2026.03. 06 本文字数：1440，阅读时长大约3分钟 作者 | 第一财 经 钱童心 中山医院的樊嘉、周俭、施国明团队发现，在高危复发肝内胆管癌的治疗中，患者在术前接受3个周 期的GEMOX化疗（吉西他滨和奥沙利铂）+靶向药物乐卫玛和免疫治疗药物特瑞普利单抗的新辅助 治疗，治疗结束后2至4周内完成手术，患者的中位生存时间为18个月，而对照组患者的中位生存时 间为8.7个月；患者的中位无复发生存期为15.4个月，显著好于对照组的9.7个月，复发风险降低了 31%。 这意味着在术前使用这种新的辅助疗法，可为高危复发肝内胆管癌患者带来显著的获益。这项研究也 是国际上第一个多中心（国内11家医院参加）、随机对照探索肝内胆管癌新辅助治疗的研究，填补 了国际空白，凸显了我国在肝脏肿瘤治疗领域的全球领先地位。 肝内胆管癌有"小癌王"之称，是肝脏第二常见的原发性恶性肿瘤，约占所有原发性肝癌的10%至 15%。对于早期肝内胆管癌患者，手术切除治疗是最佳治疗方式。然而，即使行根治性切除术，超 过一半病人术后仍出现复发，术后5年总体生存率仅25%至40%。新的辅助疗法被视为降低术后复发 率的重要手段。 3月5日，一项来自复 ...

Core Viewpoint - The approval of the new indication for TROP2 ADC drug Sacituzumab (sac-TMT) marks a significant advancement in the treatment of HR+/HER2- breast cancer, highlighting its clinical value and market urgency [1][5][13]. Group 1: Drug Approval and Indications - Sacituzumab has been approved for treating adults with unresectable locally advanced or metastatic HR+ and HER2- breast cancer who have previously received endocrine therapy and other systemic treatments [1][5]. - The approval is based on positive data from the OptiTROP-Breast02 Phase III study, which demonstrated significant survival benefits and manageable safety in a difficult-to-treat patient population [7][13]. Group 2: Drug Characteristics and Development - Sacituzumab is an innovative ADC targeting TROP2, composed of a humanized monoclonal antibody, a cleavable linker, and a novel topoisomerase I inhibitor, with a drug-antibody ratio (DAR) of 7.4, indicating strong drug delivery capabilities [5]. - The drug has multiple approved indications, including treatment for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) and non-small cell lung cancer (NSCLC) [5][6]. Group 3: Global Collaboration and Market Strategy - In May 2022, a strategic collaboration was established with MSD, granting exclusive rights for development and commercialization of Sacituzumab outside Greater China, indicating a global expansion strategy [8]. - MSD has initiated 16 global Phase III clinical studies across various cancer types, aiming to position Sacituzumab as a broad-spectrum ADC [8]. Group 4: Competitive Landscape - Currently, three TROP2 ADCs have been approved globally, including Sacituzumab, highlighting the competitive nature of the ADC market [9]. - In the domestic market, in addition to Sacituzumab, three other products are in Phase III clinical trials, intensifying competition [10]. Group 5: Market Demand and Future Outlook - HR+/HER2- breast cancer accounts for approximately 70% of all breast cancer cases, with significant unmet clinical needs due to treatment resistance and multiple lines of therapy failures [13]. - The approval of Sacituzumab not only enhances treatment options for this patient population but also strengthens the position of domestic ADCs in the international market [13][14]. - The future of the ADC industry will focus on maintaining first-mover advantages, expanding combination therapies, and improving patient accessibility [14].

Core Viewpoint - China Biologic Products (01177) announced that its wholly-owned subsidiary, Lixin Pharmaceutical Technology (Shanghai) Co., Ltd., has initiated a Phase III registration clinical trial for its self-developed innovative drug, LM-302, targeting CLDN18.2-positive advanced gastric and gastroesophageal junction adenocarcinoma [1][2]. Group 1: Clinical Development - LM-302 is the first CLDN18.2 antibody-drug conjugate (ADC) to complete patient enrollment in a Phase III clinical trial globally [1]. - The drug specifically targets CLDN18.2-positive tumor cells, delivering a small molecule toxin to achieve precise tumor cell destruction [1]. - The ongoing Phase III trial focuses on patients with locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma who have received three or more prior lines of therapy [2]. Group 2: Clinical Results - At the 2025 American Society of Clinical Oncology (ASCO) annual meeting, Lixin Pharmaceutical reported that in 41 evaluable patients, the objective response rate (ORR) was 65.9% and the disease control rate (DCR) was 85.4% [2]. - Among 32 patients with CLDN18.2 expression ≥25%, the ORR reached 71.9% and the DCR was 96.9% [2]. - The study also indicated that for patients with PD-L1 CPS <1, the ORR was 63.3%, while for those with CPS ≥1, the ORR was 77.8% [2]. Group 3: Future Plans and Regulatory Status - In addition to the ongoing Phase III study, LM-302 is set to undergo another Phase III registration trial in China, focusing on first-line treatment for CLDN18.2-positive locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma [2]. - LM-302 has been included in the breakthrough therapy designation by the China National Medical Products Administration (NMPA) and has received orphan drug designation (ODD) from the U.S. Food and Drug Administration (FDA) [2]. Group 4: Company Strategy - Leveraging strong resources and industrial capabilities, Lixin Pharmaceutical is accelerating the clinical translation and commercialization of more innovative drugs, aiming to provide accessible treatment options for global cancer patients [3].

