Taienkang Secures China's First Domestic Approval for Compound Sodium Sulfate Tablets, Seizing Blue Ocean in Colonoscopy Bowel Prep Market

For years, Chinese patients undergoing colonoscopies have faced the same unglamorous ordeal: swallowing liters of a salty, unpleasant-tasting liquid to clear their bowels before the procedure. Many simply couldn't finish it.

On June 25, Guangdong Taienkang Pharmaceutical Co., Ltd. (stock code: 301263) said it has a solution — and a potential business opportunity. The company's wholly owned subsidiary, Shandong Huabo Kaisheng Biotechnology Co., Ltd., has won China's first domestic approval to manufacture and sell compound sodium sulfate tablets, a solid-form bowel cleanser originally cleared by the U.S. Food and Drug Administration in 2020.

The approval breaks a long-standing reliance on liquid-based bowel preparations in China and hands Taienkang an exclusive foothold in a niche but fast-growing corner of the country's digestive-health market.

A Market Ready to Be Disrupted

China's colonoscopy market is expanding quickly, fueled by rising health awareness and national screening programs aimed at catching digestive-tract cancers early. The country's soft endoscope market is projected to surpass 8.1 billion yuan (roughly $1.1 billion at current exchange rates) in sales by 2025, according to industry estimates cited by the company.

Every one of those procedures requires bowel preparation. Yet the dominant product in China — compound polyethylene glycol electrolyte powder — has well-documented drawbacks. Patients must drink large volumes of liquid, the taste is poor, and compliance is low.

The newly approved compound sodium sulfate tablet relies on an osmotic laxative mechanism combining sodium sulfate and magnesium sulfate. Designed specifically for adult colonoscopy prep, it is positioned as a direct upgrade to the traditional liquid regimen: fewer sips, better taste, and noticeably less discomfort.

Clinical Data That Matches — and May Beat — the Standard

Taienkang's Phase III clinical trial — a multi-center, randomized, single-blind study with a positive-drug parallel control — found the new tablet to be as effective and as safe as the polyethylene glycol standard.

But it also outperformed on key measures. The tablet achieved higher Boston Bowel Preparation Scale scores across the entire colon and in the transverse colon, a region that is notoriously difficult to clean. Patient satisfaction was significantly higher, the company said, because subjects had to drink less water and reported fewer adverse sensations.

A Three-Year Head Start

Huabo Kaisheng is currently the only company in China holding a production registration certificate for compound sodium sulfate tablets. Under National Medical Products Administration rules, the product enjoys a three-year data-protection period running through June 22, 2029 — giving Taienkang a meaningful window to establish the brand before generics can follow.

For Taienkang, the launch is a strategic milestone in its digestive-health portfolio. The product fills a gap in China's market for next-generation solid bowel-prep agents, the company said, and rides a structural tailwind as colonoscopy penetration continues to climb.

Looking ahead, Taienkang said it will continue to focus on innovation and unmet clinical needs, leveraging its R&D capabilities to bring differentiated products to market. The company also pledged to move carefully through a regulatory and reimbursement environment that remains in flux, as it works to turn a first-mover advantage into commercial results.