Group 1 - Shimai Pharmaceutical has submitted a listing application to the Hong Kong Stock Exchange, with Huatai International as the sole sponsor. The company, founded in 2017, is a pioneer in next-generation T cell engagers (TCE) aimed at utilizing the human immune system to combat cancer. It has developed a next-generation TCE therapy that can be selectively activated in tumors for the treatment of solid tumors, with four self-developed clinical-stage candidates currently in its pipeline [1] - The listing will accelerate research and development, allowing the company to seize market opportunities in the growing TCE sector [1] Group 2 - Gilead Sciences announced that its new generation of once-monthly GLP-1 receptor agonist ASC36 and dual-target agonist ASC35 has entered clinical development. The company expects to submit clinical trial applications to the FDA for ASC36 and ASC35 for obesity treatment by the second quarter of 2026 [2] - ASC36 and ASC35 are proprietary long-acting formulations with superior physicochemical stability, designed to treat metabolic diseases including obesity. ASC36 is positioned as a cornerstone therapy with potential efficacy and tolerability advantages over existing GLP-1 therapies [2] Group 3 - InnoCare Pharma reported a nearly 60% increase in total revenue for the first three quarters of 2025, reaching 1.12 billion yuan, driven by sustained sales growth of its core product, the BTK inhibitor Orelabrutinib, and upfront payments from licensing agreements [4] - The revenue from Orelabrutinib increased by 45.8% year-on-year, surpassing last year's total revenue. The company's losses narrowed by 74.8% to 70 million yuan, indicating a potential turning point in profitability [4] Group 4 - InnoCare's revenue growth and reduced losses are attributed to the expansion of Orelabrutinib's indications and additional licensing income, which will accelerate the advancement of its innovative pipeline and strengthen its position in the BTK field [4] Group 5 - Ying'en Biopharma's new drug DB-1418 has been approved for clinical trials in China, targeting advanced/metastatic solid tumors. This drug is an EGFR/HER3 bispecific antibody-drug conjugate (ADC) [3] - The approval of this ADC aims to address treatment bottlenecks in resistant solid tumors and enhance the company's pipeline competitiveness, providing new options for solid tumor treatment [3]

点评：ASC36与ASC35为专有的超长效复方制剂，具有优越的理化稳定性，在中性pH值附近没有纤维 化导致的聚集沉淀。歌礼正将ASC36打造为每月一次疗法的基石，用于治疗包括肥胖在内的心脏代谢疾 病。ASC36有望达到比GLP-1疗法更优的疗效和耐受性，是一款既可作为单药疗法，也可与其他长效制 剂如ASC35或THRβ激动剂ASC47开发成复方制剂的理想候选药物。 丨 2025年11月14日星期五丨 NO.1时迈药业拟赴香港上市 港交所官网显示，浙江时迈药业递交上市申请，华泰国际为独家保荐人。据悉，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。目 前，时迈药业拥有四款自主研发的临床阶段的候选药物。 点评：时迈药业携遮蔽型TCE核心技术赴港上市，四款临床阶段药物聚焦实体瘤，技术具有全球竞争 力。契合TCE赛道增长趋势，上市募资将加速研发，有望抢占细分市场先机。 NO.2歌礼制药宣布减重新药进入临床开发阶段 歌礼制药宣布，每月一次新一代胰淀素受体激动剂A ...

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, 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].