: 0.5px;color: rgb(0, 122, 170);"><strong>洪飞说患者要不断学习疾病知识、药物知识，试验法规知识等，更科学专业的表达自己的感受和想法</strong></span><span style="letter-spacing: 0.5px;">。</span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;"><br/></section><section style="font-size: 16px;text-align: center;margin-left: 8px;margin-right: 8px;"><img class="rich_pages wxw-img" data-galleryid="" data-ratio="0.6720604099244876" data-s="300,640" src="https://zfz-oss.oss-cn-hangzhou.aliyuncs.com/temp/d1eb7d830d94e3d7341e81cd3e19ae01.png" data-type="png" data-w="1854" style=""/></section><section style="font-size: 16px;text-align: left;margin-left: 8px;margin-right: 8px;box-sizing: border-box;margin-bottom: 0px;"><span style="color: rgb(0, 122, 170);"><strong><span style="color: rgb(0, 122, 170);letter-spacing: 0.5px;font-size: 15px;">信华医药/捷信医药创始人兼首席执行官、创始人兼董事长 林峰</span></strong></span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;"><span style="font-family: Optima-Regular, PingFangTC-light;box-sizing: border-box;letter-spacing: 0.5px;"><br style="box-sizing: border-box;"/></span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><span style="letter-spacing: 0.5px;">信华医药/捷信医药创始人兼首席执行官/创始人兼董事长林峰以自身体验讲述了参加干眼症药物的试验需要到医院随访6-7次，一个灰指甲药物的临床试验需要受试者往返20多次医院。CDE的指南中特别强调减少患者负担，他希望在试验设计时就能考虑让患者更便利的参与试验。不论入组前还是入组后，临床试验都有大量的科普和患者教育的工作，以一个在欧洲开展的RSV疫苗临床试验为例，为了让不到4个月的婴儿参加试验，</span><span style="letter-spacing: 0.5px;color: rgb(0, 122, 170);"><strong>申办方开展了大量针对研究者和受试患者家庭的沟通工作</strong></span><span style="letter-spacing: 0.5px;">。</span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><br style="box-sizing: border-box;"/></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><span style="letter-spacing: 0.5px;">张剑教授认为，对肿瘤患者和非肿瘤患者，试验方案需具体“定制”，大多数非肿瘤患者希望减少到医院的次数，而肿瘤患者往往希望能多来医院跟研究者聊天，有时医生一句话就能鼓励他们。因此，以患者为中心要多维度全面思考，研究者仍要保持研究的专业性和科学性，以达到监管机构要求的安全性和有效性。在临床研究领域，研究者和患者就像我党和民主党派的关系是“</span><span style="letter-spacing: 0.5px;color: rgb(0, 122, 170);"><strong>肝胆相照，荣辱与共</strong></span><span style="letter-spacing: 0.5px;">”，但是，是有主导的。谈到如何与患者和患者组织建立合作关系，张剑教授说，该院的受试者大多数是本院的精治病人，依从性较好，要全面、客观的与患者沟通临床试验的风险获益，研究者会尽全力保护受试者，对各种不良反应该院都采取了应急方案。</span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;"><span style="font-family: Optima-Regular, PingFangTC-light;box-sizing: border-box;letter-spacing: 0.5px;"><br style="box-sizing: border-box;"/></span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><span style="letter-spacing: 0.5px;">王皓认为，药厂开发药物，为患者提供解决方案视为己任，定会考虑患者的需求，以提供理想开发方案，并以终为始，符合患者的期望。罗氏目前有80%的临床试验都在中国同步开展，因此，与研究者、患者和患者组织的合作非常重要。例如一个SMA（脊髓性肌萎缩症）口服治疗药物的临床试验，总部曾多次来到中国与研究者交流，最后在患者组织的帮助下找到两家最适合开展研究的中心。</span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><br style="box-sizing: border-box;"/></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><span style="letter-spacing: 0.5px;">最后，与会专家认为，以患者为中心”的理念已上升到监管部门工作指南层面。而近日CSCO的CDE专场中，</span><span style="letter-spacing: 0.5px;color: rgb(0, 122, 170);"><strong>CDE副主任杨志敏的发言自始至终贯穿“以患者为中心”</strong></span><span style="letter-spacing: 0.5px;">。未来临床试验从业者应秉承这一做法，把压力化成动力，在临床试验点点滴滴的全过程深入执行“以患者为中心”。