Jingze Biopharma Re-files for Hong Kong IPO with Eight Drug Candidates in Pipeline

According to the Zhitong Finance APP, Jingze BioPharmaceutical (Hefei) Co., Ltd.-B (referred to as: Jingze Bio) submitted an application for listing on the Main Board of the Hong Kong Stock Exchange on December 31, as disclosed by the Hong Kong Stock Exchange. CICC and Guoyuan International are the joint sponsors. The company had previously submitted an application to the Hong Kong Stock Exchange on June 27, 2025.

Company Profile

According to the prospectus, this company is a biopharmaceutical firm with a history tracing back to 2014, focusing on two major sectors: assisted reproductive drugs and ophthalmic drugs. The company owns: (1) Two core products, wherein (a) JZB30 is a recombinant human follicle-stimulating hormone (rhFSH) injection for registration purposes, intended for use in (i) ovulation induction in assisted reproductive treatments, applicable to adult female patients requiring controlled ovarian stimulation due to anovulatory infertility, and (ii) treating infertility caused by hypogonadotropic hypogonadism, applicable to adult male patients; and (b) JZB05 is an anti-vascular endothelial growth factor (VEGF) intravitreal injection candidate drug, intended for treating fundus neovascular diseases (FND), including wet age-related macular degeneration (wAMD), diabetic macular edema (DME), and other FNDs, applicable to adult patients suffering from active neovascular diseases requiring anti-VEGF treatment; and (2) six pipeline products.

To address the diverse clinical needs in the fields of assisted reproduction and ophthalmology, since its establishment, the company has developed a rich pipeline of products. As of the latest practicable date (December 21, 2025), the company has eight drug candidates, three of which are in advanced stages, including (i) one candidate drug that has received NDA approval, (ii) one candidate drug for which an NDA has been submitted, and (iii) one product currently in Phase 3 clinical trials. Additionally, the company has multiple other drug candidates at various clinical stages. The product portfolio targets clinical indications in the fields of assisted reproduction and ophthalmology.

Core Product

JZB30 is the first commercial product of Shanghai Jingze Biotechnology Co., Ltd. in the field of assisted reproductive treatment. It is a lyophilized powder injection formulation of recombinant human follicle-stimulating hormone (rhFSH) developed by the company, used as an ovulation induction drug 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 1 and Phase 3 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 of Jingze Bio. It is an anti-VEGF intravitreal injection independently developed by the company, mainly used for treating wAMD, DME, and other FNDs. JZB05 is a biosimilar对标to Eylea® (Aflibercept), the ophthalmic drug with the highest global sales and the top-selling anti-VEGF drug. According to Frost & Sullivan, Eylea® (Aflibercept) achieved annual sales of $9.5 billion in 2024. As of the latest practicable date, JZB05 has completed a Phase 1 clinical study involving a head-to-head comparison with the originator drug Eylea®, and entered Phase 3 clinical research for further comparative studies in September 2023. The company expects to complete the Phase 3 clinical trial in the second half of 2026 and submit the NDA for market approval.

The company owns various Chinese invention patents related to its core products. As of the latest practicable date, the company holds six authorized invention patents, three pending invention patent applications, and one pending design patent application in China for its core products.

Main Products

JZB33 is a recombinant human follicle-stimulating hormone injection independently developed by Shanghai Jingze Biotechnology Co., Ltd. It is also an ovulation induction drug used in assisted reproductive cycles and is a biosimilar developed to match the Gonal-f® aqueous injection formulation. During the ovulation induction process, depending on the growth of the female’s follicles, typically 1-4 injections are required daily for 10-14 consecutive days. Therefore, the convenience of injection is crucial for ensuring patient compliance. JZB33 modifies the dosage form to an aqueous solution based on JZB30 and comes with a pre-filled cartridge injection pen, allowing patients to self-inject easily via a press-down mechanism. This significantly enhances the ease of medication administration, meets the varying needs of different patients, and enriches the company’s product portfolio in the ovulation induction phase of assisted reproduction.

Based on the clinical research foundation of JZB30, the company has obtained the agreement from the National Medical Products Administration (NMPA) to simplify the clinical research for JZB33. By conducting a bioequivalence clinical trial based on pharmacokinetic parameters with the original drug (Gonal-f®), along with the Phase 3 clinical trial results of JZB30, an NDA application can be made. The company has completed the bioequivalence study for JZB33 and submitted the NDA in June 2025, which has been accepted for review.

