Harbin Pharmaceutical Subsidiary Receives Drug Registration Certificate for Generic Vonoprazan Fumarate Tablets

Harbin Pharmaceutical Group Co., Ltd. said Monday that its subsidiary has received approval from China's drug regulator for a generic version of vonoprazan fumarate tablets, a treatment for reflux esophagitis and Helicobacter pylori infection.

The National Medical Products Administration issued the drug registration certificate to Harbin Pharmaceutical Group No.6 Pharmaceutical Factory, the company said in a filing to the Shanghai Stock Exchange. Harbin Pharmaceutical, listed under stock code 600664, is one of China's largest pharmaceutical manufacturers.

Vonoprazan fumarate tablets are indicated for the treatment of reflux esophagitis and, when combined with appropriate antibiotics, for the eradication of H. pylori. The drug belongs to a class of potassium-competitive acid blockers that offer an alternative to traditional proton pump inhibitors.

The approval represents a potential breakthrough in a market currently dominated by imported products. According to the company, the original compound patent for vonoprazan fumarate has not yet expired, and patent barriers have prevented generic competitors from achieving commercial launch in China. As a result, only original imported versions of the drug are currently available in the domestic market.

The market opportunity is substantial. Data from Menet, a leading Chinese pharmaceutical database, show that vonoprazan fumarate tablets generated 998 million yuan (approximately $137 million) in hospital-end sales across China in 2025. The figures cover urban public hospitals, county public hospitals, urban community health centers, and township health centers.

The approval positions Harbin Pharmaceutical to potentially become the first company to commercialize a generic version of vonoprazan fumarate in China, though the company did not specify when the product would reach the market or how it plans to navigate the existing patent landscape.

Reflux esophagitis, a condition in which stomach acid frequently flows back into the tube connecting your mouth and stomach, affects millions of patients in China. H. pylori infection, a major cause of peptic ulcers and gastric cancer, has an estimated infection rate of about 50% in the Chinese population, according to medical studies.

Harbin Pharmaceutical did not immediately respond to a request for comment on the approval's potential financial impact or the company's commercialization timeline.