LEADS BIOLABS-B(09887)
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维立志博-B(09887.HK):维利信™用于治疗复发性或转移性三阴性乳腺癌的Ib/II期临床研究首例患者已成功用药
Ge Long Hui· 2026-02-10 08:40
Core Viewpoint - The announcement highlights the successful administration of the drug Opalizumab (PD-L1/4-1BB bispecific antibody, LBL-024) to the first patient in a Phase Ib/II clinical trial for treating recurrent or metastatic triple-negative breast cancer [1] Group 1: Clinical Trial Details - The clinical trial is an open-label, multicenter Phase Ib/II study led by Professor Yin Yongmei from Jiangsu Provincial People's Hospital [1] - The trial is being conducted simultaneously across multiple hospitals nationwide [1] - The objective of the trial is to evaluate the efficacy and safety of Opalizumab administered alone or in combination with albumin-bound paclitaxel for patients with recurrent or metastatic triple-negative breast cancer [1]
维立志博-B(09887) - 自愿公告 - 维利信TM(PD-L1/4-1BB双特异性抗体奥帕替苏...
2026-02-10 08:30
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 ...
维立志博-B(09887) - 截至二零二六年一月三十一日止股份发行人的证券变动月报表
2026-02-03 04:25
FF301 股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2026年1月31日 狀態: 新提交 致:香港交易及結算所有限公司 公司名稱: 南京維立志博生物科技有限公司(於中華人民共和國注冊成立的股份有限公司) 呈交日期: 2026年2月3日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | H | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 09887 | 說明 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 153,278,691 | RMB | | 1 RMB | | 153,278,691 | | 增加 / 減少 (-) | | | | | | RMB | | | | 本月底結存 | | | 153,278,691 | RMB | | 1 RMB | | 153,278,691 | | 2. 股份 ...
港股异动 维立志博-B(09887)再涨超8% TCE双抗LBL-034获FDA快速通道资格认定
Jin Rong Jie· 2026-01-30 07:14
华福证券发布研报称,维立志博基于激动剂平台+TCE平台+ADC,全面布局下一代肿瘤免疫疗法。从 2015年的X-body平台、2016年的LeadsBody平台,到后续双抗、三抗技术积累,公司始终以"技术平台 +创新靶点"为核心,覆盖免疫检查点、多特异性抗体等前沿领域,构建差异化管线。 本文源自:智通财经网 消息面上,维立志博宣布,1月27日,公司基于TCE技术平台LeadsBody自主研发的具有独特2:1结构和 条件性激活的GPRC5D/CD3双特异性抗体LBL-034获得美国食品药品监督管理局(FDA)授予快速通道资 格认定,用于治疗复发/难治性多发性骨髓瘤。 智通财经获悉,维立志博-B(09887)再涨超8%,截至发稿,涨7.29%,报64.75港元,成交额4491.77万港 元。 ...
港股维立志博-B一度涨超8%
Mei Ri Jing Ji Xin Wen· 2026-01-30 06:15
(文章来源:每日经济新闻) 每经AI快讯,维立志博-B(09887.HK)一度涨超8%,截至发稿涨7.29%,报64.75港元,成交额4491.77万 港元。 ...
维立志博-B再涨超8% TCE双抗LBL-034获FDA快速通道资格认定
Zhi Tong Cai Jing· 2026-01-30 06:01
Core Viewpoint - The company, Valiant Bio-B (09887), has seen its stock price increase by over 8%, currently trading at 64.75 HKD, with a transaction volume of 44.92 million HKD, following the announcement of its dual-specific antibody LBL-034 receiving Fast Track designation from the FDA for treating relapsed/refractory multiple myeloma [1]. Group 1 - Valiant Bio-B's LBL-034 is developed based on the TCE technology platform LeadsBody, featuring a unique 2:1 structure and conditional activation [1]. - The company has a comprehensive layout for next-generation tumor immunotherapy, utilizing its agonist platform, TCE platform, and ADC [1]. - Since 2015, the company has focused on "technology platform + innovative targets," covering cutting-edge areas such as immune checkpoints and multi-specific antibodies, thereby building a differentiated pipeline [1].
