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复宏汉霖
2022年4月7日，复宏汉霖（2696.HK）宣布，其自主研发的PD-1抑制剂 H药 汉斯状®（斯鲁利单抗）用于治疗小细胞肺癌（SCLC）获得美国食品药品监督管理局（FDA）授予的孤儿药资格认定（Orphan-drug Designation）。这是H药获得的首个美国FDA孤儿药资格认定，有助于H药在美国的后续研发、注册及商业化等方面享受一定的政策支持。此外，公司还计划于2022年在中国及欧盟市场递交该适应症的上市注册申请，H药有望成为全球首个一线治疗SCLC的抗PD-1单抗。
孤儿药（Orphan drug）又称为罕见病药，指用于预防、治疗、诊断罕见病的药品。FDA授予的孤儿药资格认定适用于在美国每年患病人数低于20万人的罕见病的药物和生物制剂，并给与相关产品政策支持，包括但不限于（1）临床试验费用的税收抵免；（2）免除新药申请费；（3）上市后享有7年的市场独占权且不受专利的影响。
据GLOBOCAN数据显示，肺癌是全球发病率第二大高发癌种，2020年全球肺癌新发病例220万例，新发肺癌死亡病例180万例，位居癌症死亡人数第一[1]。SCLC占肺癌总数的15%-20%，是肺癌中侵袭性最强的亚型，分为局限期小细胞肺癌（LS-SCLC）和广泛期小细胞肺癌（ES-SCLC），二者共同点是恶性程度高、转移早、疾病进展迅速，总体预后不良。对于ES-SCLC而言，免疫检查点抑制剂的出现为临床提供了新的治疗选择，目前抗PD-L1单抗联合化疗已陆续被最新版NCCN指南和CSCO指南推荐为ES-SCLC一线治疗方案，但近年来多款PD-1产品在ES-SCLC领域接连折戟，未使ES-SCLC患者真正获益。另一方面，手术、化疗同步放疗仍是治疗LS-SCLC的标准治疗手段，但大多数患者容易出现对药物产生耐药性或疾病迅速复发，传统化疗药物在LS-SCLC中无明显进展[2-4]。
基于未满足的临床需求，复宏汉霖在SCLC领域推动免疫疗法的一系列探索，希望为该领域患者提供更有效的治疗方法。公司不仅针对ES-SCLC开展国际多中心III期临床研究（ASTRUM-005），亦于近期获得国家药品监督管理局管理局（NMPA）批准针对LS-SCLC开展国际多中心III期临床研究。其中，ASTRUM-005研究是一项在既往未接受过治疗的ES-SCLC患者中开展的比较H药联合化疗及安慰剂联合化疗的有效性和安全性的随机、双盲、国际多中心、III期临床研究，并在中国、土耳其、欧盟波兰、格鲁吉亚等多个国家共开设128个试验中心，入组585例受试者，其中约31.5%为高加索人。2021年12月，公司宣布ASTRUM-005研究达到总生存期（OS）的主要终点，总人群降低死亡风险达38%（中国亚组达41%）。基于该研究的积极试验结果，复宏汉霖将尽快提交该适应症的上市注册申请。
未来公司也将继续以患者需求为核心，积极推进斯鲁利单抗的免疫联合疗法和产品的国际临床注册，为全球更多患者带去福音。
关于 H药—汉斯状®
H药汉斯状®为重组人源化抗PD-1单抗注射液（通用名：斯鲁利单抗注射液），是复宏汉霖首个自主研发的创新型单抗，该产品已于2022年3月获批用于治疗微卫星高度不稳定（MSI-H）实体瘤。围绕H药，复宏汉霖积极推进其与公司其他产品的协同以及与创新疗法的联合，相继获得中国、美国、欧盟等国家及地区的临床试验许可，在全球同步开展9项肿瘤免疫联合疗法临床试验，广泛覆盖肺癌、食管癌、头颈癌和胃癌等适应症，全面覆盖肺癌一线治疗。截至目前，H药已于中国、土耳其、波兰、格鲁吉亚等国家和地区累计入组超2800人，其中2项国际多中心临床试验入组高加索人种的比例超过30%，是拥有国际临床数据较多的抗PD-1单抗之一。H药联合化疗治疗局部晚期或转移性鳞状非小细胞肺癌（sqNSCLC）的NDA已获得NMPA受理，有望今年获批。H药联合化疗一线治疗广泛期小细胞肺癌（ES-SCLC）的国际多中心III期研究达到主要终点总生存期（OS），公司计划于2022年在中国及欧盟递交该适应症的上市注册申请，有望成为全球首个一线治疗SCLC的抗PD-1单抗。
关于复宏汉霖
复宏汉霖（2696.HK）是一家国际化的创新生物制药公司，致力于为全球患者提供可负担的高品质生物药，产品覆盖肿瘤、自身免疫疾病、眼科疾病等领域，已在中国上市5款产品，在欧洲上市1款产品，13项适应症获批，1个上市注册申请获得中国药监局受理。自2010年成立以来，复宏汉霖已建成一体化生物制药平台，高效及创新的自主核心能力贯穿研发、生产及商业运营全产业链。公司已建立完善高效的全球创新中心，按照国际药品生产质量管理规范（GMP）标准进行生产和质量管控，位于上海徐汇的生产基地已获得中国和欧盟GMP认证。
复宏汉霖前瞻性布局了一个多元化、高质量的产品管线，涵盖20多种创新单克隆抗体，并全面推进基于自有抗PD-1单抗H药汉斯状®的肿瘤免疫联合疗法。继国内首个生物类似药汉利康®（利妥昔单抗）、中国首个自主研发的中欧双批单抗药物汉曲优®（曲妥珠单抗，欧洲商品名：Zercepac®）、汉达远®（阿达木单抗）和汉贝泰®（贝伐珠单抗）相继获批上市，创新产品汉斯状®（斯鲁利单抗）已获批用于治疗微卫星高度不稳定（MSI-H）实体瘤，其鳞状非小细胞肺癌适应症的上市注册申请也正在审评中。公司亦同步就12个产品、9个免疫联合治疗方案在全球范围内开展20多项临床试验，对外授权全面覆盖欧美主流生物药市场和众多新兴市场。
