Workflow
LEADS BIOLABS-B(09887)
icon
Search documents
港股生物科技股集体下挫,博安生物跌超12%
Ge Long Hui A P P· 2025-08-28 05:50
Group 1 - The Hong Kong biotechnology stocks experienced a collective decline, with notable drops in several companies [1] - WuXi AppTec (02126) saw a decrease of 12.95%, closing at 4.840 [2] - BioNTech (06952) fell by 12.53%, with a latest price of 13.750 [2] Group 2 - Other companies such as Valiant (09887) and Beihai Kangcheng (01228) also reported significant declines of 9.93% and 9.75% respectively [2] - The decline extended to companies like Saint Noble (02257) and MIRXES (02629), which dropped by 9.64% and 8.43% [2] - Overall, the biotechnology sector is facing downward pressure, impacting multiple firms [1]
临床开发全面提速!维立志博-BTCE双抗Ⅰ期疗效比肩CAR-T,Ⅱ期首例患者成功用药
Zhi Tong Cai Jing· 2025-08-25 11:18
Core Viewpoint - The company Valiant Biopharma-B (09887) has successfully completed the Phase II clinical study of its self-developed GPRC5D/CD3 bispecific antibody, marking a significant milestone in the development of targeted T-cell engagers (TCE) therapy in China [1] Group 1: Clinical Study Details - The Phase II clinical trial (CTR20232974) is a multicenter, single-arm, and multi-cohort study led by Professor Lu Jin from Peking University People's Hospital, involving over 20 hospitals nationwide [1] - The study aims to evaluate the efficacy and safety of LBL-034 in patients with various relapsed/refractory plasma cell tumors [1] Group 2: Product Characteristics - LBL-034 features a unique 2:1 structural design for the GPRC5D/CD3 bispecific antibody, which optimizes anti-CD3 affinity and spatial steric hindrance, significantly reducing the risk of non-specific T-cell activation while maintaining effective T-cell conditional activation [1] - The product demonstrates strong anti-tumor activity and improved safety, positioning it as a potential best-in-class therapy [1] Group 3: Previous Clinical Research Findings - In the previously conducted Phase I clinical study, over 50 enrolled patients showed good safety and efficacy across doses ranging from 80 to 1200 μg/kg, particularly at high doses where it exhibited CAR-T-like efficacy without additional safety risks [1] - Notably, patients with extramedullary tumors also showed significant efficacy and good safety, with a minimal residual disease (MRD) negative rate notably higher than current standard treatments [1]
临床开发全面提速!维立志博-B(09887)TCE双抗Ⅰ期疗效比肩CAR-T,Ⅱ期首例患者成功用药
智通财经网· 2025-08-25 11:13
Core Viewpoint - The company, Weili Zhizhi Bo-B (09887), has successfully completed the first patient enrollment in the Phase II clinical trial of its self-developed GPRC5D/CD3 bispecific antibody, LBL-034, which is expected to be the first domestically targeted TCE therapy for GPRC5D [1] Group 1: Clinical Trial Details - The Phase II clinical trial (CTR20232974) is a multicenter, single-arm, and multi-cohort study led by Professor Lu Jin from Peking University People's Hospital, involving over 20 hospitals nationwide [1] - The trial aims to evaluate the efficacy and safety of LBL-034 in patients with various relapsed/refractory plasma cell tumors [1] Group 2: Product Characteristics - LBL-034 features a unique 2:1 structural design for the GPRC5D/CD3 bispecific antibody, which optimizes anti-CD3 affinity and spatial steric hindrance, significantly reducing the risk of non-specific T cell activation while maintaining effective T cell conditional activation [1] - The product demonstrates strong anti-tumor activity and improved safety, positioning it as a potential best-in-class therapy [1] Group 3: Previous Clinical Research Findings - In the previously conducted Phase I clinical study, over 50 enrolled patients showed good safety and efficacy across doses ranging from 80-1200 μg/kg, particularly at high doses where it exhibited CAR-T-like efficacy without additional safety risks [1] - Notably, patients with extramedullary tumors also showed significant efficacy and good safety, with a minimal residual disease (MRD) negative rate significantly higher than current standard treatments [1]
维立志博-B:LBL-034 II期试验首例患者成功用药
Zhi Tong Cai Jing· 2025-08-25 10:35
Core Viewpoint - The announcement from Valiant Biotech-B (09887) highlights the successful Phase I data of LBL-034 (GPRC5D/CD3 bispecific antibody) and the successful treatment of the first patient in the Phase II trial, marking a significant milestone in the clinical research of LBL-034 [1] Group 1 - Valiant Biotech-B has reported promising results from the Phase I trial of LBL-034, indicating strong potential for further development [1] - The successful treatment of the first patient in the Phase II trial establishes a solid foundation for advancing subsequent clinical trials [1]
维立志博-B(09887.HK):LBL-034 II期试验首例患者用药
Ge Long Hui· 2025-08-25 10:17
Core Viewpoint - The announcement from Valiant Biopharma-B (09887.HK) highlights significant progress in the clinical research of LBL-034, a bispecific antibody targeting GPRC5D/CD3, with promising Phase I data and the successful treatment of the first patient in Phase II trials [1] Group 1: Clinical Trial Results - The Phase I trial of LBL-034 involved over 50 patients with relapsed/refractory multiple myeloma, showing positive efficacy signals and good safety at a dose of 1,200 μg/kg [1] - The overall response rate was robust, with a higher rate of complete response or deeper responses (≥CR) and minimal residual disease (MRD) negativity compared to current standard therapies [1] - Notably, significant efficacy was observed in the difficult-to-treat extramedullary (EMD) myeloma patient subgroup [1] Group 2: Future Developments - Detailed results from the study are set to be presented at the 2025 American Society of Hematology (ASH) annual meeting [1] - The Phase II trial is a multicenter, single-arm, multi-cohort study led by Professor Lu Jin from Peking University People's Hospital, involving over 20 hospitals nationwide [1] - The aim of the Phase II trial is to evaluate the efficacy and safety of LBL-034 in various relapsed/refractory plasma cell tumors [1]
维立志博-B(09887) - 自愿公告- LBL-034 II期试验首例患者用药
2025-08-25 10:08
(股 份 代 號:9887) Nanjing Leads Biolabs Co., Ltd. 南 京 維 立志博生物科技股份有限公司 自願公告 LBL-034 II期試驗首例患者用藥 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 全部或任何部分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。 (於 中 華 人 民 共 和 國 成 立 的 股 份 有 限 公 司) LBL-034是靶向GPRC5D及CD3的雙特異性T-cell engager,利用我們專有的LeadsBody™ 平 台 開 發。LBL-034採 用2:1結 構 設 計,擁 有 兩 個 靶 向GPRC5D的高親和力Fab及 一 個靶向CD3的scFv。LBL-034能夠有效地重定向及激活T細胞以靶向GPRC5D+癌 細 胞,同 時 不 易 誘 導T細 胞 衰 竭 及 細 胞 死 亡,並 大 大 降 低 細 胞 因 子 釋 放 綜 合 征 及 免 疫 毒 性 的 風 險。根 據 弗 若 斯 特 ...