异动盘点0129 | 物管股跟随内房股走高,爱高集团早盘闪崩跌超70%;存储板块走高,英特尔涨11.04%
贝塔投资智库· 2026-01-29 04:04
Group 1 - Lee & Man Paper Manufacturing (02314) rose nearly 6% after Nine Dragons Paper announced a profit forecast of approximately 2.15 billion to 2.25 billion yuan for the six months ending December 31, 2025, representing a year-on-year increase of 216.0% to 230.7% [1] - New Oriental Education (09901) increased nearly 4% following the release of its financial results for the second quarter of fiscal year 2026, showing a 14.7% year-on-year increase in net revenue and a 244.4% rise in operating profit [1] - Jolywood (06680) surged nearly 7% as rare earth prices continued to rise, with neodymium and praseodymium oxide prices increasing by over 120,000 yuan per ton [1] Group 2 - Chinese property management stocks saw a significant rise, with Sunac Services (01516) up 5.67% and Greentown Services (02869) up 5.81%, as a report predicted an average revenue growth of 6% for property management companies by 2025 [2] - Valiant Pharmaceuticals (09887) gained nearly 4% after receiving FDA fast track designation for its dual-specific antibody LBL-034 for treating relapsed/refractory multiple myeloma [2] - The commercial aerospace sector showed signs of recovery, with Junda Co. (02865) rising 12.1% as the China Aerospace Science and Technology Corporation emphasized the importance of the next decade for developing a strong aerospace industry [2] Group 3 - Aigo Group (00328) experienced a dramatic drop, falling over 88% at one point, with a total market value dropping below 35 million HKD [3] - China Overseas Development (00688) rose over 4.2% as Citigroup's report indicated that the Chinese real estate sector would face significant impairment and margin decline challenges in fiscal year 2025 [3] - Yuegangwan Holdings (01396) increased by 8% after announcing a share placement to raise 108 million yuan, with about 70% allocated for AI computing power cloud service projects [3] Group 4 - Junda Co. (02865) saw a rise of 11.99% as the China Aerospace Science and Technology Corporation held a meeting emphasizing the need to overcome challenges in commercial rocket launches and reusable technology [4] Group 5 - In the US market, New Oriental (EDU.US) rose 5.32% after reporting a net revenue of 1.191 billion USD for the second quarter of fiscal year 2026, a 14.7% year-on-year increase [5][6] - Semiconductor equipment and materials sector saw gains, with Texas Instruments (TXN.US) up 9.94% as it projected first-quarter revenue between 4.32 billion and 4.68 billion USD, slightly above analyst expectations [5] - Storage sector stocks surged, with Seagate Technology (STX.US) up 19.14% as it projected third-quarter revenue of 2.9 billion USD, significantly higher than analyst estimates [5]
维立志博-B再涨近6% TCE双抗LBL-034获FDA快速通道资格认定
Zhi Tong Cai Jing· 2026-01-29 03:09
维立志博-B(09887)再涨近6%,截至发稿,涨4.63%,报62.2港元,成交额1142.28万港元。 这是继2024年10月获FDA孤儿药认定后,该产品在国际化开发道路上的又一重要里程碑,标志着其临床 价值与开发策略进一步获得国际监管机构的认可。据悉,LBL-034是一款靶向GPRC5D及CD3的人源化 双特异性T细胞衔接器。 消息面上,维立志博宣布,公司基于专有TCE技术平台LeadsBody自主研发的GPRC5D/CD3双特异性抗 体LBL-034,获得美国食品药品监督管理局(FDA)授予的快速通道资格认定,用于治疗复发/难治性多发 性骨髓瘤(RRMM)。 ...
港股异动 | 维立志博-B(09887)再涨近6% TCE双抗LBL-034获FDA快速通道资格认定
智通财经网· 2026-01-29 03:06
这是继2024年10月获FDA孤儿药认定后,该产品在国际化开发道路上的又一重要里程碑,标志着其临床 价值与开发策略进一步获得国际监管机构的认可。据悉,LBL-034是一款靶向GPRC5D及CD3的人源化 双特异性T细胞衔接器。 智通财经APP获悉,维立志博-B(09887)再涨近6%,截至发稿,涨4.63%,报62.2港元,成交额1142.28万 港元。 消息面上,维立志博宣布,公司基于专有TCE技术平台LeadsBody自主研发的GPRC5D/CD3双特异性抗 体LBL-034,获得美国食品药品监督管理局(FDA)授予的快速通道资格认定,用于治疗复发/难治性多 发性骨髓瘤(RRMM)。 ...
维立志博-B:LBL-034(GPRC5D/CD3双特异性T-CELL ENGAGER,TCE)获美国FDA授予快速通道资格认定
Zhi Tong Cai Jing· 2026-01-28 00:49
Core Viewpoint - The company Valiant Biopharma-B (09887) announced that its drug LBL-034 (a GPRC5D/CD3 bispecific antibody) has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of relapsed/refractory multiple myeloma (RRMM) [1] Group 1 - The drug LBL-034 is specifically designed to target GPRC5D and CD3, indicating a novel therapeutic approach in the treatment of RRMM [1] - The Fast Track Designation by the FDA is aimed at facilitating the development and expedite the review of drugs that treat serious conditions and fill an unmet medical need [1] - This designation may provide the company with advantages such as more frequent communication with the FDA and eligibility for accelerated approval and priority review [1]