</span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;"><span style="font-family: Optima-Regular, PingFangTC-light;box-sizing: border-box;letter-spacing: 0.5px;"><br style="box-sizing: border-box;"/></span></section><section arial="" break-word="" gb="" neue="" rgb="" sans="" sans-serif="" sc="" style="font-size: 16px;margin-right: 8px;margin-bottom: 0px;margin-left: 8px;white-space: normal;outline: 0px;max-width: 100%;box-sizing: border-box;color: rgb(34, 34, 34);font-family: system-ui, -apple-system, " system-ui="" ui="" yahei=""><section powered-by="xiumi.us" style="margin-top: 10px;margin-bottom: 10px;outline: 0px;max-width: 100%;box-sizing: border-box;text-align: left;justify-content: flex-start;display: flex;flex-flow: row nowrap;overflow-wrap: break-word !important;"><section style="padding: 20px;outline: 0px;max-width: 100%;box-sizing: border-box;display: inline-block;width: 661px;vertical-align: top;background-color: rgb(243, 243, 243);align-self: flex-start;flex: 0 0 auto;overflow-wrap: break-word !important;"><section powered-by="xiumi.us" style="outline: 0px;max-width: 100%;box-sizing: border-box;font-size: 17px;color: rgb(49, 46, 45);letter-spacing: 0px;text-align: justify;font-family: PingFangSC-light;overflow-wrap: break-word !important;"><p style="outline: 0px;max-width: 100%;box-sizing: border-box;text-align: left;overflow-wrap: break-word !important;"><span style="font-size: 17px;"><strong><span style="font-family: Optima-Regular, PingFangTC-light;text-align: justify;color: rgb(255, 104, 39);font-size: 17px;letter-spacing: 0.5px;">肿瘤药单臂研究设计与联合用药策略</span></strong></span></p></section></section></section></section><section style="font-size: 16px;margin-right: 8px;margin-bottom: 0px;margin-left: 8px;white-space: normal;box-sizing: border-box;line-height: 1.75em;"><br/></section><section style="font-size: 16px;text-align: center;margin-left: 8px;margin-right: 8px;"><img class="rich_pages wxw-img" data-galleryid="" data-ratio="0.6240681576144835" data-s="300,640" src="https://zfz-oss.oss-cn-hangzhou.aliyuncs.com/temp/af6d0ff64f64561d958f444a50681ca6.png" data-type="png" data-w="1878" style=""/></section><section style="font-size: 16px;text-align: left;margin-left: 8px;margin-right: 8px;box-sizing: border-box;margin-bottom: 0px;"><span style="color: rgb(0, 122, 170);"><strong><span style="color: rgb(0, 122, 170);letter-spacing: 0.5px;font-size: 15px;">“肿瘤药物单臂研究设计与联合用药的临床开发与注册策略”专场嘉宾在线上研讨</span></strong></span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;"><span style="font-family: Optima-Regular, PingFangTC-light;box-sizing: border-box;letter-spacing: 0.5px;"> </span></section><section style="font-size: 16px;text-align: center;margin-left: 8px;margin-right: 8px;"><img class="rich_pages wxw-img" data-galleryid="" data-ratio="0.6648822269807281" data-s="300,640" src="https://zfz-oss.oss-cn-hangzhou.aliyuncs.com/temp/8cddabcf91e71c971bfc81ca2e0f6481.png" data-type="png" data-w="1868" style=""/></section><section style="font-size: 16px;text-align: left;margin-left: 