成都先导与白云山签订HG030产品中国大陆转让协议
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关键词：
协议白云山
资讯来源：同写意 + 订阅账号
发布时间：
2020-11-12
成都先导药物开发股份有限公司
（688222.SH，以下简称“成都先导”）
宣布与广州白云山医药集团股份有限公司
（600332.SH/00874.HK，以下简称“白云山”）
签署转让合作协议，成都先导将新药项目代号为HG030的产品在中国大陆地区的全部权利转让给白云山，后续研发与商业化将有白云山独立推进并实施。HG030是由成都先导研发的新一代抗肿瘤激酶抑制剂，已在2020年3月获得国家药品监督管理局的临床试验审批，并进入临床I期阶段。
根据协议约定，白云山将获得HG030在中国大陆后续开发及商业化的排他性权益，并且支付成都先导3,800万元人民币的转让费。随着项目的推进，成都先导还可能收到一系列的里程碑付款，以及当项目在中国大陆推进到临床阶段和产品上市后的销售提存。成都先导仍保留HG030产品中国大陆以外所有区域的全部权益。
“我们非常高兴与白云山达成此项转让合作。在过去的几年中，成都先导围绕DNA编码化合物库（DELs）技术，一直致力于打造创新药研发技术平台，并且已经与利用该项技术的全球领先的制药和生物技术公司进行了许多研究合作。HG030正是在这样的研发努力之下实现的首次转让。这项转让合作证明了成都先导在将项目从靶点提出推进到早期临床试验阶段的能力，以及对项目推进质量的保证。我们希望我们的努力将有助于针对患者需求的创新药物的研发与发展。凭借白云山大量的临床开发，生产和商业化能力以及良好的业绩记录，我期待HG030在临床开发方面取得进一步进展，并最终向市场成功推出产品。”
成都先导药物开发股份有限公司是一家从事新药研发的快速发展的生物技术公司，总部位于中国成都，在美国设有子公司。成都先导为小分子新药发现建立了一个国际领先的，以DNA编码化合物库的设计、合成和筛选为核心的技术平台。目前，公司基于数百种不同的骨架结构，已经完成千亿级结构全新、具有多样性和类药性DNA编码化合物的合成，并且已有多个案例证实了其针对已知靶点和新兴靶点筛选苗头化合物的能力。同时，成都先导建立了自己的新药研发管线，部分品种已进入临床试验阶段。成都先导业务遍布北美、欧洲及亚洲等，现已与多家国际著名制药公司、生物技术公司、化学公司、基金会以及科研机构建立合作，致力于新药的发现与应用。
广州白云山医药集团股份有限公司
（600332.SH/00874.HK）
是一家从事制药和医疗保健行业的公司。公司四大业务板块分别是“大南药”、“大商业”、“大健康”和“大医疗”。公司的“大南药”板块包括中西成药、化学原料药、天然药物、生物医药、化学原料药中间体的研究开发、生产与销售。公司的“大健康”板块包括大健康产品的研发、生产与销售。公司的“大商业”板块包括西药、中药和医疗器械的批发、零售和进出口业务。公司拥有从原料药到制剂的抗生素生产链，产品涵盖了常用抗生素，同时从事研发
（R＆D）
以及饮料和食品的生产等。
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获取更多信息，请致电：+ 86-28-85197385
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HitGen Licenses Its Trk/ROS1 Inhibitor HG030 to Baiyunshan for Development and Commercialisation in China
CHENGDU, CHINA, November 10
HitGen Inc. (HitGen, 688222.SH) announces it has entered into a collaboration and licensing agreement with
Guangzhou Baiyunshan Pharmaceutical Holdings Co., Ltd (Baiyunshan, 600332.SH/00874.HK) to develop and commercialise its HG030 programme in China. Baiyunshan is a publically listed company in Shanghai and Hong Kong engaged in the pharmaceutical and healthcare industry. HG030 is a novel inhibitor for Trk/ROS1 discovered by HitGen, which received IND approval from China’s National Medical Products Administration (NMPA) in March 2020, and is entering Phase I clinical trial in China for patients with NTRK/ ROS1 gene fusion-positive cancers.
Under the terms of the agreement, Baiyunshan will receive exclusive rights for the development and commercialisation of HG030 in the China, and will pay HitGen an upfront licensing fee of RMB 38M, followed by a series of milestones and royalty of sales as the product progresses through clinical trials and product launches in the China. HitGen retains all rights of the product in all territories outside the China.
