Core Viewpoint - The company Valiant Biopharma-B (09887) announced that its drug LBL-034 (a GPRC5D/CD3 bispecific antibody) has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of relapsed/refractory multiple myeloma (RRMM) [1] Group 1 - The drug LBL-034 is specifically designed to target GPRC5D and CD3, indicating a novel therapeutic approach in the treatment of RRMM [1] - The Fast Track Designation by the FDA is aimed at facilitating the development and expedite the review of drugs that treat serious conditions and fill an unmet medical need [1] - This designation may provide the company with advantages such as more frequent communication with the FDA and eligibility for accelerated approval and priority review [1]

Core Viewpoint - The company Valiant Pharmaceuticals-B (09887) has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) for its drug LBL-034 (GPRC5D/CD3 bispecific antibody) aimed at treating relapsed/refractory multiple myeloma (RRMM) [1] Group 1 - The FDA granted Fast Track Designation to LBL-034 on January 27, 2026 [1] - LBL-034 is specifically developed for the treatment of relapsed/refractory multiple myeloma [1]

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-034（GPRC5D/CD3雙特異性T-CELL ENGAGER，TCE） 獲美國FDA授予快速通道資格認定 本公告由南京 維 立志博生物科技股份有限公司（「本公司」）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2026年1月27日，LBL-034（GPRC5D/CD3雙 特 異 性 抗 體）獲 美 國食品藥品監督管理局（「FDA」）授予快速通道資格認定（「FTD」），用 於 治 療 復 發╱難 治 性 多 發 性 ...

Core Viewpoint - Connoa-B (02162) shares rose nearly 3%, currently up 2.24% at HKD 57, with a trading volume of HKD 19.71 million, following the announcement of CM336's fast track designation by the FDA for treating autoimmune hemolytic anemia (AIHA) and immune thrombocytopenia (ITP) [1] Group 1 - Connoa and Ouro Medicines Ltd announced that their BCMA×CD3 dual antibody CM336 (OM336) received fast track designation (FTD) from the FDA for the treatment of AIHA and ITP [1] - The fast track designation highlights the urgent need for innovative treatment options for these diseases and underscores the therapeutic potential of CM336 in autoimmune diseases [1] - CM336 has also received orphan drug designation (ODD) from the FDA for the treatment of AIHA and ITP [1] Group 2 - Connoa entered into an exclusive licensing agreement with Ouro Medicines Ltd, granting Ouro exclusive rights to research, develop, manufacture, register, and commercialize CM336 globally, excluding mainland China, Hong Kong, Macau, and Taiwan [1]

Core Viewpoint - Connoa-B (02162) has seen a nearly 3% increase in stock price, currently trading at 57 HKD, following the announcement of its drug CM336 receiving Fast Track Designation from the FDA for treating autoimmune hemolytic anemia (AIHA) and immune thrombocytopenia (ITP) [1] Group 1 - Connoa and Ouro Medicines Ltd have jointly announced that their BCMA×CD3 dual antibody CM336 (OM336) has been granted Fast Track Designation by the FDA for the treatment of AIHA and ITP [1] - The Fast Track Designation highlights the urgent need for innovative treatment options for these diseases and underscores the therapeutic potential of CM336 in autoimmune diseases [1] - CM336 has also received Orphan Drug Designation (ODD) from the FDA for the treatment of AIHA and ITP, indicating its significance in addressing rare diseases [1] Group 2 - Connoa has entered into an exclusive licensing agreement with Ouro Medicines Ltd, granting them exclusive rights to research, develop, manufacture, register, and commercialize CM336 globally, excluding mainland China, Hong Kong, Macau, and Taiwan [1]

Core Viewpoint - The company, Valiant Biopharma-B (09887), has seen a stock price increase of 3.52% to HKD 55.90 following the announcement of its drug, LBL-024, receiving Fast Track designation from the FDA for the treatment of extra-pulmonary neuroendocrine carcinoma (EP-NEC) [1] Group 1: Drug Development and Regulatory Approvals - LBL-024, a dual-specific antibody targeting PD-L1 and 4-1BB, has now received three regulatory recognitions, including Fast Track designation from the FDA [1] - The drug is currently undergoing Phase II or registration clinical trials for three indications: non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and EP-NEC, showcasing first-in-class (FIC) or best-in-class (BIC) potential [1] - The Chief Medical Officer of the company, Dr. Cai Shengli, emphasized that this milestone reflects the drug's significant clinical potential and market prospects, which will accelerate its global development and market entry [1]

