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]

Core Viewpoint - The company Valiant Bio-B (09887.HK) has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) for its drug LBL-034, a bispecific antibody targeting GPRC5D/CD3, 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 designed 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 ...

Group 1 - Wangshan Wangshui-B (02630) surged over 14%, reaching a new high, following the announcement of significant antiviral research against Nipah virus by a team including researchers from the Wuhan Institute of Virology and Shanghai Institute of Materia Medica [1] - Zhaoyi Innovation (03986) increased by over 5.6%, with a forecasted revenue of approximately 9.2 billion yuan for 2025, representing a year-on-year growth of about 25%, and a projected net profit of around 1.61 billion yuan, up 46% [1] - Youran Dairy (09858) rose over 4% after completing a placement of 299.25 million shares at a price of 3.92 HKD per share [1] Group 2 - Yijun Group Holdings (02442) experienced a decline of over 39%, despite a previous surge of 4.4 times since its relisting on December 3, 2022 [2] - Alibaba-W (09988) saw a rise of 1.82% after the launch of its Qwen3-Max-Thinking model, which has over 1 trillion parameters and 36 trillion tokens of pre-training data [2][3] - Junda Co., Ltd. (02865) fell nearly 11%, with a drop of over 30% from its recent peak, following an announcement of a strategic investment in Shanghai Xingyi Xinneng Technology Co., Ltd. [2] Group 3 - WanGuo Data-SW (09698) increased by over 6%, also in response to the launch of Alibaba's Qwen3-Max-Thinking model [3] - MicroPort Scientific Corporation-B (02160) dropped 11% after announcing a proposed share consolidation [3] - Valiant Pharmaceuticals-B (09887) rose nearly 4% after receiving orphan drug designation from the European Commission for its core product [4] Group 4 - AI application software stocks in the US saw significant gains, with Cloudflare (NET.US) up 9.17% and Zoom Communications (ZM.US) up 11.28% [5] - Apple (AAPL.US) rose 2.97% ahead of its Q1 2026 earnings report, with expected revenue growth of 11.3% year-on-year to 138.42 billion USD [5] - Intel (INTC.US) continued its decline, falling 5.72% after a previous drop, with revenue expectations for Q1 2026 significantly below market forecasts [5] Group 5 - Kingsoft Cloud (KC.US) increased by 8.1% following a strategic upgrade of its AI training and deployment platform [6] - Precious metals stocks saw pre-market gains, with First Majestic Silver (AG.US) up 1.1% as gold prices reached historical highs [6]

Core Viewpoint - The company Valiant Pharmaceuticals (维立志博-B, 09887) has seen a significant stock increase following the announcement of its core product, LBL-024, receiving orphan drug designation from the European Commission for the treatment of extra-pulmonary neuroendocrine carcinoma (EP-NEC) [1] Group 1: Product Development - LBL-024 has reached an important milestone in its global development process with the orphan drug designation [1] - The product 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] Group 2: Regulatory Approvals - On January 14, LBL-024 received Fast Track designation from the U.S. FDA for the treatment of extra-pulmonary neuroendocrine carcinoma [1] - LBL-024 is a bispecific antibody that targets both PD-L1 and 4-1BB, making it the first targeted therapy for 4-1BB receptor in the registration clinical stage for extra-pulmonary neuroendocrine carcinoma [1]

Core Viewpoint - Valiant Bio-B (09887) has seen a significant stock increase, rising over 6% and currently trading at 62.2 HKD, with a transaction volume of 24.4 million HKD, following the announcement of its core product, Valiantxin (LBL-024), receiving orphan drug designation from the European Commission for the treatment of extra-pulmonary neuroendocrine carcinoma (EP-NEC) [1] Group 1 - Valiantxin has reached an important milestone in its global development process, now in Phase II or registration clinical trials for three indications: non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and EP-NEC, demonstrating first-in-class (FIC) or best-in-class (BIC) potential [1] - On January 14, Valiantxin was granted Fast Track designation by the FDA for the treatment of extra-pulmonary neuroendocrine carcinoma, marking it as the first targeted therapy for the 4-1BB receptor to reach the registration clinical stage globally [1]

Core Viewpoint - The stock of Valiant B (09887.HK) experienced significant volatility, initially dropping sharply before recovering and closing with a gain of over 5% [2] Group 1 - Valiant B's stock rose by 5%, reaching a price of 58.85 HKD [2] - The trading volume for Valiant B was reported at 45.73 million HKD [2]

Core Viewpoint - The company Valiant Pharmaceuticals (维立志博-B, 09887) experienced a significant stock price fluctuation, initially dropping but later increasing by over 5% after the announcement of its core product, LBL-024, receiving orphan drug designation from the European Commission for the treatment of extra-pulmonary neuroendocrine carcinoma (EP-NEC) [1] Group 1: Product Development - LBL-024 has reached an important milestone in its global development process by obtaining orphan drug status, which provides various incentives including 10 years of market exclusivity and regulatory fee waivers [1] - The product has demonstrated first-in-class (FIC) or best-in-class (BIC) potential in Phase II or registration clinical trials for non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and EP-NEC [1] Group 2: Clinical Trials and Approvals - LBL-024 is an antibody that targets both PD-L1 and 4-1BB, showing promising efficacy signals in two clinical trials conducted in China [1] - The company is set to receive approval from the National Medical Products Administration (NMPA) in April 2024 to conduct a single-arm registration clinical trial, with breakthrough therapy designation for the treatment of advanced extra-pulmonary neuroendocrine carcinoma expected in October 2024 [1]

Core Viewpoint - Valiant Biosciences-B (09887) experienced a significant stock price fluctuation, initially dropping but later increasing by over 5% after the announcement of its core product, LBL-024, receiving orphan drug designation from the European Commission for the treatment of extra-pulmonary neuroendocrine carcinoma (EP-NEC) [1] Group 1 - Valiant Biosciences announced that its core product, LBL-024, has received orphan drug designation from the European Commission, marking an important milestone in its global development process [1] - LBL-024 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, demonstrating first-in-class (FIC) or best-in-class (BIC) potential [1] - The orphan drug designation provides Valiant with several incentives, including 10 years of market exclusivity and regulatory fee waivers [1] Group 2 - LBL-024 is an antibody that targets both PD-L1 and 4-1BB, showing promising efficacy signals in two clinical trials conducted in China [1] - The company is set to receive approval from the National Medical Products Administration in April 2024 to conduct a single-arm registration clinical trial and has also obtained breakthrough therapy designation for the treatment of advanced extra-pulmonary neuroendocrine carcinoma in October 2024 [1]

Core Viewpoint - The stock of Valiant Pharmaceuticals-B (09887) has increased by over 5%, currently trading at 55.2 HKD with a transaction volume of 18.0035 million HKD, following the announcement of orphan drug designation for its dual-specific antibody, Viligene (Oparatuzumab, LBL-024) for the treatment of pulmonary neuroendocrine carcinoma by the European Commission [1] Group 1 - Valiant Pharmaceuticals-B's stock rose by 4.94% to 55.2 HKD as of the report [1] - The company reported a transaction volume of 18.0035 million HKD [1] - The European Commission granted orphan drug designation for Viligene on January 22, 2026, marking a significant milestone in its global development [1] Group 2 - This designation follows the previous orphan drug recognition by the U.S. Food and Drug Administration (FDA) [1] - The dual-specific antibody Viligene is aimed at treating pulmonary neuroendocrine carcinoma [1] - The orphan drug designation is a critical step in the drug's development process, enhancing its potential marketability and support [1]