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]

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。 ...

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） ...

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。 ...

（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 ...

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 | | ...

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 ...

Core Viewpoint - The potential imposition of a 100% tariff on imported brand and patented drugs by the Trump administration starting October 1, 2025, has raised concerns among pharmaceutical companies, particularly those in China, leading to a decline in their stock prices [2][3]. Group 1: Impact on Pharmaceutical Companies - The announcement of the tariff has caused significant declines in the stock prices of Chinese pharmaceutical companies, with Heng Rui Pharmaceutical dropping 3.03% in A-shares and 2.23% in Hong Kong shares, and BeiGene falling 4.38% in A-shares and 1.55% in Hong Kong shares [2]. - The Hang Seng Innovative Drug Index (HSIDI) fell by 2.37%, with notable declines in stocks such as Fosun Pharma, which dropped 5.82%, and 3SBio, which fell by 5.34% [3]. - Industry experts suggest that the impact of the tariff on Chinese pharmaceutical companies may be limited, as many are focused on generic drugs and active pharmaceutical ingredients (APIs) [4]. Group 2: Industry Perspectives - Some industry leaders believe that the tariff policy may not be implemented as proposed, citing the high cost of drugs in the U.S. and the potential for political changes in future administrations [4][5]. - Companies like Heng Rui Pharmaceutical indicated that their current exports primarily consist of generics and APIs, suggesting minimal impact from the proposed tariffs [4]. - Other companies, such as Lepu Biopharma, noted that their licensing partnerships would shield them from significant effects [5]. Group 3: U.S. Policy Context - The Trump administration has previously threatened to impose tariffs on imported drugs, with discussions around a 200% tariff and subsequent smaller tariffs leading to a potential increase over time [6][7]. - Major multinational pharmaceutical companies have responded to the tariff threats by committing to significant investments in U.S. manufacturing, with companies like Novartis and Roche pledging $23 billion and $50 billion respectively over the next five years [8].

Core Viewpoint - The potential implementation of a 100% tariff on all brand-name and patented drugs by the U.S. government starting October 1, 2025, unless companies are building drug manufacturing plants in the U.S. [2] Group 1: Market Reaction - Pharmaceutical stocks in multiple markets, including China, Japan, and South Korea, experienced a collective decline following the announcement [3] - Specific declines included a 3.03% drop in Hengrui Medicine (600276.SH/01276.HK) A-shares and a 2.23% drop in Hong Kong shares, while BeiGene (ONC.NASDAQ/06160.HK/688235.SH) saw a 4.38% drop in A-shares and a 1.55% drop in Hong Kong shares [3] - The Hang Seng Innovative Drug Index (HSIDI) fell by 2.37%, with notable declines in stocks such as Fosun Pharma (600196.SH/02196.HK) down 5.82% and 3SBio (01530.HK) down 5.34% [4] Group 2: Industry Perspectives - Industry experts suggest that Chinese pharmaceutical companies aiming to expand internationally need to consider the potential implementation of this policy and explore possible solutions [5] - Some executives believe that the high cost of drugs in the U.S. may hinder the realization of this policy [5] - Hengrui Medicine's executive noted that the impact of the potential policy would be limited as their exports mainly consist of generic drugs and APIs [5] - Other companies, such as Lepu Biopharma, indicated that their licensing partnerships would not be significantly affected [5] - Investors pointed out that this is a political issue that could change with future administrations, suggesting that while there may be short-term negative impacts, the long-term effects may not be significant [5] Group 3: Historical Context - Historically, pharmaceuticals have been excluded from tariff lists, but President Trump has repeatedly threatened to impose tariffs on imported drugs this year [5] - The Trump administration initiated a "232 investigation" under the Trade Expansion Act of 1962, which allows for tariffs if imports threaten national security [6] - Previous statements from Trump indicated plans for escalating tariffs on imported drugs, with initial small tariffs leading to potential increases up to 250% [7] Group 4: Investment Commitments - In response to the tariff threats, several multinational pharmaceutical companies have committed to investing in U.S. manufacturing facilities, with significant investments announced by companies like Novartis, Roche, Sanofi, and AstraZeneca [8] - Notably, Novartis and Roche pledged $23 billion and $50 billion respectively over five years, while AstraZeneca committed to a $50 billion investment by 2030 [8]

Core Viewpoint - The approval of LBL-047 by the FDA marks a significant milestone for the company, indicating its potential as a first-in-class therapeutic option targeting both BDCA2 and TACI, which currently has no approved or clinical counterparts globally [1] Company Overview - The company,维立志博, has seen its stock price increase by approximately 3.45%, reaching 66 HKD, with a trading volume of 23.94 million HKD [1] - The company currently has 14 drug candidates, with 6 in clinical stages, including 1 core product and 3 major products [1] Product Details - LBL-047 is a bispecific fusion protein composed of a humanized anti-BDCA2 antibody and a modified TACI extracellular domain, showcasing its unique mechanism of action [1] - The core product, LBL-024, is a PD-L1 and 4-1BB bispecific antibody currently in the registration clinical stage, being evaluated for its efficacy against various cancers, including advanced lung neuroendocrine carcinoma and non-small cell lung cancer [1]