Core Viewpoint - The company has received FDA fast track designation for its bispecific antibody, ViliXinTM (Opa-Tisumi Monoclonal Antibody, LBL-024), for the treatment of pulmonary neuroendocrine carcinoma, indicating significant potential in addressing unmet medical needs in oncology [1][2] Group 1: FDA Designation and Drug Development - ViliXinTM has been granted fast track designation by the FDA, which accelerates the review process for drugs that treat serious conditions or fill unmet medical needs [1] - The fast track designation allows for more frequent regulatory interactions and the ability to submit a rolling new drug application [1] Group 2: Clinical Trial Results - In clinical trials in China, ViliXinTM has shown encouraging efficacy signals and good safety profiles as both a monotherapy and in combination with chemotherapy for patients with advanced pulmonary neuroendocrine carcinoma [2] - The company received approval from the National Medical Products Administration (NMPA) in April 2024 to conduct a single-arm registration clinical trial and was granted breakthrough therapy designation (BTD) in October 2024 [2] Group 3: Broader Implications and Potential - ViliXinTM targets both PD-L1 and 4-1BB, showing potential as the first approved drug for advanced pulmonary neuroendocrine carcinoma and demonstrating first-in-class or best-in-class clinical activity in various indications [1] - The drug has also shown promising clinical signals in multiple cancers with high unmet medical needs, including small cell lung cancer, cholangiocarcinoma, ovarian cancer, non-small cell lung cancer, esophageal squamous cell carcinoma, hepatocellular carcinoma, gastric cancer, triple-negative breast cancer, and melanoma [2]

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） 快速通道資格認定是FDA批准加速審查治療嚴重或危及生命病情或解決未滿 足 醫 療 需 求 的 藥 物 以 助 加 快 藥 物 開 發 的 方 法。其 提 供 若 干 重 要 程 序 性 激 勵 措 施，包 括 獲 得FDA更 頻 繁 的 監 管 互 動 與 指 導，以 及 有 權 滾 動 提 交 新 藥 申 請 以 獲 得 監 管 批 准。 關 於 維利信TM（奧 帕 替 蘇 米 單 抗，LBL-024） 維利信TM是一種同時靶向PD-L1與4-1BB的 雙 特 異 性 抗 體，為 針 對 肺 外 神 經 內 分泌癌的全球首款達到註冊臨床階段的靶 ...

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之內容概不 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 就 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之任何損失承擔任何責 任。 Sihuan Pharmaceutical Holdings Group Ltd. 四環醫藥控股集團有限公司 四 環 醫 藥 控 股 集 團 有 限 公 司（「本公司」或「四環醫藥」，連 同 其 附 屬 公 司，統 稱 為 「本集團」）董 事 會（「董事會」）欣 然 宣 佈，本 集 團 旗 下 非 全 資 附 屬 公 司 軒 竹 生 物 科 技 股 份 有 限 公 司（「軒竹生物」）從 臨 床 階 段 腫 瘤 公 司Akamis Bio Ltd.（「Akamis」）授 權引進的產品NG-350A獲 得 美 國 食 品 藥 品 監 督 管 理 局（「FDA」）授 予 快 速 通 道 資 格(Fast Track designation)，用 於 治 療 錯 配 修 復 功 能 完 整(pMMR)的局部晚期直腸癌 (LARC)。軒 竹 生 物 擁 有N ...

Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) announced that JSKN003 has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) for the treatment of platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer, marking a significant milestone in the global development of JSKN003 [1] Group 1 - JSKN003 has been granted FTD by the FDA for treating platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer, indicating its clinical potential [1] - The FDA has also approved a Phase II clinical trial for JSKN003 targeting platinum-resistant recurrent epithelial ovarian cancer with no restrictions on HER2 expression levels [1] - JSKN003 has received breakthrough therapy designation from the National Medical Products Administration (NMPA) for both PROC and colorectal cancer (CRC), and orphan drug designation from the FDA for gastric/gastroesophageal junction cancer (GC/GEJ) [1] Group 2 - The Phase III clinical trial for JSKN003 in treating platinum-resistant recurrent epithelial ovarian cancer is currently progressing smoothly in China [1] - The FTD designation further underscores the confidence of international regulatory bodies in the clinical potential and importance of JSKN003 as a novel therapeutic candidate [1]