Major Events - Lai Kai Pharmaceutical-B (02105) reported positive preliminary results from Phase I clinical MAD study, with LAE102 showing encouraging trends in muscle gain and fat loss [1] - Fuhong Hanlin (02696) received FDA approval for the Phase I clinical trial application of HLX13 for first-line treatment of unresectable hepatocellular carcinoma (HCC) patients [1] - Ningmeng Media (09857) has commenced filming the urban medical emotional drama "Asking Heart 2" [1] - CRRC Corporation (01766) and its subsidiaries signed significant contracts totaling approximately 54.34 billion [1] - Heng Rui Pharmaceutical (01276) received approval to conduct clinical trials for SHR-7787 injection, SHR-4849 injection, Bevacizumab injection, and Atezolizumab injection [1] - Hema Medical (03309) entered into a tripartite global licensing and collaboration agreement with Gilead and Hanmi regarding enecuidar [1] - Jinfang Pharmaceutical-B (02595) completed the enrollment of the first patient in the Phase I/II clinical trial of the molecular glue Pan RAS(ON) inhibitor GFH276 for RAS mutant cancer patients [1] - Gao Shi Medical (02407) obtained international certification for its medical device quality management system [1] Operating Performance - Shenzhen Expressway Company (00548) reported toll revenue of 114 million for the Outer Ring project in August [1] - China National Automobile (00026) announced an annual performance with a post-tax loss attributable to shareholders of 185 million HKD, a year-on-year reduction of 29.64% [1] - OKURA HOLDINGS (01655) reported an annual profit attributable to shareholders of 1.342 billion JPY, a year-on-year decrease of 34.34% [1] - Elephant Future Group (02309) disclosed an annual performance with a loss attributable to owners of approximately 314 million HKD, a year-on-year increase of 71.77% [1] - Henghe Group (00513) reported an annual performance with a loss attributable to owners of approximately 259 million HKD, a year-on-year increase of 0.7% [1]

复宏汉霖(02696)公布，近日，公司自主研发的伊匹木单抗生物类似药HLX13(重组抗CTLA-4全人单克隆 抗体注射液)(HLX13)一线治疗不可切除的肝细胞癌(HCC)患者的1期临床试验申请(IND)获美国食品药品 管理局(FDA)批准。公司拟于条件具备后于美国开展该国际多中心临床试验。 ...

智通财经APP讯，复宏汉霖(02696)公布，近日，公司自主研发的伊匹木单抗生物类似药HLX13(重组抗 CTLA-4全人单克隆抗体注射液)(HLX13)一线治疗不可切除的肝细胞癌(HCC)患者的1期临床试验申请 (IND)获美国食品药品管理局(FDA)批准。公司拟于条件具备后于美国开展该国际多中心临床试验。 ...

Core Viewpoint - The company has received FDA approval for its self-developed biosimilar HLX13, intended for the first-line treatment of unresectable hepatocellular carcinoma (HCC) patients, and plans to conduct an international multi-center clinical trial in the U.S. [1] Group 1 - HLX13 is a biosimilar of ipilimumab, targeting multiple cancers including melanoma, renal cell carcinoma, colorectal cancer, HCC, non-small cell lung cancer, malignant pleural mesothelioma, and esophageal squamous cell carcinoma [2] - The mechanism of HLX13 involves blocking CTLA-4 to enhance immune response against tumors [2] - The clinical trial application for HLX13 in HCC was approved by the National Medical Products Administration in June 2023, and further approvals for other cancers were granted in November 2023 [2] Group 2 - In April 2025, the company signed a licensing agreement with Sandoz AG, granting exclusive rights for the commercialization of HLX13 in the U.S., certain European regions, Japan, Australia, and Canada [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 （於中華人民共和國註冊成立的股份有限公司） （股份代號：2696） 自願公告 伊匹木單抗生物類似藥HLX13（重組抗CTLA-4全人單克隆抗體 注射液）一綫治療不可切除的肝細胞癌(HCC)患者的臨床試驗 申請獲美國食品藥品管理局(FDA)批准 HLX13是本公司自主研發的伊匹木單抗生物類似藥，擬用於黑色素瘤、腎細 胞癌、結直腸癌、肝細胞癌、非小細胞肺癌、惡性胸膜間皮瘤及食管鱗狀細 胞癌等原研藥已獲批的適應症。伊匹木單抗是全人、具有κ輕鏈的抗CTLA-4 （細胞毒T淋巴細胞相關抗原4，又稱CD152）的IgG1型單克隆抗體，通過阻 斷CTLA-4與配體的結合，增強免疫反應進而達到殺傷腫瘤的目的。2023年 6月，HLX13用於肝癌(HCC)治療的臨床試驗申請獲國家藥品監督管理局批 准。2023年11月，HLX13 ...

