BAO PHARMA-B(02659): Clinical trial application for BJ044 injection (recombinant ustekinumab) has been approved by the National Medical Products Administration.

BAO PHARMA-B (02659) announced that on June 29, 2026, the company's independently developed and globally leading recombinant urokinase BJ044 injection (recombinant urokinase, BJ044) clinical trial application (IND) has been approved by the National Medical Products Administration of the People's Republic of China (NMPA) and granted permission to conduct clinical trials. BJ044 may be the only recombinant urokinase developed through synthetic biology in China and even globally. Urokinase, also known as bikunin, is a glycoprotein with strong inhibitory activity, first discovered in human urine in 1909. Urokinase can be widely used to treat acute pancreatitis, acute exacerbations of chronic recurrent pancreatitis, and acute circulatory failure. With its effective enzyme inhibition and anti-inflammatory properties, urokinase has been widely used in the treatment of a range of major life-threatening diseases and has shown good clinical efficacy, including sepsis, severe pneumonia, acute respiratory distress syndrome (ARDS), acute poisoning, severe heatstroke, burns, and severe trauma. Currently available urokinase products derived from human urine rely on a non-standardized production process of collecting and purifying urine, which carries the risk of viral contamination and inconsistent quality between batches. In contrast, recombinant forms of urokinase (such as BJ044) aim to overcome these limitations, providing a more stable, more efficient, and more scalable production method. The recombinant technology used in BJ044 minimizes contamination risks and enhances the safety for clinical use, offering advantages such as high purity, good consistency, and significant cost-effectiveness, while eliminating ethical issues associated with traditional biochemical extraction methods.