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 全部或任何部份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） 自願公告 LBL-047於I期試驗的首例受試者用藥 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，評 價LBL-047安 全 性、耐 受 性、藥 代 動 力 學╱藥 效 動 力 學 及 初 步臨床有效性的I期 臨 床 研 究 首 例 受 試 者 已 成 功 用 藥。 該I期研究為在健康成年人和系統性紅斑狼瘡（SLE）患 者 中 進 行 ...

Group 1 - The company Valiant Biopharma-B (09887) announced that its self-developed candidate drug LBL-047 has received approval for clinical trials (IND) from the National Medical Products Administration (NMPA) of China on November 25, 2025 [1] - LBL-047 is the world's first bispecific fusion protein targeting both plasmacytoid dendritic cells (pDC) and B cells, with a unique mechanism of action that positions it as a first-in-class and best-in-class potential therapy [1] - The approved clinical trial is a double-blind, randomized, placebo-controlled, dose-escalation Phase I study assessing the safety, tolerability, and preliminary clinical efficacy of LBL-047 in healthy adults and patients with systemic lupus erythematosus (SLE) [1] Group 2 - On October 16, 2025, the company entered into an exclusive global partnership with Dianthus Therapeutics (NASDAQ: DNTH) to develop transformative therapies for severe autoimmune diseases, granting Dianthus exclusive global rights for the research, production, and commercialization of LBL-047 outside Greater China [2] - The collaboration aims to advance the global development of LBL-047 and maximize its clinical value and commercial potential [2]

Core Insights - The company Valiant Biopharma-B (09887) has received approval from the National Medical Products Administration (NMPA) in China for the clinical trial application of its candidate drug LBL-047, marking it as the first bispecific fusion protein to achieve dual reporting and approval in both China and the U.S. [1] - LBL-047 targets both plasmacytoid dendritic cells (pDC) and B cells, with no other drug currently approved for clinical trials that simultaneously targets these cells, indicating its potential as a first-in-class and best-in-class therapy [1] - The approved clinical trial is a double-blind, randomized, placebo-controlled, dose-escalation Phase I study assessing the safety, tolerability, and preliminary clinical efficacy of LBL-047 in healthy adults and patients with systemic lupus erythematosus (SLE) [1] Collaboration and Commercialization - On October 16, 2025, the company entered into an exclusive global partnership with Dianthus Therapeutics (NASDAQ: DNTH) to grant Dianthus exclusive global rights for the research, development, production, and commercialization of LBL-047 outside of Greater China, aiming to maximize its clinical value and commercial potential [2]

Core Viewpoint - The approval of the IND application for LBL-047 marks a significant milestone for the company, as it is the first bispecific fusion protein to receive dual regulatory approval in both the US and China, indicating its potential as a first-in-class and best-in-class therapeutic option [1] Group 1: Drug Development - LBL-047 is a bispecific fusion protein targeting both plasmacytoid dendritic cells (pDC) and B cells, with no other drugs currently approved for clinical trials that simultaneously target these cells globally [1] - The clinical trial approved is a double-blind, randomized, placebo-controlled, dose-escalation Phase I study, assessing the safety, tolerability, and preliminary clinical efficacy of LBL-047 in both healthy adults and patients with systemic lupus erythematosus (SLE) [1] Group 2: Research Leadership - The trial involving healthy volunteers will be led by Professor Meng Xianmin from Shanghai Public Health Clinical Center, while the trial involving SLE patients will be conducted by Professors Ye Shuang and Chen Sheng from Renji Hospital, affiliated with Shanghai Jiao Tong University School of Medicine [1]

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） 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 全部或任何部份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。 （股 份 代 號：9887） 自願公告 LBL-047取 得NMPA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，於2025年11月25日，其 自 主 研 發 候 選 藥 物LBL-047的新藥臨床 試 驗（「IND」）申請已獲中華人民共和國國家藥品監督管理局（「NMPA」）批 准。 LBL-047為 全 球 首 個 實 現 中 美 雙 報 雙 批 ...

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]

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 ...