Jingze Biopharmaceutical's IPO Faces Headwinds: Intense Competition in Core Products, Uncertain Commercialization Outlook, and Pre-IPO Investors Exiting

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Recently, Jingze Bio (Hefei) Co., Ltd. (hereinafter referred to as "Jingze Bio") submitted an application for listing to the Hong Kong Stock Exchange, planning to list on the Main Board of the Hong Kong Stock Exchange, with joint sponsors being...CICCAnd Guoyuan International. Previously, the company planned to apply for listing on the STAR Market of the Shanghai Stock Exchange in 2021 and hired CICC to provide tutoring and preliminary compliance consulting based on the requirements of the China Securities Regulatory Commission. In January 2023, the company began participating in the listing tutoring, but as of the latest practicable date, the listing tutoring has not been completed.

The prospectus shows that the company focuses on two major tracks: assisted reproductive drugs and ophthalmic drugs. It currently has eight drug candidates, among which the recombinant human follicle-stimulating hormone lyophilized powder injection, JZB30, has been approved and is about to be commercialized, with expected revenue generation by 2026. Additionally, the recombinant human follicle-stimulating hormone aqueous injection and JZB05 (anti-VEGF intravitreal injection) are in the stages of NDA submission and Phase III clinical trials, respectively.

Despite the company's imminent entry into the commercialization phase, a review of the prospectus and related materials reveals several underlying concerns. First, all of the company’s pipelines nearing commercialization consist of generic drugs, facing fierce market competition. In addition to established products from leading companies, there are multiple late-stage clinical pipelines under development, casting uncertainty over its commercial prospects. Furthermore, phenomena such as the surge in valuation driven by密集入股from investment institutions following the initiation of IPO coaching, a strained cash reserve, and pre-IPO investors exiting their positions entirely may also signal potential risks for the company.

　Core Pipeline Consists of Generic Drugs, Fierce Market Competition, Unclear Commercialization Prospects

From a product perspective, all of Jingze Bio's late-stage R&D pipelines are generic drugs. Its first commercial product, JZB30, a freeze-dried powder injection of recombinant human follicle-stimulating hormone, is used as an ovulation induction drug in assisted reproductive cycles. It corresponds to the original drug Gonal-f®, the imported powder injection with the highest market share in the global ovulation induction market. The NDA application for this product was approved by the National Medical Products Administration in April 2025.

It is worth noting that, as a company that has just entered the commercialization stage, Jingze Bio's JZB30 will still face significant challenges if it wants to quickly capture the market. From the perspective of the competitive landscape, as of the latest practicable date, there are already seven recombinant human follicle-stimulating hormone injections available in the Chinese market, including Merck's Gonal-f®.Changchun High-TechJin Sai Heng® from Jin Sai Pharmaceuticals, An Xin Bao® from Qilu Pharmaceuticals, etc.

At the same time, apart from JZB33, a recombinant human follicle-stimulating hormone injection developed by Shanghai Jingze Biotechnology Co., Ltd., and the already marketed products, there are two similar competing products in China that have entered the registration application stage: Follitropin alfa from Livzon Pharmaceutical and LM001 from Alphamab Oncology. The future market competition will continue to intensify.

In the Chinese market, Jin Sai Pharmaceutical's recombinant human follicle-stimulating hormone (powder injection) was approved for marketing in 2015, as the first domestically produced recombinant human follicle-stimulating hormone product in China. With price and product advantages, its market share has gradually increased. According to sample hospital data, the company's sales of injectable recombinant human follicle-stimulating hormone grew from RMB 0.11 billion in 2016 to RMB 1.02 billion in 2023; its market share rapidly increased from 5.63% in 2016 to 68.84% in 2023.

Currently, the market share of recombinant human follicle-stimulating hormone in China is largely monopolized by Jin Sai Pharmaceuticals and Merck. From 2021 to 2023, products from these two companies almost occupied the entire in-hospital market share. Qilu Pharmaceutical, a well-established domestic pharmaceutical company with a comprehensive sales system and channel advantages, has struggled to make headway with its similar product, Anxinbao®, even after gaining approval at the end of 2021. By 2023, its market share was only around 5%. Facing industry giants with first-mover advantages, latecomers face significant challenges in breaking through.

From the perspective of market size, against the backdrop of continuously declining fertility intentions among young people, the market for injectable recombinant human follicle-stimulating hormone itself has little room for growth.Zheshang SecuritiesResearch report data shows that from 2015 to 2023, the total sales revenue of recombinant human follicle-stimulating hormone for injection in sample hospitals were 187 million yuan, 202 million yuan, 200 million yuan, 201 million yuan, 112 million yuan, 141 million yuan, 174 million yuan, 162 million yuan, and 197 million yuan respectively. Although the market total has rebounded in recent years after a significant drop in 2019, sales revenue is still fluctuating within a narrow range and has yet to reach the levels seen between 2016 and 2018.

