Release time：Jul 01, 2025
Mabwell (688062.SH), an innovative biopharmaceutical company with entire industrial chain, announced that its wholly-owned subsidiary T-mab successfully passed the GMP inspection by the National Institute of Food and Drug Administration of Colombia (“INVIMA”) for its denosumab injections, 9MW0311 (Prolia? biosimilar) and 9MW0321 (Xgeva? biosimilar). The facility was granted conclusion of “Compliance” from INVIMA. This is the first time that Mabwell’s production line has passed the on-site GMP inspection by an overseas regulatory agency.
Colombia is one of the strategic countries in the Latin American market, with a population of approximately 50 million. It has a strict drug regulatory system, and its review standards are highly reference to international authoritative organizations such as FDA, EMA and WHO, which is highly recognized in South America. Mabwell has previously entered into a strategic partnership for its denosumab injections in the Colombian market. The Colombian auditor conducted a 5-day detailed inspection of all aspects and links of T-mab’s plant facilities, quality system, manufacturing, warehousing, testing and release, and gave a good appraisal of the audit process and results.
Mr. Huiguo Hu, Board Member, Senior Vice President, and Board Secretary of Mabwell, said, “The Colombian GMP inspection system has been recognized in recent years as one of the strictest in emerging markets. Passing the GMP on-site verification with ‘zero dificiencies’ result is another international recognition of Mabwell's quality management system and production capacity, which also lays a solid foundation for the subsequent commercialization of the product in more countries and will help further enhance the accessibility of the product to more patients.”
