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Hengrui Pharmaceutical (01276): Application for marketing licensing of fluzoparil capsules was accepted by EMA
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Zhitong Finance App News, Hengrui Pharmaceutical (01276) issued an announcement. Recently, the company received a notice from the European Medicines Agency (European Medicines Agency, hereinafter referred to as “EMA”). The EMA officially confirmed and accepted the marketing license application for fluzoparil capsules submitted by the company. This is the company's second self-developed innovative drug to submit a marketing application to the European Union.

Fluzopalil capsules are a polyadenosine diphosphate ribose polymerase (PARP) inhibitor that blocks tumor cell DNA repair by inhibiting PARP enzyme activity. Fluzopalil was approved for marketing in China in December 2020. It is the first self-developed PARP inhibitor approved in China. According to inquiries, a number of PARP inhibitors have been approved for marketing worldwide. Overseas, similar products Olaparib, Rucaparib, Niraparib, and Talazoparib have been approved for sale in the US and the European Union; in China, Pamipali capsules from BeiGene and Senapali capsules from Yingpai Pharmaceuticals have also been approved for marketing. According to the EvaluatePharma database, the total global sales volume of similar products over 2025 was approximately US$4.56 billion. Up to now, the total R&D investment for projects related to fluzopalil capsules is about 1,203.7 million yuan (unaudited).

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