岸迈生物IPO：临床仅至II期、授权收入大幅下滑、对赌协议悬顶 21亿美元BD光环背后隐忧浮现

Core Viewpoint - Anmi Biotech Co., Ltd. is a clinical-stage biopharmaceutical company focused on developing T-cell engagers for cancer and autoimmune diseases, facing significant financial and operational challenges as it approaches its IPO [1][13]. Group 1: Company Overview - Anmi Biotech was established in 2015 and specializes in T-cell engager development for various cancers and autoimmune diseases [1][13]. - The company has established multiple global licensing collaborations with a total deal value exceeding $2.1 billion, ranking second globally in the T-cell engager field [1][13]. Group 2: Product Pipeline - The company has eight pipeline assets, with three in clinical stages: EMB-01, EMB-06, and EMB-07, while five are in preclinical stages [2][14]. - EMB-01 is the most advanced, having entered Phase II clinical trials for gastrointestinal cancers, but its Phase II trial has not yet started [4][16]. Group 3: Clinical Data - In the Phase Ib/II study of EMB-01 for heavily pre-treated metastatic colorectal cancer, the overall response rate (ORR) was 24.1% and the disease control rate (DCR) was 82.8% [5][17]. - The efficacy of EMB-01 remains uncertain due to small sample sizes and lack of survival data, and the Phase II trial for this indication is still pending [5][17][6]. Group 4: Financial Performance - The company reported a loss of 595 million RMB in 2023, with total accumulated losses exceeding 2.4 billion RMB as of September 30, 2025 [7][20]. - Revenue for 2024 is projected at 459 million RMB, primarily from licensing agreements, but income from EMB-06 has significantly declined [18][19]. Group 5: Debt and Financial Pressure - Anmi Biotech has a net debt of approximately 2.396 billion RMB, largely due to redeemable preferred shares amounting to 2.743 billion RMB [10][21]. - The company faces potential redemption obligations if the IPO fails, adding to its financial pressure [10][21]. Group 6: Governance and Regulatory Concerns - Several non-executive directors resigned shortly before the IPO application, raising concerns about governance [22]. - The company is under scrutiny from regulatory authorities regarding its shareholding structure and compliance with listing requirements [12][22].