Baiyunshan Pharmaceutical General Factory Receives NMPA Approval for Oseltamivir Phosphate Dry Suspension

Zhitong Finance APP News: Guangzhou Baiyunshan Pharmaceutical Holdings Company (00874) announced that its branch, Guangzhou Baiyunshan Pharmaceutical General Factory of Guangzhou Baiyunshan Pharmaceutical Holdings Company Limited (Baiyunshan Pharmaceutical General Factory), recently received the "Drug Registration Certificate" approved and issued by the National Medical Products Administration for Oseltamivir Phosphate for Suspension.

Oseltamivir Phosphate for Oral Suspension is indicated for the treatment of influenza A and B in adults and children aged 2 weeks and older, as well as for the prophylaxis of influenza A and B in individuals aged 1 year and older. The originator of Oseltamivir Phosphate for Oral Suspension is Roche Pharmaceuticals Ltd., which received approval for its launch in the United States in December 2000, followed by approvals in Japan and the European Union. In October 2021, Oseltamivir Phosphate for Oral Suspension was approved for marketing in China.

On October 25, 2024, Guangzhou Baiyunshan Pharmaceutical General Factory submitted a drug marketing registration application to the National Medical Products Administration (NMPA), which was accepted on October 30, 2024. Currently, the main manufacturers and distributors of Oseltamivir Phosphate for Oral Suspension include Hetero Labs Limited, BrightGene Pharmaceutical Co., Ltd. (Suzhou), and Qilu Pharmaceutical (Hainan) Co., Ltd. According to data from Menet, the sales revenue of Oseltamivir Phosphate for Oral Suspension in urban and county-level public hospitals, as well as urban and online pharmacies in China, amounted to RMB 135.01 million in 2025.

As of the present date, Baiyunshan Pharmaceutical General Factory has incurred a total of approximately RMB 22.1172 million in research and development expenses for the oseltamivir phosphate dry suspension project (unaudited).