Core Viewpoint - Jingze Biopharmaceutical (Hefei) Co., Ltd. has submitted its prospectus for an IPO on the Hong Kong Stock Exchange, facing challenges due to significant losses and a reliance on a single approved drug while having multiple candidates in development [1][8]. Group 1: Company Overview - Jingze Biopharmaceutical was established in 2014, focusing on assisted reproduction and ophthalmic drugs, and is one of the leading companies in China for clinical-stage macromolecule drugs in these fields [2][3]. - The company has eight drug candidates, with only one product, JZB30, approved for commercialization in the assisted reproduction sector [3][4]. Group 2: Product Pipeline - JZB30, a recombinant human follicle-stimulating hormone lyophilized powder injection, was approved by the National Medical Products Administration in April 2025, targeting the global ovulation market [3]. - JZB33, a biosimilar to the imported drug Ganirelix, has completed bioequivalence studies and an NDA has been submitted [4]. - In the ophthalmic sector, JZB05, an anti-VEGF intravitreal injection, is in Phase III clinical trials, with an NDA submission expected in the second half of 2026 [4]. Group 3: Financial Performance - Jingze Biopharmaceutical reported losses of CNY 246 million and CNY 243 million for 2023 and 2024, respectively, with R&D expenses of CNY 122 million and CNY 133 million [5]. - As of the end of 2024, the company had cash and cash equivalents of CNY 68.59 million, with net current liabilities increasing to CNY 1.325 billion [5]. Group 4: Funding and Future Plans - The company has raised a total of CNY 927 million through various funding rounds from 2018 to 2023, with a post-investment valuation of CNY 3.09 billion in the C+ round [5]. - The IPO proceeds are intended to advance clinical trials and production development for multiple pipelines [5]. Group 5: Operational Challenges - Jingze Biopharmaceutical relies heavily on third-party contract research organizations (CROs) for preclinical and some clinical trials, which poses risks related to timely delivery and compliance [6]. - The company plans to establish a sales network in collaboration with well-known domestic pharmaceutical companies to distribute JZB30 and has partnered with Nanjing Jianyou for U.S. market registration of JZB33 [6]. Group 6: Market Strategy - The company aims to build a business team to assist partners in market development, although this requires significant time and funding [7]. - The success of the company is highly dependent on the successful development and commercialization of its drug candidates, which are primarily in preclinical or clinical stages [7].

Core Viewpoint - Jingze Biopharma is pursuing an IPO on the Hong Kong Stock Exchange, focusing on high-growth areas of assisted reproduction and ophthalmic drugs, despite facing significant financial challenges and uncertainties in its development pipeline [1][3]. Company Overview - Jingze Biopharma specializes in assisted reproduction and ophthalmic drugs, with a notable presence in clinical-stage large molecule drugs in China as of June 20, 2025 [3]. - The company’s core product, JZB30 (recombinant human follicle-stimulating hormone lyophilized powder injection), received commercialization approval in April 2025, targeting the leading imported drug in the global ovulation market [3]. - Another key product, JZB33 (recombinant human follicle-stimulating hormone aqueous injection), has completed bioequivalence trials and submitted a New Drug Application (NDA) as of June 2025 [3]. Product Pipeline - Jingze Biopharma has a total of eight drug candidates, with JZB30 approved and JZB33 submitted for NDA. JZB05 (anti-VEGF intravitreal injection) is undergoing Phase III clinical trials across over 40 centers in China, aiming for submission in the second half of 2026 [4]. - The company is also developing JZB32 for symptomatic vitreomacular adhesion, currently in Phase I clinical trials, along with several other products at various stages of development [4]. Financial Performance - Jingze Biopharma has reported net losses of 246 million yuan and 243 million yuan for 2023 and 2024, respectively, totaling over 480 million yuan in losses over two years [4]. - Research and development expenditures for the same period were 122 million yuan and 133 million yuan, accounting for over 70% of total operating expenses [4]. - As of the end of 2024, the company’s net current liabilities reached 1.325 billion yuan, an increase from 948 million yuan at the end of 2023, indicating significant liquidity pressure [4]. Operational Challenges - The company heavily relies on third-party contract research organizations (CROs) for preclinical research and some clinical trials, as well as third-party manufacturers for production, which poses risks related to timely delivery and compliance [5]. - Jingze Biopharma lacks experience in successfully commercializing drugs, planning to collaborate with established domestic pharmaceutical companies for the distribution of JZB30 while also preparing to build its own sales team, which requires substantial investment and time [5].