Beyond ADC and PD-1 Red Sea, how can Baoji Pharmaceutical find a “second growth curve” for biomedicine?

As China's biomedical industry enters an era where opportunities and challenges coexist, on the one hand, technological innovation and capital help drive the rapid development of the industry; on the other hand, intense homogenized competition has also made “internal volume” an inescapable keyword.

Meanwhile, hundreds of companies are crowded on popular target tracks such as ADC (antibody-conjugated drugs) and PD-1. In the midst of intense competition from the speed of clinical enrollment to future market pricing, Shanghai Baoji Pharmaceutical Co., Ltd. (hereinafter referred to as “Baoji Pharmaceutical”) chose a completely different strategic path of differentiation.

Based on addressing real and unmet clinical and market needs, Baoji Pharmaceutical's three core products — KJ103, KJ017, and SJ02 — which have entered the post-clinical stage, NDA registration and commercialization stages, have avoided the Red Sea such as ADC and PD-1, and have respectively targeted emergency treatment of fatal autoimmune diseases, revolutionary platforms for subcutaneous administration of biopharmaceuticals, and experience upgrades in the field of assisted reproduction.

From the perspective of a short clinical cycle, high market value certainty, and effective solutions to existing pain points, what unique value creation main line runs behind the three seemingly very different products, and how will they shape the future market pattern?

First aid “antidote” for emergency and severe illness: KJ103's best-in-class potential and clinical value

In the field of autoimmune disease treatment, especially dangerous conditions, antibody-mediated acute severe illness, and organ transplantation, there is a huge unmet clinical need. Existing treatments such as plasma replacement (PE) or high-dose immunoglobulin (IVIg) generally have limitations such as slow efficacy, complicated operation, high risk, and limited sources. The market urgently needs an intervention that can quickly, efficiently, and safely remove pathogenic antibodies.

Baoji Pharmaceuticals' KJ103 is a “best-in-class” (best-in-class) variety. With “the world's first and only low-reserve antibody IgG degrading enzyme”, it is a leading position in research and development in the field of kidney transplant desensitization, hundreds of IgG-mediated autoimmune diseases, including anti-GBM disease and Gillain-Barre syndrome (GBS), which do not meet clinical needs.

According to the Zhitong Finance App, KJ103, as a novel low reserve antibody IgG degrading enzyme, has a core mechanism of action that can quickly, specifically, and efficiently degrade all subtypes of pathogenic IgG antibodies in the body after entering the human body, solving the root causes of many acute and severe autoimmune diseases.

Compared to traditional treatments, KJ103's revolutionary advantage is that it is “fast.” According to phase I clinical trials, IgG levels can be reduced by more than 90% within 1 hour of administration, reduced by 95% within 6 hours, and maintained an average IgG reduction of 70% or more for 1 week. This lightning-fast onset and long-lasting inhibitory effect provides an essential “time window” for follow-up treatment of critical illnesses such as GBM disease and Guillain-Barre syndrome (GBS), and can be called the first aid “antidote” for antibody-mediated diseases.

At the same time, another key advantage of KJ103 is its “low reserve antibody”. Phase I clinical data shows that its pre-stored antibody ratio and titer are far lower than similar competitors already marketed in Europe around the world, which means higher safety, lower risk of hypersensitivity reactions, and repeated administration, thus broadening the treatment window and increasing clinical applicability.

Currently, its leading position and clinical value have been highly recognized by regulators. KJ103 has been granted “Breakthrough Therapy Certification” (BTD) by the State Drug Administration for both renal transplantation desensitization treatment and anti-GBM disease. This not only confirms the advanced nature of its technology, but is also expected to significantly speed up its review and approval process.

In terms of prospects, the market value of KJ103 is mainly reflected in three major areas:

1. The field of organ transplantation: In desensitization treatment of highly allergenic kidney transplants, kJ103 is expected to become the first IgG degrading enzyme approved in China, filling gaps in China, providing clinical solutions for a large number of patients without transplant conditions, and significantly increasing the success rate of transplantation. Its success in xenotransplantation preclinical research further indicates its huge potential in the field of cutting-edge medicine.

2. In the field of acute and severe self-preventable diseases: In serious diseases that are currently untreatable, such as fighting GBM disease and GBS, KJ103 can reverse the course of the disease within a few hours and avoid serious consequences such as organ failure or even death, and is expected to become a revolutionary standard treatment plan.

