Core Viewpoint - The stock of Valiant Pharmaceuticals-B (09887) has increased by over 5%, reaching 55.2 HKD, following the announcement of orphan drug designation for its drug Valiant (Oparatuzumab, LBL-024) by the European Commission [1] Group 1 - On January 22, Valiant Pharmaceuticals-B announced that the European Commission granted orphan drug designation for its PD-L1/4-1BB bispecific antibody, Valiant, for the treatment of pulmonary neuroendocrine carcinoma [1] - This designation is a significant milestone, marking the second orphan drug designation for Valiant after receiving similar recognition from the U.S. Food and Drug Administration (FDA) [1] - The announcement reflects Valiant's progress in its global development efforts [1]

每经AI快讯，维立志博-B(09887.HK)一度涨超5%，截至发稿，涨4.94%，报55.2港元，成交额1800.35万 港元。 （文章来源：每日经济新闻） ...

消息面上，1月22日，维立志博-B发布公告，于2026年1月22日，欧盟委员会(EC)发布关于PD-L1/4-1BB 双特异性抗体维利信™(奥帕替苏米单抗，LBL-024)用于治疗肺外神经内分泌癌获授孤儿药认定的2026 年1月9日委员会执行决定。这是继获得美国食品药品监督管理局(FDA)认定后，维利信™获得的第二项 孤儿药认定，标志着维利信™在全球开发进程中的又一个重要里程碑。 智通财经APP获悉，维立志博-B(09887)涨超5%，截至发稿，涨4.94%，报55.2港元，成交额1800.35万港 元。 ...

Core Insights - The company is strategically positioned in the next-generation tumor immunotherapy space through its platforms, including the Agonist platform, TCE platform, and ADC, focusing on innovative targets and differentiated pipelines [1] Group 1: Product Development - LBL-024 (PDL1/4-1BB bispecific antibody) has shown historical best data in lung neuroendocrine carcinoma, with excellent efficacy in first-line SCLC and promising preliminary results in NSCLC; it demonstrates a low incidence of ≥3 grade liver enzyme elevation at only 1.3%, indicating superior safety [2] - LBL-034 (GPRC5D/CD3 bispecific antibody) has a 2:1 structure that enhances TAA binding while balancing efficacy and safety; in I/II clinical studies, it achieved an ORR of 77.8% at 400μg/kg and 90.9% at 800μg/kg, comparable to CAR-T efficacy [3] Group 2: Clinical Research and Pipeline - 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 others, showing promising clinical effects [2] - Other pipeline developments include BDCA2×TACI expected to file IND in the second half of 2025, a CD19/BCMA/CD3 trispecific antibody IND anticipated in Q1 2026, and DLL3 TCE ADC expected to file IND in the first half of 2027 [3] Group 3: Financial Projections - Revenue forecasts for the company are projected at 1.80 billion, 0.94 billion, and 0.10 billion yuan for 2025, 2026, and 2027 respectively, with growth rates of 833%, -48%, and -90% [3] - Using a DCF model with a WACC of 8.78% and a perpetual growth rate of 1%, the company's fair stock price is estimated at 101.86 HKD, leading to a fair market capitalization of 20.3 billion HKD [3]