8px;margin-right: 8px;box-sizing: border-box;margin-bottom: 0px;"><span style="color: rgb(0, 122, 170);"><strong><span style="color: rgb(0, 122, 170);letter-spacing: 0.5px;font-size: 15px;">前国家药监局CDE临床主审审评员 周明博士</span></strong></span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;line-height: 1.75em;margin-left: 8px;margin-right: 8px;"><span style="font-family: Optima-Regular, PingFangTC-light;box-sizing: border-box;letter-spacing: 0.5px;"><br style="box-sizing: border-box;"/></span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><span style="letter-spacing: 0.5px;">最后的讨论是法律法规经验分享，泰格医药政策法规事务副总裁常建青主持“肿瘤药物单臂研究设计与联合用药的临床开发与注册策略”。前国家药监局CDE临床主审审评员周明博士做了“单臂试验和联合用药再思考”的报告。近两年FDA ODAC会议对加速批准的PI3K抑制剂和免疫检查点抑制剂的撤销，以及CDE审评团队的一系列单臂文章和指南，均强调了RCT是金标准、单臂试验存在局限性、不确定性的风向，进入单臂门槛进一步提高的观点。</span><span style="letter-spacing: 0.5px;color: rgb(0, 122, 170);"><strong>由此可见，CDE对单臂进一步收紧</strong></span><span style="letter-spacing: 0.5px;">。</span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><br style="box-sizing: border-box;"/></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><span style="letter-spacing: 0.5px;">那么，未来单臂上市趋势如何？周明老师提到，单臂上市路径始终存在，但CDE对单臂门槛将进一步提高，需要有前期自身数据量、疗效数据、疗效观察时间、总暴露量和安全性、同类竞品数据等丰富的证据；而重大急需和难治疾病药物的突出疗效是监管接受单臂上市的关键；单臂联合策略的挑战在于无法提供直接的疗效析因证据。企业一旦进入单臂试验赛道后，临床推进效率是核心，迫使竞品以最快速度关门。</span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><br style="box-sizing: border-box;"/></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><span style="letter-spacing: 0.5px;">他还介绍了联合治疗策略，申请人需再三思考联合开发的必要性，联合治疗IND递交的时机，RP2D和安全性的思考以及如何解读“当单药无效/单药疗效不足，可尽早开展联合探索”的策略以及单臂联合可行性讨论等。</span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><br style="box-sizing: border-box;"/></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><span style="letter-spacing: 0.5px;">他以联合失败的PI3K案例和IMpower150成功案例让与会者思考联合用药中每个单药的贡献是有效性获益还是安全性风险。在单臂联合可行性讨论中，需更加关注析因和分线。他最后认为，联合是高成本、高风险研发策略，企业需周全制定联合开发策略，包括适应症选择、联合药物、析因、终点和临床价值，尽可能提高联合治疗疗效(强强联合)，同时需要平衡联合治疗的不良反应，而罕见肿瘤联合治疗更加需要关注早期探索性析因。“</span><span style="letter-spacing: 0.5px;color: rgb(0, 122, 170);"><strong>能单药，不联合，能少联，就少联</strong></span><span style="letter-spacing: 0.5px;">。”周明博士说。</span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><br style="box-sizing: border-box;"/></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><span style="letter-spacing: 0.5px;">长期从事药品注册法规工作的元羿生物执行副总裁、药政事务部左珺博士、映恩生物首席医学官顾薇博士、恒瑞医药副总经理施薇围绕单臂试验和联合用药的实际操作问题进行了互动。例如，两个或多个联合治疗临床试验的IND 和NDA如何申请，如何有效简化不必要的流程，有利于联合治疗的快速批准上市，满足患者用药。本环节中，天境生物注册事务负责人副总经理付洁鹰也参与了大量策划。与会嘉宾一致感谢大会提供的学习交流机会。</span></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><br style="box-sizing: border-box;"/></section><section style="font-size: 16px;white-space: normal;box-sizing: border-box;margin-left: 8px;margin-right: 8px;line-height: 1.75em;font-family: PingFangSC-light;margin-bottom: 0px;"><span style="letter-spacing: 0.5px;">研发客临床年会暨ChinaTrials14圆满结束，衷心感谢所有讲者的真知灼见和参与人员。让我们明年线下再会！</span></section><section style="font-size: 16px;white-space: 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