Baoji Pharmaceutical (02659) Differentiated pipelines create a deep moat and open up a “poor perception” market

Zhitongcaijing · 2d ago

For Hong Kong stock 18A biotech companies, a simple target-following and energy-intensive R&D model is no longer sustainable. The market urgently needs to find high-quality targets with differentiated pipelines, clear commercialization paths, and strong financial security.

Recently, Baoji Pharmaceutical (02659) announced its results for the first half of 2026. In this mid-term questionnaire, Baoji Pharmaceutical not only reduced losses at the financial level, but also ushered in an explosive period of more flowering in terms of commercialization and international layout.

According to data, in the first half of 2026, the company's losses during the period narrowed to 154 million yuan, a sharp decrease of 16.1% over the previous year, showing excellent operating efficiency and refined management level in the current industry context. At the same time, the company held up to 1,042 billion yuan in cash and cash equivalents at the end of the period, and had sufficient book capital, providing a rich capital moat for the promotion and commercialization of the subsequent clinical pipeline. The company achieved continuous optimization of its revenue structure in the first half of the year, and also used real money to verify the commercial expansion capabilities of its core technology platform.

R & D towards commercial implementation: Shengnova® and Baoshuyi® accelerate volume, and platform-based revenue is beginning to appear

According to the Zhitong Finance App, in the first half of 2026, Baoji Pharmaceutical further ushered in a good harvest period of commercialization. Two major products were introduced to the market one after another, marking the company's official entry into the fast track of commercialization and international two-wheel drive.

This is also the first key to understanding Baoji Pharmaceuticals' 2026 interim results. Over the past few years, the company's greatest value has been to establish a technology and product system for recombinant biopharmaceuticals around high-volume subcutaneous administration, antibody-mediated autoimmune diseases, assisted reproduction, and synthetic biological upgrading.

According to the 2025 annual report, the company had 12 independently developed candidate products at the time, of which KJ017, SJ02, and KJ103 formed the core product echelon. By the first half of 2026, these three products have each reached different stages of “approval for listing, preparation for commercial release, and key clinical implementation”.

Among them, changes in KJ017 are particularly noteworthy. The Zhitong Finance App learned that in March 2026, injecting human hyaluronidase KJ017, or Baoshuyi®, was approved for marketing by the State Drug Administration to aid subcutaneous infusion, making it the first recombinant human hyaluronidase product approved for marketing in China. During the reporting period, the company and Shanghai Laishi launched strategic cooperation on new dosage forms of blood products. At the same time, more than 60 partners have used the company's recombinant hyaluronase for product development. The scope of cooperation covers from early research to clinical stage.

As we all know, traditional intravenous infusions require the establishment of intravenous channels, and hyaluronidase can temporarily change the permeability of subcutaneous tissue to create conditions for subcutaneous administration of large volumes of liquids and other drugs. Therefore, as a product that is expected to move towards a platform, KJ017's real market space comes partly from its commercialization as an adjuvant subcutaneous infusion drug, and partly from its use as a “de-venous” technology platform, providing new delivery routes for other biopharmaceuticals, blood products, and even some chemical drugs.

Today, this platform attribute has begun to be reflected through collaboration. In January of this year, the company reached a strategic cooperation with Shanghai Laishi for new dosage forms of blood products. In the past, it has also established cooperative relationships with Yao Ming Biotech, Quanxin Biotech, and Shang Jian. If more macromolecular drugs are administered subcutaneously through hyaluronidase in the future, the value of KJ017 may expand from single product sales to a diversified revenue model of “product+technical service+supply”. This also echoes the sharp year-on-year increase in the company's technical service revenue in the first half of the year.

Another Shengnova®, which has already entered the commercialization stage, represents another path for Baoji Pharmaceutical's transformation from an R&D enterprise to a commercial enterprise.

The Zhitong Finance App learned that SJ02 is the first long-term recombinant human follicle-promoting hormone approved for marketing in China. The half-life of FSH is extended through structural modification. A single injection can replace traditional short-acting FSH administration for 7 consecutive days, converting daily injections to once a week, greatly improving the convenience and treatment experience for patients.

In terms of commercialization, Baoji Pharmaceutical has adopted an extremely intelligent external partnership strategy to grant exclusive promotion and sales rights for Shengnova® in Greater China to Anke Biotech (300009.SZ), which has accumulated deep reproductive channels in women. Under the efficient impetus of Anke Biotech as an exclusive contract sales organization, as of June 30, 2026, Shenova® has successfully completed online procurement platform connectivity and market access in 29 provinces across the country, successfully covered more than 70 medical institutions, and has fully launched actual commercial sales. It is achieving terminal deployment at a very rapid pace, contributing a steady stream of performance cash flow to the company.