HG030 is a second-generation small molecule Trk inhibitor designed to treat patients with NTRK gene fusion-positive cancers, regardless of cancer type. Most patients with NTRK-rearranged advanced cancer are sensitive to tyrosine kinase inhibitor (TKI) therapy. These TKIs have dramatically improved outcomes for patients with advanced Trk-positive cancer, yet these cancers remain incurable. Resistance invariably develops, such as acquired mutations G595R and G667C. HG030 is a novel, highly potent, selective, second-generation Trk inhibitor with clear activities in preclinical models against most known resistance mutations in patients with advanced Trk-positive cancer. Therefore, HG030 might be an effective therapeutic strategy for patients with Trk-positive advanced cancer who were naive or had become resistant to currently available TKIs.
“We are very pleased to enter this licensing agreement with Baiyunshan. Over the past few years, HitGen has been developing an innovative drug discovery technology platform centred on DNA-encoded libraries (DELs), and has entered into a number of research collaborations with leading pharmaceutical and biotechnology companies worldwide utilising this technology. In addition to the development and applications of DELs technology, we have also been applying our discovery research capabilities to build a portfolio of innovative drug discovery projects for collaboration and licensing. HG030 is the first out-licensing result of such an effort. This collaboration and licensing demonstrates HitGen’s capability in progressing discovery projects from target nomination to early clinical trials, as well as the quality of the programme. We hope our effort of this type will contribute to the discovery and development of innovative medicines for patients. With their tremendous clinical development, manufacturing and commercialisation capabilities and track record, I look forward to seeing further progress of HG030 in clinical development and ultimate successful product launch by Baiyunshan”,
said Dr Jin Li, Chairman and CEO of HitGen Inc.
HitGen is a rapidly growing biotech company with headquarters in Chengdu, China, and a subsidiary in the USA. HitGen has established an industry-leading platform for early-stage drug discovery research, centred on DNA-encoded chemical libraries (DELs). HitGen’s DELs include encoded syntheses for hundreds of billions of novel, diverse, drug-like small molecule and macrocycle compounds. These compounds are members of DELs synthesized from many hundreds of distinct chemical scaffolds, designed and assembled with tractable chemistry based on proven results for identifying drug-like leads against biological targets from known and novel classes. HitGen is working with multiple pharmaceutical and biotech companies, foundations and research institutes in North America, Europe, Australia and Asia to discover and develop novel therapeutics of the future.
About Guangzhou Baiyunshan Pharmaceutical Co., Ltd
Guangzhou Baiyunshan Pharmaceutical Holdings Company Limited (600332.SH/00874.HK) is engaged in the pharmaceutical and healthcare industry. The Company's segments are Great Southern TCM, Great Commerce, Great Health and Great Medical Care. The Company's Great South TCM includes research, development, manufacturing and sales for Chinese and western medicine, chemical raw medicine, natural drug, biological medicine and intermediates of chemical raw medicine. The Company's Great Health segment includes research, development, manufacturing and sales for the products of Great Health. The Company's Great Commerce segment includes wholesale, retail, import and export for western medicine, Chinese medicine and medical apparatus and instruments. The Company has an antibiotic production chain ranging from raw material medicine to preparation, with products covering commonly used antibiotics. It is engaged in the research and development (R&D), and manufacturing of beverage and food, among others.
About Vernalis (R&D) Limited
For media inquiries: media@hitgen.com
For investor inquiries: investors@hitgen.com
For business development: bd@hitgen.com
For more information, please call +86-28-85197385
This press release has been prepared by HitGen Inc. (the “Company”). The information contained in this press release is intended for information purpose only and does not take your investment objectives, financial status, and special needs into consideration. This press release does not constitute legal, regulatory, accounting tax or investment advice to you, or any form of financial opinion or recommendation by the Company or any other party at any time. We recommend that you seek independent third party legal, regulatory, accounting, tax, investment and/or financial advice regarding the contents of this press.
This press release does not contain all relevant information relating to the Company or its securities, particularly with respect to the risks and special considerations involved with an investment in the securities of the Company. All relevant information relating to the Company should be subject to the information disclosed publicly by the Company. No securities of the Company may be sold in China without registration with China Securities Regulatory Commission (the “CSRC”) or an exemption from such registration. Any public offer of securities would be made pursuant to an effective registration statement and prospectus prepared by the Company that would contain material information not contained herein. Any offering of the securities of the Company to be made in China will be made solely on the basis of the information contained in the statutory prospectus included in a registration statement to be filed by the Company with the CSRC. If you invest in any securities of the Company, you should read such statutory prospectus and other documents that the Company may file with the CSRC.
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