炒股就看金麒麟分析师研报，权威，专业，及时，全面，助您挖掘潜力主题机会！ 近日，翰思艾泰生物医药科技（武汉）股份有限公司（以下简称"翰思艾泰"）再次向港交所提交上市申 请，工银国际为其独家保荐人。此前，公司曾于2024年11月24日首次递交上市申请。 招股书显示，翰思艾泰是一家拥有结构生物学、转化医学及临床开发方面自主专业技术及经验的创新生 物科技公司，致力开发新一代免疫疗法。公司历史可追溯至2017年，成立至今，公司已先后完成3轮融 资，IPO前投资者包括贝达药业、杭州泰鲲（泰格医药持股49%）、扬子香港（金斯瑞生物间接拥有） 等。 这样的案例并非孤例，除了吉利德之外，专注于CD47靶点开发的明星Biotech Arch Oncology也于2023年 宣布终止其在CD47抗体上的研发工作，公司大部分员工离职。凭借CD47管线纳斯达克上市的ALX Oncology也宣布终止核心管线SIRPα融合蛋白（CD47-SIRPα信号通路的巨噬细胞一端）Evorpacept的临 床研究。2023年9月22日，艾伯维终止与天镜生物就CD47抗体lemzoparlimab的合作协议。 此外，从临床研究各阶段成功率来看，临 ...

Group 1 - The core viewpoint of the article is that Hansai Aitai Biopharmaceutical Technology (Wuhan) Co., Ltd. has submitted its listing application to the Hong Kong Stock Exchange, with ICBC International as the exclusive sponsor [1] - The company focuses on structural biology, translational medicine, and clinical development, having developed an innovative drug pipeline since 2016, including its core product HX009 and nine other pipeline candidates [1][2] - HX009 is a self-developed PD-1/SIRPα dual-function antibody fusion protein currently undergoing multiple clinical trials in China for treating advanced melanoma, relapsed/refractory EBV-positive non-Hodgkin lymphoma, and advanced biliary cancer [1][2] Group 2 - The company has two main products, HX301 and HX044, with HX301 being a multi-target kinase inhibitor in a Phase II clinical trial for glioblastoma in China, and HX044 being a novel dual-function anti-CTLA-4 antibody SIRPα fusion protein in Phase I/IIa trials for advanced solid tumors in Australia and China [2] - According to a Frost & Sullivan report, HX009 is leading globally in clinical trial progress among similar CD47-targeting bispecific antibodies/dual-function fusion proteins, while HX044 is the only CTLA-4/SIRPα dual-specific antibody/dual-function fusion protein in clinical trials [2] - The company has developed proprietary platforms, VersatiBody and autoRx40, for creating antibody drugs with enhanced therapeutic capabilities, and has received royalties from HX008, a PD-1 monoclonal antibody approved in 2022 [2] Group 3 - As of the fiscal years ending December 31, 2023, and 2024, the company's R&D costs are projected to be RMB 46.7 million and RMB 74.7 million, accounting for 73.0% and 61.8% of total operating expenses, respectively [2] - The company has not yet achieved profitability and continues to invest heavily in R&D activities [2] - The company faces significant risks, including uncertainties in drug development, potential unmet expectations in clinical trial results, and challenges in obtaining regulatory approvals or commercializing its products [3]

Group 1 - The core viewpoint is that the Hong Kong stock market is experiencing a technical bull market, leading to a revaluation of innovative pharmaceutical companies, driven by improved liquidity and policy expectations [1][17] - The Hang Seng Index has risen over 20% this year, while the Hang Seng Healthcare Index has increased by over 40%, indicating strong market performance [1] - The revaluation of the innovative drug sector is attributed to global capital reassessing the long-term logic of China's innovative drug industry [1][19] Group 2 - AI medical technology breakthroughs, comprehensive policy support, and enhanced commercialization capabilities are expected to provide greater valuation expansion potential for Hong Kong's innovative drug sector compared to A-shares [4] - Companies with differentiated innovative pipelines and commercialization potential are becoming market focal points, entering a phase of valuation expansion [4][21] - Lepu Biopharma's 2024 financial report validates this logic, showcasing rapid commercialization and differentiated advantages in its three major pipelines [4][21] Group 3 - Lepu Biopharma achieved approximately 368 million yuan in revenue for 2024, with its main product, Pu You Heng®, generating around 300 million yuan, marking a threefold increase from the previous year's 100 million yuan [6] - The company has established a complete commercialization loop through a specialized marketing team, enhancing its market penetration and professional trust [6][7] - Lepu Biopharma has completed access to procurement platforms in 27 provinces and covers approximately 81 key cities with its sales channels [6] Group 4 - Lepu Biopharma's R&D pipeline focuses on three major areas: ADC, cancer immunotherapy, and oncolytic viruses, which collectively build competitive barriers [9][16] - The ADC pipeline, particularly the core product MRG003, demonstrates significant clinical potential and has received priority review from NMPA and orphan drug designation from FDA [11][13] - The company is also advancing other ADC candidates, such as MRG004A and MRG006A, which show promising clinical results and potential for broad application across various cancers [13][14] Group 5 - The supportive policy environment and recovering capital market are expected to accelerate industry growth and enhance valuation recovery [19][21] - The global healthcare financing activities are rebounding, with an estimated total of $58.2 billion in 2024, indicating a positive trend after two years of decline [19] - Lepu Biopharma is positioned at a critical point for performance and valuation growth, driven by strengthened commercialization capabilities and breakthroughs in its pipeline [21]