维立志博-B(09887)发布公告，于2025年12月6日至9日，第67届ASH年会在美国佛罗里达州奥兰多召 开。公司自主研发用于治疗复发性╱难治性多发性骨髓瘤("RRMM")的GPRC5D/CD3双特异性抗体LBL- 034在大会首日第一个进行口头报告。 LBL-034的I/II期临床研究由北京大学人民医院路瑾教授牵头，在全国17家中心开展，研究证实LBL-034 对RRMM患者(包括具有高危特征的难治亚组)表现出良好的安全性和令人振奋的抗肿瘤活性，展现出同 类最佳治疗潜力。 LBL-034的主要临床亮点包括： LBL-034剂量递增至1,200μg/kg，未观察到任何剂量限制性毒性(DLT)，未达到最大耐受剂量(MTD)。与 生活质量密切相关不良事件均为1至2级，多数不良事件发生于第一周期，在后续治疗中的发生率显著降 低，不影响治疗连续性。味觉、皮肤和指甲毒性发生率低，且有自愈倾向。 在400至1,200μg/kg剂量范围(n=40)，客观缓解率(ORR)为82.5%，≥完全缓解(CR)为52.5%，≥非常好的部 分缓解(VGPR)为72.5%，微小残留病灶(MRD)阴性率为80.0%。在800μg/kg ...

Core Viewpoint - The company, Wuxi Biologics, is set to present its innovative GPRC5D/CD3 bispecific antibody LBL-034 for treating relapsed/refractory multiple myeloma (RRMM) at the 67th ASH Annual Meeting, showcasing promising clinical results and safety profile [1][2]. Group 1: Clinical Research Highlights - LBL-034's I/II clinical trial, led by Professor Lu Jin from Peking University People's Hospital, demonstrated good safety and encouraging anti-tumor activity in RRMM patients, including those with high-risk features [1]. - No dose-limiting toxicities (DLT) were observed at doses up to 1,200 μg/kg, and the maximum tolerated dose (MTD) has not been reached [1]. - Adverse events related to quality of life were mostly grade 1-2 and primarily occurred during the first treatment cycle, with significantly reduced incidence in subsequent treatments [1]. Group 2: Efficacy Data - In the dose range of 400 to 1,200 μg/kg (n=40), the objective response rate (ORR) was 82.5%, with a complete response (CR) rate of 52.5% and a very good partial response (VGPR) rate of 72.5% [2]. - At the 800 μg/kg dose level, ORR and CR rates increased to 90.9% and 63.6%, respectively [2]. - In patients with extramedullary disease (EMD), the ORR was 75.0%, with two cases achieving stringent complete response (sCR), and in the 1,200 μg/kg group, the ORR for EMD patients reached 100% [2]. - The 12-month progression-free survival (PFS) rate was 61.2% with a median follow-up of 9.6 months, and for the 400 μg/kg group (n=11), the median follow-up time was 13.1 months with a 12-month PFS rate of 56.8% [2].

格隆汇12月7日丨维立志博-B(09887.HK)公告，于2025年12月6日至9日，第67届ASH年会在美国佛罗里 达州奥兰多召开。公司自主研发用于治疗复发性╱难治性多发性骨髓瘤("RRMM")的GPRC5D/CD3双特 异性抗体LBL-034在大会首日第一个进行口头报告。LBL-034的I/II期临床研究由北京大学人民医院路瑾 教授牵头，在全国17家中心开展，研究证实LBL-034对RRMM患者(包括具有高危特征的难治亚组)表现 出良好的安全性和令人振奋的抗肿瘤活性，展现出同类最佳治疗潜力。LBL-034的主要临床亮点包括： LBL-034剂量递增至1,200μg/kg，未观察到任何剂量限制性毒性(DLT)，未达到最大耐受剂量(MTD)。与 生活质量密切相关不良事件均为1至2级，多数不良事件发生于第一周期，在后续治疗中的发生率显著降 低，不影响治疗连续性。味觉、皮肤和指甲毒性发生率低，且有自愈倾向。 在400至1,200μg/kg剂量范围，观察到持续获益趋势，12个月无进展生存期(PFS)率为61.2%(中位随访时 间：9.6个月)。400μg/kg(n=11)中位随访时间已达13.1个月，12个月PFS ...

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） 自願公告 LBL-034臨床數據於第67屆ASH年會發布 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。 茲提述本公司日期為2025年10月9日 及2025年11月4日 的 公 告，內 容 有 關5篇研究 摘要入選美國血液學會（「ASH」）以於其第67屆 年 會 上 展 示，以 及1項LBL-034臨 床 研 究 獲 選 在 大 會 首 日 作 第 一 個 口 頭 ...