维立志博-B:稳定价格行动及稳定价格期间结束
Zhi Tong Cai Jing· 2025-08-21 10:46
Core Viewpoint - The announcement details the end of the stabilization period for the global offering of Vili International Holdings Limited (维立志博-B) on August 21, 2025, and outlines the actions taken during this period by Morgan Stanley Asia Limited [1] Group 1: Stabilization Actions - During the stabilization period, a total of 12.8217 million H-shares were allocated in excess of the international offering, representing approximately 15% of the total shares available for subscription under the global offering [1] - The overall coordinator exercised the over-allotment option on August 6, 2025, for a total of 5.5293 million H-shares at a price of HKD 35.00 per share to facilitate the delivery of H-shares to subscribers who agreed to the global offering [1] - No H-shares were bought or sold in the market by the stabilization agent during the stabilization period [1] Group 2: Compliance and Regulations - Following the end of the stabilization period, the company will continue to comply with the public float requirements as stipulated in Listing Rule 19A.13A [1]
维立志博-B(09887.HK)稳定价格行动及稳定价格期间结束
Ge Long Hui· 2025-08-21 10:44
格隆汇8月21日丨维立志博-B(09887.HK)公告,公司宣布,有关全球发售的稳定价格期间于2025年8月21 日(星期四)(即递交香港公开发售申请截止日期起计第30天)结束。稳定价格操作人摩根士丹利亚洲有限 公司或其联属人士或代其行事的任何人士于稳定价格期间进行的稳定价格行动载列如下: 于稳定价格期间,稳定价格操作人并无在市场上买卖任何H股以稳定价格。紧随稳定价格期间结束后, 公司将继续遵守上市规则第19A.13A条的公众持股量规定。 (1)于国际发售超额分配合共12,821,700股H股,占全球发售项下可供认购发售股份总数约15%(经计及发 售量调整权获悉数行使,惟于任何超额配股权获行使前);及(2)整体协调人(为其本身及代表国际包销 商)于2025年8月6日(星期三)按每股H股35.00港元(即全球发售项下的每股H股发售价,不包括1%经纪佣 金、0.0027%证监会交易徵费、0.00565%联交所交易费及0.00015%会财局交易徵费)悉数行使超额配股 权,涉及合共5,529,300股H股,以便向同意其根据全球发售认购的相关H股延迟交付的承配人交付部分 H股。 ...
维立志博-B(09887) - 稳定价格行动及稳定价格期间结束
2025-08-21 10:34
香 港 交 易 及 結 算 所 有 限 公 司、香 港 聯 合 交 易 所 有 限 公 司(「聯交所」)及香港中央結算有限公司 (「香港結算」)對 本 公 告 的 內 容 概 不 負 責,對 其 準 確 性 或 完 整 性 亦 不 發 表 聲 明,並 明 確 表 示,概 不對因本公告全部或任何部分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。 穩定價格行動及穩定價格期間結束 根據香港法例第571W章證券及期貨(穩 定 價 格)規則第9(2)條,本 公 司 宣 布,有 關全球發售的穩定價格期間於2025年8月21日(星 期 四)(即 遞 交 香 港 公 開 發 售 申 請截止日期起計第30天)結 束。穩 定 價 格 操 作 人 摩 根 士 丹 利 亞 洲 有 限 公 司 或 其 聯屬人士或代其行事的任何人士於穩定價格期間進行的穩定價格行動載列如 下: 除 本 公 告 另 有 界 定 者 外,本 公 告 所 用 詞 彙 與 南 京 維 立志博生物科技股份有限公司(「本公司」) 日期為2025年7月17日的招股章程(「招股章程」)所 界 定 者 具 有 相 同 涵 義。 本公告乃根據香港法例第571W章 ...
维立志博-B(09887.HK)拟8月29日举行董事会会议以审批中期业绩
Ge Long Hui· 2025-08-19 10:51
格隆汇8月19日丨维立志博-B(09887.HK)公告,董事会将于2025年8月29日(星期五)举行会议,旨在(其中 包括)审议及批准公司及其附属公司截至2025年6月30日止6个月的中期业绩及其刊发,以及考虑派发股 息的建议(如有)。 ...