Baiyunshan (ASX: 00874) has announced that its controlling subsidiary, Guangzhou Baiyunshan Tianxin Pharmaceutical Co., Ltd. ("Tianxin Pharmaceutical"), recently received a Drug Registration Certificate approved and issued by the National Medical Products Administration for Irbesartan Hydrochlorothiazide Tablets.

Irbesartan Hydrochlorothiazide Tablets are used for the treatment of essential hypertension. This fixed-dose combination is indicated for patients whose blood pressure cannot be effectively controlled with irbesartan or hydrochlorothiazide alone.

The original research manufacturer of Irbesartan Hydrochlorothiazide Tablets is Sanofi Pharmaceutical Co., Ltd. The drug was approved for marketing in the United States in 1997 and in China in 2011.

On April 2, 2025, Tianxin Pharmaceutical submitted a drug registration application to the National Medical Products Administration, which was accepted on April 30, 2025.

Currently, the main manufacturers and sellers of Irbesartan Hydrochlorothiazide Tablets include Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd., Sanofi (Hangzhou) Pharmaceutical Co., Ltd., and Zhejiang Huahai Pharmaceutical Co., Ltd., among others.

According to data from Menet, in 2025, sales of Irbesartan Hydrochlorothiazide Tablets in domestic urban and county-level public hospitals as well as urban and online pharmacies reached RMB 1,608.15 million.

As of now, Tianxin Pharmaceutical has invested a total of approximately RMB 12.9153 million (unaudited) in research and development expenses for the Irbesartan Hydrochlorothiazide Tablets project.