BAO PHARMA-B (02659) recently announced that the Investigational New Drug (IND) application for its self-developed recombinant Ulinastatin (BJ044) has been formally accepted by the National Medical Products Administration (NMPA). As a significant strategic move by the company in the field of recombinant protein drugs, this progress not only marks the transition of the classic clinical drug Ulinastatin into a recombinant form but also reflects continuous technological breakthroughs in China at the intersection of biopharmaceuticals and synthetic biology.
**A Global First: Technological Revolution from "Urine Extraction" to "Bio-Manufacturing"** Ulinastatin is a broad-spectrum protease inhibitor originally derived from human urine, belonging to the Kunitz-type protease inhibitor family. It functions by inhibiting the activity of various serine proteases, including trypsin and elastase. Its pharmacological effects extend beyond inhibiting proteolytic reactions to include stabilizing lysosomal membranes, reducing the release of inflammatory mediators, and modulating immune responses. Consequently, the drug is widely used clinically in the treatment of critical conditions such as acute pancreatitis, sepsis, systemic inflammatory response syndrome (SIRS), acute respiratory distress syndrome (ARDS), and acute circulatory failure.
However, currently marketed Ulinastatin products globally still primarily rely on extraction from healthy human urine. This traditional production method increasingly shows significant limitations within modern biopharmaceutical systems. On one hand, the urine source is constrained by collection systems and donor scale, leading to unstable raw material supply. On the other hand, the extraction process struggles to completely avoid potential viral contamination risks, while also exhibiting considerable batch-to-batch quality variation, posing challenges for quality control. Furthermore, this method faces inherent bottlenecks in scaling up production capacity, making it difficult to meet growing clinical demands.
In this context, leveraging its recombinant protein technology platform, BAO PHARMA has successfully achieved the engineered expression and scaled production of Ulinastatin. BJ044 has become the first recombinant Ulinastatin product globally to enter the clinical application stage, signifying a fundamental shift in the production paradigm for this drug from "biochemical extraction" to "bio-manufacturing." This technological approach not only enhances product quality consistency and safety but also provides a key solution for the long-term sustainable supply of such drugs.
**Clinical Value and Market Prospects: "Strategic Reserve" for Life Protection** From a pharmacological perspective, Ulinastatin plays a crucial role in various acute and critical illnesses by multi-target regulation of protease activity and inflammatory response networks. It not only inhibits inflammatory cascades but also potentially protects against multi-organ dysfunction by safeguarding vascular endothelium, improving microcirculation, and reducing cell apoptosis. For this reason, the drug has become a standard treatment for acute pancreatitis and is gradually being extended to clinical scenarios such as sepsis, shock, severe pneumonia, ARDS, as well as severe trauma, burns, and acute poisoning.
Within the critical care medical system, Ulinastatin is often regarded as an important supportive therapeutic agent. Particularly in high-mortality diseases, there is a clear correlation between its early application and improved patient outcomes. At the molecular level, BJ044 fully retains the multi-target anti-inflammatory and organ-protective functions of natural Ulinastatin. Simultaneously, through recombinant expression, it achieves higher purity, improved safety, and more stable supply capacity, thereby systematically optimizing product attributes based on the classic mechanism.
From a market perspective, Ulinastatin has established a relatively mature clinical application foundation in China. Data indicates that the Chinese Ulinastatin market size was approximately RMB 1.16 billion in 2023. Concurrently, by the end of 2023, China's population aged 65 and above reached about 217 million, accounting for 15.4% of the total population, indicating a continuing trend of population aging. Due to declining physiological function, the elderly are more susceptible to inflammation-related diseases such as acute pancreatitis, severe pneumonia, and ARDS, thereby driving increased demand for anti-inflammatory and organ-protective drugs. Against this backdrop, recombinant Ulinastatin, with its quality advantages and secure supply capability, is expected to gradually replace traditional extracted products and further expand its clinical application boundaries.
**Strategic Synergy: Dual-Driving Force of the Recombinant Technology Platform** The acceptance of the IND for BJ044 demonstrates clear strategic synergy with the clinical progress of the company's other key product, recombinant human chymotrypsin KJ101. KJ101, a recombinant protease drug developed based on synthetic biology, received clinical trial approval from the NMPA in February 2025. It is currently undergoing a Phase II clinical study (CTR20252263) targeting wound healing for various wounds, including burns, trauma, surgical incisions, pressure injuries, and diabetic foot ulcers. Furthermore, in March 2026, the product received an additional approval for the indication of "dissolving and removing gastric mucus during gastroscopy," further expanding its clinical application scenarios.
From a technological pathway perspective, BJ044 and KJ101 represent two major directions—protease inhibitors and protease drugs, respectively—forming a dual-core layout for the company within the "recombinant protein ecosystem." The simultaneous advancement of both not only demonstrates the company's platform capabilities in recombinant protein expression and purification technologies but also strengthens the feasibility and replicability of the core strategy of "recombinant replacement of extraction."
**Strategic Significance and Social Value: Safeguarding a Healthy China with Synthetic Biology** BAO PHARMA is committed to systematically addressing the long-standing challenges associated with traditional biochemical extraction drugs—such as safety, supply stability, and ethical compliance—through its focus on the "recombinant replacement of extraction" technological pathway. From a biosafety standpoint, recombinant technology can fundamentally avoid the risks of viruses or prions potentially carried by animal-derived or human-derived materials, thereby establishing a more reliable drug safety system. On the supply side, utilizing microbial fermentation and engineered production can eliminate dependence on upstream resources like urine or animal tissues, enabling scaled and controllable manufacturing, and enhancing the nation's capacity to secure critical drug supplies.
Regarding quality, recombinant technology enables high-purity expression and significantly reduces batch-to-batch variation, thereby improving the stability and predictability of clinical medication. Simultaneously, this pathway helps reduce potential immunogenicity risks, offering patients safer treatment options.
From an industrial development perspective, this technological route is expected to propel China's biopharmaceutical industry from a "catch-up development" model towards an "innovation-led development" model, establishing international competitiveness in the field of recombinant protease drugs.
Overall, the IND acceptance for BJ044 represents not just progress for a single product but signifies a technological direction with long-term strategic value. As synthetic biology and biopharmaceuticals deepen their integration, recombinant proteases and related drug systems are poised to play an increasingly important role in the future, providing continuous innovation momentum for the "Healthy China 2030" strategy.
**About BAO PHARMA** BAO PHARMA is an innovative biotechnology company that utilizes synthetic biology technology to develop and produce recombinant biologic drugs that are difficult to express through conventional genetic engineering, aiming to meet broad clinical needs. The company focuses on replacing traditional biochemical extraction drugs and upgrading existing therapies, having established a diversified product pipeline with differentiated characteristics. This pipeline covers areas such as large-volume subcutaneous administration, antibody-mediated autoimmune diseases, assisted reproduction, and replacing traditional biochemical products with recombinant biopharmaceuticals. Leveraging leading chassis cell construction capabilities, a stable commercial production system, and an experienced R&D team, BAO PHARMA is committed to becoming a pioneer in the global recombinant biologic drug field.
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