2026年3月26日，复星医药子公司复宏汉霖（2696.HK）告示，公司鼎新式重组东谈主SIRPα-Fc交融卵白打针液HLX701聚首西妥昔单抗及化疗调治晚期RAS/BRAF野生型结直肠癌患者的Ib/II期临床讨论（HLX701-CRC201）完成首例患者给药。
结直肠癌是我国乃至巨匠高发的恶性肿瘤。2022年，巨匠新发结直肠癌约192.6万例，圆寂约90.4万例，其中我国新发及圆寂病例分手达51.7和24.0万例，位居恶性肿瘤发病率的第二位，圆寂率的第四位1-2。对于晚期/转化性结直肠癌，一、二线轨范调治决策主要为基于氟尿嘧啶类的化疗药物聚首抗血管生成药物（抗VEGF靶向调治）或抗EGFR靶向调治。其中，西妥昔单抗（抗EGFR单抗）聚首化疗是RAS/BRAF野生型晚期结直肠癌的轨范一线调治决策之一。跟着疾病发扬，后线调治弃取有限且获益仍有待升迁，当今可选决策包括瑞戈非尼、呋喹替尼、TAS-102等3-7，临床亟需更灵验、可聚首的调治计谋。靶向CD47-SIRPα信号通路的免疫调治已在结直肠癌等实体瘤和血液瘤中伸开了初步临床探索，尤其聚首调治在肿瘤特定分子分型中表露出协同调治后劲8-9。跟着新一代CD47-SIRPα靶向药物的握续升级和迭代，其疗效及聚系数谋亟待在临床讨论中进一步考证。
HLX701是复宏汉霖自汉康生技（HanchorBio）旗下FBD Biologics Limited（简称“FBD”）引进，并由两边依据和谐左券共同鼓动拓荒的新一代SIRPα-Fc交融卵白。该分子是一种工程改进的东谈主类SIRPα免疫球卵白（IgV）结构域与东谈主免疫球卵白G4（IgG4）片断可结晶（Fc）区域卵白团结的交融卵白，简略以高亲和力团结肿瘤细胞上的CD47，灵验阻断按捺性CD47“别吃我”抗团结信号，从而促进巨噬细胞对肿瘤细胞的团结作用及增强抗肿瘤活性，并通过抗原呈递激活T细胞、辨识抗原，最终达成先天免疫与适宜性免疫的系统性协同。
伸开剩余89%值得海涵的是，临床前和早期临床讨论表露，HLX701在弃取性团结肿瘤CD47的同期，与红细胞（RBC）等宽泛细胞上的CD47团结亲和力较低，且不引起RBC凝集、不劝诱巨噬细胞团结RBC， 因而HLX701在临床上激勉贫血和血小板减少等常见反作用的可能性较低。临床前讨论表露，HLX701聚首化疗、免疫查验点按捺剂、表皮助长因子受体按捺剂及抗血管生成药物等在结直肠癌、胃癌、乳腺癌、肺癌等动物模子中王人可产生协同抗肿瘤疗效。当今，HLX701单药剂量递加的I期临床讨论正在中好意思同步开展，其聚首不同药物的剂量递加及剂量推广的Ib/IIa期临床讨论也已在中国运行。
复宏汉霖深耕肿瘤免疫调治领域，已前瞻性布局了包括H药 汉斯状（斯鲁利单抗）、抗PD-L1 ADC HLX43 等多款具有广谱调治后劲的鼎新分子。当今，H药算作巨匠首个获批一线调治小细胞肺癌（SCLC）的抗PD-1单抗，同期是巨匠首个且惟一胃癌围手术期III期注册讨论到手的抗PD-1单抗，已在中国、德国、英国、印度、新加坡等40多个国度和地区获批上市。HLX43为潜在同类最优（best-in-class）的鼎新式PD-L1 ADC，兼具免疫查验点阻断（IO）与载荷细胞毒性（ADC）的双重疗效，在非小细胞肺癌（NSCLC）、宫颈癌、食管鳞癌等实体瘤中展现出令东谈主荧惑的安全性和初步疗效，并在更多实体瘤中链接考证。算作复宏汉霖肿瘤免疫管线的要紧构成，HLX701相反化的分子策划有望带来更好的安全性特征，与复宏汉霖现存管线造成深度协同，为新一代肿瘤免疫调治决策开辟旅途。
曩昔，复宏汉霖将握续聚焦未即兴的临床需求，立足于公司在抗体领域的积存上风，束缚引申鼎新后劲靶点，积极探索前沿技能与疗法，加强优质鼎新钞票的和谐，银河国际(GALAXY)为巨匠患者带来更多高质料、可包袱的鼎新调治决策。
对于HLX701-CRC201
本讨论为一项在既往选用过化疗的复发性、不成切除或转化性RAS/BRAF野生型结直肠癌患者中，相比HLX701聚首西妥昔单抗和化疗（FOLFOX/FOLFIRI）对比抚慰剂聚首西妥昔单抗和化疗（FOLFOX/FOLFIRI）的1b/2期临床讨论。该讨论包括三个阶段：第一阶段为安全导入期，遴荐 3+3 剂量递加策划，设5 mg/kg至18mg/kg共4个剂量组，受试者将选用不同剂量的HLX701聚首西妥昔单抗和化疗（FOLFOX/FOLFIRI）进行调治，每周一次静脉给药；第二阶段为剂量推广期，设8 mg/kg至18 mg/kg 共3个剂量组，每周一次静脉给药，旨在评价不同剂量水平HLX701聚首西妥昔单抗和化疗（FOLFOX/FOLFIRI）的临床疗效和安全性；第三阶段为立时、双盲、多中心讨论，对比HLX701或抚慰剂聚首西妥昔单抗和化疗的疗效和安全性。
本讨论第一阶段的主要特别为评估剂量规矩毒性（DLT）的发生比例，次要特别为不良事件等安全性成见、客不雅缓解率（ORR）和疾病掌握率（DCR）等疗效成见、PK参数、免疫原性等；第二阶段主要特别为探索2期保举剂量（RP2D）、零丁影像评估委员会（BICR）评估的ORR和无发扬糊口期（PFS）；第三阶段主要特别为BICR评估的ORR、PFS；第二和第三阶段的次要特别包括不良事件等安全性成见、总糊口期（OS）、讨论者评估的ORR、PFS等疗效成见、PK参数和免疫原性等，同期将探索生物记号物与疗效的联系性。
