2019年11月28日，中国南京和首尔，先声药业与日本生物技术公司GI Innovation今天公布：彼此签定独家代理地区授权文件，协同产品研发和商业化包含GI-101以内的一系列自主创新药物候选分子结构。这种分子结构归属于潜在性的全世界类似首例双非特异融合蛋白，可用以医治实体瘤。彼此企业管理层参加签字仪式 (左起) GI Innovation老总Myoung Ho Jang博士，CEO Su Youn Nam博士；先声药业CSO王品博士，高级副总裁唐任宏博士依据协作条文，先声药业将承担协作商品在我国（包含中国内地，中国香港、澳門及台湾省）的临床实验、申请注册和商业化。GI Innovation企业将得到首付款、里程碑式支付及在我国的市场销售分为。彼此高层住宅及新项目精英团队合照先声药业顶尖科学研究官王品博士表达：“直到现在癌证依然是具备极大未考虑临床医学要求的致命性病症。近些年癌证免疫治疗法，如免疫控制点缓聚剂（Immune Checkpoint Inhibitors，下通称ICI）的取得成功，为很多癌证病人产生了新的期待。但病人的整体减轻率不尽相同：一般 只能一部分病人对医治反映优良，完全缓解和痊愈的病案比较不足。因而急需解决开发设计下一代癌证免疫药物，便于大量病人可以从免疫治疗法中长久获利。GI Innovation有着出色的科学研究和营销团队，并已创建起合理的技术性服务平台，可系统软件发觉用以免疫医治的微生物分子结构；而先声药业在药物产品研发和商业化层面阅历丰富。人们针对与GI Innovation的协作十分激动，并期待先声药业和GI Innovation的携手并肩勤奋可以加快GI-101等分子结构的开发设计，尽早惠及癌证病人。” GI InnovationceoSu Youn Nam博士表达：“人们坚信，与先声协作产品研发的候选药物可根据独立应用或协同医治处理未考虑的临床医学要求。由于目前为止所观查到非凡的功效和安全系数信息，人们觉得这种候选药物即将处理第一代免疫恶性肿瘤药物功效的局限。人们将在ICI已获准的癌证适用范围中开发设计与ICI联用的治疗法，致力于较大水平地提升功效并降低负作用。此外，人们还将试着第二套临床医学开发设计对策：将‘冷恶性肿瘤’变化为具备免疫特异性的‘热恶性肿瘤’，在ICI失效的恶性肿瘤中诱发防癌免疫反映。”有关候选药物协议书包括的系列产品候选药物归属于全世界类似首例双非特异融合蛋白，可用以实体瘤医治。在其中GI-101是免疫细胞因子候选药物，具备双向作用：可消除免疫抑止的另外激话防癌免疫反映。临床医学前科学研究得出结论，GI-101可提升恶性肿瘤侵润淋巴细胞的总数，意味着更强的抗癌单药特异性。此外在人源化宫颈癌小白鼠实体模型中，GI-101具备协作抗癌特异性。 有关GI InnovationGI Innovation是公司总部日本的生物科技公司，着眼于融合基本生物研究和转化医学自主创新成效，为全世界病人开发设计生物大分子药物。GI Innovation的发展战略聚焦点免疫恶性肿瘤、脂肪移植免疫和季节性过敏病症行业。GI Innovation已创建起GI-SMART服务平台技术性，可保持多靶点融合蛋白的高效率提升，进而加速生物大分子候选药物的开发设计。GI Innovation还与学界协作紧密配合，并获得日本环境卫生福利部2019年恶性肿瘤免疫转化医学科学研究重点支助。其他信息请浏览：www.gi-innovation.com/en/有关先声药业先声药业是我国领跑的产品研发驱动器型制药公司，有着“转化医学与自主创新药物國家重中之重试验室”，聚焦点恶性肿瘤、神经系统、本身免疫等重疾行业，着眼于让病人尽早用起更强药物。凭着出色的商业化工作能力，其关键商品在我国维持领跑的市场占有率。先声药业秉持着开放式创新的产品研发对策，与好几家海外药品生产企业变成战略伙伴，推动全世界生物科学成效在我国的使用价值保持。其他信息请浏览：www.simcere.com Simcere and GI Innovation Announce Collaboration and Exclusive License Agreement for Immunotherapy Drugs in ChinaThursday, Nov 28, 2019，Nanjing, China & Seoul, South Korea，Simcere and South Korean pharmaceutical company GI Innovation today announced that they have entered into an exclusive regional licensing agreement for the development and commercialization of a class of innovative drug candidates including GI-101, potential first-in-class bi-specific fusion proteins for the treatment of solid tumors.A signing ceremony attended by executives from both companies marks the finalization of licensing agreement:(From left) GI Innovation’s Founder & Chairman Dr. Myoung Ho Jang, CEO Dr. Su Youn Nam;Simcere’s CSO Dr. Pin Wang, VP Dr. Renhong Tang Pursuant to the terms of the licensing agreement, Simcere will be responsible for the clinical development, regulatory approval and commercialization of the assets in China, including mainland China, Hong Kong, Macau and Taiwan. GI Innovation will receive upfront payment, milestone payments and tiered royalties in the above territories. Both sides' senior management and project team membersDr. Pin Wang, CSO of Simcere said: “Cancer remains to be devastating diseases with significantly unmet medical needs. Recent success of cancer immunotherapy such as checkpoint inhibitor treatments offers new hopes for many cancer patients, but overall response rates vary and only a subset of patients respond favorably to the treatment. Complete response and cure are limited. Thus, development of next generation cancer immunotherapy drugs is urgent so that more patients can gain durable benefits from immunotherapies. GI Innovation is led by a strong scientific and management team and has established an efficient technology platform for discovering biological molecules for immunotherapeutic applications, whereas Simcere is very experienced in drug development and commercialization. We are extremely excited in this collaborative opportunity with GI Innovation and hope that our joint efforts could accelerate the clinical development so that cancer patients can benefit from these promising immunotherapeutic drugs sooner.”GI Innovation’s CEO Dr. Su Youn Nam: “We believe that those drug candidates may address the unmet medical needs through combination therapy as well as monotherapy. Considering the superior efficacy and safety profiles observed to date, our assets hold their potential as viable answers to the issues of limited efficacy seen with first-generation immuno-oncology drugs. We will develop combination therapies with immune checkpoint inhibitors in cancer indications for which first-generation checkpoint inhibitors are approved, which is aimed at maximizing efficacy and reducing side effects,” she said. “The second strategy is to induce anti-cancer immune responses in those tumors that are resistant to checkpoint inhibitors by converting the ‘cold tumors’ into immunologically-active ‘hot tumors’.” About the assetsThe development candidates are first-in-class bi-specific fusion proteins for the treatment of solid tumors. GI-101, the lead asset, is an immune-cytokine drug candidate that has the dual ability of not only prevent immune inhibition, but also stimulating anti-cancer immune responses. Preclinical data shows that GI-101 treatment produces higher numbers of tumor-infiltrating lymphocytes which translates into more potent
