Shanghai Bao Pharmaceuticals Wins NMPA Approval to Begin Clinical Trials of World's First Recombinant Ulinastatin BJ044
核心洞察
Shanghai Bao Pharmaceuticals (搜索) received NMPA IND approval for BJ044 (搜索), the world's first recombinant ulinastatin to enter clinical development.
BJ044 (搜索) addresses critical limitations of urine-derived ulinastatin, including viral contamination risks, quality inconsistencies, and supply constraints.
The Chinese ulinastatin market reached approximately 1.16 billion yuan in 2023, with growing demand driven by an aging population of 217 million aged 65 and above.
Shanghai Bao Pharmaceuticals (搜索) Co Ltd has received approval from China's National Medical Products Administration (NMPA) for the investigational new drug (IND) application of BJ044 (搜索) Injection, a recombinant ulinastatin developed via synthetic biology. The product is positioned as a globally leading candidate and may become the only recombinant ulinastatin of its kind in China and worldwide, marking a fundamental shift in production methods from biochemical extraction to bio-manufacturing.
A Technological Revolution: From Urine Extraction to Recombinant Expression
Ulinastatin is a broad-spectrum protease inhibitor belonging to the Kunitz-type protease inhibitor family, with the ability to inhibit various serine protease activities such as trypsin and elastase. Its pharmacological effects include stabilizing lysosomal membranes, reducing inflammatory mediator release, and modulating immune responses on multiple levels. The drug is widely used in the clinical treatment of critical conditions such as acute pancreatitis (搜索), sepsis (搜索), Systemic Inflammatory Response Syndrome (搜索) (SIRS), Acute Respiratory Distress Syndrome (搜索) (ARDS), and acute circulatory failure.
Currently marketed ulinastatin products globally still predominantly rely on extraction from healthy human urine. This traditional production method increasingly reveals significant limitations: raw material supply is constrained by collection systems and donor size, the extraction process struggles to fully avoid potential viral contamination risks, batch-to-batch quality variation poses challenges for quality control, and capacity expansion faces inherent bottlenecks.
BJ044 (搜索) successfully achieves engineered expression and scaled-up production of ulinastatin based on the company's recombinant protein technology platform. The product fully retains the multi-target anti-inflammatory and organ-protective functions of natural ulinastatin while achieving higher purity, enhanced safety, and more stable supply capabilities through recombinant expression.
Clinical Value and Market Prospects
From a pharmacological function perspective, ulinastatin plays a vital role in various acute and critical conditions by regulating protease activity and inflammation networks through multiple targets. It not only inhibits inflammatory cascade reactions but also protects vascular endothelium, improves microcirculation, and reduces cell apoptosis, potentially offering protective effects against multi-organ dysfunction. Within critical care medicine, ulinastatin is often regarded as an essential supportive therapeutic agent, particularly in high-mortality diseases where early application has been clearly linked to improved patient outcomes.
The Chinese ulinastatin market size was approximately 1.16 billion yuan in 2023. As of the end of 2023, the population aged 65 and above in China reached about 217 million, accounting for 15.4% of the total population, with the aging trend continuing to intensify. Due to declining bodily functions, the elderly are more prone to inflammation-related diseases such as acute pancreatitis (搜索), severe pneumonia, and ARDS, driving demand for anti-inflammatory and organ-protective drugs.
Strategic Synergy with the Recombinant Protein Platform
The acceptance of BJ044 (搜索)'s IND application forms a clear strategic synergy with the clinical progress of the company's other key product, recombinant human chymotrypsin KJ101. KJ101 received clinical trial approval from the NMPA in February 2025 and is currently conducting Phase II clinical research for wound healing applications, including burns, trauma, surgical incisions, pressure injuries, and diabetic foot ulcers. In March 2026, this product was newly approved for an indication to dissolve and remove gastric mucus during endoscopy.
BJ044 (搜索) and KJ101 respectively represent the two major directions of protease inhibitors and protease drugs, forming the dual-core layout within the company's recombinant protein ecosystem. The simultaneous advancement of both products demonstrates the company's platform capabilities in recombinant protein expression and purification technologies.
Strategic Significance for Biopharmaceutical Innovation
Baoji Pharmaceuticals focuses on the technical pathway of "recombinant replacement of extraction," committed to systematically addressing long-term challenges faced by traditional biochemical extraction-based drugs in safety, supply stability, and ethical compliance. From a biosafety perspective, recombinant technology can eliminate the risks of viruses or prions potentially carried by animal- or human-derived materials at the source. On the supply side, microbial fermentation and engineered production eliminate dependence on upstream resources such as urine or animal tissues, enabling scalable and controllable production.
Management cautions that development and commercialization outcomes remain uncertain for investors. Nevertheless, the acceptance of BJ044 (搜索)'s IND application represents not only the progress of a single product but a technologically significant direction with long-term strategic value, potentially strengthening China's biopharmaceutical industry's transition from a follower model to an innovation-driven leadership model in the field of recombinant protease drugs.