山东罗欣药业集团股份有限公司招标公告
November 26, 2015, Shandong Luoxin Pharmaceutical Group Stock Co., Ltd (“Luoxin”) entered into a collaboration agreement with Shanghai Institute of Materia Medica, Chinese Academy of Sciences ( SIMM) and Fudan University (the “Partners”) in the area of developing a cancer therapeutic product (the “Product”).
2015年11月26日，山东罗欣药业集团股份有限公司（“罗欣药业”）宣布，与中国科学院上海药物所及复旦大学（“合作方”）签订了一项抗癌药物的合作研发合同。
Under this Agreement, Luoxin agrees to make payments to the Partners, including immediate cash payments and subsequent progress billings of clinical, regulatory and performance-based payments for an exclusive right to research and development (“R&D”), manufacturing and commercialization of the Product in the People’s Republic of China (the “PRC”), Hong Kong and Macau. The rights to the Product in markets beyond the PRC, Hong Kong and Macau will be jointly owned by Luoxin and the Partners. The team will work together to expedite the R&D efforts in all stages of the product development. In addition, the Partners will receive commercial royalty based on certain percentage of the Product sales upon its launch to the market. Upon entering into the Agreement, Luoxin and the Partners are expected to submit an application for Investigational New Drug (IND) to the China Food and Drug Administration (CFDA) and related foreign drug administrative authorities soon.
根据该合同，罗欣药业同意支付包括即时现金付款，及其后的临床、监管及以业绩为基准按进度的付款予合作方，以获得该药物在中国（包括香港及澳门地区）的研发、生产和销售的独家权利。罗欣药业与合作方共同拥有该药物于中国（包括香港及澳门地区）以外市场的权利，并将共同推进该药物的研发工作。根据该合同，待该药物上市后，合作方将获得基于产品销售收入的一定比例提成作为收益。签订该合同后，本公司及合作方预计将于短期内向中国国家食品药品监督管理总局以及相关海外药政当局提交临床研究申请
"R&D focus has always been the top priority of Luoxin, on top of the Group’s existing generic drugs, we have strengthened the efforts in R&D of innovative drugs, through collaboration with different partners and in-licensing assets, to further expand the innovative drug product line step by step. The R&D of innovative drugs focuses on oncological, gastrointestinal, respiratory and cardiovascular treatments." said Baoqi Liu, Chairman of the Board of Luoxin. "This collaboration with SIMM and Fudan University on the Drug Development is a major step in the R&D strategy of innovative high-end therapeutics. The organic combination of generic drugs with innovative drugs forms a quality product portfolio with enriched resources, enabling the Group to lay a solid foundation for future development. ”
罗欣药业董事会主席刘保起先生表示：“罗欣药业对研发投入一直保持高度重视，在已有仿制药研发的基础上，我们继续加大了对创新药研发的力度，通过与不同的机构之间的合作，项目引进等多元化方式，逐步建立集团的创新药产品线，重点放在肿瘤、消化、呼吸、心血管代谢治疗领域。这次与中科院上海药物所及复旦大学对该药物的合作研发就是我们在创新药研发方向的重大举措之一。仿制药与创新专利药有机组合，将形成优质丰富的产品资源组合，为罗欣药业未来更好发展做好充足的准备。”
The collaborative project will focus on a new and ATP competitive mTOR kinase inhibitor that acts as potent and highly selective dual inhibitor of mTORC1 and mTORC2. The PI3K-AKT-mTOR is an essential signal transduction pathway in the cancer cells and plays a crucial role in controlling the process of tumor formation, growth and resistance to current treatments. Given that about 50% of human tumors occur by abnormal activation of mTOR and the central position of mTOR in the tumor signal network, mTOR-targeted therapy may offer a new treatment strategy for multiple hard-to-treat solid tumors driven by numerous distinct “driver mutations” and drug resistance mechanisms . Compared with simple mTORC1 inhibitor, mTOR kinase inhibitor, with its prospect in broadening cancer spectrum and enhancing effectiveness of cancer treatment, may offer enormous clinical application going forward, especially in the fields of treating breast cancer, lung cancer and gastric cancer.
