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 維利信™（PD-L1/4-1BB雙特異性抗體 奧 帕 替 蘇 米 單 抗，LBL-024） 用於治療肺外神經內分泌癌 獲歐盟委員會授予孤兒藥認定（ODD） 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 潜 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22日，歐 盟 委 員 會（「EC」）發布關於PD-L1/4-1BB雙 特 異性抗體 維利信™（奧 帕 替 蘇 米 單 抗，LBL-024）用於治療肺外神經內分泌癌獲 ...

Core Viewpoint - Huafu Securities initiates coverage on Weili Zhibo (09887) with a "Buy" rating, projecting revenue for 2025-2027 to be 1.80, 0.94, and 0.10 million yuan, with growth rates of 833%, -48%, and -90% respectively [1] Group 1: Company Overview - The company is focused on next-generation tumor immunotherapy through its agonist platform, TCE platform, and ADC, establishing a comprehensive layout [1] - The company has consistently emphasized "technology platform + innovative targets" since 2015, covering cutting-edge fields such as immune checkpoints and multi-specific antibodies, thereby building a differentiated pipeline [1] Group 2: Clinical Developments - LBL-024 (PDL1/4-1BB bispecific antibody) shows historical best data in lung neuroendocrine carcinoma, with excellent efficacy in first-line SCLC and promising preliminary efficacy in NSCLC [1] - LBL-024 enhances the efficacy of second-generation CAR-T therapy, demonstrating low liver toxicity with ≥3 grade liver enzyme elevation at only 1.3%, comparable to PD-1 monoclonal antibodies, indicating superior safety and a broad therapeutic window [1] - LBL-024 is the first 4-1BB targeted molecule to reach critical clinical stages globally, with ongoing clinical research approved in multiple cancer types including SCLC, BTC, OC, and NSCLC, showing encouraging clinical results [1] Group 3: Additional Pipeline Insights - LBL-034 (GPRC5D/CD3 bispecific antibody) demonstrates improved safety and dosage intensity, with a 2:1 structure enhancing TAA binding while balancing efficacy and safety [2] - In I/II clinical studies, LBL-034 achieved an ORR of 77.8% at a dosage of 400μg/kg and 90.9% at 800μg/kg, comparable to CAR-T efficacy [2] - Other pipeline developments include BDCA2×TACI with IND expected in the second half of 2025, and CD19/BCMA/CD3 trispecific antibody IND anticipated in Q1 2026 [2]

Core Viewpoint - The recent announcement by Vaili Zhibo has not garnered significant market attention despite the potential of its core product reaching key R&D milestones, which typically attracts investor interest in the Hong Kong stock market for unprofitable 18A companies [3][4]. Market Reaction - Following the announcement, Vaili Zhibo's stock price rose by 3.15% and 1.44% on January 15 and 16, respectively, but subsequently experienced a "three consecutive declines" trend, influenced by the overall pullback in the Hong Kong medical sector and the upcoming cornerstone lock-up expiration [3][4]. - The Hang Seng Healthcare Index reached a peak of 4326.18 points on January 15 before entering a "four consecutive down" trend, indicating a market correction after a period of gains [4]. Trading Volume and Technical Analysis - Vaili Zhibo experienced a "seven consecutive up" trend from December 30 to January 8, coinciding with the company's participation in the JPM conference, but this rally lacked substantial trading volume support, indicating a potential "false breakout" in technical terms [6][8]. - The daily trading volume peaked at 224.58 million shares at the start of the rally but subsequently declined, suggesting a lack of market support and leading to a downward price trend [6]. Cornerstone Lock-up Expiration - Vaili Zhibo's cornerstone investors, who collectively subscribed for $69 million (approximately 542 million HKD) during the IPO, will face a lock-up expiration on January 25, 2025, which could lead to profit-taking and market pressure [8][10]. - As of January 21, the stock price was 51.25 HKD, indicating that cornerstone investors have an approximate 50% unrealized gain, providing them with a favorable exit opportunity [8]. Future Market Dynamics - The upcoming inclusion of Vaili Zhibo in the Hong Kong Stock Connect program in March 2025, with an average market capitalization of 9.462 billion HKD, positions it as a potential target for new capital inflows [10][12]. - The behavior of cornerstone investors during the lock-up expiration will serve as a critical indicator for market sentiment and could influence the stock's performance in the context of new capital entering the market [10][14]. Company Fundamentals - Vaili Zhibo's innovative strategy focuses on T cell connectors, tumor immunology 2.0, and antibody-drug conjugates, with its core product LBL-024 being a significant asset in its pipeline [13][14]. - LBL-024 has received fast track designation from the FDA for treating neuroendocrine cancer, highlighting its potential and the recognition from regulatory bodies [13].

