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 ...

Group 1 - The Hang Seng Index rose by 0.07%, gaining 19 points to close at 26,465 points, while the Hang Seng Tech Index increased by 0.39% [1] - The early trading volume in Hong Kong stocks reached 160.2 billion HKD [1] Group 2 - New pharmaceutical stocks in the Hong Kong Stock Connect saw significant gains, with ZhiJie AnKang-B (02617) surging over 49%, reaching a market capitalization of over 240 billion HKD; BaiZe Medical (02609) rose over 76%; and TongYuanKang Pharmaceutical-B (02410) increased by over 36% [1] - Fosen Pharmaceutical (01652) experienced a dramatic rise of over 410%, closing at 1.35 HKD, up 297%, following the approval of Metformin and Ertugliflozin tablets [2] - Shanghai Fudan (01385) increased by 5.87%, with the company well-prepared for supply chain disruptions, and Morgan Stanley noted limited impact on demand [2] - SF Express (09699) rose over 6% as its "SoFast" service officially launched in Macau, with Daiwa optimistic about the company's revenue growth prospects [2] - Valiant Bio-B (09887) increased by over 13%, with its core product LBL-024 for melanoma completing its first patient dosing in trials [2] - Bilibili-W (09626) rose by 2.78%, accumulating a total increase of about 25% over the past six days, with the new game "Three Kingdoms: Hundred Generals" set for testing in October [2] - LionTeng Holdings (02562) surged over 7% as it plans to acquire leading companies in artificial intelligence and blockchain to expand its digital finance layout [2] - GCL-Poly Energy (03800) rose by 3.97%, planning a discounted placement to raise approximately 5.392 billion HKD for structural adjustments in polysilicon capacity [2] - China General Nuclear Power Corporation Mining (01164) increased by 6.7%, as the U.S. seeks to expand its strategic uranium reserves, with institutions expecting a recovery in uranium prices [2] - Yunfeng Financial (00376) fell over 16% after announcing a discounted placement to raise about 1.15 billion HKD [2]

Market Overview - The Hang Seng Index rose by 0.07%, gaining 19 points to close at 26,465 points, while the Hang Seng Tech Index increased by 0.39% [1] - Early trading volume in Hong Kong stocks reached HKD 160.2 billion [1] Notable Stock Movements - New pharmaceutical stocks in the Hong Kong Stock Connect surged, with Yaojie Ankang-B (02617) rising over 49%, reaching a market capitalization of over HKD 240 billion [1] - Baize Medical (02609) saw an increase of over 76% [1] - Tongyuan Kang Pharmaceutical-B (02410) rose by over 36% [1] Specific Company Highlights - Fosen Pharmaceutical (01652) experienced a dramatic rise of over 410%, closing at HKD 1.35, up 297%, following the approval of Metformin and Ertugliflozin tablets [2] - Shanghai Fudan (01385) increased by 5.87%, with the company prepared for supply chain disruptions, and Morgan Stanley noted limited impact on demand [2] - SF Express (09699) rose by over 6% as its "SoFast" service launched in Macau, with positive revenue growth prospects according to Daiwa [2] - Valiant Pharmaceuticals-B (09887) increased by over 13%, completing the first medication trial for its core product LBL-024 for melanoma [2] - Bilibili-W (09626) rose by 2.78%, accumulating a 25% increase over six days, with the new game "Three Kingdoms: Hundred Generals" set for testing in October [2] - Liontech Holdings (02562) surged over 7% as it plans to acquire a leading AI and blockchain company to expand its digital finance footprint [2] - GCL-Poly Energy (03800) rose by 3.97%, planning a discounted share placement to raise approximately HKD 5.392 billion for structural adjustments in polysilicon capacity [2] - CGN Mining (01164) increased by 6.7% amid expectations of rising uranium prices as the U.S. seeks to expand its strategic uranium reserves [2] - Yunfeng Financial (00376) fell over 16% after announcing a discounted share placement to raise about HKD 1.15 billion [2]

Core Viewpoint - The article highlights significant movements in the Hong Kong and US stock markets, focusing on specific companies and their recent performance, driven by various strategic announcements and market conditions. Hong Kong Stock Market Summary - China General Nuclear Power Corporation (01164) rose over 6% following US Energy Secretary Chris Wright's suggestion to consider expanding strategic uranium reserves, indicating potential upward price adjustments for uranium [1] - Yunfeng Financial (00376) fell over 18% after announcing a rights issue at a discount of approximately 16.8%, aiming to raise about HKD 1.15 billion [1] - GCL-Poly Energy Holdings (03800) increased over 2% as it plans a rights issue at a discount of about 8.73%, targeting net proceeds of HKD 5.392 billion for structural adjustments in polysilicon production [1] - Lion Group Holding (02562) surged over 6% after signing a letter of intent to acquire a leading AI and blockchain company, expanding its digital finance footprint [1] - Pharmaron Beijing Co., Ltd. (02617) skyrocketed over 53% after being included in the Hong Kong Stock Connect list, with a cumulative increase of nearly 10 times since its inclusion, and northbound investors adding over HKD 300 million in two days [1] - Anta Sports Products (02020) rose over 2% as retail sales of sports goods showed rapid growth in the first eight months, indicating marginal improvement in sales [1] - SF Technology (09699) increased over 5% after launching its "SoFast" brand in Macau, marking a significant step in its overseas business expansion [1] - Shanghai Fudan (01385) rose over 6% as Morgan Stanley reported the company is well-prepared for supply chain disruptions, with limited demand impact expected [2] - Tianyue Advanced (02631) increased over 1% after being included in the Hong Kong Stock Connect, with silicon carbide expected to see new market growth [2] - Valiant Co., Ltd. (09887) rose over 10% after announcing the completion of the first patient dosing in a trial for its core product LBL-024 for melanoma [2] US Stock Market Summary - Tesla (TSLA.US) rose 3.56% as the head of its German factory announced an increase in production plans for Q3 and Q4 due to strong sales data [3] - NVIDIA (NVDA.US) fell 0.04% as it faces further investigation for violating antitrust laws [3] - Hesai Technology (HSAI.US) increased 4.31% after announcing a partnership with a leading US Robotaxi company, securing over USD 40 million in lidar orders [3] - XPeng Motors (XPEV.US) rose 2.20% after formalizing a deep cooperation with Magna Steyr in Austria, marking the start of local production in Europe [3] - NIO (NIO.US) increased 4.34% as it announced the NIO Day 2025 event, scheduled for September 20, where the new ES8 will be launched [3] - Apple (AAPL.US) rose 1.12% as Morgan Stanley reported that demand for the iPhone 17 series exceeded that of the previous year's iPhone 16 series during its first week of launch [4] - Fangdd Network Group (DUO.US) fell 9.17% following the National Bureau of Statistics' report indicating a decline in residential property prices in August [3] - Alibaba (BABA.US) rose 1.92% ahead of the 2025 Cloud Summit scheduled for September 24-26 in Hangzhou [4] - ASML Holding (ASML.US) increased 6.56% after announcing a EUR 1.3 billion investment in French AI startup Mistral AI, becoming its largest shareholder [4] - Bilibili (BILI.US) rose 6.40% as it announced the upcoming public test of its new strategy card game, "Three Kingdoms: Hundred Generals Card" [4] - Oracle (ORCL.US) increased 3.41% as management disclosed that its cloud infrastructure revenue is set to experience steep growth [4]