该药物是一种新的三磷酸腺苷（ATP）竞争性mTOR激酶抑制剂，是具高度选择性的mTORC1和 mTORC2双重抑制剂。PI3K-AKT-mTOR是细胞内非常重要的信号转导通路，在肿瘤的发生、发展和耐药等过程中发挥着极其重要的调控功能。鉴于大约50%的人类肿瘤涉及mTOR的异常激活和mTOR在肿瘤信号网络的核心位置，mTOR抑制剂应该是瘤谱宽，对多种分子机制的肿瘤有抑制效果的新一代靶向药物。与单纯mTORC1抑制剂相比，有望拓宽肿瘤谱和提高抗肿瘤效果，在包括乳腺癌、肺癌、胃癌等实体肿瘤领域具有很好的开发前景。
Cancer remains a leading threat to human health nowadays. According to statistics in the World Cancer Report 2014 by the World Health Organization (WHO), there were approximately 14 million new cancer cases in 2012, with 8.2 million mortality cases. China saw approximately 3.12 million new cancer cases, with around 2.2 million mortality cases. New cancer cases in China is estimated to reach 5 million per year by 2025. The five illnesses with the highest incidence and mortality rates are, in order, lung cancer, liver cancer, gastric cancer, colorectal cancer and breast cancer amongst females. Developing countries like the PRC still have a long way to go in catching up the developed countries’ general standard of cancer treatment, and the cancer patients’ need is well short of being sufficiently addressed.
癌症依然是目前人类健康的巨大威胁，据世界卫生组织（WHO）2014年世界癌症报告统计：2012年约有1400万新发癌症病例，癌症死亡率达820万例；其中，中国新发癌症病例约312万，死亡人数约220万。预计到2025年，我国每年新增病例数增至500万人，发病及死亡率排名前5位的癌症依次为肺癌、肝癌、胃癌、结直肠癌和女性的乳腺癌。与世界上发达国家相比，包括中国在内的发展中国家的癌症整体治疗水平还有相当的距离，远未能满足临床患者的需求。
About Luoxin
关于罗欣药业
Luoxin is a well-established domestic pharmaceutical company in China, which has the full chain capability of R&D, manufacture, supply, and commercialization. In 2014, sales revenue reached 1B USD. In 2014, Luoxin Shanghai R&D center was set up, with the commitment to enrich current pipelines (generics) with innovative medicines, through in-licensing and strategic partnerships. With the comprehensive capabilities in China market, Luoxin is committed and dedicated to provide good medicines to Chinese patients. For further information, please visit us at www.luoxinbio.com.
罗欣药业是一家拥有完善体系的中国本土医药公司，具备完整的研发、生产、供应和商业化能力，在2014年销售收入达到10亿美元。2014年，罗欣药业在上海设立研发中心，致力于通过创新药物的引进与战略合作，在现有仿制品药物基础上完善及加强其产品线。基于在中国市场的的综合实力优势，罗欣药业致力于为中国患者提供优良的药物。更多资料请访问www.luoxinbio.com.
About SIMM
关于中国科学院上海药物所
Shanghai Institute of Materia Medica (hereafter referred as SIMM), Chinese Academy of Sciences, has the longest history as a comprehensive research institution for drug discovery in China, now located in Zhang Jiang Hi-Tech Park in Shanghai. SIMM was evolved from Peking Institute of Materia Medica, Academia Sinica founded in 1932. In line with frontiers in life sciences and aiming at solving key scientific problems in drug discovery, SIMM carries out both basic and applied studies and develops new theories, methods and technologies. Through several generations’efforts, SIMM has become one of the leading interdisciplinary centers of excellence in China. It is recognized worldwide by its outstanding achievements and distinguished research team.
中国科学院上海药物研究所前身是国立北平研究院药物研究所，创建于1932年，次年迁至上海，法定住所为上海市浦东新区张江高科技园区祖冲之路555号。上海药物研究所是以创新药物的基础研究、应用基础和应用开发研究为主的综合性研究所，是我国历史最悠久的药物研究机构，隶属于中国科学院。经过几代药物所人的努力，上海药物所已发展成为学科齐全、成就卓著、人才荟萃、在国内外享有较高声誉的综合性药物研究机构，成为我国最重要的创新药物研究基地之一。
About Fudan university
关于复旦大学
Fudan University, founded in 1905, is one of China's most prestigious learning institutions. Fudan is a comprehensive multi-disciplinary Research University with many highly-ranked subject programs. Fudan School of Pharmacy (formerly School of Pharmacy, Shanghai Medical University), located in Zhangjiang High-Tech Park in Shanghai, is one of the internationally well-known colleges for Pharmacy Sciences, with comprehensive research disciplines and specialties, excellent faculty and research facility. The School is charged with producing highly qualified graduates who devote themselves to global biomedical and pharmaceutical research and development and make contribution to world health.
复旦大学创建于1905年，为教育部直属的重点综合性研究型大学。复旦大学面向国际前沿，面向国家需求，培养一流人才，产出一流成果，服务于国家安全和经济发展。复旦大学下属药学院是我国历史最悠久的药学专业高等教育院系之一，培养药学专业人才，开展药学基础研究和创新药物研究。
Contract 联系人
Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.山东罗欣药业集团股份有限公司
Peter Ji
Business Development Director业务发展总监
86(21)50860180 - 8865
peterji@luoxinbio.com
