四、请发行人结合药物研发技术路线等情况说明发行人及下属公司经营范围、实际业务是否涉及"人体 干细胞、基因诊断与治疗技术开发和应用"或其他外商投资准入限制或禁止领域及相关判断依据，本次 发行上市前后是否持续符合外商投资准入政策要求。 一、请说明主要境内运营实体历次股权变动均合法合规的结论性意见，汇总说明发行人及境内股东在公 司股权架构搭建过程中履行外汇登记、境外投资、外商投资等程序的情况，并说明是否符合当时有效的 外汇管理、境外投资、外商投资、税务管理等监管规定的结论性意见。 二、请发行人说明第一大股东Sanaron Inc.，的设立及股权变动情况。并请说明上述股东向上穿透后的 实际控制人与信托受益人的关联关系。 三、Everlasting Wisdom Holdings Limited持有发行人5.37%的股权，请对照《监管规则适用指引——境 外发行上市类第2号》，说明该名股东向上穿透后的自然人股东信息。并请结合上述自然人股东以及发 行人主要股东Yajun Xu的背景情况说明两名股东入股发行人的原因、时间、定价的公允性，以及与发行 人董事、高管或发行人业务经营是否存在关联关系。 9月5日，中国证监会公示《境外 ...

四、请发行人结合药物研发技术路线等情况说明发行人及下属公司经营范围、实际业务是否涉及"人体 干细胞、基因诊断与治疗技术开发和应用"或其他外商投资准入限制或禁止领域及相关判断依据，本次 发行上市前后是否持续符合外商投资准入政策要求。 智通财经APP获悉，9月5日，中国证监会公示《境外发行上市备案补充材料要求(2025年8月29日—2025 年9月4日)》，证监会国际司共对12家企业出具补充材料要求。其中要求岸迈生物补充说明本次发行上 市前后是否持续符合外商投资准入政策要求等。据港交所6月17日披露，岸迈生物科技有限公司向港交 所主板递交上市申请，中信证券和招银国际为联席保荐人。 据招股书，岸迈生物是一家处于临床阶段的生物技术公司，处于双特异性抗体治疗领域的创新前沿，专 注于在全球范围内开发治疗各类癌症和自身免疫性疾病的T细胞衔接器。 岸迈生物的肿瘤学业务管线包括三款处于临床阶段的候选药物，包括(i)核心产品EMB-01(靶向 EGFR/cMET)，用于治疗结直肠癌，(ii)两款基于T细胞衔接器的关键产品EMB-06(靶向BCMA/CD3)，用 于治疗多发性骨髓瘤("MM")和EMB-07(靶向ROR1/CD3) ...

Core Viewpoint - The announcement from Valiant Biopharma-B (09887.HK) highlights significant progress in the clinical research of LBL-034, a bispecific antibody targeting GPRC5D/CD3, with promising Phase I data and the successful treatment of the first patient in Phase II trials [1] Group 1: Clinical Trial Results - The Phase I trial of LBL-034 involved over 50 patients with relapsed/refractory multiple myeloma, showing positive efficacy signals and good safety at a dose of 1,200 μg/kg [1] - The overall response rate was robust, with a higher rate of complete response or deeper responses (≥CR) and minimal residual disease (MRD) negativity compared to current standard therapies [1] - Notably, significant efficacy was observed in the difficult-to-treat extramedullary (EMD) myeloma patient subgroup [1] Group 2: Future Developments - Detailed results from the study are set to be presented at the 2025 American Society of Hematology (ASH) annual meeting [1] - The Phase II trial is a multicenter, single-arm, multi-cohort study led by Professor Lu Jin from Peking University People's Hospital, involving over 20 hospitals nationwide [1] - The aim of the Phase II trial is to evaluate the efficacy and safety of LBL-034 in various relapsed/refractory plasma cell tumors [1]

Group 1 - The core viewpoint of the news is that Anmai Biotech has submitted its listing application, with CITIC Securities and China Merchants International Capital serving as joint sponsors [1] - Anmai Biotech, established in 2015, is a clinical-stage biotechnology company focused on developing T-cell engagers for treating various cancers and autoimmune diseases [1] - The oncology pipeline includes three clinical-stage candidates: EMB-01 targeting EGFR/cMET for colorectal cancer, EMB-06 targeting BCMA/CD3 for multiple myeloma, and EMB-07 targeting ROR1/CD3 for lymphoma and solid tumors [1] Group 2 - Anmai Biotech's core business model leverages nearly a decade of experience in the field, utilizing proprietary bispecific antibody platforms and CD3 binding domain libraries for the discovery, development, and commercialization of bispecific antibodies and T-cell engagers [2] - As of the end of 2023, Anmai Biotech has established multiple global licensing collaborations with a total transaction value exceeding $2.1 billion, ranking second globally in the T-cell engager field [2] - Financially, Anmai Biotech is projected to generate approximately 459 million RMB in revenue for the fiscal year 2024, with a loss of 595 million RMB in 2023 and a profit of 48 million RMB anticipated for 2024 [2]