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维立志博-B(09887) - 内幕消息 - 就LBL-047 与DIANTHUS签订全球独家许可协...
2025-10-16 12:48
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。 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) 內幕消息 就LBL-047與DIANTHUS簽訂全球獨家許可協議 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」)根據香港聯合交易所有限公司證券上市規則(「上市規則」)第13.09 條以及香港法例第571章證券及期貨條例第XIVA部 作 出。 本 公 司 欣 然 宣 布, 於2025年10月16日, 本 公 司 與Dianthus Therapeutics, Inc. (「Dianthus」,納 斯 達 克 代 碼:DNTH)簽訂全球獨家許可協議(「全球獨家許可協 議」),據 此,本 公 司 ...
维立志博康小强:不卷PD-1,领跑肿瘤免疫治疗2.0
Jing Ji Guan Cha Wang· 2025-10-10 22:54
Core Insights - The article discusses the rise of innovative drug companies in China, particularly in the field of cancer immunotherapy, as they shift from following trends to pioneering original research and development [1] Industry Overview - The Nobel Prize in Physiology or Medicine was awarded to three scientists for their discovery of regulatory T cells in the immune system, which opens new avenues for treating autoimmune diseases and cancer [2] - Immunotherapy has been a significant area of focus since the 1980s, with PD-1 inhibitors gaining prominence after their approval in 2014, demonstrating better efficacy and safety compared to traditional treatments [2] - The global sales of the PD-1 drug "K药" are projected to reach approximately $32.056 billion in 2024, maintaining its position as the world's top-selling drug [2] Company Focus - Weili Zhibo-B (维立志博-B) is a Chinese innovative drug company specializing in tumor immunotherapy, currently in clinical stages [2] - The company aims to address cancers that do not respond to existing PD-1 therapies, with a pipeline of 14 candidate drugs, four of which are in advanced clinical stages and have the potential to be first-in-class [4][6] - The company has developed a strategic focus on next-generation immunotherapy, emphasizing complex regulatory mechanisms to enhance immune system efficacy [4] Clinical Development - The PD-L1/4-1BB dual antibody (LBL-024) is the company's fastest progressing product, currently in Phase III clinical trials, showing promising results with a 75% objective response rate and a 92.3% disease control rate in a recent study [8][12] - The company is also advancing two CD3 TCE drugs, which have shown efficacy similar to CAR-T therapies but at a significantly lower cost, making them more accessible [13] Financing and Market Strategy - Weili Zhibo-B has successfully completed multiple funding rounds, raising a total of 1.084 billion yuan, with a significant increase in valuation from 40 million yuan in 2015 to 3.1 billion yuan in 2024 [10][11] - The company plans to leverage a light-asset strategy for commercialization, collaborating with CDMO partners for production while considering establishing its own facilities in the future [15] Future Outlook - The company aims to expand its indications from rare cancers to larger cancer types, with plans to submit a biological product license application for LBL-024 in the third quarter of 2026 [14] - The Chinese market for innovative drugs is expected to grow as economic development and consumer purchasing power increase, supported by favorable government policies [15]
维立志博康小强:不卷PD-1,领跑肿瘤免疫治疗2.0 | 进击的创新药企
经济观察报· 2025-10-10 12:25
Core Viewpoint - The article discusses the innovative strategies and advancements of Weilizhibo, a Chinese biopharmaceutical company focused on cancer immunotherapy, particularly in developing next-generation therapies that address limitations of existing PD-(L)1 treatments [4][5][6]. Group 1: Company Overview - Weilizhibo has 14 candidate innovative drugs, with 4 in the top three of global clinical progress, aiming to become first-in-class drugs [6][7]. - The company was founded by Kang Xiaoqiang and Lai Shoupeng in 2012, focusing on cancer immunotherapy after extensive research in the U.S. [8][9]. Group 2: Market Context - The global market for innovative drugs is rapidly evolving, with significant investment interest, particularly in the field of cancer immunotherapy [4]. - The PD-(L)1 inhibitors have shown a response rate of only about 20%, indicating a substantial unmet need in cancer treatment [6][10]. Group 3: Strategic Focus - Weilizhibo aims to address cancers that do not respond to PD-(L)1 therapies, focusing on