Major Events - UBTECH (09880) plans to invest 300 million yuan to establish a partnership for investments in the smart robotics industry chain [1] - Tian Ge Interactive (01980) received a 1.41% discount from Sina Hong Kong for a partial tender offer to acquire 32.5 million shares, with trading resuming on January 22 [1] - Fosun Pharma (02196) received approval for the drug registration application of heavy tartrate norepinephrine injection [1] - Valiant (09887) received orphan drug designation (ODD) from the European Commission for Valiant™ for the treatment of extra-pulmonary neuroendocrine carcinoma [1] - GCL-Poly Energy (01050) secured orders for AI giant server enclosures, accelerating ASIC business production, and commenced construction of a new base in Thailand [1] - China Rare Earth Holdings (03788) plans to raise approximately 783 million HKD to support the development of the Mt Bundy gold mine project [1] - Nanshan Aluminum International (02610) plans to place 31 million shares, aiming to raise approximately 1.9868 billion HKD [1] - Qiming Medical-B (02500) reported a patent infringement lawsuit against Edwards by Cardiovalve Ltd. and MTH IP, L.P. regarding US Patent No. 385 [1] - Minmetals Resources (01208) expects total copper production of 506,900 tons in 2025, a year-on-year increase of 27% [1] - Prudential (02378) invested approximately 375 million USD to increase its stake in PAMB to 70% [1] - Nocoda Technology (00519) successfully implemented innovative smart handling robots in Hong Kong public housing estates [1] - Idali Holdings (00720) B-ON Global S.àr.l. plans to acquire 1.3 billion shares of the company, becoming the major shareholder [1] Bonds and Notes - China Shipbuilding Leasing (03877) subsidiary plans to issue 2.338 billion HKD convertible bonds [2] Buybacks/Reductions - China Communications Construction (01800) repurchased 1.06837 million HKD worth of 1.2588 million A-shares on January 22 [2] - Kuaishou-W (01024) spent approximately 29.9714 million HKD to repurchase 380,000 shares on January 22 [2] - Xiaomi Group-W (01810) repurchased shares worth 201 million HKD, acquiring 5.7138 million shares on January 22 [2] - Xiaomi Group-W (01810) plans to repurchase up to 2.5 billion HKD of Class B ordinary shares [2] - Sanhua Intelligent Control (02050) controlling shareholders, directors, and executives plan to collectively reduce their holdings by up to approximately 10.2037 million A-shares [2] Operating Performance - AsiaInfo Technologies (01675) expects to turn cash flow positive by 2025, driven by rapid growth in AI business [2] - Zhaoyi Innovation (03986) issued a profit warning, expecting a net profit of approximately 1.61 billion yuan in 2025, a year-on-year increase of about 46% [2] - MicroPort Medical (00853) issued a profit warning, expecting a net profit of no less than 20 million USD in 2025, turning profitable year-on-year [2]

Core Viewpoint - The European Commission has granted orphan drug designation to Viligene (Opalizumab, LBL-024) for the treatment of extra-pulmonary neuroendocrine carcinoma, marking a significant milestone in its global development process after receiving similar recognition from the FDA [1][2]. Group 1 - The orphan drug designation is intended for medicines used to diagnose, prevent, or treat life-threatening or chronically debilitating diseases with a prevalence of less than 5 in 10,000 in the EU [2]. - The designation provides several key incentives, including scientific advice from the European Medicines Agency (EMA) on research design related to drug quality, benefits, and risks [2]. - The orphan drug status grants a 10-year market exclusivity period in the EU, during which no similar drugs for the same indication can be approved, ensuring protection even without patent coverage [2]. Group 2 - Additional benefits of orphan drug designation include fee reductions for regulatory guidance, marketing authorization applications, and post-marketing changes [2]. - Companies may also access funding from the European Commission, Horizon Europe, and other sources upon receiving orphan drug designation [2]. - Extra incentives are available for micro, small, and medium-sized enterprises, including regulatory, administrative, and procedural assistance, as well as fee reductions [2].

根据EC的定义，孤儿药是拟用于诊断、预防或治疗危及生命或慢性衰弱性疾病且患病率在欧盟低于万 分之五的药品。授予孤儿药认定提供多项关键激励措施，包括但不限于：(1)方案指导，据此，欧洲药 品管理局("EMA")提供涵盖药品质量、获益及风险等不同方面相关研究设计意见的科学建议；(2)欧盟市 场十年独占权，据此，自上市许可批准日期起，授予10年的市场独占期，期间，欧盟及其成员国的监管 部门不得批准其他公司针对相同适应症的类似药品，且该市场独占权与专利保护分别施行，即使在无任 何专利的情况下亦维持有效；(3)监管费用减免，包括方案指导、上市许可申请及核查、上市后变更及 年度维护相关费用减免；(4)获取资金，获授予孤儿药认定后，可自EC、Horizon Europe及其他来源获得 资金；及(5)针对微型、小型及中型企业的额外激励措施，包括监管、行政及程序性援助以及费用减 免。 格隆汇1月22日丨维立志博-B(09887.HK)公告，公司欣然宣布于2026年1月22日，欧盟委员会("EC")发布 关于PD-L1/4-1BB双特异性抗体维利信™(奥帕替苏米单抗，LBL-024)用于治疗肺外神经内分泌癌获授 孤儿药认定的20 ...

