Baiyunshan (00874): Tianxin Pharmaceutical received the “Drug Registration Certificate” for irbesartan hydrochlorothiazide tablets approved and issued by the State Drug Administration

Zhitong Finance App News, Baiyunshan (00874) issued an announcement. Recently, Guangzhou Baiyunshan Tianxin Pharmaceutical Co., Ltd. (hereinafter referred to as “Tianxin Pharmaceutical”), a holding subsidiary of Guangzhou Baiyunshan Pharmaceutical Group Co., Ltd. (hereinafter referred to as the “Company”), received a “Drug Registration Certificate” for irbesartan hydrochlorothiazide tablets approved by the State Drug Administration.

Irbesartan hydrochlorothiazide tablets are used to treat essential hypertension. This fixed-dose combination is used to treat patients who cannot effectively control blood pressure with irbesartan or hydrochlorothiazide alone. The original manufacturer of irbesartan hydrochlorothiazide tablets is Sanofi Pharmaceuticals Co., Ltd., which was approved for marketing in the US in 1997 and approved for marketing in China in 2011.

On April 2, 2025, Tianxin Pharmaceutical submitted a drug registration application to the State Drug Administration, which was accepted on April 30, 2025. Currently, the main manufacturers and sellers of irbesartan hydrochlorothiazide tablets include Nanjing Zhengda Tianqing Pharmaceutical Co., Ltd., Sanofi (Hangzhou) Pharmaceutical Co., Ltd., and Zhejiang Huahai Pharmaceutical Co., Ltd. According to data from the Internet, the sales volume of irbesartan hydrochlorothiazide tablets in domestic cities, county-level public hospitals, cities, and online pharmacies in 2025 was RMB 1,608.15 million.

Up to now, Tianxin Pharmaceutical has invested a total of about RMB 129.153 million (unaudited) in research and development projects for irbesartan hydrochlorothiazide tablets.