Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has been granted Orphan Drug Designation (ODD) by the National Medical Products Administration (NMPA) for its antibody drug conjugate (ADC), 7MW3711. The drug targets B7-H3, a receptor overexpressed in various cancers, and is specifically indicated for the treatment of small cell lung cancer (SCLC). After administration, 7MW3711 binds to tumor cell antigens and is internalized, releasing small molecule cytotoxic drugs through enzymatic hydrolysis to precisely target cancer cells .
7MW3711’s stable structure, uniform composition, and high purity, coupled with its ease of industrial-scale production, position it as a promising candidate for effective tumor targeting. The drug has demonstrated superior tumor-killing capabilities in multiple animal tumor models compared to similar drugs available in the global market.
The receipt of ODD for 7MW3711 underscores Mabwell’s commitment to developing innovative therapies for treating orphan diseases with high unmet medical needs. This designation is expected to expedite the drug’s regulatory review process and potentially provide market exclusivity for a limited period post-approval.
Mabwell’s 7MW3711, with its novel mechanism of action and orphan drug designation, holds significant potential in improving treatment outcomes for SCLC patients, a population that has long been in need of more effective therapies. The company’s announcement highlights the growing trend of Chinese biopharmaceutical companies targeting global health challenges and underscores China’s burgeoning role in the development of next-generation cancer treatments.- Flcube.com