3. Broad-spectrum expansion potential: Its mechanism of action makes it theoretically useful for treating “hundreds of pathological IgG-mediated autoimmune diseases”. The potential of this “one medicine, multiple uses” “one disease type” platform has opened up huge room for imagination for its long-term value growth.

According to Frost & Sullivan's predictions, China's IgG degrading enzyme market is expected to reach 6.386 billion yuan in 2033. As the leader, KJ103 will undoubtedly occupy the core market share.

KJ017: An “all-in-one” enabling platform for the “decontamination” of Chinese biopharmaceuticals

In the global biopharmaceutical market, the transition from traditional intravenous injections (IV) to more convenient subcutaneous injections (SC) has become an irreversible trend. This is not only a leap forward in patient treatment experience, but also an inevitable choice for improving the efficiency of the medical system and meeting the development of pharmacoeconomics.

In this historic transformation, KJ017 (recombinant human hyaluronidase), the core product of Baoji Pharmaceutical, is playing the role of an enabling platform and critical infrastructure for Chinese biopharmaceuticals to “de-venealize” and “everything can be subcutaneously”.

Among them, the core mechanism of action of KJ017 is to temporarily degrade hyaluronic acid in subcutaneous tissue and instantly open up the “channel” of intercellular interstitial cells. This effect solves the “physical bottleneck” of biomacromolecular drugs such as monoclonal antibodies and ADCs due to large doses and high viscosity when injected subcutaneously, that is, the pain point where traditional subcutaneous injection (SC) volume is limited to 1-2 ml.

By using it in combination with KJ017, the treatment time of intravenous infusion (IV), which originally required 30 minutes to 7 hours, can be drastically reduced to only 2 to 5 minutes of subcutaneous injection. This revolutionary increase in efficiency has greatly improved the convenience and compliance of patients, and perfectly meets the needs of hospitals to “reduce costs and increase efficiency” such as DRG/DIP fee control. As a result, patients do not need to occupy expensive inpatient beds to perform long-term infusions.

The Zhitong Finance App learned that currently, KJ017 is “the first and only recombinant human hyaluronase” in China to enter the NDA stage, and is also “the third recombinant human hyaluronase in the world to reach the NDA stage or above,” breaking the US company Halozyme's global technology monopoly in one fell swoop. For many Chinese biopharmaceutical companies facing “patent cliffs” and “internal pressure,” the strategic value of KJ017 is self-evident:

·Strategic necessities: Upgrading major intravenous products to subcutaneous dosage forms is a strategic necessity for pharmaceutical companies to extend product life cycles, build new barriers, and withstand the impact of biosimilar drugs; ·Domestic substitution and supply chain safety: providing local pharmaceutical companies with only one or very few viable localization solutions to avoid dependence on expensive overseas technology; ·International standard recognition: KJ017 has completed the DMF filing with the US FDA, laying the foundation for its international cooperation A solid regulatory foundation.

Compared to the exclusive target licensing model adopted by Halozyme, Baoji Pharmaceutical has adopted an open cooperation model with non-exclusive targets, making it the only or very few options for local Chinese pharmaceutical companies to achieve product differentiation and extend the product life cycle. This business model binds the value of KJ017 to the sales share of the downstream 100 billion biopharmaceutical market and the supply of high-margin raw materials. The revenue is stable and the risk is extremely low.

According to Frost & Sullivan data, the global recombinant human hyaluronidase market is expected to reach 9.094 billion US dollars by 2033, while the Chinese market is expected to reach 6.980 billion yuan. Its application scenarios cover multiple dimensions:

The first is monotherapy, which is used for high-volume subcutaneous infusion of crystal solutions as an alternative to intravenous infusion, especially for children, the elderly, or critically ill patients who have difficulty finding venous blood vessels. The single drug market is expected to reach RMB 1,507 billion by 2033; the second is combined use with antibody drugs (such as cooperating with Quanxin Biotech, Shangjian, etc., to independently develop subcutaneous antibodies such as KJ015, BJ045, and BJ047) to improve dosage forms under the venous transdermal system;

Third, we are committed to developing subcutaneous antibiotics (such as BJ007, BJ008, and BJ009). This not only responds to the country's “transit restriction order”, but also penetrates the broad primary care market. It aims to cover the high-end and primary care markets to ensure recovery from droughts and floods. Furthermore, KJ017 has completed DMF registration with the US FDA, laying the regulatory foundation for its international cooperation.

