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 ...

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不 負 責，對 其 準 確 性 或 完 整 性 亦 不 發 表 任 何 聲 明，並 明 確 表 示，概 不 對 因 本 公 告 全部或任何部份內容而產生或因倚賴該等內容而引致的任何損失承擔任何責 任。 Nanjing Leads Biolabs Co., Ltd. （於 中 華 人 民 共 和 國 成 立 的 股 份 有 限 公 司） （股 份 代 號：9887） 自願公告 維 利 信™（PD-L1/4-1BB雙 特 異 性 抗 體 奧 帕 替 蘇 米 單 抗，LBL-024） 於一線食管鱗狀細胞癌II期試驗的首例患者入組 本公告由南京 維 立志博生物科技股份有限公司（「本公司」，連 同 其 附 屬 公 司 統 稱「本集團」）自 願 作 出，以 告 知 本 公 司 股 東 及 潛 在 投 資 者 有 關 本 公 司 的 最 新 業 務 發 展 情 況。 本 公 司 欣 然 宣 布，評 價 維 利 信™（PD-L1/4-1BB雙 特 異 性 抗 體 奧 帕 替 蘇 米 單 抗， LBL-024）用於治療一線食管鱗狀細胞癌的II期 臨 床 研 究 首 ...

Core Viewpoint - The announcement highlights the successful administration of the first patient in a Phase Ib/II clinical trial for the treatment of recurrent or metastatic triple-negative breast cancer (TNBC) using the bispecific antibody, Opalizumab (LBL-024), which targets PD-L1 and 4-1BB [1] Group 1: Clinical Trial and Drug Development - The Phase Ib/II clinical trial is an open-label, multicenter study led by Professor Yin Yongmei from Jiangsu Provincial People's Hospital, aiming to evaluate the efficacy and safety of Opalizumab alone or in combination with albumin-bound paclitaxel for TNBC patients [1] - Opalizumab is the first bispecific antibody targeting both PD-L1 and 4-1BB, showing potential as a leading therapy for advanced pulmonary neuroendocrine carcinoma and demonstrating promising clinical activity in various indications [1][2] - The drug has received several regulatory designations, including Breakthrough Therapy Designation (BTD) from the NMPA in October 2024 and Orphan Drug Designation from the FDA in November 2024 for neuroendocrine carcinoma [2] Group 2: Market Need and Cancer Statistics - Cancer remains a leading cause of morbidity and mortality globally, with breast cancer being the second most common cancer, accounting for approximately 2.3 million new cases annually [3] - In China, the incidence of breast cancer continues to rise, with an estimated 360,000 new cases and 75,000 deaths each year, highlighting the urgent need for effective treatments, particularly for TNBC, which represents 15% to 20% of all breast cancer cases [3] - TNBC is characterized by high malignancy, recurrence rates, and poor prognosis, indicating a significant unmet clinical need for more effective treatment options beyond standard chemotherapy [3]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不 負 責，對 其 準 確 性 或 完 整 性 亦 不 發 表 任 何 聲 明，並 明 確 表 示，概 不 對 因 本 公 告 全部或任何部份內容而產生或因倚賴該等內容而引致的任何損失承擔任何責 任。 Nanjing Leads Biolabs Co., Ltd. 南 京 維 立志博生物科技股份有限公司 （於 中 華 人 民 共 和 國 成 立 的 股 份 有 限 公 司） （股 份 代 號：9887） 維 利 信™是一種同時靶向PD-L1與4-1BB的 雙 特 異 性 抗 體，為 針 對 肺 外 神 經 內 分泌癌的全球首款達到註冊臨床階段的靶向4-1BB受 體 的 療 法。於 非 小 細 胞 肺 癌、小 細 胞 肺 癌 及 肺 外 神 經 內 分 泌 癌 這3種適應症的II期 或 註 冊 臨 床 試 驗 中， 維 利 信™展 現 出 同 類 第 一 或 同 類 最 佳 臨 床 活 性 潛 力。維 利 信™亦有望成為治療 晚 期 肺 外 神 經 內 分 泌 癌 的 首 款 獲 批 藥 物。憑 藉 我 們 自 主 研 發 並 具 有 知 識 產 ...

在易感个体中，瓜氨酸化蛋白会激活T细胞驱动的一系列事件，促进B细胞成熟与活化，进而产生致病 性抗瓜氨酸化蛋白抗体（ACPA）。ACPA与更差的预后相关，常表现为更严重的关节损伤和快速进展 的病程。在体外实验中，AZD1163能抑制RA患者血清和滑液中存在的蛋白质瓜氨酸化及升高的PAD活 性。 根据ClinicalTrials官网，阿斯利康正在开展AZD1163治疗类风湿关节炎患者的一项2期临床研究。本次该 产品在中国获批临床，意味着其在中国的临床研究即将开展。 2025 ACR年会首次公布了AZD1163在健康志愿者中的安全性、耐受性、药代动力学特性及其对系统性 PAD酶活性影响的药效学数据研究。研究表明，AZD1163的暴露量呈剂量比例性增加，皮下给药后最大 浓度出现在第10天。皮下给药的生物利用度估计为65%。平均系统清除率为0.15升/天，平均消除半衰期 为38天。观察到对PAD2/4活性显著且剂量依赖性的抑制，最大抑制率超过95%，证实了靶标结合。在 AZD1163接受者中，抗药物抗体（ADA）发生率较低，为6.7%。不良事件较少，剂量递增耐受性良 好。 智通财经APP获悉，近日，中国国家药监局药品审 ...