智通财经APP讯，中国生物制药(01177)发布公告，集团全资附属公司礼新医药科技(上海)有限公司(礼新 医药)自主研发的国家1类创新药维特柯妥拜单抗(研发代号：LM-302)"CLDN18.2 ADC"正在开展用于治 疗三线及以上CLDN18.2阳性的局部晚期或转移性胃及胃食管交界部腺癌的III期注册临床试验(LM302- 03-101)，已顺利完成患者入组。其中，LM302是全球首款完成注册III期临床试验入组的CLDN18.2 ADC 药物。 LM-302是一款靶向CLDN18.2的抗体偶联药物(ADC)，通过与CLDN18.2阳性肿瘤细胞特异性结合，并 经内吞作用进入细胞后释放小分子毒素，从而实现对肿瘤细胞的精准杀伤。作为潜在同类首创 (FIC)药 物，LM-302在胃癌、胰腺癌及胆道癌等多个消化道肿瘤中展现出良好的临床开发潜力，并有望为 CLDN18.2低表达和PD-L1低表达患者提供新的治疗选择。 在2025年美国临床肿瘤学会(ASCO)年会上，礼新医药公布了LM-302联合特瑞普利单抗治疗胃癌的最新 研究数据：在41例疗效可评估的患者中，客观缓解率(ORR)为65.9%，疾病控制率(DCR)为 ...

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. 四川科倫博泰生物醫藥股份有限公司 （於 中 華 人 民 共 和 國 註 冊 成 立 的 股 份 有 限 公 司） （股 份 代 號：6990） 自願公告 核心產品TROP2 ADC蘆康沙妥珠單抗(sac-TMT) 獲 國 家 藥 品 監 督 管 理 局 批 准 第 四 項 適 應 症 上 市， 用於治療2L+ HR+/HER2-乳腺癌 四 川 科 倫 博 泰 生 物 醫 藥 股 份 有 限 公 司（「本公司」）董 事（「董 事」）董 事 會（「董 事 會」）欣 然 宣 佈，近 日，本 公 司 靶 向 人 滋 養 細 胞 表 面 抗 原2(TROP2)的抗體 偶聯藥物(ADC)蘆 康 沙 妥 珠 單 抗（sac-TMT，亦稱SKB264/MK-2870）（佳 泰 萊®） 的一項新增適應症上市申請 已獲中國國家藥品監督管理局(NMPA)批 准， 用於治療既往接受過內分泌治療且在晚期疾病階段接受過至少一線化療 的不可切除或轉移性的激素受體陽性(HR+)且人類表皮生長因子受體2陰 性（HER2-）（免 疫 組 織 化 ...

医药 医药 2026 年 01 月 22 日 行业日报 看好/维持 太平洋医药日报（20260122）：第一三共 ADC 新药 R-DXd 在华获 突破性疗法认定 ◼ 走势比较 (10%) 0% 10% 20% 30% 40% 25/1/22 25/4/5 25/6/17 25/8/29 25/11/10 26/1/22 ◼ 子行业评级 | 化学制药 | 无评级 | | --- | --- | | 中药生产 | 无评级 | | 生物医药Ⅱ | 中性 | | 其 他 医 药 医 | 中性 | | 疗 | | 相关研究报告 <<太平洋医药日报（20260121）：礼来 ADC 药物 LY4170156 获 FDA 突破性疗 法认定>>--2026-01-22 <<太平洋医药日报（20260120）：GSK 将以 22 亿美金收购 RAPT>>--2026- 01-21 <<太平洋医药日报（20260119）：武田 Oveporexton 在 华 申 报 上 市 >>-- 2026-01-20 证券分析师：周豫 电话： E-MAIL：zhouyua@tpyzq.com 分析师登记编号：S1190523060002 ...

