BAO PHARMA-B (ASX: 02659) has announced that on June 29, 2026, the Investigational New Drug (IND) application for its self-developed, globally leading BJ044 injection (recombinant ulinastatin, BJ044) was approved by China's National Medical Products Administration.

The approval permits the initiation of clinical trials for the candidate, which was developed using synthetic biology. BJ044 is potentially the only recombinant ulinastatin developed via synthetic biology in China and possibly globally.

Ulinastatin, also known as bikunin, is a glycoprotein with potent inhibitory activity, first discovered in human urine in 1909. It is widely used to treat acute pancreatitis and acute exacerbations of chronic recurrent pancreatitis, as well as acute circulatory failure.

Due to its effective enzyme inhibition and anti-inflammatory properties, ulinastatin has broad applications in treating a range of major and life-threatening conditions, demonstrating good clinical efficacy. These conditions include sepsis, severe pneumonia, acute respiratory distress syndrome (ARDS), acute poisoning, severe heatstroke, burns, and major trauma.

Currently marketed ulinastatin products derived from human urine rely on a non-standardized production process involving urine collection and purification. This carries risks of viral contamination and inconsistent quality between batches.

In contrast, recombinant forms of ulinastatin, such as BJ044, are designed to overcome these limitations by offering a more stable, efficient, and scalable production method.

The recombinant technology employed for BJ044 minimizes contamination risks and enhances clinical safety. It offers advantages including high purity, consistent quality, and significant cost-effectiveness, while also eliminating the ethical concerns associated with traditional biochemical extraction methods.