Hengrui Pharma Wins China Regulator's Nod for Three Drugs

MT Newswires Live07-30

Jiangsu Hengrui Pharmaceuticals (SHA:600276, HKG:1276) has received market approval from China's National Medical Products Administration (NMPA) for its insulin sudelidec injection, according to a Wednesday filing to the Hong Kong stock exchange.

The company independently developed the Class 1 therapeutic biological product for treating adults with type 2 diabetes mellitus, with approvals granted for 3ml:300 units in both pre-filled injection pen and cartridge formats.

Additionally, the pharmaceutical firm secured regulatory acceptance for its drug marketing authorization application for Ruikang Luzetutamab for Injection (SHR-A2009), intended for adult patients with lung cancer that has progressed after epidermal growth factor receptor tyrosine kinase inhibitor therapy.

In a separate filing, Hengrui announced that its subsidiary, Fujian Shengdi Medicine, received NMPA approval to initiate a Phase II clinical trial for HRS5580 for Injection, a selective neurokinin-1 receptor antagonist designed to prevent postoperative nausea and vomiting.

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