Core Viewpoint - The company has completed the first patient dosing of its self-developed biosimilar HLX17 in an international multi-center Phase 1 clinical study for patients with various resected solid tumors, with plans to expand trials to the US, Europe, and Australia once conditions permit [1]. Group 1: Clinical Study Overview - The Phase 1 clinical study is a multi-center, randomized, double-blind, parallel-controlled trial aimed at evaluating the pharmacokinetics (PK), efficacy, safety, and immunogenicity similarity of HLX17 compared to KEYTRUDA in patients with various resected solid tumors, including non-small cell lung cancer, melanoma, and renal cell carcinoma [2]. - Eligible participants will be randomly assigned in a 1:1 ratio to either Group A (receiving HLX17) or Group B (initially receiving KEYTRUDA followed by HLX17), with treatment continuing for up to 12 months or until certain endpoints are met [2]. - The primary endpoint of the study is the area under the serum drug concentration-time curve from 0 to 21 days (AUC0-21d) after the first dose, along with secondary endpoints including other PK parameters, efficacy, safety, and immunogenicity [2]. Group 2: Product and Regulatory Status - HLX17 is a biosimilar of pembrolizumab, with potential indications including melanoma, non-small cell lung cancer, esophageal cancer, head and neck squamous cell carcinoma, colorectal cancer, hepatocellular carcinoma, cholangiocarcinoma, triple-negative breast cancer, and other tumors with specific genetic defects [3]. - The mechanism of action involves blocking the interaction between PD-1 and its ligands PD-L1 and PD-L2, thereby enhancing the immune response against tumor cells [3]. - The clinical trial application for HLX17 was approved by the National Medical Products Administration (NMPA) in September 2024, and the Investigational New Drug (IND) application for the Phase 1 trial in the US was approved by the FDA in September 2025 [3].

本研究一项多中心、随机、双盲、平行对照的1期临床研究，旨在评估HLX17与KEYTRUDA(美国市售) 在多种已切除实体肿瘤(包括非小细胞肺癌、黑色素瘤或肾细胞癌)受试者中的药代动力学(PK)特徵、有 效性、安全性和免疫原性相似性。合格的受试者将按1:1的比例随机分配至A组和B组，A组受试者每3周 接受一次HLX17治疗;B组受试者前8个周期(24周)每3周接受一次KEYTRUDA治疗，随后转为接受 HLX17治疗，所有受试者持续接受治疗至随机化后12个月(约17个周期)或研究者评估的疾病复发、死 亡、开始新抗肿瘤治疗、出现不可耐受的药物毒性、撤回知情同意书或研究终止(以先发生者为準)。本 研究的主要研究终点为首次给药后从0到21天血清药物浓度-时间曲线下面积(AUC0-21d)以及第6次给药 后稳态下单个给药间隔内的血清药物浓度-时间曲线下面积(AUCss)。次要研究终点包括其他PK参数、 有效性、安全性和免疫原性。 复宏汉霖(02696)公布，近日，公司自主研发的帕博利珠单抗生物类似药HLX17(重组抗PD-1人源化克隆 抗体注射液)(HLX17)在多种已切除实体瘤患者中开展的国际多中心1期临床研究于中国 ...

复宏汉霖晚间公告，公司自主研发的帕博利珠单抗生物类似药HLX17（重组抗PD-1人源化克隆抗体注 射液）在多种已切除实体瘤患者中开展的国际多中心1期临床研究于中国境内完成首例患者给药。本研 究是一项多中心、随机、双盲、平行对照的1期临床研究，旨在评估HLX17与KEYTRUDA 在多种已切 除实体肿瘤受试者中的药代动力学特征、有效性、安全性和免疫原性相似性。 （文章来源：第一财经） ...

格隆汇9月26日丨复宏汉霖(02696.HK)发布公告，近日，公司自主研发的帕博利珠单抗生物类似药 HLX17(重组抗PD-1人源化克隆抗体注射液)("HLX17")在多种已切除实体瘤患者中开展的国际多中心1期 临床研究于中国境内(不包括中国港澳台地区)完成首例患者给药。公司亦将于条件具备后于美国、欧洲 及澳大利亚等国家/地区开展该国际多中心临床试验。 ...

（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。 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） 自願公告 帕博利珠單抗生物類似藥HLX17 （重組抗PD-1人源化克隆抗體注射液） 在多種已切除實體瘤患者中開展的國際多中心1期臨床研究 於中國境內完成首例患者給藥 A. 緒言 D. 市場情況 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，本公司自主研發的帕博利珠單抗 生物類似藥HLX17（重組抗PD-1人源化克隆抗體注射液）（「HLX17」）在多種 已切除實體瘤患者中開展的國際多中心1期臨床研究於中國境內（不包括中國 港澳台地區）完成首例患者給藥。本公司亦將於條件具備後於美國、歐洲及 澳大利亞等國家/地區開展該國際多中心臨床試驗。 ...