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]

SIM0709为集团基于自有多特异性抗体平台自主研发的长效人源化双特异性抗体。SIM0709可同时靶向 肿瘤坏死因子配体超家族成员15(TL1A)和白介素-23(IL-23)，从而阻断参与炎症性肠病发生及进展的两 条核心通路。SIM0709在体外原代细胞实验和体内动物实验中均表现出优异的药效协同效果，甚至优于 两个单药的联用。 智通财经APP讯，先声药业(02096)发布公告，于2026年1月26日，集团附属公司先声药业有限公司(江苏 先声)与勃林格殷格翰签署独家授权许可协议。根据该协议条款，勃林格殷格翰将获得用于炎症性肠病 的TL1A/IL-23p19双特异性抗体SIM0709在大中华区以外的全球独家权益。本次授权许可进一步验证了 集团自身免疫研发平台的创新性及领先性。 根据该协议条款，集团有权收取4200万欧元的首付款，以及基于研发进展、监管审批及商业化等情况， 最高达10.16亿欧元的里程碑付款。此外，集团亦有权就大中华区以外的净销售额收取分级特许权使用 费。 （原标题：先声药业(02096)与勃林格殷格翰就SIM0709(TL1A/IL-23p19双特异性抗体)订立独家授权许 可协议） ...

Core Viewpoint - The announcement by Xiansheng Pharmaceutical (02096) regarding the exclusive licensing agreement with Boehringer Ingelheim for the dual-specific antibody SIM0709 highlights the company's innovative and leading position in the field of autoimmune research [1] Group 1: Licensing Agreement Details - Xiansheng Pharmaceutical's subsidiary, Jiangsu Xiansheng, signed an exclusive licensing agreement with Boehringer Ingelheim on January 26, 2026, granting Boehringer 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 on the company's proprietary multi-specific antibody platform [1] - The antibody targets both TNF superfamily member 15 (TL1A) and interleukin-23 (IL-23), blocking two key pathways involved in the onset and progression of inflammatory bowel disease [1] - SIM0709 has demonstrated superior synergistic efficacy in both in vitro primary cell experiments and in vivo animal studies, outperforming the combination of two single agents [1]