At the same time, at the European development level, the company also plans to submit a clinical trial application (IND) for Shenova® to the European Medicines Agency (EMA) to unleash its global commercial value at full speed.

This means that Baoji Pharmaceutical is no longer simply a biotech waiting for product approval, but has begun to enter a more complex stage of commercialization, such as hospital admission, doctor education, patient awareness, and commercial channel construction. Especially for assisted reproduction products, the efficacy of the product is only part of the competition. Doctors' familiarity with new products, patients' approval of the convenience of medication use, and the establishment of hospital procurement and prescription systems also determine the speed of product release.

Seen from this perspective, the narrowing of losses in the first half of 2026 is certainly positive, but what is really worth noting is that the company already has two commercial products, and KJ103 is becoming the third most imaginable growth curve. The three core products deal with “subcutaneous drug delivery platforms,” “assisted reproduction,” and “antibody-mediated autoimmune diseases,” respectively. Among them, products are not simply parallel relationships, but rather form a certain synergy in underlying capabilities such as recombinant proteins, synthetic biology, and innovation in dosage methods.

The value of synthetic biology platforms is gradually showing, and Blue Ocean indications fill clinical gaps

If the approval of Shengnova® and Baoshuyi® will determine the “chassis” of Baoji Pharmaceutical's commercial revenue in the next few years, then the breakthrough of KJ103 and the advancement of synthetic biology upgrade platforms are more likely to determine the company's valuation limit.

The Zhitong Finance App learned that in mid-2026, KJ103, the core product independently developed by Baoji Pharmaceutical, ushered in a landmark clinical report: its Phase III registered clinical trial for desensitization treatment of highly sensitive kidney transplant patients successfully reached the main end.

The data showed that in this trial, the success rate of desensitization treatment for patients with high sensitivity reached 100.0% before kidney transplantation, and the success rate of subsequent kidney transplantation also reached 100.0%, and no cases of hyperacute rejection occurred.

In May 2026, the company officially submitted an NDA application for KJ103 to the National Drug Review Center, and was included in the priority review process in the same month. The marketing license application was officially accepted in June of the same year, and it is expected to be officially approved for listing in 2027. The acceptance and priority review by the State Drug Administration also means that KJ103 has moved from “technical feasibility verification” to “countdown for commercialization approval.”

It is worth mentioning that judging from the market space, kidney transplantation desensitization is a blue ocean of immediate need that has been seriously overlooked for a long time. According to the Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology, about 15% to 30% of patients with terminal kidney disease registered in China are in a “highly allergic state” due to pre-existing antibodies in their bodies. Due to the presence of highly allergenic antibodies, matching is extremely difficult. Once forcibly transplanted, it will lead to a devastating hyperacute rejection reaction. As a result, they were determined to be “untransplantable patients” and can only barely survive through long-term dialysis.

Looking at overall supply and demand, the clinical gap in this market is also very obvious. The National Health Commission's Human Tissue and Organ Transplantation and Medical Big Data Center revealed that as of October 2024, there were about 171,000 organ failure patients awaiting transplantation across the country, of which 144,700 were waiting for kidney transplants, and the ratio of organ supply to demand reached 1:8.36. Earlier public information from the Yunnan Health and Health Commission also showed that there were more than 1 million uremia patients requiring dialysis in China, while the number of kidney transplants in 2023 was only over 13,000.

Therefore, the meaning of KJ103 is not simply to participate in a limited-scale kidney transplant drug market, but rather to enter the most scarce link in the kidney transplantation industry chain — so that patients who originally had difficulty finding suitable kidney donors due to antibody issues can get more transplant opportunities.

For highly allergic patients, if desensitization treatment can effectively reduce the level of pathogenic antibodies, it may expand the range of admissible renal donors and shorten the waiting time. In other words, KJ103 solves the problem of “there is a kidney donation but the patient cannot successfully accept it”, and its clinical value and economic value are significantly higher than ordinary adjuvant treatment drugs.

Prior to KJ103, there was no approved desensitization treatment in the domestic market, and there was no standard clinical desensitization method. Given KJ103's absolute leading edge in this indication and breakthrough therapy identification (BTD), the product will quickly fill this huge clinical and market gap after launch.

What is more noteworthy is that KJ103 is not only an indication for kidney transplantation; its expansion in the field of pathological autoimmune diseases such as anti-glomerular basement membrane (GBM) disease is also advancing by leaps and bounds.

