SHANDONG XINHUA (00719.HK): Obtains Drug Registration Certificate for Dapagliflozin Tablets

NewTimeSpace News: On 21 August 2026, SHANDONG XINHUA (00719.HK) announced that it has obtained the drug registration certificate for dapagliflozin tablets (10mg and 5mg), indicated for type 2 diabetes and heart failure.

NewTimeSpace News: On 21 August 2026, Shandong Xinhua Pharmaceutical Company Limited (stock code: 00719) disclosed that it has received the Drug Registration Certificate for dapagliflozin tablets approved by the National Medical Products Administration, in strengths of 10mg and 5mg, classified as chemical drug Category 4 with domestic production, with approval numbers 国药准字H20265648 and 国药准字H20265670. The registration application was submitted in March 2025 and approved in August 2026.

According to the announcement, dapagliflozin tablets are indicated for adult patients with type 2 diabetes (as monotherapy or in combination with metformin hydrochloride or insulin) and for adult patients with heart failure to reduce the risk of cardiovascular death.

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