JZB32 is a recombinant truncated human plasmin (OcuPlasmin) injection independently developed by the company for the treatment of symptomatic vitreomacular adhesion (sVMA). OcuPlasmin is a microplasmin optimized from endogenous plasmin to address structural instability while retaining its catalytic properties for degrading adhesive tissues. Compared with vitrectomy, which physically removes adhesions using microsurgical tools, OcuPlasmin acts as a molecular scalpel, enzymatically degrading abnormal adhesions as substrates to rapidly and precisely relieve vitreoretinal adhesion or traction, thereby preserving vision. According to Frost & Sullivan, JZB32 is the first OcuPlasmin product under research in China. As of the latest practicable date, JZB32 remains in Phase 1 clinical trials.

In addition to sVMA, the company is exploring the application of JZB32 in other fundus disease areas. It is currently evaluating the use of JZB32 in polypoidal choroidal vasculopathy (PCV) as a Category 2.2 modified biologic product, further unlocking its clinical potential.

Financial Information

Income

For the year 2023, the year 2024, and the six months ended June 30, 2025, the company's other income amounted to RMB 9.799 million, RMB 12.381 million, and RMB 0.829 million, respectively.

Loss

For the fiscal years 2023 and 2024, and the six months ended June 30, 2025, the company's total loss for the year and comprehensive loss amounted to approximately RMB 246 million, RMB 243 million, and RMB 128 million, respectively.

R&D

For the fiscal years 2023 and 2024, and the six months ended June 30, 2025, the company's R&D expenditures were approximately RMB 122 million, RMB 133 million, and RMB 50.768 million, respectively.

Industry Overview

Global biologics sales increased from USD 286.4 billion in 2019 to USD 441.9 billion in 2024, with a compound annual growth rate (CAGR) of 9.1%. It is projected to grow at a CAGR of 11.0% from 2025 to 2030, reaching USD 828.6 billion.

The market size of China's biopharmaceuticals grew from RMB 312 billion in 2019 to RMB 493 billion in 2024, with a compound annual growth rate (CAGR) of 9.6%. It is projected to grow at a CAGR of 13.1% from 2025 to 2030, reaching RMB 1,021 billion.

The market size of China's assisted reproductive drugs increased from RMB 4.2 billion in 2019 to RMB 5.7 billion in 2024, with a compound annual growth rate (CAGR) of 6.0%. It is expected to continue growing at a CAGR of 13.5% from 2025 to 2030, reaching RMB 11.9 billion.

The market size of ophthalmic drugs in China grew from RMB 19.4 billion in 2019 to RMB 29.5 billion in 2024 at a compound annual growth rate (CAGR) of 8.7%, and is expected to continue growing to RMB 53.7 billion by 2030, with a CAGR of 11.0% from 2025 to 2030.

Board Materials

The board consists of nine directors, including two executive directors, three non-executive directors, and four independent non-executive directors. The board is responsible for and has general authority over the management and operation of the group's business, including determining business strategies and investment plans, formulating group management measures, implementing resolutions passed at shareholders' meetings, and exercising other powers, functions, and responsibilities granted by the articles of association. The board also assumes the responsibility of formulating and reviewing the company’s policies and practices in corporate governance, risk management, internal control, and compliance with legal and regulatory requirements.

Equity Structure

As of the latest practicable date, Mr. Peng held approximately 32.40% interest in all issued shares, including approximately 25.72% direct interest and approximately 6.68% indirect interest held through Jingze Zhongzhi and Jingze Zhongkang (where Mr. Peng is the general partner and controls the exercise of voting rights over the shares held by Jingze Zhongzhi and Jingze Zhongkang).

Intermediary Team

Joint Sponsors: China International Capital Corporation Hong Kong Securities Limited, Guoyuan Financing (Hong Kong) Company Limited;

Legal Advisors: Freshfields Bruckhaus Deringer, Tian Yuan Law Firm;

Auditor and Reporting Accountant: Ernst & Young;

Industry Advisor: Frost & Sullivan (Beijing) Consulting Co., Ltd. Shanghai Branch;

Independent Property Valuer: Beijing Colliers International Land and Real Estate Appraisal Co., Ltd.