alternative immune checkpoint inhibitors like LAG-3 and 4-1BB [10][11]. - The company has developed three core technology platforms: IO2.0, TCE, and ADC, which are expected to define the future of oncology [11][12]. Group 4: Clinical Progress - The PD-L1/4-1BB dual antibody (LBL-024) is currently in Phase III clinical trials and has shown promising results, with an objective response rate of 75% in a recent study [12][19]. - Weilizhibo's GPRC5D/CD3 dual antibody has completed Phase II trials and received orphan drug designation from the FDA, indicating its potential in treating multiple myeloma [19][20]. Group 5: Financial Strategy - Weilizhibo has successfully completed multiple funding rounds, raising a total of 1.084 billion yuan, with a significant increase in valuation from 40 million yuan in 2015 to 3.1 billion yuan in 2024 [15][16]. - The company strategically increased its IPO fundraising target to 189 million USD due to favorable market conditions, resulting in a successful listing on the Hong Kong Stock Exchange [16][17]. Group 6: Future Outlook - The company plans to expand its indications from rare cancers to larger cancer types, with a goal of submitting a biological license application by Q3 2026 [20][21]. - Weilizhibo intends to adopt a light-asset strategy for commercialization, collaborating with CDMOs for production while considering establishing its own facilities in the future [21][22].
维立志博康小强:不卷PD-1,领跑肿瘤免疫治疗2.0 | 进击的创新药企
Jing Ji Guan Cha Wang· 2025-10-10 08:58
Core Insights - The article discusses the rise of innovative drug companies in China, particularly in the field of cancer immunotherapy, as they shift from following trends to pioneering original research and development [2] Company Overview - Leads Biolabs, a Chinese company focused on tumor immunotherapy, is currently in clinical stages and aims to address diseases that existing PD-(L)1 therapies cannot treat [3][5] - The company has 14 candidate innovative drugs, with 4 in the top three of global clinical progress, potentially becoming first-in-class drugs [5] Market Context - The PD-(L)1 target has become highly competitive, with 20 approved monoclonal antibodies in China, yet the response rate for PD-(L)1 monotherapy is only about 20%, leaving a significant portion of patients without effective treatment [4][10] - The global sales of the PD-1 drug "K" reached approximately $32.056 billion in 2024, highlighting the lucrative nature of immunotherapy [3] Strategic Focus - The company has chosen to focus on LAG-3 and other targets instead of PD-(L)1, aiming to develop unique therapies that can address the limitations of existing treatments [10][11] - The company has established three core technology platforms: IO2.0 (4-1BB), TCE (CD3), and ADC (antibody-drug conjugates), which are expected to define the future of oncology [10][16] Clinical Development - The PD-L1/4-1BB dual antibody (code LBL-024) is currently in Phase III clinical trials in China, showing promising results with a 75% objective response rate and a 92.3% disease control rate in a recent study [11][12] - The company plans to submit a biological product license application to the Chinese regulatory authority in Q3 2026, with conditional approval expected by Q2 2027 [17] Financing and IPO - Leads Biolabs has completed 8 rounds of financing, raising a total of 1.084 billion yuan, with a significant increase in valuation from 40 million yuan in 2015 to 3.1 billion yuan in 2024 [13][14] - The company went public in July 2025, initially aiming to raise $100 million but increasing the target to $189 million due to market conditions, achieving a record subscription rate on its first trading day [15] Future Outlook - The company aims to expand its indications from rare cancers to larger cancer types, with plans to target 8 indications this year and 10 next year [17] - The commercialization strategy involves a light asset approach, collaborating with CDMOs for production while considering establishing its own manufacturing base in the future [18]
维立志博-B(09887.HK):2款创新药研究成果将亮相第67届ASH年会
Ge Long Hui· 2025-10-08 22:58
格隆汇10月9日丨维立志博-B(09887.HK)发布公告,美国血液学会("ASH")公布了第67届年会摘要评 审结果。公司2款创新药共5篇研究摘要成功入选,包括1篇口头报告、3篇壁报展示和1篇在线发表。 公司已连续多年在ASH、美国临床肿瘤学会(ASCO)等国际舞台上发表创新药研发成果。此次多项研 究成果集中入选第67届ASH年会,代表了国际学术界对公司科研创新实力的高度认可。 ...
