Beyond the Red Sea of ADC and PD-1, how can Baoji Pharmaceutical Industry find the "second growth curve" of biopharmaceuticals?

As China's biopharmaceutical industry enters an era of opportunities and challenges, on one hand, technological innovation and capital are driving the industry's rapid development; on the other hand, intense competition is making "internal competition" an unavoidable keyword. In the race for popular targets such as ADCs (antibody-drug conjugates) and PD-1, hundreds of companies are crowded in for competition. In this highly competitive environment, Shanghai Baohai Pharmaceutical Co., Ltd. (referred to as "Baohai Pharmaceutical") has chosen a completely different path of differentiation. Focusing on addressing real and unmet clinical and market needs, Baohai Pharmaceutical has three core products in late-stage clinical development, NDA registration, and commercialization KJ103, KJ017, and SJ02. These products avoid the crowded ADC and PD-1 spaces and instead target urgent treatments for life-threatening autoimmune diseases, a revolutionary platform for subcutaneous administration of biologics, and an enhancement of the reproductive assistance field. Starting from the perspective of short clinical cycles, high market value certainty, and effective solutions to existing pain points, these seemingly diverse products share a unique value creation mainline. How will they shape the future market landscape? The emergency lifesaving "antidote" for acute autoimmune diseases: KJ103's Best-in-Class potential and clinical value In the field of autoimmune disease treatment, especially in life-threatening conditions, there is a great unmet clinical need. Existing therapies such as plasma exchange (PE) or high-dose immunoglobulin therapy (IVIg) have limitations such as slow onset, complexity of operation, high risk, and limited sources. The market urgently needs an intervention that can rapidly, efficiently, and safely clear pathogenic antibodies. Baohai Pharmaceutical's KJ103 is a "Best-in-Class" large molecule with the distinction of being the "first and only low pre-formed antibody IgG-degrading enzyme to reach the registered clinical stage globally." It has a leading position in the research and development of IgG-mediated autoimmune diseases such as kidney transplant desensitization, anti-GBM disease, and Guillain-Barr syndrome, addressing unmet clinical needs in these areas, aiming at this critical emergency care area. KJ103, as a new type of low pre-formed antibody IgG-degrading enzyme, can enter the body and rapidly, specifically, and efficiently degrade all subtypes of pathogenic IgG antibodies, solving the root cause of many acute autoimmune diseases. Compared to traditional therapies, KJ103's revolutionary advantage lies in its speed. Phase I clinical trials have shown that IgG levels can be reduced by over 90% within 1 hour of administration, 95% within 6 hours, and maintained at over 70% reduction on average for up to a week. This rapid onset and sustained inhibitory effect provide a crucial "time window" for the subsequent treatment of critical conditions such as anti-GBM disease and Guillain-Barr syndrome. Another key advantage of KJ103 is its "low pre-formed antibodies." Phase I clinical data shows that its levels of pre-existing anti-drug antibodies and titers are much lower than those of similar products already on the market in Europe, indicating higher safety, lower risk of hypersensitivity reactions, and the ability for repeat dosing, thus widening the treatment window and increasing clinical applicability. Its leading position and clinical value have been highly recognized by regulatory authorities. KJ103 has been granted breakthrough therapy designation (BTD) by the National Medical Products Administration for the treatment of kidney transplant desensitization and anti-GBM disease, underscoring its advanced technology and the potential for a significant acceleration in the evaluation and approval process. In terms of prospects, KJ103's market value mainly lies in three areas: 1. Organ Transplantation: In the field of high sensitization kidney transplant desensitization, KJ103 is expected to become the first approved IgG-degrading enzyme in China, filling a domestic gap and providing clinical solutions for a large number of patients who are not eligible for transplantation, significantly increasing the success rate of transplants. Its success in preclinical research on xenotransplantation also foreshadows its enormous potential in cutting-edge medical fields. 2. Emergency Autoimmune Diseases: In severe diseases such as anti-GBM disease and Guillain-Barr syndrome with no available treatments, KJ103's rapid onset advantage can reverse the disease process within hours, avoiding organ failure and even death, potentially becoming a revolutionary standard treatment. 