SSY Group (02005.HK): Obtains Production Registration Approvals for Three Products; Fat-Soluble Vitamin Injection Approved as First Domestic Enterprise

NewTimeSpace News: SSY Group Limited (02005.HK) announced that the Group has obtained drug production registration approvals from the National Medical Products Administration (NMPA) for three products. Among them, Fat-Soluble Vitamin Injection (Ⅰ) (10ml) is the first approved domestic enterprise, deemed to have passed the consistency evaluation, for intravenous nutritional supplementation in children and infants. Metformin Hydrochloride Tablets (0.5g and 0.25g) are used for the treatment of type 2 diabetes mellitus. Doxazosin Mesylate Extended-Release Tablets (4mg) are indicated for benign prostatic hyperplasia and hypertension.

NewTimeSpace News: SSY Group Limited (02005.HK) released a voluntary announcement on May 6, 2026, disclosing the latest progress in product development.

For Fat-Soluble Vitamin Injection (Ⅰ) (10ml), the Group is the first domestic enterprise to obtain the drug production registration approval from the NMPA. Classified as a Class 3 chemical drug, it is deemed to have passed the consistency evaluation. This product is mainly used for children and infants under 11 years old as a supplement to intravenous nutrition to meet daily requirements of fat-soluble vitamins A, D2, E and K1.

For Metformin Hydrochloride Tablets (0.5g and 0.25g), the Group has obtained the drug production registration approval from the NMPA. Classified as a Class 4 chemical drug, it is deemed to have passed the consistency evaluation. This product is mainly used for the treatment of type 2 diabetes mellitus when blood glucose cannot be controlled by diet and exercise alone.

For Doxazosin Mesylate Extended-Release Tablets (4mg), the Group has obtained the drug production registration approval from the NMPA. Classified as a Class 4 chemical drug, it is deemed to have passed the consistency evaluation. This product is mainly used for the symptomatic treatment of benign prostatic hyperplasia and the treatment of hypertension. Previously, the Group’s doxazosin mesylate active pharmaceutical ingredient (API) has been approved by the NMPA for use in marketed preparations.

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