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Simcere Receives IND Approval in the US for Bi-functional Fusion Protein, SIM0237 ——the Second US IND Approval This Year

Release time:2022-10-27

NANJING, China and BOSTON Massachusetts October27, 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. 

Media contact:  simcere.mediarelations@simcere.com 

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding its: strategy, business plans and objectives for the SIM0237 antibody program; and plans and timelines for the clinical development of Simcere Pharmaceuticals’ product candidates, including the therapeutic potential and clinical benefits thereof. The words "may," “might,” "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," “expect,” "estimate," “seek,” "predict," “future,” "project," "potential," "continue," "target" and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks associated with: the impact of COVID-19 on countries or regions in which we have operations or do business, as well as on the timing and anticipated results of our current preclinical studies and future clinical trials, strategy and future operations; the delay of any current preclinical studies or future clinical trials or the development of Simcere Therapeutics’ drug candidates; the risk that the results of current preclinical studies may not be predictive of future results in connection with future clinical trials; Simcere Therapeutics’ ability to successfully demonstrate the safety and efficacy of its drug candidates; the timing and outcome of the Company’s planned interactions with regulatory authorities; and obtaining, maintaining and protecting its intellectual property. In addition, any forward-looking statements represent Simcere Therapeutics’ views only as of today and should not be relied upon as representing its views as of any subsequent date. Simcere Therapeutics explicitly disclaims any obligation to update any forward-looking statements. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.