Hengrui Pharmaceuticals (01276.HK): NDA for HRG2010 Capsules Accepted

NewTimeSpace News: On August 24, 2026,Hengrui Pharmaceuticals(01276.HK) issued an overseas regulatory announcement, stating that the Company has received the Acceptance Notice from the National Medical Products Administration for the New Drug Application of HRG2010 Capsules. According to the announcement, HRG2010 is a Class‑2 new drug independently developed by the Company. It is a compound formulation composed of levodopa and carbidopa, featuring rapid onset, sustained and stable therapeutic effect via optimised release mechanism.

Hengrui Pharmaceuticalsstated that this application is supported by China’s first Phase III confirmatory study in Parkinson’s disease patients using carbidopa‑levodopa controlled‑release tablets as active comparator, involving 84 clinical centres nationwide. Study results show that HRG2010 Capsules can shorten“off‑time”and prolong favourable“on‑time”. Its safety profile is consistent with compound levodopa‑based drugs, with no new safety signals identified.

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