As far as KJ017 is concerned, its market space does not depend on its own sales volume, but is deeply tied to the growth of the entire 100 billion biopharmaceutical market. Its business model can be called a typical “water seller” logic. The target US company HaloZyme has a market value of about 8 billion US dollars with its enhanze® platform; while South Korea's Alteogen reached an exclusive cooperation with MSD on the subcutaneous dosage form of K medicine to match the value of the company's other pipelines, the market value once soared to about 17 billion US dollars. As a leader in the Chinese market, KJ017's commercial potential is also immeasurable.

SJ02: Accurate card slots assist reproduction to reshape the market pattern with “experience upgrade”

In the dual social context of declining fertility rates and rising infertility rates, the assisted reproduction market in China is facing a continuous increase in demand. At the same time, the driving force of technological innovation is quietly shifting from simply pursuing success rates to improving patients' experience and quality of life throughout the treatment process.

As a long-acting recombinant human follicle-stimulating hormone (FSH) fusion protein, SJ02's core differentiating advantage lies in its “long-term” properties. In the ovulation promotion process of assisted reproduction, traditional short-acting FSH products require patients to inject continuously every day, which not only causes physical discomfort and psychological burden to patients, but also seriously affects treatment compliance.

However, through advanced molecular modification technology, SJ02 combines FSH with CTP (Carboxyl Terminal Peptide) stabilized peptides, significantly extending the half-life of the drug, so that a single injection can maintain efficacy for up to a week, and optimizes the frequency of injections that originally required “once a day” to “once a week, without reducing the effectiveness”. The breakthrough greatly reduced the treatment burden on patients, solved the pain points of compliance during assisted reproduction, and significantly improved the treatment experience.

The Zhitong Finance App learned that currently the SJ02 is the “first long-term FSH product approved for marketing” in China. In overseas markets, only one similar product is on the market, and it is difficult to enter the Chinese market in the short term. As a result, the market value and scarcity of products stand out.

According to Frost & Sullivan data, China's assisted reproductive drug market is expected to reach RMB 14.9 billion by 2033, while the overall size of the FSH market is expected to reach RMB 10.2 billion by 2033. As a long-acting formulation, SJ02 is expected to usher in a structural explosion. The long-term FSH market in China, where it is located, is expected to reach RMB 3.6 billion by 2033.

It is worth mentioning that although the previous licensing cooperation with Ogallon was terminated, the company quickly adjusted its commercialization strategy and signed an exclusive sales agency agreement with Anke Biotech, which has reproductive medicine channel resources, in July 2025, to be responsible for commercialization in Greater China and ensure its market launch speed and commercial potential.

Summary

The three core products of Baoji Pharmaceuticals—the KJ103, which breaks the situation in acute and severe cases, the platform-enabled KJ017, and the experience-upgraded SJ02 seem to belong to different treatment fields, but they all reflect the company's underlying development strategy of common origin.

On the one hand, the three major products of Baoji Pharmaceutical are not creating a new target out of thin air, but are fundamentally upgrading treatment methods that have been widely proven clinically. This strategy of “technology upgrade” and “drug administration improvement” abandons the common target chase model in the industry, makes the commercialization implementation cycle shorter and more certain, and effectively avoids the high risk of pure innovative drugs.

In terms of product positioning, all three target the scarce position of “China's first” or “global leader”, and are working together to address the clinical pain points of existing treatments, focusing on improving the quality of life and ease of administration of medication. At the same time, all three products are complex recombinant biopharmaceuticals, which rely on the company's core strengths in difficult enzyme engineering (industrial mass production of KJ017 and KJ103) and long-term fusion protein engineering (long-term transformation of SJ02).

Through their respective roles as “enablers,” “replacers,” and “first responders,” the three have jointly formed a commercial defense system with multiple sources of revenue, progress and retreat, and a stable foundation, thus forming the company's strategic foundation for long-term value during the critical period of global biomedicine from “local commercialization” to “innovative breakthroughs”.