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].

维立志博-B(09887)发布公告，美国食品药品监督管理局(美国FDA)已于2025年9月19日批准其自主研发 药物LBL-047的新药临床试验(IND)申请。LBL-047是一种由人源化抗血液树突状细胞抗塬2(BDCA2)抗 体及经改造的跨膜激活剂和钙调亲环素配体相互作用分子(TACI)胞外域组成的双特异性融合蛋白。目前 全球范围内尚无同时靶向BDCA2及TACI的融合蛋白获批或处于临床阶段，表明LBL-047具有同类第一 的潜力。 ...

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 ...