Boji Pharmaceutical (02659) restructured the IND application of Ustekinumab (BJ044) and received acceptance, opening a new era of recombinant protein drugs.

Recently, Baoji Pharmaceutical (02659) announced that the company's independently developed recombinant ulinastatin (BJ044) clinical trial application (IND) has formally been accepted by the National Medical Products Administration (NMPA). As an important layout in the field of recombinant protein drugs, this development not only signifies the transition of ulinastatin, a classic clinical drug, into the recombinant phase, but also reflects the continuous technological breakthroughs in the intersection of biopharmaceuticals and synthetic biology in China. Global innovation: from "urine extraction" to "biological intelligent manufacturing" technology revolution Ulinastatin is a broad-spectrum protease inhibitor derived from human urine, belonging to the Kunitz-type protease inhibitor family, with the ability to inhibit various serine protease activities such as pancreatic elastase. Its pharmacological effects include not only inhibiting protein hydrolysis reactions but also stabilizing lysosomal membranes, reducing the release of inflammatory mediators, and regulating immune responses on multiple levels. Therefore, this 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, the currently marketed ulinastatin products worldwide still primarily rely on extraction from urine of healthy individuals, a traditional production method that has shown significant limitations in the modern biopharmaceutical system. On one hand, urine source collection is limited by collection systems and donor scales, leading to insufficient raw material supply stability; on the other hand, extraction processes are difficult to completely eliminate potential risks of viral contamination, while batch-to-batch quality variations pose challenges to quality control. Additionally, this route also faces natural bottlenecks in capacity expansion, making it difficult to match the growing clinical demand. Against this backdrop, Baoji Pharmaceutical has successfully achieved the engineering expression and scale production of ulinastatin through its recombinant protein technology platform. BJ044 has become the world's first recombinant ulinastatin product to enter the clinical filing stage, marking a fundamental shift in production methods from "biochemical extraction" to "biological intelligent manufacturing". This technological approach not only enhances the consistency and safety of the product but also provides a key solution for the long-term sustainable supply of such drugs. Clinical value and market prospects: "strategic reserve" guarding the front line of life From a pharmacological functional perspective, ulinastatin plays an important role in multiple critical conditions by regulating protease activity and the inflammatory response network through multiple targets. It not only inhibits inflammatory cascade reactions but can also protect vascular endothelium, improve microcirculation, and reduce cell apoptosis, potentially providing protective effects against multi-organ dysfunction. As a result, the drug has become a standard treatment for acute pancreatitis and has gradually expanded to clinical scenarios such as sepsis, shock, severe pneumonia, ARDS, severe trauma, burns, and acute poisoning. In critical care medicine systems, ulinastatin is often seen as an important supportive therapeutic agent, particularly in high mortality diseases, where there is a clear association between its early use and patient prognosis improvement. At the molecular level, BJ044 retains the multi-target anti-inflammatory and organ protective functions of natural ulinastatin, while achieving higher purity, better safety, and more stable supply capacity through recombinant expression, thereby optimizing product attributes based on classical mechanisms. From a market perspective, ulinastatin has established a mature clinical application foundation in China. Data shows that the ulinastatin market in China is expected to reach approximately 11.6 billion yuan by 2023. At the same time, by the end of 2023, the population aged 65 and above in China had reached about 217 million, accounting for 15.4% of the total population, and the aging population trend continues to intensify. Due to the decline in bodily functions, the elderly are more prone to inflammatory-related diseases such as acute pancreatitis, severe pneumonia, and ARDS, driving the demand for anti-inflammatory and organ protective drugs. In this context, recombinant ulinastatin, with quality advantages and supply guarantees, is expected to gradually replace traditional extraction products and further expand its clinical application boundaries. Strategic synergy: dual-drive of recombinant technology platform The acceptance of IND for BJ044, along with the clear strategic synergy with the company's other key product recombinant human plasminogen KJ101, forms a distinct strategic synergy. KJ101, a recombinant protease drug developed based on synthetic biology, received clinical trial approval from NMPA in February 2025 and is currently conducting phase II clinical research (CTR20252263) for wound healing (including burns, trauma, surgical incisions, pressure ulcers, diabetic foot ulcers, etc.). In addition, the product obtained an additional indication in March 2026 for "dissolving and removing gastric mucosa during gastroscopy", further expanding its clinical application scenarios. From a technological path perspective, BJ044 and KJ101 represent the two major directions of protease inhibitors and protease drugs, respectively, forming the dual-core layout of the company in the "recombinant protein ecosystem". Their simultaneous advancement not only reflects 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 Baoji Pharmaceutical is dedicated to systematically addressing the long-term challenges of traditional biochemical extraction drugs in safety, supply stability, and ethical compliance through the technical path of "recombinant replacement of extraction". From a biological safety perspective, recombinant technology can avoid potential virus or prion risks carried by animal or human-derived materials from the source, establishing a more reliable drug safety system. On the supply side, through microbial fermentation and engineering production, the company can overcome its reliance on upstream resources such as urine or animal tissues, achieve scaled and controllable production, and enhance the assurance capability of critical national drugs. On the quality level, recombinant technology can achieve high purity expression and significantly reduce batch-to-batch variations, thereby improving the stability and predictability of clinical drug use. At the same time, this path also helps reduce potential immunogenicity risks, providing patients with safer treatment choices. From an industrial development perspective, this technological route has the potential to drive China's biopharmaceutical industry from "follower-type development" to "innovation-led development", establishing international competitive advantages in the field of recombinant protease drugs. Overall, the acceptance of IND for BJ044 is not just an advancement of a single product but represents a technology direction with long-term strategic value. With the deep integration of synthetic biology and biopharmaceuticals, the recombinant protease and related drug systems are expected to play a more important role in the future, providing continuous innovative driving force for the "Healthy China 2030" strategy. About Baoji Pharmaceutical Baoji Pharmaceutical is an innovative biotechnology company focused on developing and producing recombinant biopharmaceuticals that are difficult to express through conventional genetic engineering using synthetic biology technology to meet the clinical needs. The company focuses on replacing traditional biochemical extraction drugs and upgrading existing therapies, forming a differentiated product pipeline covering large volume subcutaneous administration, antibody-mediated autoimmune diseases, assisted reproduction, and replacing traditional biochemical products with recombinant biopharmaceuticals. With leading chassis cell construction capabilities, a stable commercial production system, and an experienced R&D team, Baoji Pharmaceutical is committed to becoming a pioneer in the global field of recombinant biopharmaceuticals.