Group 1 - The Hong Kong biotechnology sector experienced a widespread decline, with notable drops in several companies' stock prices [1] - Specifically, Gilead Sciences-B fell over 13%, while Sanofi-B dropped more than 10% [1] - Other companies such as Crystal Technology Holdings and Hualing Pharmaceutical-B also saw declines exceeding 6% [1] Group 2 - Gilead Sciences-B's latest price is 11.750, with a market capitalization of 116.56 billion and a year-to-date increase of 290.37% [2] - Sanofi-B's latest price is 7.000, with a market capitalization of 7.44 billion and a year-to-date increase of 102.31% [2] - Crystal Technology Holdings has a latest price of 9.330, a market capitalization of 401.48 billion, and a year-to-date increase of 56.02% [2] - Hualing Pharmaceutical-B's latest price is 3.230, with a market capitalization of 34.13 billion and a year-to-date increase of 121.23% [2] - Other companies like Wangshan Wangshui-B and Sanleaf Biotech-B also reported significant declines, with year-to-date increases of 123.25% and 920.75% respectively [2]

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: 2025年11月30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） 呈交日期: 2025年12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 | | ...

Group 1 - The company Valiant Biopharma-B (09887) announced that its self-developed candidate drug LBL-047 has received approval for clinical trials (IND) from the National Medical Products Administration (NMPA) of China on November 25, 2025 [1] - LBL-047 is the world's first bispecific fusion protein targeting both plasmacytoid dendritic cells (pDC) and B cells, with a unique mechanism of action that positions it as a first-in-class and best-in-class potential therapy [1] - The approved clinical trial is a double-blind, randomized, placebo-controlled, dose-escalation Phase I study assessing the safety, tolerability, and preliminary clinical efficacy of LBL-047 in healthy adults and patients with systemic lupus erythematosus (SLE) [1] Group 2 - On October 16, 2025, the company entered into an exclusive global partnership with Dianthus Therapeutics (NASDAQ: DNTH) to develop transformative therapies for severe autoimmune diseases, granting Dianthus exclusive global rights for the research, production, and commercialization of LBL-047 outside Greater China [2] - The collaboration aims to advance the global development of LBL-047 and maximize its clinical value and commercial potential [2]

Core Insights - The company Valiant Biopharma-B (09887) has received approval from the National Medical Products Administration (NMPA) in China for the clinical trial application of its candidate drug LBL-047, marking it as the first bispecific fusion protein to achieve dual reporting and approval in both China and the U.S. [1] - LBL-047 targets both plasmacytoid dendritic cells (pDC) and B cells, with no other drug currently approved for clinical trials that simultaneously targets these cells, indicating its potential as a first-in-class and best-in-class therapy [1] - The approved clinical trial is a double-blind, randomized, placebo-controlled, dose-escalation Phase I study assessing the safety, tolerability, and preliminary clinical efficacy of LBL-047 in healthy adults and patients with systemic lupus erythematosus (SLE) [1] Collaboration and Commercialization - On October 16, 2025, the company entered into an exclusive global partnership with Dianthus Therapeutics (NASDAQ: DNTH) to grant Dianthus exclusive global rights for the research, development, production, and commercialization of LBL-047 outside of Greater China, aiming to maximize its clinical value and commercial potential [2]

Core Viewpoint - The approval of the IND application for LBL-047 marks a significant milestone for the company, as it is the first bispecific fusion protein to receive dual regulatory approval in both the US and China, indicating its potential as a first-in-class and best-in-class therapeutic option [1] Group 1: Drug Development - LBL-047 is a bispecific fusion protein targeting both plasmacytoid dendritic cells (pDC) and B cells, with no other drugs currently approved for clinical trials that simultaneously target these cells globally [1] - The clinical trial approved is a double-blind, randomized, placebo-controlled, dose-escalation Phase I study, assessing the safety, tolerability, and preliminary clinical efficacy of LBL-047 in both healthy adults and patients with systemic lupus erythematosus (SLE) [1] Group 2: Research Leadership - The trial involving healthy volunteers will be led by Professor Meng Xianmin from Shanghai Public Health Clinical Center, while the trial involving SLE patients will be conducted by Professors Ye Shuang and Chen Sheng from Renji Hospital, affiliated with Shanghai Jiao Tong University School of Medicine [1]

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） 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。 （股 份 代 號：9887） 自願公告 LBL-047取 得NMPA的IND批 准 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，於2025年11月25日，其 自 主 研 發 候 選 藥 物LBL-047的新藥臨床 試 驗（「IND」）申請已獲中華人民共和國國家藥品監督管理局（「NMPA」）批 准。 LBL-047為 全 球 首 個 實 現 中 美 雙 報 雙 批 ...