According to the Zhitong Finance App, fighting GBM disease is another typical “small disease, big value” market. This disease is a rare but rapidly progressing autoimmune disease. Anti-GBM antibodies in patients attack the glomerular basement membrane and may also cause pulmonary hemorrhage. Traditional treatment mainly relies on plasma replacement, glucocorticoids, and cyclophosphamide. One of the treatment goals is to remove pathogenic antibodies from circulation as soon as possible and inhibit further production.

However, the real problem is that anti-GBM disease is not a disease that is “treated slowly”. Once patients have severe kidney failure or even need dialysis, the room for recovery of kidney function will drop significantly. Previous studies have shown that patients who were already dependent on dialysis at the onset of the disease had a 1-year survival rate of about 65%, and the kidney survival rate was only about 8%. This means that for fighting GBM disease, “rapidly reducing pathogenic antibodies” itself is an important part of the therapeutic value.

And the KJ103 phase II data just hit this clinical pain point. Research results disclosed by the company showed that the overall survival rate of KJ103 after 3 months of treatment was 100%, of which 66.7% of patients did not need dialysis and preserved kidney function; the overall survival rate was still 100% after 6 months of treatment, and 75% of patients did not need dialysis and preserved kidney function.

In contrast, in the historical standard intensive treatment data used by the company, the 3-month overall survival rate was 81.2%, and the proportion that did not require dialysis and preserved kidney function was 30.6%. The relevant results were presented at the 63rd Annual Meeting of the European Kidney Association in June 2026.

Of course, it must be emphasized here that historical comparison is not equivalent to a randomized controlled clinical trial. It cannot simply be determined that KJ103 has been comprehensively superior to existing standard treatments based on this. Future phase III results will still be the key to determining the final clinical value of the product. However, judging from the mechanism, clinical requirements, and early data, KJ103 does have the potential to form a differentiated treatment plan.

In addition to kidney transplant desensitization and anti-GBM disease, KJ103 is also promoting GBS, or pathogenic IgG-mediated diseases such as Guillain-Barre syndrome. In August 2026, the company further submitted an application for GBS orphan drug qualification to the FDA. This means that the company is trying to transform KJ103 from a single nephropathy drug into a platform-based treatment product for “pathogenic IgG.”

It is also worth observing that in June 2026, the company promoted recombinant urastatin BJ044 to obtain IND approval from the National Drug Administration. BJ044 is positioned by the company as the only recombinant urastatin developed using synthetic biology in China and the world. According to the Zhitong Finance App, urastatin itself is not an unfamiliar drug. Existing products are already used in fields such as acute pancreatitis, chronic recurrent pancreatitis, and acute circulatory failure, and are covered by medical insurance. According to public industry data, the market size of usastadine in China in 2023 is about 1.16 billion yuan.

The logic behind Baoji Pharmaceutical's entry into this market is “restructuring and alternative extraction.” In the past, a large variety of clinically indispensable drugs, such as chymotrypsin and urastatin, relied heavily on crude biochemical extraction methods such as animal tissue or human urine for a long time. This production method has the risk of animal-derived viruses or urine contamination, and batch quality is extremely inconsistent, which can easily cause serious clinical allergic reactions and biosafety risks. With a chassis cell transformation platform, Baoji Pharmaceutical avoids the inherent risks of traditional processes at the source.

Among them, urastatin has an extremely large and mature market base. It is a “star drug” for treating acute pancreatitis, sepsis, acute circulatory failure, severe heat stroke, and severe trauma in intensive care units. The clinical efficacy is extremely accurate. However, BJ044 recombinant products not only provide pharmaceutical-grade products with extremely high purity and excellent consistency, but also completely eliminate the hidden risk of viral contamination and avoid medical ethics issues.

Due to sufficient clinical awareness of this indication and huge market capacity, BJ044's IND approval indicates that the company is about to enter this ready-made multi-billion market with safer restructured products, and its replacement effects and monopoly potential are immeasurable. For an old drug market that has formed the basis for clinical use, this technological upgrade does not necessarily mean that market demand is being re-created, but it may drive a reshuffle of the product structure.

The company's other pipeline in the “recombinant alternative extraction” field, recombinant human chymosin (KJ101), also underwent intensive catalysis in the first half of 2026. The phase II clinical trial for wound healing was successfully completed in June of this year, and in March of the same year, IND, which has new indications for gastroscopy to dissolve and remove gastric mucus, was also approved by the NMPA. It is expected to become another representative product of the company's product layout in synthetic biology technology to replace biological extraction preparations.

