Core Viewpoint - The company, Fuhong Hanlin (02696), has announced that its self-developed Hanbeitai® (Bevacizumab Injection) has received acceptance for its Biologics License Application (BLA) by the U.S. Food and Drug Administration (FDA) [1] Summary by Categories Product Development - The BLA application for Hanbeitai® includes indications for: 1. Metastatic colorectal cancer 2. First-line treatment of unresectable locally advanced, recurrent, or metastatic non-squamous non-small cell lung cancer in combination with carboplatin and paclitaxel 3. Recurrent adult glioblastoma 4. Treatment of metastatic renal cell carcinoma in combination with interferon α 5. Epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer 6. Treatment of persistent, recurrent, or metastatic cervical cancer in combination with paclitaxel and cisplatin, or paclitaxel and topotecan [1]

Core Viewpoint - The company, Junshi Biosciences (复宏汉霖), has received acceptance from the FDA for its Biologics License Application (BLA) for Hanbeitai® (Bevacizumab Injection), indicating a significant step forward in its drug development pipeline [1] Group 1: FDA Acceptance - The FDA has accepted the BLA for Hanbeitai®, which is a major milestone for the company [1] - The application includes multiple indications, showcasing the drug's potential versatility in treating various cancers [1] Group 2: Indications Included - The BLA covers the following indications: 1. Metastatic colorectal cancer 2. First-line treatment of unresectable locally advanced, recurrent, or metastatic non-squamous non-small cell lung cancer in combination with Carboplatin and Paclitaxel 3. Recurrent adult glioblastoma 4. Metastatic renal cell carcinoma in combination with Interferon α 5. Epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer 6. Persistent, recurrent, or metastatic cervical cancer in combination with Paclitaxel and Cisplatin, or Paclitaxel and Topotecan [1]

Core Viewpoint - The company, Junshi Biosciences (复宏汉霖), announced that its self-developed drug Hanbeitai® (Bevacizumab Injection) has received acceptance for its Biologics License Application (BLA) by the U.S. Food and Drug Administration (FDA) [1] Summary by Categories Product Development - The BLA application includes indications for multiple cancers: 1. Metastatic colorectal cancer 2. First-line treatment of unresectable locally advanced, recurrent, or metastatic non-squamous non-small cell lung cancer in combination with carboplatin and paclitaxel 3. Recurrent adult glioblastoma 4. Metastatic renal cell carcinoma in combination with interferon α 5. Epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer 6. Persistent, recurrent, or metastatic cervical cancer in combination with paclitaxel and cisplatin, or paclitaxel and topotecan [1]

Shanghai Henlius Biotech, Inc. 上海復宏漢霖生物技術股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：2696） 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，並明確表示概不就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。 1 自願公告 漢貝泰® （貝伐珠單抗注射液）的生物製品許可申請(BLA) 獲美國食品藥品管理局(FDA)受理 A. 緒言 本公告由上海復宏漢霖生物技術股份有限公司（「本公司」）自願作出，以告知 本公司股東及潛在投資者本公司最新業務更新。 本公司董事會（「董事會」）欣然宣佈，近日，本公司自主研發的漢貝泰® （貝伐 珠單抗注射液）（「漢貝泰®」）的生物製品許可申請（「BLA」）獲美國食品藥品 管理局（「FDA」）受理，本次申請涉及的適應症包括：(1)轉移性結直腸癌； (2)聯合卡鉑和紫杉醇一線治療不可切除的局部晚期、復發性或轉移性非鱗狀 非小細胞肺癌；(3)復發性成人膠質母細胞瘤；(4)聯合干擾素α治療轉移性腎 細胞癌；(5)上皮性卵巢癌、輸卵管癌 ...

每经AI快讯，复宏汉霖(02696.HK)再涨超8%，截至发稿涨8.05%，报69.8港元，成交额1864.08万港元。 （文章来源：每日经济新闻） ...

Group 1 - The core viewpoint of the article highlights the significant rise in the stock price of Fuhong Hanlin (02696), which increased by 8.05% to HKD 69.80, with a trading volume of HKD 22.8793 million [2][5] - On January 9, Fuhong Hanlin presented its Phase II proof-of-concept data for PD-L1 ADC HLX43 targeting recurrent/metastatic esophageal squamous cell carcinoma (ESCC) at the 2026 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI) [5] - The data released indicates promising efficacy and good safety profile of HLX43 in previously treated advanced ESCC patients, demonstrating its potential as a treatment option [5] Group 2 - HLX43 has shown consistent efficacy and safety trends across multiple solid tumor indications, including non-small cell lung cancer, cervical cancer, esophageal squamous cell carcinoma, and thymic cancer [5] - The broad anti-tumor potential of HLX43 is gradually being validated through clinical practice, laying a crucial foundation for the expansion into more indications [5]

