Shanghai Pharmaceuticals' Clevidipine Emulsion Injection Approved for Production

Jiemian··CNUS·Read original
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Summary · why it matters

Shanghai Pharmaceuticals announced that its subsidiary Shanghai First Biochemical Pharmaceutical has received the Drug Registration Certificate for Clevidipine Emulsion Injection from the National Medical Products Administration, with specifications of 50ml:25mg and 100ml:50mg, registered as a Category 3 chemical drug. The drug is mainly used to treat hypertension when oral medication is inappropriate or expected to be ineffective. It was originally developed by AstraZeneca and approved for marketing in the United States in August 2008. Shanghai First Biochemical Pharmaceutical submitted its marketing application in July 2024 and was accepted, with cumulative R&D investment of approximately 52.2 million yuan. The company stated that this approval will help expand the drug's market share and enhance market competitiveness, but drug sales are affected by uncertainties such as national policies and the market environment, and sales may fall short of expectations. Investors should be aware of the risks.

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Biotech & Genomic Medicine▲
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Shanghai Pharmaceuticals Holding Co Ltd
601607
▲ PositiveRegulationrelevance

Subsidiary Shanghai First Biochemical received NMPA Drug Registration Certificate for Clevidipine Emulsion Injection, expanding its drug portfolio and market competitiveness.

Off-coverage companies 1

Shanghai SPH First Biochemical Pharmaceutical Co Ltdi
Private▲ PositiveRegulationrelevance

Shanghai First Biochemical Pharmaceutical received the Drug Registration Certificate for Clevidipine Emulsion Injection from the NMPA, allowing production and marketing.