Release time：May 08, 2021
May 8, 2021, Shanghai— Mabwell Bioscience Co., Ltd. ("Mabwell") announced today that its application for conducting the clinical trial of its product Anti-ST2 Antibody Injection (9MW1911) was formally approved by the Center for Drug Evaluation (CDE) of China National Medical Products Administration. The approved indications include asthma and chronic obstructive pulmonary disease. 9MW1911 Injection is the first China-made antibody directed against the target of ST2 that has been authorized by China NMPA to conduct clinical trials in China.
It is an innovative humanized monoclonal antibody drug independently developed by Mabwell, a doemstic pharmaceutical company in China. The drug’s antibody molecule is derived based on the B-lymphocyte screening platform, and the product is characterized by higher binding affinity and potent biological activity. Nonclinical studies have shown that the in vivo mechanism of action of this product in animals was definite and clear. After binding specifically to the target ST2, it blocks the activation of ST2-mediated signaling pathway induced by cytokine IL-33, hence inhibiting the inflammatory reactions and achieving therapeutic effects in multiple auto-immune diseases.
Currently, Mabwell has completed the establishment of molecular discovery and druggability investigation system, process development and quality study system and production transformation system. Its comprehensive R&D pipelines have covered more than 10 novel drug varieties in various therapeutic fields such as auto-immune diseases, tumor, metabolic disorders, ophthalmologic diseases and infections. Of these, one variety has been applied for manufacturing and 4 varieties have entered into the stage of critical registration application for clinical trials. In the near future, the synergistic advantages between the company's various platforms will be further exerted to accelerate the development of new drug molecules within the R&D pipelines and expedite the overall process of related clinical trials.