近日，又一创新药企正式向港交所提交上市申请。根据港交所披露，浙江时迈药业股份有限公司-B(简 称：时迈药业)已递交主板上市招股书，由华泰国际担任独家保荐人。在此之前，时迈药业已于2022年 成功完成3.3亿元C轮融资，投后估值达到22.3亿元，吸引了包括贝达药业（300558）、贝加投资、温氏 股份（300498）、杭州高新金投、浙商证券（601878）及迈百瑞等多家知名机构的参与。 公开信息显示，时迈药业成立于2017年，作为下一代T细胞衔接器(TCE)疗法的先驱及全球领军企业， 旨在利用并引导人体免疫系统对抗癌症的下一代免疫疗法，公司已开发下一代先锋疗法遮蔽型TCE，可 在肿瘤中被选择性激活，用于治疗实体瘤。 时迈药业此番冲刺资本市场，正值全球TCE赛道进入高速发展期。自2024年下半年以来，该领域交易热 度持续攀升，国际巨头争相加码TCE赛道。在此背景下，作为一家专注于实体瘤TCE疗法、且具备多款 全球前列临床管线的企业，时迈药业的上市进程亦自然备受瞩目。 布局TCE疗法 四款创新药物处于临床阶段 智通财经APP了解到，时迈药业目前仍处于临床研发阶段，并无产品商业化。财务数据显示，2023年、 2024 ...

Core Viewpoint - Zhejiang Shimai Pharmaceutical Co., Ltd. has submitted its prospectus for an IPO on the Hong Kong Stock Exchange, with Huatai International as the sole sponsor, amid a backdrop of significant interest in TCE therapies and multiple rounds of financing from investors like Betta Pharmaceuticals [1][2]. Group 1: Company Overview - Founded in 2017, Shimai Pharmaceutical focuses on the development of TCE (T-cell engager) drugs, with no products commercialized yet and four clinical-stage candidates in its pipeline [2]. - The company reported revenues of 14.65 million yuan, 6.62 million yuan, and 2.28 million yuan for 2023, 2024, and the first half of 2025, respectively, with corresponding losses of 74.94 million yuan, 59.89 million yuan, and 25.42 million yuan, totaling over 160 million yuan in cumulative losses [2]. - The company has received three rounds of financing, with a post-Series C valuation of 2.23 billion yuan, and its major shareholders include the controlling shareholder Xiaozuoxiang and Betta Pharmaceuticals [2]. Group 2: Financial Management - The current CFO, Liu Yang, joined the company shortly before the IPO process, bringing over 12 years of experience in the international healthcare industry and capital markets [4]. - The company has seen frequent changes in its financial leadership, with four different CFOs from 2021 to 2025, indicating potential instability in financial management [5]. - Despite a peak net asset value of 236 million yuan, the company has shown a preference for structured deposits, with financial assets of 216 million yuan, 164 million yuan, and 67 million yuan for the years 2023, 2024, and the first half of 2025, respectively [6]. Group 3: Research and Development - The company has reduced R&D expenses significantly, with expenditures of 76.11 million yuan, 53.38 million yuan, and 22.39 million yuan for 2023, 2024, and the first half of 2025, respectively, alongside a decrease in administrative expenses [7]. - The R&D investment for core products DNV3 and SMET12 has also seen substantial cuts, raising concerns about the company's commitment to its pipeline [7]. - The safety profile of the core products remains a concern, with high rates of adverse events reported in clinical trials, including 81.8% for DNV3 and 93.8% for SMET12 [8].

Core Viewpoint - Zhejiang Shimai Pharmaceutical Co., Ltd. has submitted its listing application to the Hong Kong Stock Exchange, focusing on the development of TCE drugs and aiming to raise funds for clinical development and operational needs [1][5]. Company Overview - Established in 2017, Shimai Pharmaceutical specializes in TCE drug development, with four clinical-stage candidates: DNV3, SMET12, CMD011, and CMDE005 [1]. - The company has a current valuation of 2.23 billion RMB following its latest Series C financing, attracting investments from notable pharmaceutical companies [1]. Financial Performance - For the reporting period from 2023 to the first half of 2025, Shimai Pharmaceutical reported other income and gains of 14.65 million RMB, 6.62 million RMB, and 2.28 million RMB, while total losses reached 74.94 million RMB, 59.90 million RMB, and 25.42 million RMB, accumulating over 160 million RMB in total losses [2][3]. - The company has not yet commercialized any products, leading to significant ongoing losses, with revenue primarily from government subsidies and investment income [2][4]. Research and Development - R&D expenses for the reporting period were 76.11 million RMB, 53.38 million RMB, and 22.39 million RMB, with a notable decrease in R&D spending raising concerns about the progress of core product development [4]. - The R&D expenditure for core product SMET12 decreased by 73.7% in the first half of 2025 compared to the same period in 2024, indicating potential challenges in sustaining development efforts [4]. Market Potential - The global TCE market is projected to reach approximately 3 billion USD by 2024, with a compound annual growth rate of 40% expected to grow to 121.1 billion USD by 2035. The Chinese TCE market is anticipated to reach 700 million RMB by 2024, with a growth rate of 63.8% projected to reach 159.6 billion RMB by 2035 [5].