Core Viewpoint - The announcement by Vili Zhibo-B (09887) regarding the orphan drug designation for LBL-024 (Opalizumab) for the treatment of pulmonary neuroendocrine carcinoma marks a significant milestone in its global development process, following a similar designation from the FDA [1] Group 1 - The European Commission (EC) granted orphan drug designation for LBL-024 on January 9, 2026, which is the second such designation after receiving FDA recognition [1] - Orphan drugs are defined by the EC as those intended for the diagnosis, prevention, or treatment of life-threatening or chronically debilitating conditions with a prevalence of less than 5 in 10,000 in the EU [2] Group 2 - The orphan drug designation provides several key incentives, including scientific advice from the European Medicines Agency (EMA) on various aspects of research design [2] - It grants a 10-year market exclusivity period in the EU from the date of marketing authorization, preventing other companies from approving similar drugs for the same indication during this time [2] - Additional benefits include fee reductions for regulatory processes and potential funding from the EC and Horizon Europe, as well as extra incentives for micro, small, and medium-sized enterprises [2]

根据EC的定义，孤儿药是拟用于诊断、预防或治疗危及生命或慢性衰弱性疾病且患病率在欧盟低于万 分之五的药品。授予孤儿药认定提供多项关键激励措施，包括但不限于：方案指导，据此，欧洲药品管 理局(EMA)提供涵盖药品质量、获益及风险等不同方面相关研究设计意见的科学建议;欧盟市场十年独 占权，据此，自上市许可批准日期起，授予10年的市场独占期，期间，欧盟及其成员国的监管部门不得 批准其他公司针对相同适应症的类似药品，且该市场独占权与专利保护分别施行，即使在无任何专利的 情况下亦维持有效;监管费用减免，包括方案指导、上市许可申请及核查、上市后变更及年度维护相关 费用减免;获取资金，获授予孤儿药认定后，可自EC、Horizon Europe及其他来源获得资金;及针对微 型、小型及中型企业的额外激励措施，包括监管、行政及程序性援助以及费用减免。 智通财经APP讯，维立志博-B(09887)发布公告，于2026年1月22日，欧盟委员会(EC)发布关于PD-L1/4- 1BB双特异性抗体维利信™(奥帕替苏米单抗，LBL-024)用于治疗肺外神经内分泌癌获授孤儿药认定的 2026年1月9日委员会执行决定。这是继获得美国食品药品监 ...

Core Viewpoint - The company announced that its PD-L1/4-1BB bispecific antibody, Velesin™ (Oparizumab, LBL-024), received orphan drug designation from the European Commission for the treatment of pulmonary neuroendocrine carcinoma, marking a significant milestone in its global development process after previously receiving similar recognition from the FDA [1]. Group 1 - The European Commission's orphan drug designation is granted to drugs intended for the diagnosis, prevention, or treatment of life-threatening or chronically debilitating conditions with a prevalence of less than 5 in 10,000 in the EU [2]. - The orphan drug designation provides several key incentives, including scientific advice from the European Medicines Agency (EMA) on research design related to drug quality, benefits, and risks [2]. - The designation grants a 10-year market exclusivity period in the EU from the date of marketing authorization, during which no similar drugs for the same indication can be approved [2]. Group 2 - Additional incentives include fee reductions for regulatory guidance, marketing authorization applications, and post-marketing changes, as well as access to funding from the EC, Horizon Europe, and other sources [2]. - There are also extra incentives for micro, small, and medium-sized enterprises, including regulatory, administrative, and procedural assistance, along with fee reductions [2].