HANSIZHUANG Granted Orphan-Drug Designation in the United States for Small Cell Lung Cancer
Shanghai, China, April 7th, 2022 - Shanghai Henlius Biotech, Inc. (2696.HK) announced that the United States Food and Drug Administration (FDA) has granted Orphan-Drug Designation (ODD) for HANSIZHUANG (serplulimab) for the treatment of small cell lung cancer (SCLC). This is the first such designation granted to HANSIZHUANG . The ODD granted by the FDA is beneficial for the continuous development of HANSIZHUANG and the enjoyment of certain policy support in terms of registration and commercialization in the United States. The company plans to file its NDA in China and MAA in the EU in 2022, making HANSIZHUANG potentially to be the world's first PD-1 inhibitor for the first-line treatment of SCLC.
Orphan drugs refer to pharmaceutical products developed for the prevention, diagnosis, and treatment of rare diseases or conditions affecting fewer than 200,000 people in the U.S. at the time of designation and to offer certain policy support, including but not limited to: 1) tax credits for clinical trial costs; 2) waiver of application fees for new drugs; and 3) seven years of market exclusivity without being affected by patent.
According to GLOBOCAN 2020, lung cancer (LC) is the second most common cancer around the world. There were 2.2 million new LC cases and 1.8 million new deaths in 2020 worldwide, and LC is the leading cause of cancer deaths[1]. SCLC accounts for 15%–20% of all cases and is the most aggressive type of LC. It is classified into two stages: limited stage (LS-SCLC) and extended stage (ES-SCLC), with both exhibiting high malignancy, strong invasiveness, early metastasis, fast disease progression, and a poor prognosis. The advent of immune checkpoint inhibitors has been proved to bring hope to patients with ES-SCLC but fraught with challenges. In recent years, a number of PD-1 mAbs have failed in the area. On the other hand, the standard treatment regimens for LS-SCLC is surgery, chemotherapy and concurrent radiotherapy. Traditional chemotherapeutic drugs did not exhibit significant progress in patients with LS-SCLC, and most patients tend to develop drug resistance or rapid relapse[2-4].