Core Viewpoint - Raludotatug Deruxtecan (R-DXd, DS-6000a) has received Breakthrough Therapy Designation (BTD) from the China National Medical Products Administration (NMPA) for the treatment of adult patients with platinum-resistant epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer who have previously been treated with Bevacizumab and express CDH6 [1] Group 1 - Raludotatug Deruxtecan is developed by Daiichi Sankyo and co-developed with Merck [1] - The drug is a CDH6-targeted antibody-drug conjugate (ADC) [1]

Group 1 - The National Medical Products Administration (NMPA) accepted the market application for the first-class new drug BL-B01D1, which is indicated for recurrent or metastatic esophageal squamous cell carcinoma that has failed previous PD-1/PD-L1 monoclonal antibody combined with platinum-based chemotherapy [1] - BL-B01D1 (Iza-bren) is a globally innovative dual-antibody ADC that blocks signals from EGFR and HER3 to tumor cells, inhibiting their proliferation and survival [1] - The drug's mechanism includes antibody-mediated endocytosis, which releases therapeutic payloads that induce genotoxic stress, ultimately leading to tumor cell death [1] Group 2 - In December 2023, the company entered into an exclusive licensing and collaboration agreement with Bristol-Myers Squibb (BMS) for the global development and commercialization of Iza-bren [2] - BMS will pay the company an upfront fee of $800 million, along with two milestone payments of $250 million each; additional payments could reach up to $7.1 billion based on development, registration, and sales milestones [2] - The total potential deal value could reach $8.4 billion, setting a record for the highest total price for a single drug licensing agreement in the ADC field [2] - Currently, there are only 10 biopharmaceutical new drugs approved for esophageal cancer treatment globally, with no ADCs approved yet; if approved, BL-B01D1 will be the first ADC for esophageal cancer treatment [2]

智通财经记者 | 黄华 1月上旬，据港交所信披，浙江博锐生物制药股份有限公司（文中简称"博锐生物"）已提交上市申请， 联席保荐人为华泰国际和摩根大通。 博锐生物在医药行业小有名气，它由老牌药企海正药业孵化，前身是海正药业的生物制剂业务部门，于 2019年1月起重组为有限公司。据招股书披露，PAG Highlander（太盟投资集团）及海正药业直接持股 44.62%、39.62%。 在2022年1月接受《21世纪经济报道》专访时，博锐生物时任首席执行官（CEO）王海彬表示，希望企 业会在未来成为全球性的免疫疾病领域龙头。就现阶段而言，博锐生物有不少自免药物，也确实是自 免"大药"阿达木单抗生物类似药的销冠，但距离全球龙头目标尚远，尤其是企业在创新药和国际化方面 只能说是刚刚起步。 1月7日，就博锐生物的IPO动态，智通财经向企业发送了采访邮件。截至发稿时，尚未收到回复。 是阿达木单抗国内销冠 博锐生物是国内隐形的生物药大户，代表产品为阿达木单抗（商品名：安健宁®）。 阿达木单抗是艾伯维公司开发的自免领域生物药，曾11年蝉联全球药王。凭借难以超越的商业成就，原 研商品名修美乐几乎能和药王画上等号。该产品于2003 ...

Group 1 - WuXi AppTec announced a voluntary conditional cash offer to acquire all issued shares of Dongyao Pharmaceutical at a price of HKD 4 per share, representing a premium of approximately 99% over the closing price of HKD 2.01 on the last unaffected trading day [1][3] - The maximum consideration for the acquisition is approximately HKD 2.79 billion, with funding sourced from internal resources [1][3] - Citibank is serving as the financial advisor for this transaction [1] Group 2 - The acquisition aims to expand and acquire additional operational manufacturing capacity in China, aligning with the company's ongoing business development plan [3] - The transaction is expected to enrich the project portfolio and expand the customer base, thereby strengthening the company's market position in the contract development and manufacturing organization (CDMO) sector for antibody-drug conjugates (ADC) [3] - Following the completion of the acquisition, WuXi AppTec plans to maintain Dongyao Pharmaceutical's listing status on the Hong Kong Stock Exchange [3] Group 3 - WuXi AppTec issued a positive earnings forecast for the fiscal year 2025, expecting revenue growth of over 45% year-on-year, gross profit growth of over 70%, and adjusted net profit growth (excluding interest income and expenses) of over 45% [3] - When excluding the impact of exchange rate fluctuations, the expected growth rate is anticipated to exceed 65% [3] - Both WuXi AppTec and Dongyao Pharmaceutical are part of the contract research organization (CRO) sector, focusing on the research and production services of ADCs, which have a high barrier to commercialization [3]