消息面上，12月30日，复宏汉霖宣布，公司三款潜力创新分子——基于自研T细胞衔接器(TCE)平台开 发的DLL3xDLL3xCD3xCD28四特异性TCE HLX3901、潜在同类最优(BIC)的新型KAT6A/B口服小分子 抑制剂HLX97、以及潜在同类首创(FIC)的B7H3-唾液酸酶融合蛋白HLX316的新药临床试验申请均已获 得国家药品监督管理局受理。以上三款产品皆拟用于实体肿瘤的治疗。 复宏汉霖(02696)现涨近9%，截至发稿，涨8.62%，报63.65港元，成交额2904.28万港元。 ...

智通财经APP获悉，复宏汉霖(02696)现涨近9%，截至发稿，涨8.62%，报63.65港元，成交额2904.28万 港元。 消息面上，12月30日，复宏汉霖宣布，公司三款潜力创新分子——基于自研T细胞衔接器（TCE）平台 开发的DLL3xDLL3xCD3xCD28四特异性TCE HLX3901、潜在同类最优（BIC）的新型KAT6A/B口服小 分子抑制剂HLX97、以及潜在同类首创（FIC）的B7H3-唾液酸酶融合蛋白HLX316的新药临床试验申请 均已获得国家药品监督管理局受理。以上三款产品皆拟用于实体肿瘤的治疗。 ...

Group 1 - The Singapore Government Investment Corporation increased its stake in Fuhong Hanlin (02696) by acquiring 177,000 shares at a price of HKD 56.7593 per share, totaling approximately HKD 10.0464 million [1] - After the acquisition, the total number of shares held by the Singapore Government Investment Corporation reached 9.9171 million, representing a holding percentage of 6.07% [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。 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） 1 於2025年12月31日（星期三）舉行的 2025年第四次臨時股東會 所提呈決議案之投票結果 上海復宏漢霖生物技術股份有限公司（「本公司」）董事（「董事」）會（「董事會」）欣 然宣佈於2025年12月31日（星期三）上午九時正假座中國上海市徐匯區宜州路188 號B8幢10樓會議室舉行的2025年第四次臨時股東會（「臨時股東會」）之投票結果。 茲提述本公司日期為2025年12月3日之臨時股東會通告及有關臨時股東會的通函 （「通函」）。除文義另有所指外，本公告所用詞彙與通函所界定者具有相同涵義。 臨時股東會 於臨時股東會日期，本公司已發行股份（「股份」）總數為543,494,853股（包含 380,066,312股非上市股份及163,428,5 ...

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。 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） 持續關連交易 重續物業租賃框架協議 本公司茲提述本公司日期為2022年11月17日的公告，內容有關本公司分別與克 隆高技術及復坤醫藥於2022年11月17日訂立的2023年克隆物業租賃框架協議及 2023年復坤物業租賃框架協議項下的持續關連交易，據此，本公司自克隆高技 術及復坤醫藥租用若干物業，為期三年，自2023年1月1日起至2025年12月31日 止。 2023年克隆物業租賃框架協議及2023年復坤物業租賃框架協議的期限將於2025 年12月31日屆滿。於2025年12月31日，本公司分別與克隆高技術及復坤醫藥訂 立克隆物業租賃框架協議及復坤物業租賃框架協議，據此，本集團將繼續自克 隆高技術及復坤醫藥租用若干物業，自2026年1月1日起至2 ...

Group 1 - Hong Kong biopharmaceutical stocks weakened during trading on December 30, with Genscript Biotech falling nearly 4% [1] - Fuhong Hanlin declined by nearly 3%, while Kelun-Biotech dropped over 2% [1] - Other stocks such as CanSino Biologics, Rongchang Biologics, and Kanyin Biologics also experienced declines of over 1.5% [1]

Core Viewpoint - The company has initiated a Phase 1 clinical trial for HLX37, a dual-specific antibody targeting PD-L1 and VEGF, in patients with advanced/metastatic solid tumors, marking a significant step in its development pipeline [1][2]. Group 1: Clinical Trial Details - The Phase 1 clinical study of HLX37 has completed its first patient dosing in mainland China, excluding Hong Kong, Macau, and Taiwan [1]. - The study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of HLX37 in advanced/metastatic solid tumor patients, consisting of two parts: 1a (dose escalation) and 1b (dose expansion) [1]. - In the 1a phase, single-agent treatment will explore six dose levels ranging from 1.0 mg/kg to 45.0 mg/kg, administered every three weeks, while combination therapy will be assessed in advanced non-small cell lung cancer patients [1]. - The primary endpoint of the study is to assess the incidence of dose-limiting toxicities (DLT) to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) [1]. Group 2: Mechanism and Market Potential - HLX37 is designed to simultaneously target two pathways: blocking the PD-1/PD-L1 signaling pathway to restore T cell activity against tumors, and inhibiting VEGF to reduce tumor angiogenesis, potentially leading to synergistic anti-tumor effects [2]. - Preclinical studies have shown that HLX37 can inhibit tumor growth with a favorable safety profile, indicating its potential as a competitive treatment option [2]. - According to IQVIA MIDASTM, the global sales for dual-specific antibodies targeting PD-1/PD-L1 and VEGF are projected to reach approximately $920 million in 2024, with the first product expected to be approved in May 2024 [3].

