Aosaikang Pharmaceutical's Empagliflozin Tablets Approved for Market Launch in China

On November 19, the information on the pending collection of drug approval certificates from the National Medical Products Administration showed that AOSAIKANG PHARM's empagliflozin tablets have been approved for marketing.

Empagliflozin, a SGLT2 inhibitor jointly developed by Boehringer Ingelheim and Eli Lilly and Company, is taken orally once daily. In patients with type 2 diabetes with higher blood glucose levels, empagliflozin prevents the kidneys from reabsorbing sugar by inhibiting SGLT2, allowing more sugar to be excreted through urine. Additionally, empagliflozin reduces salt reabsorption, increasing salt excretion in the body and reducing fluid load in the vascular system. The changes in sugar, salt, and water metabolism induced by empagliflozin may contribute to reducing cardiovascular mortality.

Empagliflozin was approved by the U.S. FDA in August 2014, with the brand name Jardiance®, indicated for glycemic control in patients with type 2 diabetes in conjunction with diet and exercise. In December 2016, empagliflozin received another FDA approval for a new indication to reduce cardiovascular risk in patients with type 2 diabetes.

According to the 2021 Canadian Heart Failure Guidelines, based on substantial clinical research evidence, the central role of SGLT-2 inhibitors in heart failure treatment has been affirmed. SGLT-2 inhibitors (Empagliflozin Tablets), originally introduced as a diabetes treatment, will undoubtedly bring a novel market growth once approved for the treatment of chronic heart failure, marking a "cross-boundary" advancement in drug therapy.

Currently, Empagliflozin Tablets from Hosa Pharmaceutical, Kelun Pharmaceutical, Zhengda Tianqing, and Wanbang Pharmaceutical have all been approved for marketing in China. The first generic version by Hosa Pharmaceutical was approved on July 30, 2020, followed by Kelun Pharmaceutical on August 14, 2020. Empagliflozin Tablets from Zhengda Tianqing and Wanbang Pharmaceutical were successively launched in 2021.