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].