Core Viewpoint - The company has initiated a Phase 1 clinical trial for HLX37, a dual-specific antibody targeting PD-L1 and VEGF, in patients with advanced/metastatic solid tumors in mainland China, marking a significant step in its development pipeline [1][3]. Group 1: Clinical Trial Details - The Phase 1 study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of HLX37 in advanced/metastatic solid tumor subjects, consisting of two parts: 1a (dose escalation) and 1b (dose expansion) [2]. - In the 1a phase, single-agent treatment will explore six dose levels ranging from 1.0 mg/kg to 45.0 mg/kg, administered every three weeks, while combination therapy will assess different dosing regimens of HLX37 with pemetrexed or paclitaxel and carboplatin in advanced non-small cell lung cancer patients [2]. - The primary endpoint of the study is to assess the incidence of dose-limiting toxicities (DLT) to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) for both single-agent and combination therapies [2]. Group 2: Mechanism and Potential - HLX37 is a recombinant humanized dual-specific antibody that targets both PD-L1 and VEGF, aiming to treat advanced/metastatic solid tumors by blocking the PD-1/PD-L1 signaling pathway and inhibiting angiogenesis [3]. - The dual-target design may produce a synergistic anti-tumor effect and potentially reduce the risk of resistance, with preclinical studies indicating that HLX37 can inhibit tumor growth while demonstrating good safety profiles [3]. - The drug is expected to achieve regulatory approval from the National Medical Products Administration (NMPA) for its Phase 1 clinical trial in November 2025 [3]. Group 3: Market Potential - According to IQVIA MIDASTM, the global sales of dual-specific antibodies targeting PD-1/PD-L1 and VEGF are projected to reach approximately $920 million in 2024, with the first product in this category expected to be approved in May 2024 [4].

Core Viewpoint - The company has completed the first patient dosing in a Phase 1 clinical trial of HLX37, a dual-specific antibody targeting PD-L1 and VEGF, for advanced/metastatic solid tumors in mainland China [1][2] Group 1: Clinical Trial Details - The Phase 1 study is an open-label trial assessing the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of HLX37 in patients with advanced/metastatic solid tumors [1] - The trial consists of two parts: Part 1a involves dose escalation (including monotherapy and combination therapy) with six dose levels ranging from 1.0 mg/kg to 45.0 mg/kg administered every three weeks; Part 1b will expand based on results from Part 1a [1] - The primary endpoint is to evaluate the incidence of dose-limiting toxicities (DLT) to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) for both monotherapy and combination therapy [1] Group 2: Mechanism and Potential Benefits - HLX37 is designed to target two different pathways: it blocks the PD-1/PD-L1 signaling pathway to restore T-cell activity against tumors and inhibits VEGF to reduce tumor angiogenesis, potentially leading to synergistic anti-tumor effects and reduced risk of resistance [2] - Preclinical studies indicate that HLX37 can inhibit tumor growth and has a favorable safety profile [2] - The National Medical Products Administration (NMPA) approved the Phase 1 clinical trial application for HLX37 in November 2025 [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。 Shanghai Henlius Biotech, Inc. 上海復宏漢霖生物技術股份有限公司 （股份代號：2696） （於中華人民共和國註冊成立的股份有限公司） C. 關於HLX37 HLX37是本公司自主研發的重組人源化抗PD-L1與抗VEGF雙特異性抗體， 擬用於治療晚期/轉移性實體瘤。HLX37可同時作用於兩個不同的靶點，其作 用機制結合了兩種治療路徑：(1)阻斷PD-1/PD-L1信號通路：通過阻斷腫瘤 細胞表面PD-L1與T細胞表面的PD-1結合，解除腫瘤免疫抑制作用，從而恢 復T細胞對腫瘤的殺傷能力；(2)阻斷血管生成通路：通過抑制VEGF與其受 體結合，減少腫瘤血管生成，從而限制腫瘤的生長和轉移。這種雙靶點設計 可能產生協同抗腫瘤效應，並可能降低耐藥性風險。通過特異性結合腫瘤細 胞PD-L1實現腫瘤內部HLX37雙抗分子的富集，實現大於抗PD-L1單抗和抗 VEGF單抗的聯合療效。臨床前研 ...