Based on the unmet clinical needs, Henlius promotes a series of immunotherapy studies in the field of SCLC, with the goal of providing more effective treatment approaches for patients. Henlius has undertaken multiple trials to investigate therapy options for both LS-SCLC and ES-SCLC, including the global multi-centre phase 3 study of HANSIZHUANG for the first-line treatment of ES-SCLC (ASTRUM-005) and the investigational new drug application (IND) of international multi-centre phase 3 studies of HANSIZHUANG (serplulimab) approval from the National Medical Products Administration (NMPA). In detail, ASTRUM-005 is a randomised, double-blind, international, multi-centre, phase 3 clinical study aimed to compare the efficacy and safety of HANSIZHUANG with placebo when combined with chemotherapy (carboplatin-etoposide) in previously untreated patients with SCLC. This study has set up about 128 sites in China, Turkey, Poland, Georgia, etc. and 585 subjects were enrolled, among whom 31.5% were Caucasian. In Dec 2021, ASTRUM-005 has met the primary study endpoint of the overall survival (OS), reducing the risk of death by 38% of the overall population (41% in the Asian subgroup). Based on the excellent readouts, the company intends to file NDA for the indication shortly.
In the future, Henlius will continue to emphasize unmet clinical needs and actively promote the combination immunotherapy of serplulimab and international regulatory registration to benefit more patients around the world.
About HANSIZHUANG
HANSIZHUANG (recombinant humanized anti-PD-1 monoclonal antibody injection, generic name: serplulimab injection) is the first innovative monoclonal antibody developed by Henlius. It is approved by the NMPA for the treatment of MSI-H solid tumors in March 2022. Henlius actively promotes HANSIZHUANG in conjunction with in-house products of the company and innovative therapies. It has successively obtained clinical trial licenses in China, the United States, the European Union and other countries and regions to initiate 9 clinical trials on immuno-oncology combination therapies of HANSIZHUANG worldwide in a wide variety of indications, such as lung cancer, esophageal carcinoma, head and neck squamous cell carcinoma and gastric cancer, etc., and covering the full range of first-line treatments of lung cancers. Up to date, the company has enrolled more than 2,800 subjects in China, Turkey, Poland, Georgia and other countries and regions, and the proportion of Caucasian is over 30% in two MRCTs, making HANSIZHUANG an anti-PD-1 mAb with one of the largest global clinical data pools. The NDA of the treatment for squamous non-small cell lung cancer (sqNSCLC) has been accepted by the NMPA and is expected to be approved in 2022. Furthermore, the global multi-center phase 3 clinical study of HANSIZHUANG in combination with chemotherapy in previously untreated extensive small-cell lung cancer (ES-SCLC) met the primary endpoint of overall survival (OS) with remarkable readouts and its NDA in China and MAA in the EU are expected to be filed in 2022, making this product potentially the world’s first anti-PD-1 mAb for the first-line treatment of SCLC.
About Henlius
Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases and ophthalmic diseases. Up to date, 5 products have been launched in China, 1 in Europe, 13 indications approved worldwide, and 1 New Drug Application (NDA) accepted for review in China. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centers and a Shanghai-based manufacturing facility certificated by China and the EU Good Manufacturing Practice (GMP).
Henlius has pro-actively built a diversified and high-quality product pipeline covering over 20 innovative monoclonal antibodies (mAbs) and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as backbone. Apart from the launched products HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab, Zercepac® in Europe), the first China-developed mAb biosimilar approved both in China and Europe, HANDAYUAN (adalimumab) and HANBEITAI (bevacizumab), the innovative product HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumors and its NDA for the treatment of squamous non-small cell lung cancer is under review. What's more, Henlius has conducted over 20 clinical studies for 12 products and 9 combination therapies worldwide, expanding its presence in major market as well as emerging market.
2022第七届易贸生物产业大会EBC暨易贸生物产业展览
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大会名称：2022第七届易贸生物产业大会EBC暨易贸生物产业展览
主办单位：易贸医疗
指导单位：苏州工业园区管理委员会
协办单位：苏州工业园区投资促进委员会
会议时间：2022年6月26-28日
会议地点：苏州国际博览中心
参与群体：覆盖创业者、科学家、临床医生、投资人和供应商等
易贸生物产业展览
EBC覆盖体外诊断、抗体药物、细胞治疗、基因治疗、mRNA等生物医药创新领域，通过EBC会议、展览、活动三种形式，共建生物产业交流合作平台。三大展馆全方位展示，C3展馆坐拥业内优秀品牌企业，更有大型娱乐展区，采访区，易贸快闪店；D3展馆集聚各类精彩品牌企业，更有约见区，观众休息区等交流集聚地；E3展馆企业展示区，更有用餐区，特色小食区。为生物医药企业提供一站式采购服务。
