Jingze Bio Files Third HKEX IPO Application, Spotlighting Biosimilar Competition in China's Fertility and Ophthalmology Markets
核心洞察
Jingze Biopharmaceutical (搜索) has filed its third listing application with the Hong Kong Stock Exchange, with CICC and Guoyuan International as joint sponsors.
The company's lead asset JZB30, an rhFSH biosimilar to Ganafert, received NMPA approval in April 2025 for assisted reproduction, while JZB33 (a Gonal-F biosimilar) has an NDA under review.
JZB05, an aflibercept biosimilar targeting wet AMD and DME, is in Phase III trials with completion expected in the second half of 2026.
Jingze Biopharmaceutical (搜索) (Hefei) Co., Ltd. has submitted its third listing application to the Main Board of the Hong Kong Stock Exchange, according to exchange disclosures dated July 3. The biopharmaceutical company, which focuses on assisted reproductive medicines and ophthalmic drugs, is being jointly sponsored by China International Capital Corporation Hong Kong Securities Limited and Guoyuan Financing (Hong Kong) Limited. Previous filings were made on June 27, 2025, and December 31, 2025.
The company's pipeline features two core products and six additional pipeline candidates, positioning it at the intersection of two rapidly expanding therapeutic markets in China.
JZB30: A Commercial-Stage rhFSH Biosimilar
JZB30, a recombinant human follicle-stimulating hormone (rhFSH) injection, represents Jingze Bio's first commercial product in the assisted reproduction space. The lyophilized powder formulation was developed as a biosimilar to Ganafert, which held the largest global market share in the ovulation-induction market in 2024 and through the first quarter of 2025.
The company completed Phase I and Phase III clinical trials comparing JZB30 head-to-head with Ganafert in patients undergoing controlled ovarian stimulation for assisted reproductive technologies. The National Medical Products Administration (NMPA) approved the New Drug Application (NDA) for JZB30 in April 2025. Jingze Bio is also advancing JZB30 for an expanded indication: the treatment of hypogonadotropic hypogonadism in adult male patients.
Building on JZB30's clinical foundation, the company developed JZB33, an aqueous rhFSH injection formulated as a biosimilar to Gonal-F. Packaged in a pre-filled cartridge-type pen, JZB33 enables patient self-administration. The NMPA permitted a streamlined clinical development pathway: a bioequivalence study based on pharmacokinetic parameters relative to the reference product, combined with JZB30's Phase III results. The bioequivalence study has been completed, and the NDA was submitted in June 2025 and accepted for review.
JZB05: An Aflibercept Biosimilar in Late-Stage Development
JZB05 is an intravitreal anti-VEGF formulation developed as a biosimilar to aflibercept (Eylea), which generated annual sales of US$9.5 billion in 2024, according to Frost & Sullivan (搜索). The candidate targets fundus neovascular diseases (FND), including wet age-related macular degeneration (搜索) (wAMD) and diabetic macular edema (搜索) (DME).
A Phase I clinical study comparing JZB05 head-to-head with Eylea has been completed, and the candidate entered a confirmatory Phase III trial in September 2023. The company anticipates completing the Phase III trial in the second half of 2026, with a subsequent NDA submission for market approval.
JZB32: A First-in-Class Opportunity
JZB32, a recombinant human truncated fibrinolytic enzyme (Oc-fibrinolysin) injection, targets symptomatic vitreomacular adhesion (搜索) (sVMA). According to Frost & Sullivan (搜索), JZB32 is the only Oc-fibrinolysin product currently under development in China. The candidate functions as a "molecular scalpel," using abnormal adhesive components as substrates to achieve enzymatic degradation of vitreoretinal adhesions. Phase I clinical trials for sVMA have been completed, and the company is exploring applications in polypoidal choroidal vasculopathy (PCV) as a Class 2.2 improved biologic.
Market Context and Financial Position
China's assisted reproductive drug market grew from RMB 4.2 billion in 2019 to RMB 5.8 billion in 2025, a compound annual growth rate (CAGR) of 5.4%, and is projected to reach RMB 11.3 billion by 2030 at a CAGR of 12.8%. Within this segment, the rhFSH market is expected to expand from RMB 2.5 billion in 2025 to RMB 6.1 billion by 2030, outpacing urinary FSH growth.
The anti-VEGF biologics market for FND treatment in China reached RMB 6.4 billion in 2025, up from RMB 2.4 billion in 2019 (CAGR 17.7%), and is forecast to hit RMB 12.6 billion by 2030. Five anti-VEGF agents are currently approved in China: aflibercept (20.0% market share), ranibizumab (21.5%), conbercept (38.1%), faricimab (19.6%), and brolucizumab (0.8%).
Financially, Jingze Bio reported other income of RMB 675,000 for the four months ended April 30, 2026, with a total comprehensive loss of RMB 89.322 million. R&D expenses attributable to core products were RMB 16.2 million, representing 54.4% of total R&D expenditures for the period. For the full year 2025, the company's total comprehensive loss was approximately RMB 270 million.