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Simcere Zaimig announces new IND approval of SIM0237, an anti-PD-L1/IL-15 bispecific antibody by NMPA

Release time:2023-10-16

On Oct 15, 2023, Simcere Zaiming, an innovative oncology-focused biopharmaceutical company and a subsidiary of Simcere Pharmaceutical Group announced that a new indication of SIM0237 for injection, an anti-PD-L1/IL-15 bispecific antibody independently developed by the company has obtained Clinical Trial Approval issued by the National Medical Products Administration (NMPA) of China, which is intended to be used in patients with Non-muscle Invasive Bladder Cancer (NMIBC).


Bladder cancer is a common urological malignancy. At its initial stage, around 70% of patients suffer from non-muscle-invasive bladder cancer (NMIBC), whereas the remaining suffer from muscle-invasive bladder cancer (MIBC). Despite varies treatment methods exist for NMIBC, including surgical resection, postoperative intravesical chemotherapy and/or BCG treatment, many patients still face high risk of recurrence and progression. Radical cystectomy can provide long-term disease control for such patients but also seriously impair their Quality of Life (Qol). Tumor immunotherapies such as PD-(L)1 immune checkpoint inhibitors are emerging as effective treatments for progressive disease, that provide the patients with new therapeutic choices other than cystectomy and achieve better Qol.


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 Simcere Zaiming’s protein engineering platform. It is currently being developed simultaneously in China and the United States for Phase I studies in advanced solid tumors. As a bifunctional protein, the compound 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 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. 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 Zaiming

Simcere Zaiming is an oncology-focused biopharmaceutical company and a subsidiary of Simcere Pharmaceutical Group Limited. Founded in 2023, the Company is committed to developing disruptive therapies that have the potential to address unmet clinical needs for cancer patients around the world. Simcere Zaiming has built an innovative R&D pipeline, with differentiated clinical values. Several products of Zaiming are commercially available in China, which include COSELA®, Endostar®, and Envafolimab. Simcere Zaiming strives to bring potentially breakthrough treatments options to cancer patients worldwide through in-house R&D, manufacturing and commercialization, as well as collaborations with global partners of innovative cancer therapeutics. pr@zaiming.com 


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.  simcere.mediarelations@simcere.com