先声药业与GI Innovation宣布合作，在中国联合研发和商业化肿瘤免疫治疗药物

2019年11月28日，中国南京和韩国首尔，先声药业与韩国生物技术公司GI Innovation今日宣布：双方签署独家区域许可协议，联合研发和商业化包括GI-101在内的一系列创新药物候选分子。这些分子属于潜在的全球同类首个双特异性融合蛋白，可用于治疗实体瘤。

双方公司高管出席签字仪式 (左起)

GI Innovation董事长Myoung Ho Jang博士，CEO Su Youn Nam博士；先声药业CSO王品博士，副总裁唐任宏博士

根据合作条款，先声药业将负责合作产品在中国（包括中国大陆，香港、澳门及台湾地区）的临床研究、注册和商业化。GI Innovation公司将获得首付、里程碑付款及在中国的销售分成。

双方高层及项目团队合影

先声药业首席科学官王品博士表示：“时至今日癌症仍然是具有巨大未满足临床需求的致命疾病。近年来癌症免疫疗法，如免疫检查点抑制剂（Immune Checkpoint Inhibitors，下简称ICI）的成功，为许多癌症患者带来了新的希望。但患者的总体缓解率各不相同：通常只有一部分患者对治疗反应良好，完全缓解和治愈的病例较为有限。因此迫切需要开发下一代癌症免疫药物，以便更多患者能够从免疫疗法中持久获益。GI Innovation拥有优秀的科学和管理团队，并已建立起有效的技术平台，可系统发现用于免疫治疗的生物分子；而先声药业在药物研发和商业化方面经验丰富。我们对于与GI Innovation的合作非常兴奋，并希望先声药业和GI Innovation的携手努力能够加速GI-101等分子的开发，早日造福癌症患者。”

GI Innovation首席执行官Su Youn Nam博士表示：“我们相信，与先声合作研发的候选药物可通过单独使用或联合治疗解决未满足的临床需求。鉴于迄今为止所观察到卓越的疗效和安全性数据，我们认为这些候选药物有望解决第一代免疫肿瘤药物疗效的局限性。我们将在ICI已获批的癌症适应症中开发与ICI联用的疗法，旨在最大程度地提高疗效并减少副作用。另外，我们还将尝试第二套临床开发策略：将‘冷肿瘤’转变为具有免疫活性的‘热肿瘤’，在ICI无效的肿瘤中诱导抗癌免疫反应。”

关于候选药物

协议包含的系列候选药物属于全球同类首个双特异性融合蛋白，可用于实体瘤治疗。其中GI-101是免疫细胞因子候选药物，具有双重功能：可解除免疫抑制的同时激活抗癌免疫反应。临床前研究结果表明，GI-101可增加肿瘤浸润淋巴细胞的数量，预示着更强的抗肿瘤单药活性。另外在人源化乳腺癌小鼠模型中，GI-101具有协同抗肿瘤活性。

关于GI Innovation

GI Innovation是总部位于韩国的生物技术企业，致力于整合基础生命科学研究和转化医学创新成果，为全球患者开发生物大分子药物。GI Innovation的战略聚焦免疫肿瘤、自体免疫和过敏性疾病领域。GI Innovation已建立起GI-SMART平台技术，可实现多靶点融合蛋白的高效优化，从而加快大分子候选药物的开发。GI Innovation还与学术界合作密切合作，并得到韩国卫生福利部2019年肿瘤免疫转化医学研究专项资助。

更多信息请访问：www.gi-innovation.com/en/

关于先声药业

先声药业是中国领先的研发驱动型制药公司，拥有“转化医学与创新药物国家重点实验室”，聚焦肿瘤、神经、自身免疫等重大疾病领域，致力于让患者早日用上更好药物。凭借优异的商业化能力，其主要产品在中国保持领先的市场份额。先声药业秉持开放式创新的研发策略，与多家跨国药企成为战略合作伙伴，促进全球生命科学成果在中国的价值实现。

更多信息请访问：www.simcere.com

Simcere and GI Innovation Announce Collaboration and Exclusive License Agreement for Immunotherapy Drugs in China

Thursday, 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 members

Dr. 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 assets

The 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 anti-tumor effect as a single agent. A synergistic anti-tumor effect is also observed in humanized breast cancer mouse model featuring transplanted human immune cells.

About GI Innovation

GI Innovation is a South Korean bio-venture company, integrating basic science and translational innovation in developing biologics for patients around the world. GI Innovation’s strategic focus is on immuno-oncology and inflammation/immunology diseases. GI Innovation has established GI-SMART platform technology that is designed to accelerate the development of biologics through the efficient optimization of multi-targeting fusion protein therapeutics with high quality and high productivity. GI Innovation has also benefited greatly from academic collaboration, funded through a national project called ‘2019 Translational Research Program for Immuno-oncology’ run by South Korea’s Ministry of Health and Welfare. For more information, please visit: www.gi-innovation.com/en/

About Simcere

Simcere is a research and development-driven Chinese pharmaceutical company with a State Key Lab of Translational Medicine and Innovative Drug Development, committed to delivering high quality and effective therapies to patients. Simcere achieves this by focusing its efforts on therapeutic areas of oncology, neurology, inflammation/immunology diseases etc. By leverage of its commercial capability, all top products of the company have a leading market share in China. Simcere continues to promote the advance of international scientific and medical breakthroughs through an open and collaborative R&D strategy, and extensive strategic alliance with global partners. For more information, please visit: www.simcere.com.

编辑 | Amanda 玉紫龙
审核 | Yuehua 镜外那片海