IPO News | Baoji Pharmaceutical passed the Hong Kong Stock Exchange hearing that its core product SJ02 has received NDA approval from the National Drug Administration

The Zhitong Finance App learned that according to the Hong Kong Stock Exchange's disclosure on November 26, Shanghai Baoji Pharmaceutical Co., Ltd. - B (hereinafter: Baoji Pharmaceutical) passed the Hong Kong Stock Exchange's main board listing hearing, and CITIC Securities and Cathay Pacific Haitong were co-sponsors. As of November 22, 2025, the company's core product, SJ02, has received NDA approval from the State Drug Administration in August 2025, and two drug candidates (i.e. core products KJ103 and KJ017) have entered the advanced testing or NDA registration stage in China.

According to the prospectus, Baoji Pharmaceutical is a biotechnology company founded in 2019 that strategically focuses on four major areas: (i) high-volume subcutaneous administration, (ii) antibody-mediated autoimmune diseases, (iii) assisted reproduction; and (iv) recombinant biopharmaceuticals. The company's pipeline mainly includes 12 self-developed products under development, including three core products (KJ017, KJ103 and SJ02 (Shengnova®)), four other clinical-stage drug candidates (BJ007, KJ015, SJ04 and KJ101), and five preclinical assets (BJ008, BJ009, BJ045, BJ047 and BJ044).

The company's core products include: (i) SJ02 (Shengnova®), a long-acting recombinant human follicle stimulating hormone carboxyl-terminal peptide fusion protein (FSH-CTP), which is used as an assisted reproduction to perform controlled ovarian stimulation, promote polyvesicle development, and induce ovulation. It was approved by the National Drug Administration in August 2025; (ii) KJ017, a recombinant human hyaluronidase in the NDA stage for subcutaneous administration (combination therapy), and adjuvant dermal treatment due to various causes Lower rehydration (combination therapy); and (iii) KJ103 is an innovative recombinant immunoglobulin G (IgG) degrading enzyme in phase III development to treat pre-kidney desensitization and pathological IgG-mediated autoimmune diseases.

According to Frost & Sullivan, the total clinically accessible market size of the company's four strategic treatment areas in China will reach about RMB 50 billion by 2033, including: (i) high-volume subcutaneous administration, of which recombinant hyaluronidase accounts for nearly RMB 7 billion; (ii) antibody-mediated autoimmune diseases driven by IgG-related autoimmune diseases with a market size of RMB 26.7 billion; and (iv) biopharmaceutical recombination exceeding RMB 5.3 billion; and (iv) recombinant pharmaceutical biopharmaceuticals exceeding RMB 5.3 billion protease.

As far as core products are concerned, (i) KJ017 is a highly glycosylated recombinant human hyaluronidase, an engineered enzyme modified with sugar molecules that can break down hyaluronic acid in the skin, thereby accelerating the absorption of injectable drugs, and was developed to achieve rapid, high-volume subcutaneous administration of conjugated drugs; (ii) KJ103 is an innovative recombinant immunoglobulin G (IgG) degrading enzyme, a genetically engineered enzyme that can break down pathogenic IgG antibodies, and these antibodies are considered to be key drivers of autoimmune diseases and are used to treat pathological IgG g Activities Driven by various immune diseases and conditions. Currently, the company is conducting clinical trials at various stages to evaluate the effects of KJ103 in kidney transplant desensitization (a technical solution designed to reduce or remove pre-stored antibodies in transplant recipients to prevent rejection of donor organs), anti-glomerular basement membrane disease (anti-GBM disease, an autoimmune disease where antibodies attack kidney structure and cause serious damage), and Gillan-Barre syndrome (GBS, an autoimmune disease where the immune system attacks nerves, leading to muscle weakness and paralysis); and (SJIII) 02 is a long-acting recombinant human follicle CTP Fusion protein (FSHCTP, a bioengineered hormone fused with a stable peptide to prolong its action time) is intended to be used in combination with gonadotropin-releasing hormone (GnRH) antagonists for controlled ovarian stimulation (COS).

As of November 22, 2025, the company's core product, SJ02, has received NDA approval from the State Drug Administration in August 2025, and two drug candidates (namely the company's core products KJ103 and KJ017) have entered the post-trial or NDA registration stage in China. Additionally, the company is actively promoting a variety of other pipeline products, particularly innovative recombinant biologics, including KJ101 and BJ044, as transformative alternatives to traditional biochemically-derived drugs.

The company has established commercial-scale production capacity, can achieve cost-effective and standardized production, and has a cost advantage, thereby enabling the business to expand into other treatment fields and explore new market opportunities.

On the financial side, for the six months ended June 30 in 2023, 2024, and 2025, the company's revenue was 6.93 million yuan, 6.16 million yuan, and 41.99 million yuan respectively; in the same period, R&D expenses were approximately 133 million yuan, 251 million yuan, and 111 million yuan, respectively.