Judging from the product mechanism, chymoprotease is a classic serine proteolytic enzyme that has been used clinically for over 60 years. It can selectively break down necrotic tissue, fibrin, and mucus, and has almost no effect on normal living tissue. Therefore, it has accumulated long-term and accurate clinical value in scenarios such as wound cleansing, expectoration, and anti-inflammatory swelling reduction. However, traditional chymotrypsin products have long relied on animal tissue extraction such as bovine pancreas and pig pancreas. Not only are there inherent risks of animal-derived virus contamination and large differences in activity between batches, but the supply of raw materials is also limited by the animal husbandry farming cycle. KJ101 uses a recombinant expression process of yeast fermentation to achieve “higher purity, better consistency, and more controllable safety” pharmaceutical-grade production from the source. It is another implementation of Baoji Pharmaceutical's strategic logic of “replacing traditional biochemical extraction with synthetic biological upgrades” on the chymosin circuit.

According to public data, more than 20 million gastroscopes are performed in China every year, and this number continues to rise as awareness of early gastric cancer screening increases and related screening programs advance. In gastroscopy, gastric mucus and foam are the main interfering factors affecting the clarity of mucosal vision, directly limiting the detection efficiency of minor lesions and early cancer; by dissolving gastric mucus protein and significantly improving mucosal visibility, chymosin can effectively shorten the examination time and increase the detection rate of lesions, and its clinical value is being verified by more and more evidence-based data. Up to now, no recombinant chymoprotease products have been approved in the Chinese market. Once KJ101 is on the market, it is expected to share and even reshape this market with “safer recombinant quality+first-mover card slot.”

Wound healing is another growth curve for KJ101 that has been underestimated by the market. There are more than 140 million diabetic patients in China. The annual incidence of diabetic foot ulcers is about 8% to 12%. Combined with huge and rigid cleaning requirements such as pressure sores and post-operative incisions, chronic wound management is becoming a long-term clinical pain point faced by the Chinese medical system. The traditional enzymological clean-up market has long been dominated by animal-derived products. With better purity and safety, recombinant chymosin is expected to achieve rapid penetration in this “large patient base and rigid demand” circuit. The two indications anchor “incremental screening” and “immediate stock demand” respectively, making KJ101 far more flexible in valuation than a single indicated variety.

In line with the full pipeline explosion and commercial supply, the approximately 63,000-square-meter GMP production site built by Baoji Pharmaceutical in Shanghai is operating efficiently, and the newly built 37,000-square-meter production site is also expected to be completed and put into use by the end of 2026. The company's production capacity will be increased by leaps and bounds, opening up an end-to-end closed loop of “R&D - clinical - large-scale green biomantry - global commercialization”, and fully enter the fast track of high-quality development.

This is where Baoji Pharmaceutical is worth revisiting in the capital market. The company's core capability is not simply to replicate an existing drug, but rather its completely self-built synthetic biology upgrade platform aimed at “large-scale genetic engineering to replace traditional biochemical extraction” to try to recreate some products with clear clinical needs but obvious limitations to traditional solutions through synthetic biology, recombinant proteins, and novel drug delivery technologies.

Among them, KJ017 solved the problem of ease of intravenous administration, KJ103 solved the problem of rapid elimination of pathogenic IgG, and BJ044 tried to solve the production and quality consistency problem of traditional extracted urastatin.

Summarize

As a new biomedical star founded in 2019 and successfully listed on the Hong Kong Stock Exchange in December 2025, Baoji Pharmaceutical's current valuation logic in the capital market has not been fully explored. The core reason behind this is that instead of adopting a regular circuit of homogenized competition, Baoji Pharmaceutical strategically focuses on the four major fields of high-volume subcutaneous administration, antibody-mediated autoimmune diseases, assisted reproduction, and synthetic bioupgrading recombinant biopharmaceuticals.

Among them, most of the company's product pipelines have disruptive industry innovations, such as using synthetic biology technology to upgrade and replace traditional biochemical extracts from animal sources or human urine with limited safety, or developing the world's first “devenous” subcutaneous administration excipients and new dosage forms.

Since these products and indications are pioneering in clinical application, the market and patients are currently not fully aware of these innovative mechanisms and potential clinical value.

However, judging from commercial logic, this kind of “insufficient awareness” has just formed a huge valuation depression and first-mover barrier for Baoji Pharmaceutical. As the two core products successfully achieved commercial sales or approval for listing in the first half of 2026, and the core pipeline reached major clinical endpoints and entered the NDA stage, Baoji Pharmaceutical is using solid data and industry progress to break down market cognitive barriers and usher in a critical inflection point in valuation restructuring.