岸迈生物递表港交所：核心管线均处早期 盈利模式未稳累亏超20亿元

Core Viewpoint - Company aims to list on the Hong Kong Stock Exchange under Chapter 18A, focusing on T-cell engagers for cancer and autoimmune diseases, with significant overseas business development (BD) achievements [1][10]. Company Overview - Founded in 2015, the company is a clinical-stage biopharmaceutical firm specializing in T-cell engagers for various cancers and autoimmune diseases [1]. - The company has established multiple overseas licensing agreements since late 2023, with a total transaction value exceeding $2.1 billion [1]. Product Pipeline - The company has eight pipeline assets, including three clinical-stage candidates: EMB-01 (targeting EGFR/cMET), EMB-06 (targeting BCMA/CD3), and EMB-07 (targeting ROR1/CD3) [2]. - EMB-01 is the most advanced, currently in Phase II clinical trials for gastrointestinal cancers, with a focus on metastatic colorectal cancer [4][5]. Clinical Data - In a Phase Ib/II trial for EMB-01, the overall response rate (ORR) was 24.1% and the disease control rate (DCR) was 82.8% among 29 patients with heavily pre-treated metastatic colorectal cancer [4]. - The company emphasizes the potential of EMB-01 for colorectal cancer treatment, although the efficacy remains to be fully validated due to small sample sizes and lack of survival data [5]. Financial Overview - The company reported a cumulative loss of RMB 2.355 billion, with no revenue in 2023 and a loss of RMB 595 million for the same year [6]. - The company has entered into several global licensing agreements, with potential total transaction values exceeding $2.1 billion, ranking second globally in the T-cell engager field [6]. Capital Structure - As of the end of 2024, the company's net debt was RMB 2.344 billion, primarily due to convertible redeemable preferred shares amounting to RMB 2.747 billion [7]. - The company has issued convertible notes totaling $12 million, which were converted into preferred shares, leading to a post-investment valuation of $492 million [8]. IPO Considerations - The company faces significant challenges, including early-stage clinical pipelines, the uncertainty of EMB-01's efficacy, and the potential redemption of preferred shares if the IPO fails [10].