3. Broad Expansion Potential: Its mechanism of action theoretically allows it to be used to treat "hundreds of pathological IgG-mediated autoimmune diseases." This "one-drug multi-use" platform potential opens up huge imaginative space for its long-term value growth. According to Frost & Sullivan forecasts, the Chinese IgG-degrading enzyme market is expected to reach 6.38 billion RMB by 2033, with KJ103 as the leader undoubtedly occupying a core market share. KJ017: China's biopharma "devenulization" "versatile" enabling platform In the global biopharmaceutical market, the transition from traditional intravenous injection (IV) to more convenient subcutaneous injection (SC) for large molecule drugs has become an irreversible trend. This not only represents a leap in patient treatment experience but also enhances medical system efficiency and aligns with the development of pharmacoeconomics. In this historic transformation, Baohai Pharmaceutical's core product, KJ017 (recombinant human hyaluronidase), plays a role in enabling China's biopharmaceutical industry to achieve "devenulization" and "all can be subcutaneous" empowering platform and key infrastructure. The core mechanism of KJ017 is the temporary degradation of hyaluronic acid in subcutaneous tissue, instantaneously opening the "channel" between cells. This action solves the "physical bottleneck" encountered by biologic molecules such as monoclonal antibodies and ADCs during subcutaneous injections due to high viscosity and large volume, restricting traditional subcutaneous injections to 1-2 milliliters. By using KJ017 in combination, the treatment time that originally required 30 minutes to 7 hours of intravenous infusion (IV) can be significantly reduced to just 2 to 5 minutes of subcutaneous injection. This revolutionary efficiency improvement greatly enhances patient convenience, compliance, and perfectly aligns with hospital reimbursement strategies like DRG/DIP, reducing the need for expensive inpatient beds for long infusion times. Currently, KJ017 is the "first and only recombinant human hyaluronidase to enter the NDA stage in China" and also the "third recombinant human hyaluronidase to reach the NDA stage or above globally", breaking the global technical monopoly of US-based Halozyme. For many Chinese biopharmaceutical companies facing "patent cliffs" and competitive pressures, the strategic value of KJ017 is evident: Strategic Necessity: Upgrading major intravenous injection products to a subcutaneous dosage form is a strategic necessity for companies to extend product life cycles, build new barriers, and defend against biosimilars; Domestic Replacement and Supply Chain Security: It provides a unique or one among few feasible domestic solutions for local companies, avoiding dependence on expensive overseas technology; International Standard Recognition: KJ017 has completed a DMF filing with the US FDA, laying a solid regulatory foundation for international collaborations. Unlike Halozyme's exclusive target licensing model, Baohai Pharmaceutical adopts an open collaboration model for target non-exclusivity, making it the only or one of the few Chinese local companies to offer differentiated products to extend product life cycles. This business model binds the value of KJ017 to downstream sales shares in the multibillion-dollar biopharmaceutical market and provides high-margin raw material supplies, ensuring stable income and low risk. According to Frost & Sullivan data, the global recombinant human hyaluronidase market is expected to reach $9.094 billion by 2033, with the Chinese market expected to reach 6.98 billion RMB. Its application scenarios cover multiple dimensions: One is monotherapy, used for large-volume subcutaneous infusion of crystal solutions as an alternative to intravenous infusion, particularly suitable for pediatric, elderly, or critically ill patients who are difficult to find veins. Its monotherapy market is expected to reach 1.507 billion RMB by 2033; Second is combination with monoclonal antibody drugs (e.g. in collaboration with companies such as Qilu Bio, Shangjian, or independent development of KJ015, BJ045, BJ047, and other subcutaneous antibodies) to improve dosage forms for intravenous to subcutaneous drug delivery; Third is the development of subcutaneous antibiotics (such as BJ007, BJ008, BJ009), which not only comply with the national "restriction order" but also tap into the vast primary healthcare market, aiming to cover both high-end and grassroots markets for stable performance. In addition, KJ017 has completed a DMF registration