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Sihuan Unit Wins China Nod for Phase III Anaprazole Trial in H. pylori

Story Highlights
  • Xuanzhu Biopharm gained Chinese approval to begin a Phase III trial testing an Anaprazole-based quadruple therapy against standard esomeprazole treatment for Helicobacter pylori.
  • Success in expanding Anaprazole’s indications could bolster Xuanzhu Biopharm’s position in China’s growing gastrointestinal market and support its long-term commercialization strategy.
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Sihuan Unit Wins China Nod for Phase III Anaprazole Trial in H. pylori

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Sihuan Pharmaceutical Holdings Group ( (HK:0460) ) has provided an update.

Sihuan Pharmaceutical’s subsidiary Xuanzhu Biopharm has received approval from China’s drug regulator to launch a Phase III trial of a bismuth-containing quadruple regimen using Anaprazole Sodium Enteric-coated Tablets for Helicobacter pylori eradication. The multicentre, randomized, double-blind trial will enroll 556 adults and compare Anaprazole-based therapy with an esomeprazole-based standard, measuring eradication rates via 13C-urea breath test after treatment.

Helicobacter pylori infection affects an estimated 44% of China’s population, with the treatment market valued at RMB5.5 billion in 2024 and expected to grow strongly over the next decade. Expanding Anaprazole’s indications beyond its current duodenal ulcer approval, alongside ongoing Phase III work in reflux esophagitis, could strengthen Xuanzhu Biopharm’s position in the digestive disease segment and support its long-term commercialization strategy in China’s fast-growing gastrointestinal drug market.

More about Sihuan Pharmaceutical Holdings Group

Sihuan Pharmaceutical Holdings Group is a China-focused drug maker with a portfolio that includes innovative therapies for digestive diseases, oncology and metabolic conditions. Its non-wholly owned subsidiary Xuanzhu Biopharm, listed in Hong Kong, develops Class 1 innovative drugs across small and large molecule platforms, targeting unmet clinical needs and building integrated R&D, manufacturing and commercialization capabilities.

Average Trading Volume: 35,647,692

Technical Sentiment Signal: Buy

Current Market Cap: HK$13.34B

See more data about 0460 stock on TipRanks’ Stock Analysis page.

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