Investment Rating - The report assigns an "Accumulate" rating for the company, marking its first coverage [1]. Core Insights - The company positions itself as a leader in next-generation tumor immunotherapy, leveraging three major technology platforms to establish a high-quality R&D pipeline [3][12]. - The 4-1BB co-stimulation signal market shows significant potential, with the product LBL-024 demonstrating notable competitive advantages [4][25]. - The TCE technology platform has been validated through clinical data, with LBL-034 showing superior efficacy and safety compared to competitors [5][22]. - The company is currently in the new drug development investment phase, with projected revenues of 175 million, 314 million, and 187 million yuan for 2025, 2026, and 2027 respectively, and expected net losses of 200 million, 99 million, and 262 million yuan [5]. Summary by Sections Section 1: Three Platforms Supporting Next-Generation Tumor Immunotherapy - The company aims to address diseases that current therapies, such as PD-1/PD-L1 antibodies, cannot treat, focusing on cutting-edge targets like 4-1BB and PD-L1 dual targets [3][12]. - The R&D team is robust, with extensive experience in new drug development, and has established a pipeline of 14 new drugs, including 6 in clinical stages and 4 with leading global clinical progress [13][22]. Section 2: 4-1BB Co-Stimulation Signal Market Potential - 4-1BB serves as a co-stimulation immune checkpoint molecule, providing a second signal for T-cell activation [25][31]. - LBL-024, a low-affinity 4-1BB dual antibody, has shown excellent efficacy and safety balance in clinical trials, with significant improvements in overall survival compared to existing treatments [4][35]. Section 3: TCE Technology Platform Validation - The TCE platform, particularly the CD3 TCE drug LBL-034, has demonstrated the ability to conditionally activate T-cells in tumor microenvironments, showing advantages in safety and efficacy over similar products [5][22]. - The company has plans for new generation TCE and TCE ADC platforms, with the CD3/MUC16 TCE positioned among the top globally [5][22].

Investment Rating - The report provides a positive investment rating for the MCE therapy in the treatment of B cell autoimmune diseases, particularly systemic lupus erythematosus (SLE) [8][10]. Core Insights - The report highlights the urgent need for effective treatments for SLE, which currently lacks a root-cause therapy, and emphasizes the potential of B cell-targeted therapies like MCE to address this unmet clinical need [10][22]. - It discusses the advantages of MCE therapy over existing treatments such as CAR-T and TCE, particularly in terms of safety and efficacy in depleting pathogenic B cells [10][42]. - The report identifies key companies to watch in the clinical progress of MCE therapies, including 宜明昂科, 赛诺菲, Dren Bio, and LTZ Therapeutics [11][12]. Summary by Sections 1. B Cell Autoimmune Diseases: Diverse Types and Large Population - Autoimmune diseases involve the immune system mistakenly attacking the body's own tissues, with significant prevalence among conditions like rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), multiple sclerosis (MS), and others [14][15]. 2. SLE: Large Population and Heavy Disease Burden - SLE affects approximately 7.8 million people globally, with a significant patient population in China, estimated at around 1 million [18][19]. - The disease presents severe symptoms and complications, leading to a high demand for effective treatments [19]. 3. SLE Treatment: Significant Unmet Clinical Needs, B Cell Therapy as a Mainstream Development - Current treatments for SLE are inadequate, with a low long-term remission rate and high recurrence risk [20][21]. - Innovative therapies that can achieve long-term remission or potential cures are urgently needed in the SLE treatment landscape [22]. 4. T Cell Killing: CAR-T and TCE - CAR-T and TCE therapies are explored for their potential to target and deplete pathogenic B cells, with CAR-T showing promising long-term efficacy in SLE patients [25][26]. - However, challenges such as high costs and safety concerns remain significant barriers to widespread adoption [32][33]. 5. Myeloid Cell Killing: MCE - MCE therapy utilizes myeloid cells to target and eliminate pathogenic B cells, showing potential for improved safety profiles compared to CAR-T and TCE therapies [47][50]. - The report emphasizes the innovative mechanisms of MCE and its potential to address the limitations of existing therapies [52].