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羅欣藥業(yè)與中國科學(xué)院上海藥物所及復(fù)旦大學(xué)宣布共同進(jìn)行一項(xiàng)抗癌藥物研發(fā)(2015/11/27)

發(fā)布時(shí)間：2015年11月27日 瀏覽次數(shù)：

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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(yè)集團(tuán)股份有限公司（“羅欣藥業(yè)”）宣布，與中國科學(xué)院上海藥物所及復(fù)旦大學(xué)（“合作方”）簽訂了一項(xiàng)抗癌藥物的合作研發(fā)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(jù)該合同，羅欣藥業(yè)同意支付包括即時(shí)現(xiàn)金付款，及其后的臨床、監(jiān)管及以業(yè)績?yōu)榛鶞?zhǔn)按進(jìn)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(qū)）的研發(fā)、生產(chǎn)和銷售的獨(dú)家權(quán)利。羅欣藥業(yè)與合作方共同擁有該藥物于中國（包括香港及澳門地區(qū)）以外市場(chǎng)的權(quán)利，并將共同推進(jìn)該藥物的研發(fā)工作。根據(jù)該合同，待該藥物上市后，合作方將獲得基于產(chǎn)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(yù)計(jì)將于短期內(nèi)向中國國家食品藥品監(jiān)督管理總局以及相關(guān)海外藥政當(dāng)局提交臨床研究申請(qǐng)
"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(yè)董事會(huì)主席劉保起先生表示：“羅欣藥業(yè)對(duì)研發(fā)投入一直保持高度重視，在已有仿制藥研發(fā)的基礎(chǔ)上，我們繼續(xù)加大了對(duì)創(chuàng)新藥研發(fā)的力度，通過與不同的機(jī)構(gòu)之間的合作，項(xiàng)目引進(jìn)等多元化方式，逐步建立集團(tuán)的創(chuàng)新藥產(chǎn)品線，重點(diǎn)放在腫瘤、消化、呼吸、心血管代謝治療領(lǐng)域。這次與中科院上海藥物所及復(fù)旦大學(xué)對(duì)該藥物的合作研發(fā)就是我們?cè)趧?chuàng)新藥研發(fā)方向的重大舉措之一。仿制藥與創(chuàng)新專利藥有機(jī)組合，將形成優(yōu)質(zhì)豐富的產(chǎn)品資源組合，為羅欣藥業(yè)未來更好發(fā)展做好充足的準(zhǔn)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(xì)胞內(nèi)非常重要的信號(hào)轉(zhuǎn)導(dǎo)通路，在腫瘤的發(fā)生、發(fā)展和耐藥等過程中發(fā)揮著極其重要的調(diào)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(hào)網(wǎng)絡(luò)的核心位置，mTOR抑制劑應(yīng)該是瘤譜寬，對(duì)多種分子機(jī)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(shí)體腫瘤領(lǐng)域具有很好的開發(fā)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(jù)世界衛(wèi)生組織（WHO）2014年世界癌癥報(bào)告統(tǒng)計(jì)：2012年約有1400萬新發(fā)癌癥病例，癌癥死亡率達(dá)820萬例；其中，中國新發(fā)癌癥病例約312萬，死亡人數(shù)約220萬。預(yù)計(jì)到2025年，我國每年新增病例數(shù)增至500萬人，發(fā)病及死亡率排名前5位的癌癥依次為肺癌、肝癌、胃癌、結(jié)直腸癌和女性的乳腺癌。與世界上發(fā)達(dá)國家相比，包括中國在內(nèi)的發(fā)展中國家的癌癥整體治療水平還有相當(dāng)?shù)木嚯x，遠(yuǎn)未能滿足臨床患者的需求。
About Luoxin
關(guān)于羅欣藥業(yè)
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(yè)是一家擁有完善體系的中國本土醫(yī)藥公司，具備完整的研發(fā)、生產(chǎn)、供應(yīng)和商業(yè)化能力，在2014年銷售收入達(dá)到10億美元。2014年，羅欣藥業(yè)在上海設(shè)立研發(fā)中心，致力于通過創(chuàng)新藥物的引進(jìn)與戰(zhàn)略合作，在現(xiàn)有仿制品藥物基礎(chǔ)上完善及加強(qiáng)其產(chǎn)品線?；谠谥袊袌?chǎng)的的綜合實(shí)力優(yōu)勢(shì)，羅欣藥業(yè)致力于為中國患者提供優(yōu)良的藥物。更多資料請(qǐng)?jiān)L問www.luoxinbio.com.
About SIMM
關(guān)于中國科學(xué)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(xué)院上海藥物研究所前身是國立北平研究院藥物研究所，創(chuàng)建于1932年，次年遷至上海，法定住所為上海市浦東新區(qū)張江高科技園區(qū)祖沖之路555號(hào)。上海藥物研究所是以創(chuàng)新藥物的基礎(chǔ)研究、應(yīng)用基礎(chǔ)和應(yīng)用開發(fā)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(jī)構(gòu)，隸屬于中國科學(xué)院。經(jīng)過幾代藥物所人的努力，上海藥物所已發(fā)展成為學(xué)科齊全、成就卓著、人才薈萃、在國內(nèi)外享有較高聲譽(yù)的綜合性藥物研究機(jī)構(gòu)，成為我國最重要的創(chuàng)新藥物研究基地之一。
About Fudan university
關(guān)于復(fù)旦大學(xué)
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(fù)旦大學(xué)創(chuàng)建于1905年，為教育部直屬的重點(diǎn)綜合性研究型大學(xué)。復(fù)旦大學(xué)面向國際前沿，面向國家需求，培養(yǎng)一流人才，產(chǎn)出一流成果，服務(wù)于國家安全和經(jīng)濟(jì)發(fā)展。復(fù)旦大學(xué)下屬藥學(xué)院是我國歷史最悠久的藥學(xué)專業(yè)高等教育院系之一，培養(yǎng)藥學(xué)專業(yè)人才，開展藥學(xué)基礎(chǔ)研究和創(chuàng)新藥物研究。
Contract 聯(lián)系人

Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.山東羅欣藥業(yè)集團(tuán)股份有限公司
Peter Ji
Business Development Director業(yè)務(wù)發(fā)展總監(jiān)
86(21)50860180 - 8865
peterji@luoxinbio.com