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]

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, Valiant Biopharma-B (09887), saw its stock rise nearly 4%, trading at 66 HKD with a transaction volume of 23.94 million HKD [1]. - Valiant Biopharma 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 registration clinical stages, being evaluated for its efficacy against various advanced cancers, including small cell lung cancer and non-small cell lung cancer [1].

Core Viewpoint - The company Valiant Pharmaceuticals-B (09887) has received FDA approval for its new drug clinical trial application for LBL-047, indicating significant progress in its drug development pipeline [1] Group 1: Drug Development - LBL-047 is a bispecific fusion protein composed of a humanized anti-blood dendritic cell antigen 2 (BDCA2) antibody and a modified transmembrane activator and calcium-modulating cyclophilin ligand (TACI) extracellular domain [1] - The approval from the FDA is set for September 19, 2025, marking a critical milestone for the company [1] - There are currently no other bispecific fusion proteins targeting both BDCA2 and TACI approved or in clinical stages globally, highlighting LBL-047's first-in-class potential [1]

Core Viewpoint - The U.S. FDA has approved the IND application for LBL-047, a novel drug developed by the company, indicating significant progress in its clinical development [1] Company Summary - LBL-047 is a bispecific fusion protein targeting BDCA2 and TACI, which has not been approved or entered clinical stages globally, highlighting its first-in-class potential [1]

Core Viewpoint - The approval of LBL-047's IND application by the FDA indicates a significant advancement for the company, positioning LBL-047 as a first-in-class bispecific fusion protein targeting BDCA2 and TACI, with potential applications in various autoimmune diseases [1][2]. Group 1: Drug Development - The FDA approved the IND application for LBL-047 on September 19, 2025, marking a critical milestone for the company [1]. - LBL-047 is a bispecific fusion protein composed of a humanized anti-BDCA2 antibody and a modified TACI extracellular domain, with no other similar proteins currently approved or in clinical stages globally [1]. Group 2: Mechanism of Action - LBL-047 targets BAFF/APRIL and BDCA2 to simultaneously inhibit the activity of plasmacytoid dendritic cells (pDC) and the differentiation and activation of B cells and plasma cells [2]. - The TACI domain binds to BAFF and APRIL, inhibiting downstream signaling, while BDCA2 specifically expressed on pDC can effectively suppress the release of type I interferons (IFN-I) [1][2]. Group 3: Therapeutic Potential - LBL-047 shows strong therapeutic potential for autoimmune diseases such as systemic lupus erythematosus (SLE), dermatomyositis, IgA nephropathy (IgAN), and Sjögren's syndrome [2]. - The drug's glycosylation modification enhances its ability to broadly inhibit various abnormal immune responses, playing a critical role in the treatment of these diseases [2]. - The modification of the Fc region extends the half-life of LBL-047, potentially reducing dosing frequency and improving patient compliance [2].

Nanjing Leads Biolabs Co., Ltd. 南 京 維 立志博生物科技股份有限公司 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） （股 份 代 號：9887） 自願公告 LBL-047取得美國FDA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，美 國 食 品 藥 品 監 督 管 理 局（「美 國FDA」）已 於2025年9月19日 批 准其自主研發藥物LBL-047的新藥臨床試驗（「IND」）申 請。LBL-047是一種由人源 化抗血液樹突狀細胞抗原2（BDCA2）抗體及經改 ...

南 京 維 立志博生物科技股份有限公司 章 程 （H股 發 行 後 適 用） 2025年8月 | 第一章 | 總 | | 則 | | | | | | | | 3 | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 第二章 | | | 經營宗旨和範圍 | | | | | | | | 4 | | | | | 第三章 | 股 | | 份 | | | | | | | | 5 | | | | | 第一節 | | | 股份發行 | | | | | | | | 5 | | | | | 第二節 | | | 股份增減和回購 | | | | | | | | 9 | | | | | 第三節 | | | 股份轉讓 | | | | | | | | 11 | | | | | 第四章 | | | 股東和股東會 | | | | | | | | 14 | | | | | 第一節 | | 股 | 東 | | | | | | | | 14 | | | | | 第二節 | | | 股東會的一般規定 ...

（股 份 代 號：9887） 修改章程 本公告由南京 維 立志博生物科技股份有限公司（「本公司」）根據香港聯合交易 所有限公司證券上市規則第13.51(1)條 作 出。 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） 茲提述本公司日期為2025年7月24日 的 公 告，內 容 有 關 最 終 發 售 價 及 配 發 結 果， 涉及於香港聯交所主板上市合共36,862,500股H股，及 日 期 為2025年8月7日的公 告，內 容 有 關 悉 數 行 使 超 額 配 股 權，涉 及 合 共5,529,300股H股，佔 全 球 發 售 項 下 可供認購發售股份總數約15%（經 計 及 發 售 量 調 整 權 獲 悉 數 行 使 ...