From the perspective of dosage forms, freeze-dried powder injections need to be dissolved first for injection administration and must be used under the supervision of medical staff; whereas patients can self-administer water-based injections using an injection pen. In January 2024, Jin Sai Pharmaceutical's recombinant human follicle-stimulating hormone water injection was approved for marketing in China, forming a synergy with the powder injection that was approved in 2015, while Jingze Bio's water injection has yet to be approved.

From the perspective of product iteration, existing follicle-stimulating hormone (FSH) drugs have a relatively short half-life, requiring patients to inject daily, which leads to poor compliance. Therefore, companies in the field are actively developing long-acting FSH formulations. Currently, the recombinant human follicle-stimulating hormone-CTP fusion protein injection for assisted reproduction developed by Jinsai Pharmaceuticals is in Phase III clinical trials. The recombinant human follicle-stimulating hormone-CTP fusion protein-SJ02 developed by Suzhou Shengji Pharmaceuticals is under marketing application. Meanwhile, the long-acting formulation developed by Jingze Bio has just entered the clinical stage.

Similar to assisted reproductive drugs, the situation of Jingze Bio's ophthalmic drug JZB05 (anti-VEGF intravitreal injection) is also far from optimistic. Data shows that VEGF-targeted therapy has become highly mature. As of the latest practicable date, five anti-VEGF molecules have been approved for FND in China, including Aflibercept, Ranibizumab, Conbercept, Faricimab, and Brolucizumab. In 2024, the revenue market share of Aflibercept, Ranibizumab, Conbercept, and Faricimab in China’s anti-VEGF biologics market for treating FND was 25.1%, 29.7%, 44.1%, and 1.1%, respectively.

JZB05 is a biosimilar of aflibercept. Currently, multiple biosimilars and innovative VEGF-targeting drugs are under development in China. According to PharmaCube data, Qilu Pharmaceutical's aflibercept biosimilar and ranibizumab biosimilar have been approved for marketing, while Ocumension Therapeutics/BioRay Biotech’s aflibercept biosimilar has submitted an application for marketing approval. Additionally, there are currently five VEGF-targeting ophthalmic biosimilars in Phase III clinical trials in China, including three for aflibercept and two for ranibizumab. In terms of innovative drugs, there are 18 ophthalmic anti-VEGF innovative drugs currently under development in China.

　　Some Investors Cash Out Before IPO, Cash Reserves Already Strained

In terms of financial data, due to the lack of commercialized products previously, Jingze Bio has long been in a state of loss, mainly relying on equity financing and loans to maintain normal business operations. In 2023 and 2024, the company's annual losses were approximately 246 million yuan and 243 million yuan, respectively.

Since its establishment, the company has completed six rounds of financing, raising a total of approximately 930 million yuan. Among these, the C+ round of financing conducted in 2023 after the company initiated its IPO coaching raised about 490 million yuan, accounting for over 50%. This may indicate a phenomenon of concentrated shareholding before filing to boost valuation.

Notably, during the period from 2024 to March 2025, when the company was preparing for its IPO, some pre-IPO investors had already chosen to cash out and exit. The prospectus reveals that JM Wisdom Investment, a Series B investor who invested in 2018, transferred 158,262 shares of Jingze Bio to Chengdu Minchen in July 2024 for RMB 5 million; in December 2024, it transferred 154,281 shares to Guangji Investment for RMB 5 million; and in March 2025, it transferred 151,231 shares to Huangtu Pharmaceuticals for RMB 5 million.

At the same time, in September 2024, C+ round investor Zhongke Haichuang, who just invested in 2023, transferred its 194,052 shares to Nanjing Jianyou at a transfer cost of 10 million yuan. After the completion of the above equity transfer, Jinzhi Investment is no longer a shareholder of the company, while Zhongke Haichuang remains on the list of shareholders.

With continuous financing, the company's valuation has also risen steadily. After the completion of the C+ round of financing, the company's post-investment valuation reached 3.09 billion yuan. In addition, due to the redemption rights stipulated in the financing agreement, the company's redemption liabilities have also continued to increase. As of 2024, the total amount of the company's redemption liabilities reached 1.327 billion yuan. Large redemption liabilities led to the company's net liabilities being 1.021 billion yuan and 1.258 billion yuan respectively for the corresponding periods, with net current liabilities of 948 million yuan and 1.325 billion yuan respectively.

From the perspective of cash reserves, as of December 31, 2024, and April 30, 2025, the company's cash and bank balances were RMB 68.586 million and RMB 27.08 million, respectively. Meanwhile, the net cash used in operating activities in 2023 and 2024 was RMB 145 million and RMB 122 million, respectively. The company’s cash reserves have become insufficient, urgently requiring financing to replenish its resources.

Editorial Responsibility: Company Observation