1月14日晚，维立志博-B(09887)发布公告，宣布其在研核心品种抗PD-L1/4-1BB双特异性抗体维利信®(LBL-024)获得美国食品药品监督管理局(FDA)授予快 速通道资格认定，用于治疗肺外神经内分泌癌(EP-NEC)。 对于一家未盈利的港股18A企业而言，在暂时没有商业化里程碑的发展前期，有巨大潜力的核心品种到达关键研发里程碑，往往都会引发场内投资者关注并 获得市场配置，这也是港股不少18A标的走出阶段性上涨行情的原因之一。然而，维立志博此次重磅公告披露似乎并未得到相应关注。 智通财经APP观察到，在维立志博发布公告后，公司股价分别在1月15日和16日分别收涨了3.15%和1.44%，之后便迎来一个"三连跌"跳水行情。而这一方面 与港股医药板块回调有关(1月15日至20日，恒生医疗保健指数走出"四连跌")，另一方面或与维立志博即将基石解禁有关。 板块"跳水"叠加基石解禁，观望情绪主导市场 1月15日，随着JPM大会的落幕，港股医药板块也在充分定价各种会议利好后，进入了利好兑现期。此外，截至目前多家医药公司将陆续发布2025年全年业 绩预告。在规避市场不确定性的逻辑下，投资者通常会选择观望。 在上 ...

LBL-024（PDL1/4-1BB双抗）在肺外神经内分泌癌展现历史最佳数据 一线SCLC疗效优异，NSCLC初步疗效振奋：4-1BB明显提升二代CAR-T疗效，LBL-024采用2:2结构设 计，弱化了4-1BB亲和力，在同类双抗中LBL-024的肝毒性低。≥3级的肝酶升高仅为1.3%，与PD-1单抗 相当，证明了LBL-024卓越的安全性和广阔的治疗窗口。同类双抗中LBL-024的临床进展领先，是全球 首款达到关键临床阶段的4-1BB靶向分子。除EP-NEC外，在有大量未满足临床需求的SCLC、BTC、 OC、NSCLC、ESCC、TNBC等领域均已获批开展临床研究，并已在SCLC、BTC、OC等多个癌种看到 令人振奋的临床效果，有望成为一款具有前景的针对广泛适应症的有效抗肿瘤药物，1年内迎来关键临 床节点。 LBL-034(GPRC5D/CD3)双抗：更优安全性与剂量强度支撑更大空间 2:1的结构放大了TAA的结合，空间位阻使TAA结合才暴露激活CD3，同时弱化CD3亲和力，做到有效 性和安全性的平衡，在最高剂量800μg/kg下未观察到DLT或≥3级CRS。在I/II期临床研究中，LBL-034剂 量 ...

