| EN

Simcere Zaiming Partners with MabPharm on anti-EGFR Monoclonal Antibody CMAB009 in China

Release time:2023-08-22

On August 20, 2023, Simcere Zaiming Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Simcere pharmaceutical Group Ltd., ("Simcere Zaiming”) announced that Simcere Zaiming has entered into a collaboration agreement with Taizhou Mabtech Pharmaceutical Limited, an indirectly wholly-owned subsidiary of MabPharm Limited (2181.HK), ("MabPharm”). According to the agreement, Simcere Zaiming will obtain the exclusive commercial rights to MabPharm’s anti-EGFR monoclonal antibody CMAB009 in China.


"CMAB009 is an anti-tumor product with clinical differentiation advantages, which can benefit a huge patient population with various tumor types, such as colorectal cancer. The clinical value and positioning of this product is in line with Simcere Zaiming’s business development strategy. We are pleased to reach a collaboration agreement with MabPharm and look forward to working with MabPharm to provide more efficient medicines to cancer patients in near future,” said Renhong Tang, Ph.D., Chairman and Chief Executive Officer of Simcere Zaiming.


"We are thrilled to have built a partnership with Simcere Zaiming," said Hao Wang, Ph.D., Chief Executive Officer of MabPharm. “CMAB009 is the first EGFR antibody that was developed in China. It has obtained the Investigational New Drug (“IND”) approval in China. The New Drug Application ("NDA”) of this product has already been accepted by the National Medical Products Administration (“NMPA”). We believe that combining MabPharm’s high quality research with Simcere Zaiming’s commercialization expertise builds a powerful alliance that can bring better and more accessible innovative biopharmaceuticals to our patients."



CMAB009 is a recombinant anti-epidermal growth factor receptor (“EGFR”) chimeric monoclonal antibody and it will be used in combination with FOLFIRI regimen as a first-line treatment for metastatic colorectal cancer (“mCRC”). CMAB009 is prepared by using a specific expression process and, thus, effectively avoiding glycosylation modification that may lead to hypersensitivity. The safety and efficacy of CMAB009 have been confirmed by the results of two completed clinical trials. The data have shown significant therapeutic effect and favorable safety profiles of CMAB009 for the treatment of mCRC.


In March 2023, the NDA of CMAB009 injection was accepted by NMPA. It has the potential to become the first home-grown anti-EGFR monoclonal antibody drug for the treatment of mCRC in China and provide a more affordable biological targeted therapy with good efficacy for hundreds of thousands of Chinese cancer patients. Besides mCRC, CMAB009 also has the potential to expand its indications to other tumor types, including pancreatic cancer, head and neck squamous cell carcinomas, and cervical squamous cell carcinoma, and, when combined with a variety of small molecule drugs, may expand into even broader applications.


About MabPharm and Taizhou Mabtech Pharmaceutical

MabPharm is a leading biopharmaceutical company in China, focusing on the research, development and commercialization of new drugs and biosimilars for cancers and autoimmune diseases. MabPharm strives to bring high quality and affordable innovative biologics through its efficient R&D system and low-cost pharmaceutical production capability to the market, and develops various therapeutic products by fully utilizing its extensive R&D experience. Taizhou Mabtech Pharmaceutical is an indirectly wholly-owned subsidiary of MabPharm and one of its principal operating subsidiaries. Taizhou Mabtech Pharmaceutical principally engages in the production of marketed products of MabPharm, preparation of samples for research and development of product candidates as well as design and construction of research and development equipment and product lines.


About Simcere Zaiming

Simcere Zaiming is a pharmaceutical company specializing in oncology, and a subsidiary of Simcere Pharmaceutical Group Limited, that focuses on the R&D, production and commercialization of innovative cancer therapeutics. The company was formed in 2023 and is committed to meeting unmet clinical needs for cancer patients in China and around the world by developing breakthrough treatments. Simcere Zaiming has an innovative R&D pipeline with differentiated clinical value, among which 15 assets are currently in clinical trials. In addition to the company’s R&D portfolio, Simcere Zaiming is marketing three innovative drugs, COSELA®, Endostar®, and Envafolimab®. By collaborating with partners globally, Simcere Zaiming strives to bring potentially new innovative therapeutics to cancer patients worldwide.


Media Contact: pr@zaiming.com