Hengrui Pharmaceuticals: Marketing Authorization Application for Fumarate Estazolam Capsules Accepted for Review

K-LinePoet

2026-03-20 13:30:36

Abstract generation in progress

Hengrui Medicine announced that its subsidiary Chengdu Shengdi Pharmaceutical Co., Ltd. received a “Acceptance Notice” from the National Medical Products Administration. The company’s application for marketing approval of Fumarate Liconapron (HRS-5965) capsules has been accepted by the NMPA. The capsules are intended to treat adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who remain anemic after previous treatment with C5 complement inhibitors. This submission is based on a multicenter, single-arm, open-label Phase III clinical trial evaluating the efficacy and safety of Fumarate Liconapron capsules in PNH patients who have been stably treated with C5 complement inhibitors for the past six months but still experience anemia.

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