Simcere Receives FDA Clearance of Investigational New Drug Application (IND) for Bi-functional Fusion Protein, SIM0237

Second US IND approval this year for the global pharmaceutical group

NANJING,China and BOSTON,Oct. 27,2022 -- Simcere Pharmaceutical Group (2096.HK),an innovative global pharmaceutical company,today announced that the U.S. Food and Drug Administration (FDA) has cleared the company's investigational new drug (IND) application for SIM0237,an anti-PD-L1/IL-15 bi-functional fusion protein,for the treatment of adult patients with advanced solid tumors. It is the second IND approval Simcere obtained in the US this year. In addition,the IND application of SIM0237 in China was accepted by the National Medical Products Administration on October 10,2022.

"There is demonstrated history of PD-1/PD-L1 immune checkpoint inhibitors (ICIs) showcasing strong efficacy in a variety of cancers,but there is a large percentage of oncology patients who are either refractory these therapeutics or develop resistance," said Dr. Bijoyesh Mookerjee,M.D.,Chief Medical Officer,Oncology of Simcere. "By developing this compound as a bi-functional fusion protein,that combines an anti-PD-L1 antibody with an IL-15 cytokine,we can direct therapeutic activity to the tumor microenvironment,enabling us to potentially limit toxicity while improving tolerability and enhancing efficacy in patients with metastatic or locally advanced solid tumors."

IL-15 is an immune-activating cytokine that promotes the expansion and activation of NK cells and CD8 + T cells. Previous research has revealed that IL-15 when combined with anti-PD-L1/PD-1 antibodies showed good clinical benefits in patients with advanced malignancies including patients who have either not responded to or have relapsed after immune checkpoint inhibitor treatment. Therefore,bi-functional fusion protein,targeting both IL-15 and PD-1/PD-L1 may have the potential for antitumor efficacy in relapsed/refractory patients after immunotherapy.

About the SIM0237-101 Clinical Trial

SIM0237-101 is a phase 1,first-in-human,open-label,multicenter study to investigate the safety,tolerability,pharmacokinetics and preliminary antitumor activity of SIM0237 in adult participants with advanced solid tumors. The dose escalation phase of the study will evaluate the pharmacokinetics and pharmacodynamics and identify the maximum tolerated dose (MTD) or the recommended dose for expansion (RDE) of SIM0237. The dose expansion phase of the study assess safety,and activity of SIM0237 at the RDE.

About SIM0237

SIM0237 is an anti-PD-L1 monoclonal antibody fused with potency reduced IL-15/IL-15Rα sushi domain developed in-house by utilizing the Simcere's protein engineering platform. It can block the PD-1/PD-L1 immunosuppressive pathway via binding to PD-L1 and activate the immune system through its IL-15 part,thus playing a synergistic role of relieving immunosuppression and boosting the immune activation to exhibit antitumor effect. The attenuated IL-15 part of SIM0237 prolongs its PK,increases MTD and avoids overstimulation and accompanied anergy of NK and CD8+ T cells. In the meantime,fusion of attenuated IL-15 to full anti-PD-L1 mAb further enhances the half-life of attenuated IL-15 and delivers IL-15 directly to the tumor microenvironment avoiding notorious CRS toxicity induced by systemic IL-15 exposure. Moreover,SIM0237 is able to bridge CD8+ T and NK cells to PD-L1+ APC/tumor cells,which fosters immune synapse formation to further boost the activation of effective cells and promote tumor cell lysis. Preclinical studies showed that SIM0237 is more effective than PD-L1 or IL-15 mono treatment in mouse tumor models,suggesting a high potential for clinical development.

About Simcere

Simcere Pharmaceutical Group Limited (2096.HK) is an innovation and R&D-driven pharmaceutical company. The company focuses on three therapeutic areas,oncology,central nervous system and autoimmune diseases,with a forward-looking vision toward disease areas that may have significant clinical needs in the future,aiming to achieve the mission of "providing today's patients with medicines of the future." Leveraging its R&D capability and commercialization excellence,Simcere has built a market-leading product portfolio in China. Its vigorous in-house R&D efforts and extensive R&D collaborations have made it a strategic cooperation partner with world leading innovative companies and research institutes.

For more information,please visit: http://en.simcere.com/

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