Core Viewpoint - The China Securities Regulatory Commission (CSRC) has released a report on the status of domestic companies' overseas securities issuance and listing applications, indicating several companies are in various stages of the IPO process in Hong Kong [1]. Group 1: Companies and Their IPO Status - Sifang Precision (300468.SZ) has submitted materials for a Hong Kong IPO and has received acceptance from the CSRC [1][2]. - Zhenqu Technology is also in the process of applying for a Hong Kong IPO, with materials accepted by the CSRC [1][2]. - Jingze Biopharmaceutical (Hefei) has its Hong Kong IPO application in a supplementary materials status [1][2]. - Weili Zhibo-B (09887) has received acceptance for its full circulation application from the CSRC [1][2]. - Lingbao Gold's full circulation application is currently in a supplementary materials status [1][2]. Group 2: Application Details - Lingbao Gold Group's full circulation application was received on January 13, 2026, and is in supplementary materials status [2]. - Sifang Precision's direct overseas listing application was accepted on January 14, 2026, with the underwriting by CMB International and Guosen Securities [2]. - Weili Zhibo's full circulation application was also accepted on January 14, 2026, with legal representation from JunHe Law Offices [2]. - Beijing Extreme Intelligence Technology's full circulation application is in supplementary materials status as of January 16, 2026 [2]. - Jingze Biopharmaceutical's direct overseas listing application is in supplementary materials status as of January 16, 2026, with underwriting by CICC and legal representation from Tian Yuan Law Firm [2]. - Zhenqu Technology's direct overseas listing application was accepted on January 16, 2026, with underwriting by CITIC Securities [2].

近日，中国证监会发布境内企业境外发行证券和上市备案情况表(首次公开发行及全流通)(截至2026年1月16日)。其中，四方 精创（300468）(300468.SZ)、臻驱科技拟香港IPO获中国证监会接收材料；景泽生物拟香港IPO备案状态为补充材料；维立志 博-B(09887)股份全流通获中国证监会接收材料。灵宝黄金(03330)股份全流通备案状态为补充材料。 | 企业名称 | 申报类型 | 申报主体 | 拟上市证券交易所 | 中介机构 | | 接收日期 | 备案状态 | | --- | --- | --- | --- | --- | --- | --- | --- | | | | | | 保荐人/主承销商 | 境内律师 | | | | 灵宝黄金集团股 份有限公司 | 全流通 | | 香港联交所 | | 北京市竞天 公诚律师事 | 2026年1月13日 | 补充材料 | | | | | | | 务所 | | | | 深圳四方精创资 | 直接境外上 | | 香港联交所 | 招银国际融资有 限公司,国信证 | 金社律师事 | 2026年1月14日 | 已接收 | | 讯股份有限公司 | 市 | | | 券(香港)融 ...

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, Valiant Bio (维立志博-B), has seen its stock price increase by over 4% following the announcement of its dual-specific antibody, LBL-024, receiving Fast Track designation from the FDA for the treatment of extra-pulmonary neuroendocrine carcinoma (EP-NEC) [1] Group 1 - Valiant Bio's LBL-024 has now received three regulatory recognitions, including Fast Track designation from the FDA, and is currently in Phase II or registration clinical trials for non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and EP-NEC [1] - The Chief Medical Officer of Valiant Bio, Dr. Cai Shengli, emphasized that this latest recognition from an international regulatory authority highlights the significant clinical potential and market prospects of LBL-024 [1] - The milestone is expected to accelerate the global development process of LBL-024, facilitating its market entry and benefiting patients worldwide [1]

维立志博首席医学官蔡胜利博士表示，维利信®继此前获得中国国家药品监督管理局（NMPA）药品审 评中心（CDE）突破性治疗药物认定和FDA孤儿药资格认定后，此次再获国际权威监管机构加速审评认 可，彰显了该药物的巨大临床潜力与市场前景。这一里程碑将有力推动其全球开发进程，加速药物上 市，早日惠及全球患者。 智通财经APP获悉，维立志博-B(09887)涨超4%，截至发稿，涨4.26%，报56.3港元，成交额300.03万港 元。 消息面上，1月14日晚，维立志博宣布，公司自主研发的抗PD-L1/4-1BB双特异性抗体维利信®（LBL- 024）获得美国食品药品监督管理局（FDA）授予快速通道资格认定，用于治疗肺外神经内分泌癌（EP- NEC）。这是维利信®获得的第三项监管认定，目前，维利信®已在非小细胞肺癌（NSCLC）、小细胞 肺癌（SCLC）和EP-NEC三个适应症的二期或注册性临床试验中展示出全球首创（FIC）或同类最优 （BIC）潜力。 ...