NMPA Accepts Marketing Authorisation Application for CSPC Prusogliptin and Metformin Extended-Release Tablets

Reuters01-12

NMPA Accepts Marketing Authorisation Application for CSPC Prusogliptin and Metformin Extended-Release Tablets

CSPC Pharmaceutical Group Ltd. announced that the National Medical Products Administration (NMPA) of China has accepted the marketing authorisation application for its Prusogliptin and Metformin Extended-Release Tablets. The product is a fixed-dose, extended-release combination of CSPC's Class 1 innovative drug prusogliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, and metformin hydrochloride, a biguanide. The proposed indication is for use as an adjunct to diet and exercise in adult patients with type 2 diabetes mellitus who have inadequate glycemic control on metformin monotherapy or are already receiving combination therapy with prusogliptin and metformin. The application has been submitted as a Class 2.3 chemical drug under the chemical drugs registration classification.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. CSPC Pharmaceutical Group Ltd. published the original content used to generate this news brief via IIS, the Issuer Information Service operated by the Hong Kong Stock Exchange (HKex) (Ref. ID: HKEX-EPS-20260112-11988163), on January 12, 2026, and is solely responsible for the information contained therein.

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The product is a fixed-dose, extended-release combination of CSPC's Class 1 innovative drug prusogliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, and metformin hydrochloride, a biguanide. The proposed indication is for use as an adjunct to diet and exercise in adult patients with type 2 diabetes mellitus who have inadequate glycemic control on metformin monotherapy or are already receiving combination therapy with prusogliptin and metformin. The application has been submitted as a Class 2.3 chemical drug under the chemical drugs registration classification.\n      \n\n\nDisclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. 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