Core Insights - The article highlights the inclusion of Ivonescimab, a PD-1/VEGF bispecific antibody developed by Kangfang Biopharma, in the FirstWord Pharma's "Spotlight On: The drugs that will shape 2026" list, marking it as the only drug from a Chinese innovative pharmaceutical company [1][2] Company Overview - Kangfang Biopharma, established in 2012 in Zhongshan, focuses on addressing unmet clinical needs through technological innovation and has developed over 50 innovative drug candidates targeting major diseases [4] - The company is the only pharmaceutical firm globally with two tumor immune bispecific antibody drugs, with seven new drugs already commercialized and four additional indications under review [4] Drug Development and Market Potential - Ivonescimab is set to receive approval from the National Medical Products Administration of China in May 2024 for treating locally advanced or metastatic non-small cell lung cancer (nsq-NSCLC) after progression on EGFR-TKI therapy [2] - The drug has been recognized for its clinical value and commercial potential, being included in the national medical insurance catalog in November 2024 [2] - The global development of Ivonescimab, in collaboration with Summit Therapeutics, positions it as a leader in the PD-(L)1/VEGF bispecific antibody space, with significant attention on its potential in broader clinical applications beyond second-line NSCLC [3] Industry Context - The trend of developing PD-(L)1/VEGF bispecific antibodies is largely driven by China, with clinical studies indicating enhanced efficacy in treating non-small cell lung cancer compared to PD-1 monotherapy [3] - The biopharmaceutical industry in Zhongshan is recognized as a key sector, with the city expanding its health base and establishing a comprehensive support system for biopharmaceutical innovation, including a 10 billion yuan angel fund [4][5]

Core Viewpoint - The company Valiant Bio-B (09887) has seen a significant stock increase of nearly 6%, currently trading at 62.2 HKD, with a transaction volume of 11.42 million HKD, following the announcement of its dual-specific antibody LBL-034 receiving Fast Track designation from the FDA for the treatment of relapsed/refractory multiple myeloma (RRMM) [1] Group 1 - Valiant Bio-B's LBL-034, developed using its proprietary TCE technology platform LeadsBody, has been granted Fast Track designation by the FDA [1] - This designation marks an important milestone in the international development of LBL-034, following its orphan drug designation received in October 2024 [1] - The recognition from international regulatory bodies further validates the clinical value and development strategy of LBL-034 [1] Group 2 - LBL-034 is a humanized dual-specific T-cell engager targeting GPRC5D and CD3 [1]

Core Viewpoint - The company Valiant Pharmaceuticals-B (09887) has seen a significant stock increase of nearly 6%, currently trading at 62.2 HKD, with a transaction volume of 11.42 million HKD, following the announcement of its dual-specific antibody LBL-034 receiving Fast Track designation from the FDA for the treatment of relapsed/refractory multiple myeloma (RRMM) [1] Group 1 - Valiant Pharmaceuticals announced that its proprietary TCE technology platform LeadsBody has developed the dual-specific antibody LBL-034, which has received Fast Track designation from the FDA [1] - This designation is a significant milestone in the international development of LBL-034, following its orphan drug designation received in October 2024, indicating further recognition of its clinical value and development strategy by international regulatory authorities [1] - LBL-034 is a humanized dual-specific T-cell engager targeting GPRC5D and CD3 [1]

Core Viewpoint - The announcement of an exclusive licensing agreement between the company and Boehringer Ingelheim for the dual-specific antibody SIM0709 has positively impacted the company's stock price, reflecting investor confidence in its innovative capabilities in the autoimmune research field [1] Group 1: Licensing Agreement Details - The company’s subsidiary, Jiangsu Xiansheng, signed an exclusive licensing agreement with Boehringer Ingelheim on January 26, 2026, granting Boehringer global exclusive rights to SIM0709 outside Greater China [1] - The agreement includes an upfront payment of €42 million and potential milestone payments up to €1.016 billion based on development progress, regulatory approvals, and commercialization [1] - The company will also receive tiered royalties on net sales outside Greater China [1] Group 2: Product Information - SIM0709 is a long-acting humanized dual-specific antibody developed by the company’s proprietary multi-specific antibody platform [1] - The antibody targets TL1A and IL-23, which are key pathways involved in the onset and progression of inflammatory bowel disease [1] - Preclinical studies have shown that SIM0709 exhibits superior synergistic effects compared to the combination of two single agents in both in vitro and in vivo experiments [1]

Core Viewpoint - The company Valiant Bio-B (09887.HK) has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) for its drug LBL-034, a bispecific antibody targeting GPRC5D/CD3, aimed at treating relapsed/refractory multiple myeloma (RRMM) [1] Group 1 - The FDA granted Fast Track Designation to LBL-034 on January 27, 2026 [1] - LBL-034 is specifically designed for the treatment of relapsed/refractory multiple myeloma [1]