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New Drug Application Of Suvemcitug For Injection Has Been Accepted By the China National Medical Products Administration

Release time:2024-03-20

On March 15, 2024, Simcere Zaiming Pharmaceutical Co. Ltd. (“Simcere Zaiming”), an innovative oncology company and a subsidiary of Simcere Pharmaceutical Group Ltd. (HKEX: 2096, “Simcere”) announced today that, the new drug application of Suvemcitug for injection has been accepted by the China National Medical Products Administration (NMPA). It is intended to be used in patients with recurrent, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.


Ovarian cancer has the highest mortality rate among all gynecological malignancies, causing more than 200,000 fatal cases in the world annually. Fallopian tube cancer, as well as primary peritoneal cancer, have similar biological characteristics to that of epithelial ovarian cancer and therefore are often treated the same way. The standard treatments for ovarian cancer are surgery combined with platinum-based chemotherapy ± targeted drug therapy. However, most patients will relapse and eventually develop platinum resistance. Patients with platinum-resistant relapsed ovarian cancer have a poor prognosis and limited treatment options. In recent years, anti-VEGF vascular targeting drugs have shown high clinical value in the treatment of ovarian cancer and are considered a new option.                            

Suvemcitug is a new-generation recombinant humanized anti-VEGF rabbit monoclonal antibody co-developed by Simcere and Apexigen, Inc., (“Apexigen”). Simcere Zaiming currently holds the exclusive rights to develop and commercialize this product in greater China. The antibody can selectively bind to human VEGF and block its biological activity, reduce tumor blood vessel formation, and inhibit tumor growth. It has demonstrated good anti-tumor activity and controllable safety in preclinical models and early clinical studies.


On January 3, 2024, the phase III clinical trial of Suvemcitug for injection combined with chemotherapy versus placebo combined with chemotherapy in patients with recurrent, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer (the SCORES study) met the primary endpoint. Compared with the Placebo Group, the improvement of PFS in the Suvemcitug Group is both statistically and clinically significant.


Developed against one of the pain points of ovarian cancer, the platinum resistance, Suvemcitug is expected to improve the clinical outcomes of patients. Its clinical application is not limited by previous VEGF or PARP inhibitor treatment,and it can be combined with various chemotherapies regardless of chemotherapy type to benefit a wide range of platinum-resistant ovarian cancer patients.


About Apexigen

Apexigen is a clinical-stage biopharmaceutical company focused on discovering and developing innovative antibody therapeutics for oncology. On August 23, 2023, Apexigen was acquired by Pyxis Oncology, Inc. (a Nasdaq-listed public company in the United States –stock code: PYXS.NASDAQ). Pyxis Oncology, Inc. is a clinical-stage company focused on defeating difficult-to-treat cancers and is efficiently building next-generation therapeutics that hold the potential for mono and combination therapies.


About Simcere Zaiming

Simcere Zaiming is an oncology-focused biopharmaceutical company and a subsidiary of Simcere Pharmaceutical Group Limited (HKEX: 2096, “Simcere”). Founded in 2023, Simcere 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 assets. Several products of Simcere Zaiming are commercially available in China, which include COSELA®, Endostar®, and Envafolimab. Simcere Zaiming strives to bring potentially breakthrough treatment options to cancer patients worldwide through in-house R&D, manufacturing, and commercialization, as well as collaborations with global partners of innovative cancer therapeutics.