Jingze Biopharma Files for Hong Kong IPO with Eight Drug Candidates, Three in Late-Stage Development

According to the Zhitong Finance APP, the Hong Kong Stock Exchange disclosed on June 27 that Jingze Bio (Hefei) Co., Ltd.-B (short for: Jingze Bio) submitted an application for listing on the Main Board of the Hong Kong Stock Exchange. CICC and Guoyuan International are its joint sponsors.

According to the prospectus, Jingze Bio is a biopharmaceutical company focusing on two high-growth sectors: assisted reproductive drugs and ophthalmic drugs. Guided by unmet clinical needs, the company has established a comprehensive R&D system and commercial-scale production capabilities. Leveraging its systematic capabilities, it has independently developed multiple product pipelines and advanced several high-technical barrier drugs with significant commercial potential to the late clinical and commercialization stages.

According to Frost & Sullivan, as of June 20, 2025, Shanghai Jingze Biotechnology Co., Ltd. is one of the companies in China with the largest number of large-molecule drugs in clinical stages within the fields of assisted reproductive and ophthalmology. As of the same day, JZB30 (rhFSH lyophilized powder injection), one of the company’s core products in the assisted reproductive treatment field, has been officially approved for commercialization, while JZB33 (rhFSH aqueous injection), another key product, has submitted an NDA. Meanwhile, JZB05 (anti-VEGF intravitreal injection), a core product in the ophthalmology field, is currently undergoing Phase III clinical trials across more than 40 centers in mainland China. The company is committed to providing patients with high-quality, affordable, and stable products and aims to become a leader in China’s assisted reproductive and ophthalmic drug sectors.

To address the unmet clinical needs in the fields of assisted reproduction and ophthalmology, since its establishment, the company has built a rich product pipeline. As of June 20, 2025, it has a total of eight drug candidates, three of which are in the late stages, including one candidate drug that has received NDA approval, one candidate drug for which an NDA has been submitted, and one product currently in Phase III clinical trials. Additionally, the company has multiple other drug candidates at various clinical stages. The product portfolio covers key indications with the most prominent clinical needs in the fields of assisted reproduction and ophthalmology.

JZB30 is the first commercial product of Shanghai Jingze Biotechnology Co., Ltd. in the field of assisted reproductive treatment. It is a recombinant human follicle-stimulating hormone (rhFSH) lyophilized powder injection developed for ovulation induction in assisted reproductive cycles. JZB30 is a biosimilar developed to match Gonal-f®, the lyophilized powder formulation with the highest global market share for ovulation induction in Q1 2024 and 2025. The company has completed Phase I and Phase III clinical studies comparing JZB30 head-to-head with the reference drug (Gonal-f®) for controlled ovarian stimulation in patients undergoing assisted reproductive technology. The NDA for JZB30 was approved by the National Medical Products Administration in April 2025. The company is also developing JZB30 for the expanded indication of treating hypogonadotropic hypogonadism.

JZB05 is expected to become the first commercialized product in the ophthalmology field by Shanghai Jingze Biotechnology Co., Ltd. It is a self-developed anti-VEGF intravitreal injection, primarily used for treating wAMD, DME, and other FNDs. JZB05 is a global biosimilar对标to Eylea® (aflibercept), the ophthalmology drug with the highest global sales and an anti-VEGF medication. According to Frost & Sullivan, Eylea® (aflibercept) achieved annual sales of $9.5 billion in 2024. As of June 20, 2025, JZB05 has completed a Phase I clinical study involving a "head-to-head" comparison with the originator drug (Eylea®) and has entered Phase III clinical research for further comparative studies. The company expects to complete the Phase III clinical study in the second half of 2026 and submit an NDA for marketing approval in the same year.

Financially, in the fiscal years 2023 and 2024, Jingze Bio's research and development expenditures were approximately RMB 122 million and RMB 133 million, respectively; the total annual losses and comprehensive losses for the same periods were approximately RMB 246 million and RMB 243 million, respectively.