山東羅欣藥業集團股份有限公司招標公告
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，山東羅欣藥業集團股份有限公司（“羅欣藥業”）宣布，與中國科學院上海藥物所及復旦大學（“合作方”）簽訂了一項抗癌藥物的合作研發合同。
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.
根據該合同，羅欣藥業同意支付包括即時現金付款，及其后的臨床、監管及以業績為基準按進度的付款予合作方，以獲得該藥物在中國（包括香港及澳門地區）的研發、生產和銷售的獨家權利。羅欣藥業與合作方共同擁有該藥物于中國（包括香港及澳門地區）以外市場的權利，并將共同推進該藥物的研發工作。根據該合同，待該藥物上市后，合作方將獲得基于產品銷售收入的一定比例提成作為收益。簽訂該合同后，本公司及合作方預計將于短期內向中國國家食品藥品監督管理總局以及相關海外藥政當局提交臨床研究申請
"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. ”
羅欣藥業董事會主席劉保起先生表示：“羅欣藥業對研發投入一直保持高度重視，在已有仿制藥研發的基礎上，我們繼續加大了對創新藥研發的力度，通過與不同的機構之間的合作，項目引進等多元化方式，逐步建立集團的創新藥產品線，重點放在腫瘤、消化、呼吸、心血管代謝治療領域。這次與中科院上海藥物所及復旦大學對該藥物的合作研發就是我們在創新藥研發方向的重大舉措之一。仿制藥與創新專利藥有機組合，將形成優質豐富的產品資源組合，為羅欣藥業未來更好發展做好充足的準備。”
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.
該藥物是一種新的三磷酸腺苷（ATP）競爭性mTOR激酶抑制劑，是具高度選擇性的mTORC1和 mTORC2雙重抑制劑。PI3K-AKT-mTOR是細胞內非常重要的信號轉導通路，在腫瘤的發生、發展和耐藥等過程中發揮著極其重要的調控功能。鑒于大約50%的人類腫瘤涉及mTOR的異常激活和mTOR在腫瘤信號網絡的核心位置，mTOR抑制劑應該是瘤譜寬，對多種分子機制的腫瘤有抑制效果的新一代靶向藥物。與單純mTORC1抑制劑相比，有望拓寬腫瘤譜和提高抗腫瘤效果，在包括乳腺癌、肺癌、胃癌等實體腫瘤領域具有很好的開發前景。
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.
癌癥依然是目前人類健康的巨大威脅，據世界衛生組織（WHO）2014年世界癌癥報告統計：2012年約有1400萬新發癌癥病例，癌癥死亡率達820萬例；其中，中國新發癌癥病例約312萬，死亡人數約220萬。預計到2025年，我國每年新增病例數增至500萬人，發病及死亡率排名前5位的癌癥依次為肺癌、肝癌、胃癌、結直腸癌和女性的乳腺癌。與世界上發達國家相比，包括中國在內的發展中國家的癌癥整體治療水平還有相當的距離，遠未能滿足臨床患者的需求。
About Luoxin
關于羅欣藥業
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.
羅欣藥業是一家擁有完善體系的中國本土醫藥公司，具備完整的研發、生產、供應和商業化能力，在2014年銷售收入達到10億美元。2014年，羅欣藥業在上海設立研發中心，致力于通過創新藥物的引進與戰略合作，在現有仿制品藥物基礎上完善及加強其產品線。基于在中國市場的的綜合實力優勢，羅欣藥業致力于為中國患者提供優良的藥物。更多資料請訪問www.luoxinbio.com.
About SIMM
關于中國科學院上海藥物所
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.
中國科學院上海藥物研究所前身是國立北平研究院藥物研究所，創建于1932年，次年遷至上海，法定住所為上海市浦東新區張江高科技園區祖沖之路555號。上海藥物研究所是以創新藥物的基礎研究、應用基礎和應用開發研究為主的綜合性研究所，是我國歷史最悠久的藥物研究機構，隸屬于中國科學院。經過幾代藥物所人的努力，上海藥物所已發展成為學科齊全、成就卓著、人才薈萃、在國內外享有較高聲譽的綜合性藥物研究機構，成為我國最重要的創新藥物研究基地之一。
About Fudan university
關于復旦大學
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.
復旦大學創建于1905年，為教育部直屬的重點綜合性研究型大學。復旦大學面向國際前沿，面向國家需求，培養一流人才，產出一流成果，服務于國家安全和經濟發展。復旦大學下屬藥學院是我國歷史最悠久的藥學專業高等教育院系之一，培養藥學專業人才，開展藥學基礎研究和創新藥物研究。
Contract 聯系人
Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.山東羅欣藥業集團股份有限公司
Peter Ji
Business Development Director業務發展總監
86(21)50860180 - 8865
peterji@luoxinbio.com
