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. 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.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.