SH PHARMA(02607.HK): Omeprazole Sodium Bicarbonate for Oral Suspension (I) Approved for Production

NewTimeSpace News: Shanghai Pharmaceutical Holding Co., Ltd. (02607.HK) released an overseas regulatory announcement on 3 August 2026. Its subsidiary Shanghai SPH Xinyi Pharmaceutical Factory Co., Limited received the Drug Registration Certificate for Omeprazole Sodium Bicarbonate for Oral Suspension issued by the NMPA. The product is an oral suspension with specifications of 20mg Omeprazole and 1680mg Sodium Bicarbonate per sachet, classified as Class 3 Chemical Drug, with the drug approval number of Guo Yao Zhun Zi H20265385.

The drug is mainly used for short-term treatment of active duodenal ulcer and gastroesophageal reflux disease. Originally developed and manufactured by Salix Pharmaceuticals under the brand name Zegerid, it was approved for marketing in the United States by the FDA in June 2004. SPH Xinyi submitted the registration application in September 2024. As of the date of the announcement, accumulated R&D expenditure amounted to approximately RMB5.9355 million.

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