Hengrui Pharma's HRS-5965 Capsule Drug Application Accepted for Review

Stock News17:28

Jiangsu Hengrui Pharmaceuticals Co., Ltd. (600276.SH) announced that its subsidiary, Chengdu Shengdi Pharmaceutical Co., Ltd., recently received a notice of acceptance from the National Medical Products Administration (NMPA). The marketing authorization application for the company's Fumarate Likang Kepan (HRS-5965) capsules has been accepted for review by the NMPA. The proposed indication is for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who remain anemic after previous treatment with a C5 complement inhibitor. Fumarate Likang Kepan capsules are a complement factor B inhibitor that can suppress complement-mediated intravascular and extravascular hemolysis and increase hemoglobin levels. For this indication, Novartis's Iptacopan hydrochloride capsules (Fabhalta®) are currently the only drug with the same target approved for marketing globally. According to a query of the EvaluatePharma database, the global sales of this product in 2025 are projected to be approximately USD 505 million. As of now, the cumulative research and development investment for the HRS-5965 capsule-related project is approximately 251.5 million yuan (unaudited).

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