日前，浙江时迈药业股份有限公司（以下简称"时迈药业"）在港交所递交招股书，华泰国际为独家 保荐人。 得益于近年来TCE疗法的火热，时迈药业收获了来自贝达药业等投资方的多轮融资。资本青睐的背 后，公司也面临多重考验，其"节流"式发展路径能否支撑前沿疗法的研发，仍有待时间的进一步检验。 聚焦前沿疗法 估值"水涨船高" 作为一家成立于2017年的创新药企，时迈药业聚焦TCE（T细胞衔接器）药物的研发。 业绩方面，2023年、2024年和2025年上半年，时迈药业的收入分别为1465万元、662万元和228万 元，同期的亏损分别为7494万元、5989.9万元和2542万元，累计亏损已超过1.6亿元。产品方面，公司未 有产品商业化，共有四款自主研发的临床阶段候选药物。其中两款核心产品分别为DNV3和SMET12， 目前均在II期临床试验阶段。 据悉，近年来TCE领域交易活跃，2024年全球交易总额已突破85亿美元，全球已有12款TCE药物获 批上市。目前，TCE行业呈高速增长态势。此前，南京维立志博生物科技股份有限公司于今年7月在港 交所上市，被市场视为"TCE疗法第一股"。 得益于广阔的市场前景，时迈药业共计获得了 ...

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].

截至2025年11月5日，时迈药业拥有四款自主研发的临床阶段候选药物，包括靶向LAG3的DNV3、静脉 注射用EGFR×CD3TCE SMET12、GPC3×CD3TCE CMD011以及下一代遮蔽型TCE CMDE005。 该公司还有两款处于临床前阶段的下一代多功能/逻辑门控TCE候选药物，CMDE101和CMDE102，分别 靶向FOLR1×PD-L1×CD3和PSMA×PD-L1×CD3。 时迈药业强调其TCE疗法具有选择性激活、零级免疫细胞毒性、精准识别肿瘤和预防肿瘤复发等特点， 旨在成为未来肿瘤免疫治疗的基石疗法。 时迈药业已递表港交所主板，华泰国际为独家保荐人。 TCE是一种通过激活T细胞来对抗肿瘤的抗体疗法，具有巨大的市场增长潜力。预计全球TCE市场将从 2024年的30亿美元增长到2035年的1211亿美元，复合年增长率为40.0%。 ...

Core Viewpoint - Zhejiang Shimai Pharmaceutical Co., Ltd. has submitted an application to list on the Hong Kong Stock Exchange, with Huatai International as the sole sponsor [1]. Company Overview - Established in 2017, the company is a pioneer and global leader in next-generation T-cell engagers (TCE) therapy, designed to direct T-cells to tumor tissues and activate them to induce targeted cytotoxic effects [3][4]. - The company has developed a next-generation TCE therapy that selectively activates in tumors for the treatment of solid tumors, with a significant market potential [3][4]. Product Pipeline - As of November 5, 2025, the company has four clinical-stage candidates: 1. DNV3, targeting LAG3 2. SMET12, an intravenous EGFR×CD3 TCE 3. CMD011, a GPC3×CD3 TCE 4. CMDE005, a next-generation EGFR×CD3 TCE [4]. - Additionally, two preclinical candidates are in development, targeting FOLR1×PD-L1×CD3 and PSMA×PD-L1×CD3 [4]. Financial Performance - The company reported revenues of RMB 14.649 million, RMB 6.618 million, and RMB 2.278 million for the years 2023, 2024, and the first half of 2025, respectively [7][9]. - Losses for the same periods were RMB 74.943 million, RMB 59.899 million, and RMB 25.420 million [7][9]. - Research and development expenses were RMB 76.109 million, RMB 53.382 million, and RMB 22.389 million for the years 2023, 2024, and the first half of 2025, respectively [8][9]. Market Overview - The global TCE market is projected to grow from USD 4 billion in 2020 to USD 30 billion in 2024, with a compound annual growth rate (CAGR) of 67.6% [12]. - By 2035, the global TCE market is expected to reach USD 121.1 billion [12]. - The Chinese TCE market is anticipated to grow from RMB 1 billion in 2021 to RMB 7 billion in 2024, with a CAGR of 104.0% [12]. By 2035, it is expected to reach RMB 159.6 billion [12]. Board of Directors - The board consists of 9 members, including 3 executive directors, 3 non-executive directors, and 3 independent non-executive directors [15].