维立志博-B(09887):2款创新药研究成果将亮相第67届ASH年会
Zhi Tong Cai Jing· 2025-10-08 22:33
公司已连续多年在ASH、美国临床肿瘤学会(ASCO)等国际舞台上发表创新药研发成果。此次多项研究 成果集中入选第67届ASH年会,代表了国际学术界对公司科研创新实力的高度认可。 智通财经APP讯,维立志博-B(09887)发布公告,美国血液学会(ASH)公布了第67届年会摘要评审结果。 公司2款创新药共5篇研究摘要成功入选,包括1篇口头报告、3篇壁报展示和1篇在线发表。 (原标题:维立志博-B(09887):2款创新药研究成果将亮相第67届ASH年会) ...
维立志博-B:2款创新药研究成果将亮相第67届ASH年会
Zhi Tong Cai Jing· 2025-10-08 22:30
公司已连续多年在ASH、美国临床肿瘤学会(ASCO)等国际舞台上发表创新药研发成果。此次多项研究 成果集中入选第67届ASH年会,代表了国际学术界对公司科研创新实力的高度认可。 维立志博-B(09887)发布公告,美国血液学会(ASH)公布了第67届年会摘要评审结果。公司2款创新药共5 篇研究摘要成功入选,包括1篇口头报告、3篇壁报展示和1篇在线发表。 ...
维立志博-B(09887) - 自愿公告2款创新药研究成果将亮相第67届ASH年会
2025-10-08 22:22
(股 份 代 號:9887) 自願公告 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。 2款創新藥研究成果將亮相第67屆ASH年 會 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。 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) 本 公 司 股 東 及 潛 在 投 資 者 在 買 賣 本 公 司 股 份 時 務 請 審 慎 行 事。 承董事會命 Nanjing Leads Biolabs Co., Ltd. 南 京 維 立志博生物科技股份有限公司 董 事 長、執 行 董 事 兼 首 席 ...
维立志博-B(09887) - 截至二零二五年九月三十日止股份发行人的证券变动月报表
2025-10-02 08:32
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9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10月2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 | | ...
维立志博-B(09887) - 2025 - 中期财报
2025-09-26 13:49
南京維立誌博生物科技股份有限公司 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 2025 中期報告 Interim Report 2025 中期報告 南京維立誌博生物科技股份有限公司 Nanjing Leads Biolabs Co., Ltd. 目錄 2 公司資料 4 業務摘要 8 財務摘要 9 管理層討論及分析 38 企業管治及其他資料 55 獨立審閱報告 56 中期簡明綜合損益及其他全面收益表 57 中期簡明綜合財務狀況表 58 中期簡明綜合權益變動表 59 中期簡明綜合現金流量表 60 中期簡明綜合財務資料附註 70 釋義及詞彙表 公司資料 董事會 執行董事 康小強博士 (董事會主席、首席執行官兼總經理) 賴壽鵬博士 左鴻剛先生 非執行董事 張銀成先生 陳仁海博士 倪佳博士 獨立非執行董事 張宏冰博士 杜以龍先生 (首席獨立非執行董事) 杜季柳女士 審核委員會 杜季柳女士 (主席) 杜以龍先生 陳仁海博士 薪酬委員會 杜以龍先生 (主席) 杜季柳女士 張銀成先生 提名委員會 康小強博士 (主席) 張宏冰博士 杜季柳女士 監 ...