消息面上，1月9日，复宏汉霖在2026年美国临床肿瘤学会胃肠道肿瘤研讨会（ASCO GI）上，首度公布 了其PD-L1 ADC HLX43治疗复发/转移性食管鳞癌（ESCC）的II期概念验证（POC）数据，本次发布的 数据初步验证了HLX43在经治的晚期ESCC患者中的治疗潜力，展现出令人鼓舞的疗效及良好的安全 性。HLX43已在非小细胞肺癌、宫颈癌、食管鳞癌及胸腺癌等多项实体瘤适应症中观察到持续且一致 的疗效和安全性趋势，其广谱抗肿瘤潜力正通过临床实践逐步得到验证，为后续拓展更多适应症奠定重 要基础。 智通财经APP获悉，复宏汉霖(02696)再涨超8%，截至发稿，涨8.05%，报69.8港元，成交额1864.08万港 元。 值得注意的是，第44届摩根大通医疗健康年会(JPM 2026)将于1月12–15日在美国旧金山举行。作为全球 医疗健康领域最具影响力的年度盛会之一，JPM大会被视为全球资本市场观察医药创新与产业趋势的重 要窗口。复宏汉霖执行董事兼首席执行官朱俊博士将于当地时间1月15日在大会上发表主题演讲，围绕 公司全球化2.0阶段的发展路径、创新管线布局及中长期战略规划，向国际投资人与产业界系统分享 ...

Group 1 - The core viewpoint of the articles highlights the positive market response to Fuhong Hanlin's (复宏汉霖) announcement of promising Phase II proof-of-concept data for its PD-L1 ADC HLX43 in treating recurrent/metastatic esophageal squamous cell carcinoma (ESCC), leading to an 8.05% increase in stock price [1] - The data presented at the ASCO GI conference indicates that HLX43 shows encouraging efficacy and good safety in advanced ESCC patients, supporting its broad anti-tumor potential across various solid tumor indications [1] - Fuhong Hanlin's CEO, Dr. Zhu Jun, is scheduled to deliver a keynote speech at the upcoming JPM 2026 conference, discussing the company's globalization strategy, innovation pipeline, and long-term planning, which will provide insights to international investors and industry stakeholders [2] Group 2 - The stock price of Fuhong Hanlin reached 69.8 HKD with a trading volume of 18.64 million HKD following the announcement of the clinical data [1] - The ASCO GI conference is a significant event for the medical and health sector, serving as a key platform for observing pharmaceutical innovation and industry trends [2] - The upcoming JPM conference is recognized as one of the most influential annual events in the global healthcare sector, attracting attention from capital markets [2]

复宏汉霖HLX43的含金量还在不断上升。 作为广谱抗肿瘤、兼具IO疗效的潜在同类最优PD-L1 ADC，HLX43已在非小细胞肺癌、胸腺癌、宫颈癌等多个瘤种中验证治疗潜力，并在持续拓展治疗版 图。 就在近日举办的2026年美国临床肿瘤学会胃肠道肿瘤研讨会（ASCO GI）上，复宏汉霖首次公布了HLX43末线治疗复发/转移性食管鳞癌（ESCC）的II期概 念验证（POC）数据：在3 mg/kg剂量组的13例疗效可评估的患者中，8例患者达到了部分缓解，ORR为61.5%，DCR为100.0%，确认的ORR（cORR）为 38.5%，初步临床疗效优异且安全性良好，优势人群获益潜力显著。 值得注意的是，复宏汉霖在实体瘤领域打出的王牌，不只有HLX43。 01 HLX43的护城河 具有广谱抗肿瘤潜力，是HLX43具备大药潜质的重要体现之一。 目前，复宏汉霖已累计开展约10项HLX43治疗多项实体瘤中的临床研究，广泛覆盖肺癌、宫颈癌、食管鳞癌、头颈鳞癌、鼻咽癌、结直肠癌、胃癌/胃食管 交界部癌、胰导管腺癌等，在全球入组超过500例患者。 这种"广撒网"式的临床布局，体现了复宏汉霖的研发实力。尤其HLX43已在多个瘤种中读 ...

Core Viewpoint - The stock of Fuhong Hanlin (02696) has seen an increase of over 5% during trading, currently up 4.39% at HKD 66.65, with a trading volume of HKD 23.9053 million [1] Group 1: Clinical Data Announcement - Fuhong Hanlin has announced clinical data for its PD-L1 ADC drug HLX43, which is aimed at treating recurrent/metastatic esophageal squamous cell carcinoma (ESCC) [1] - HLX43 is a novel ADC drug targeting PD-L1, combining immune checkpoint inhibition with cytotoxic effects, showing promising efficacy and good tolerability in patients who are unresponsive to immunotherapy [1] - The Phase II study aims to evaluate the efficacy and safety of HLX43 in patients with treated recurrent/metastatic esophageal squamous cell carcinoma [1]