Baoji Pharma-B (02659) Surges Over 10% as Recombinant Ulinastatin Clinical Trial Gets NMPA Approval

Shares of Shanghai Bao Pharmaceuticals Co., Ltd. (02659.HK) surged more than 10% in early trading on Friday, before settling at a 5.82% gain to HKD 19.1, with turnover reaching HKD 5.36 million.

The rally came after the Hong Kong-listed biotech announced that its investigational drug BJ044 — a recombinant form of ulinastatin developed through synthetic biology — has received clinical trial approval from China's National Medical Products Administration (NMPA).

The IND clearance allows Bao Pharma to begin human trials of BJ044, which the company says could be the only recombinant ulinastatin in China — and possibly the world — produced via synthetic biology.

A cleaner alternative

Ulinastatin, a protease inhibitor widely used in China to treat acute pancreatitis and other inflammatory conditions, has traditionally been extracted from human urine. That process relies on collecting and purifying urine — a non-standardized production method that carries risks of viral contamination and batch-to-batch quality inconsistency.

BJ044 aims to solve those problems. By using recombinant technology, the drug is designed to deliver higher purity, greater consistency, and a more scalable manufacturing process. The company says the approach also eliminates contamination risks and sidesteps the ethical concerns associated with traditional biochemical extraction from human sources.

What's at stake

If BJ044 succeeds in clinical trials, it could disrupt a market currently dominated by urine-derived products. The recombinant version promises to offer a safer, more cost-effective alternative — a potential game-changer for a drug class that millions of patients rely on each year.

The NMPA approval marks a key milestone for Bao Pharma as it moves BJ044 from the lab into the clinic. How the drug performs in human trials will determine whether synthetic biology can finally rewrite the rules for a decades-old therapy.