Shandong Xinhua (00719): Apremilast tablets (10mg) obtain drug registration certificate.
Shandong Xinhua Pharmaceutical Co., Ltd. (00719) announced that the company has received approval and issuance of the "Eng... " by the National Medical Products Administration.
SHANDONG XINHUA (00719) announces that the company has received the approval and issuance of the Drug Registration Certificate for Empagliflozin Tablet (10mg) (hereinafter referred to as "the product") from the National Medical Products Administration. The product meets the relevant requirements for drug registration and has been approved for registration.
Empagliflozin is a sodium-glucose co-transporter-2 (SGLT-2) inhibitor jointly developed by Boehringer Ingelheim and Eli Lilly. It works by reducing glucose reabsorption in the kidneys, lowering the renal glucose threshold, promoting the direct excretion of glucose from urine, and also reducing sodium reabsorption while increasing sodium transport to the distal tubules. Empagliflozin tablets are suitable for the treatment of type 2 diabetes and for reducing the risk of hospitalization due to symptomatic chronic heart failure in adult patients.
Empagliflozin tablets are listed as a class B drug in the National Basic Medical Insurance, Work-related Injury Insurance, and Maternity Insurance Drug List (2024 edition). According to relevant statistics, the terminal sales of empagliflozin tablets in public medical institutions in China in 2023 were approximately RMB 610 million.
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