Shanxi C&Y Pharmaceutical Initiates Clinical Study for Generic Ferric Maltol with NMPA Approval

Shanxi C&Y Pharmaceutical Initiates Clinical Study for Generic Ferric Maltol with NMPA Approval

China’s Shanxi C&Y Pharmaceutical Group Co., Ltd (SHE: 300254) has announced the initiation of a clinical study for its generic version of UK firm Shield TX(UK)Limited’s iron supplement ferric maltol, following approval from the National Medical Products Administration (NMPA). The study aims to evaluate the drug’s efficacy in treating iron deficiency anemia.

Ferric Maltol: A New Approach to Iron Supplementation
Ferric maltol is a complex containing iron ions that dissociates when ingested by the gastrointestinal tract, reducing the intolerance to iron supplements commonly experienced by patients compared to iron salt compounds. This innovative approach to iron supplementation has been approved in the European Union and the United States for the treatment of iron deficiency, with approvals received in 2016 and 2019, respectively.

In-Licensing and Development in China
In January 2020, Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755) in-licensed the drug for development, manufacturing, and market promotion in Greater China. Despite the originator drug and its copycats not being approved in China, C&Y Pharma’s knockoff version, classified as a Category 3 chemical drug, is being developed to match the quality and efficacy of the originator drug.-Fineline Info & Tech

Insight, China's Pharmaceutical Industry