filing with the US FDA, laying the regulatory foundation for international collaborations. For KJ017, its market space is not determined by its own sales volume but is tied to the growth depth of the entire billion-dollar biopharmaceutical market, making its business model a typical "water seller" logic. Compared to Halozyme, with its ENHANZE platform, valued at around $8 billion, and South Korea's Alteogen, with a market value soaring to around $17 billion through an exclusive collaboration with Merck on K drug subcutaneous formulations, KJ017 as the leader in the Chinese market also has immeasurable commercial potential. SJ02: Precision positioning in reproductive assistance, reshaping the market landscape with "experience enhancement" Against the backdrop of declining birth rates and increasing infertility rates, China's assisted reproductive market is experiencing continuous growth in demand. Meanwhile, the technological innovation DRIVE is quietly shifting from a focus solely on success rates to enhancing patient experiences and quality of life throughout the treatment process. As a long-acting recombinant follicle-stimulating hormone fusion protein, SJ02's core differentiating advantage lies in its "long-acting" property. In the ovulation induction process of assisted reproduction, traditional short-acting FSH products require patients to receive daily injections, causing physical discomfort and psychological burden, and greatly impacting treatment compliance. SJ02 incorporates FSH with C-terminal peptide (CTP) fusion through advanced molecular reengineering techniques, significantly extending the drug's half-life in the body, enabling a single injection to maintain efficacy for up to a week. This optimization reduces the injection frequency from "once daily" to "once a week, maintaining efficacy without reducing injections," dramatically reducing the treatment burden for patients, addressing compliance issues in assisted reproduction, and significantly improving treatment experience. Currently, SJ02 is the "first long-acting FSH product approved for market in China", and internationally, there is only one similar product on the market, making it a scarce product with outstanding market value. According to Frost & Sullivan data, the Chinese market for assisted reproductive medicines is expected to reach 14.9 billion RMB by 2033, with the overall FSH market expected to reach 10.2 billion RMB. SJ02, as a long-acting formulation, is expected to undergo structural expansion; the Chinese long-acting FSH market is expected to reach 3.6 billion RMB by 2033. It is worth mentioning that despite the termination of the licensing cooperation with Origene, the company quickly adjusted its commercialization strategy and signed an exclusive sales agent agreement with Anhui Anke Biotechnology, which has reproductive medical channel resources in July 2025. This agreement, covering the Greater China region, ensures the speed of market landing and commercial potential. In summary Baohai Pharmaceutical's three core products the breakthrough-oriented KJ103 for acute autoimmune diseases, the platform-empowered KJ017, and the experience-enhancing SJ02 although belonging to different treatment areas, collectively reflect the company's underlying development strategy. On one hand, these three products from Baohai Pharmaceutical are not creating a completely new target from scratch; instead, they are fundamentally upgrading treatment methods that have been widely validated clinically. This strategy of "technological upgrade" and "dosage form improvement" abandons the common target chasing model in the industry, making the commercialization cycle shorter and more certain, effectively avoiding the high risks associated with innovative drugs. In terms of product positioning, all three target a "China-first" or "global-leading" scarce position and focus on solving clinical pain points of existing therapies, focusing on improving quality of life and drug convenience. At the same time, all three products are complex recombinant biologics, relying on the company's core Know-How in high-difficulty enzyme engineering (for industrialized mass production of KJ017 and KJ103) and long-acting fusion protein engineering (for the long-acting transformation of SJ02). Each product plays a role as an "enabler," "alternative," or "emergency responder", forming a diversified revenue source, adaptable, stable, and robust business defense system collectively. This foundation establishes a strategic cornerstone for long-term value creation for the company during the critical period of transitioning from "local commercialization" to "innovation breakthrough" in the global biopharmaceutical industry.