智通财经APP获悉，据港交所11月12日披露，浙江时迈药业股份有限公司-B(以下简称：时迈药业)递表港交所主板，华泰国际为其独家保荐人。 | 編纂]項下的[編纂]數目 | [編纂]股H股(視乎[編纂]行使與否而 | | --- | --- | | | 定) | | [編纂]數目 | 「編纂]股H股(可予重新分配) | | [編纂]數目 | 「編纂」股H股(可予車新分配及視乎 | | | 「編纂】行使與否而定） | | 最高[編纂] .. | 每股H股[編纂]港元,另加1.0%經 | | | 紀佣金、0.0027%證監會交易徵 | | | 費 · 0.00015% 會財局交易徵費及 | | | 0.00565%聯交所交易費(須於申請 | | | 時以港元繳足,多繳款項可予退 | | | 賞 | | 面值 | 每股人民幣0.10元 | | [編纂] | [編纂] | 据招股书，该公司成立于2017年，是下一代T细胞衔接器(TCE)疗法的先驱及全球领军企业。TCE为双特异性或多特异性抗体，其设计原理是通过同时结合 肿瘤细胞上的肿瘤相关抗原(TAA)及T细胞上的受体，从而定向至肿瘤组织并激活T细胞，以诱导靶向细胞毒性 ...

Core Viewpoint - Zhejiang Shimai Pharmaceutical Co., Ltd. has submitted an application to list on the Hong Kong Stock Exchange, positioning itself as a pioneer and global leader in next-generation T-cell engagers (TCE) therapy [1]. Company Overview - Established in 2017, the company focuses on TCE, which are bispecific or multispecific antibodies designed to target tumor-associated antigens (TAA) on cancer cells and receptors on T-cells, thereby directing T-cells to tumor tissues and activating them to induce targeted cytotoxic effects [1]. - The company recognized the differentiated potential of TCE early on, aiming to leverage and guide the human immune system to combat cancer through next-generation immunotherapy [1]. Product Pipeline - As of November 5, 2025, the company has four self-developed clinical-stage drug candidates: 1. DNV3, a potential best-in-class T-cell modulator targeting LAG3 2. SMET12, a potential first-in-class intravenous EGFR×CD3 TCE 3. CMD011, a potential best-in-class GPC3×CD3 TCE 4. CMDE005, a potential first-in-class next-generation shielding TCE targeting EGFR×CD3 [3]. - Additionally, the company has two preclinical-stage next-generation multifunctional/logical gate TCE candidates, CMDE101 and CMDE102, targeting FOLR1×PD-L1×CD3 and PSMA×PD-L1×CD3, respectively [3].

Core Viewpoint - Zhejiang Shimai Pharmaceutical Co., Ltd. has submitted an application to list on the Hong Kong Stock Exchange, with Huatai International as the sole sponsor, highlighting its position as a pioneer and global leader in next-generation T cell engagers (TCE) therapy [1][4]. Group 1: Company Overview - The company was established in 2017 and focuses on TCE therapy, which utilizes bispecific or multispecific antibodies designed to target tumor-associated antigens (TAA) on cancer cells and receptors on T cells, thereby directing T cells to tumor tissues to induce targeted cytotoxic effects [1]. - The company recognized the differentiated potential of TCE early on, aiming to leverage and guide the human immune system to combat cancer through next-generation immunotherapy [1]. Group 2: Product Pipeline - As of November 5, 2025, the company has four self-developed clinical-stage candidate drugs: (i) DNV3, a potential best-in-class T cell modulator targeting LAG3, (ii) SMET12, a potential first-in-class intravenous EGFR×CD3 TCE, (iii) CMD011, a potential best-in-class GPC3×CD3 TCE, and (iv) CMDE005, a potential first-in-class next-generation shielding TCE targeting EGFR×CD3 [4]. - Additionally, the company has two preclinical-stage next-generation multifunctional/logic-gated TCE candidates, CMDE101 and CMDE102, targeting FOLR1×PD-L1×CD3 and PSMA×PD-L1×CD3, respectively [4].