对于复宏汉霖
复宏汉霖（2696.HK）是一家海外化鼎腾达物制药企业，悉力于为巨匠患者提供高品性、可包袱的生物药，居品掩盖肿瘤、本身免疫疾病、眼科疾病等领域。自2010年拓荒以来，公司已构建涵盖巨匠研发、临床、注册、坐褥及贸易化的全产业链平台，领有巨匠职工近4，000东谈主，并在中国、好意思国和日本等多地设有运营及分支机构。依托生物访佛药造成的慎重现款流反哺鼎新研发，复宏汉霖正稳步迈入“巨匠化2.0”阶段，握续打造可复制、可握续的巨匠增长形状。限度2026年头，公司共有10款居品在巨匠60个国度和地区获批上市，其中7款已在中国获批。在泰西主流生物药市集，复宏汉霖亦取得多项里程碑式打破，已有4款居品取得好意思国FDA批准、4款居品取得欧盟EC批准，充分体现了公司在研发体系、质料惩办及坐褥能力方面已全濒临标海外最高轨范。
在鼎新驱动方面，复宏汉霖依托上海、好意思国等多地协同布局的研发体系，构建了多元化、平台化的鼎新技能矩阵，掩盖免疫查验点按捺剂、免疫细胞衔尾器（包括多特异性TCE）、抗体偶联药物（ADC）以及AI驱动的早期研发平台等前沿场所。当今，公司领有50余项处于早期阶段的鼎新钞票，其中约70%具备同类最好（Best-in-Class）后劲，并在巨匠同步鼓动30余项临床讨论。中枢居品H药 汉斯状（斯鲁利单抗，欧洲商品名：Hetronifly）算作巨匠首个获批一线调治小细胞肺癌的抗PD-1单抗，正加快巨匠布局，已在巨匠40余个市集获批上市；同期，多款后劲鼎新钞票，包括PD-L1 ADC HLX43及新表位HER2单抗HLX22正全面鼓动巨匠要害性临床讨论。依托通过中、欧、好意思三地GMP认证的坐褥体系，复宏汉霖已建成总产能达84，000升的生物药坐褥平台，造成掩盖巨匠六大洲的褂讪供应鸠合。曩昔，复宏汉霖将经久坚握以患者为中心，聚焦未即兴的临床需求，握续推动鼎新服从向临床价值与患者可及飘浮，在巨匠生物医药鼎腾达态中创造经久而慎重的价值。
First Patient Dosed in a Phase 1b/2 Clinical Trial of HLX701 Combination Therapy in Advanced Colorectal Cancer
March 26， 2026， Shanghai Henlius Biotech， Inc. (2696.HK) today announced that the first patient has been dosed in a Phase 1b/2 trial (HLX701-CRC201) evaluating its novel recombinant human SIRPα-Fc fusion protein， HLX701， in combination with cetuximab and chemotherapy in patients with advanced RAS/BRAF wild-type metastatic colorectal cancer (mCRC).
Colorectal cancer is a highly prevalent malignancy both in China and globally. In 2022， there were approximately 1.926 million new cases and 904，000 deaths worldwide， with China accounting for 517，000 new cases and 240，000 deaths， ranking second in incidence and fourth in mortality among all cancers1-2. Standard first- and second-line treatments for advanced/metastatic colorectal cancer typically include fluoropyrimidine-based chemotherapy combined with either anti-angiogenic agents (anti-VEGF targeted therapy， e.g.， bevacizumab) or anti-EGFR targeted therapy. Specifically， for patients with RAS/BRAF wild-type mCRC， cetuximab (anti-EGFR targeted agents) plus chemotherapy is one of the recommended first-line regimens. However， as the disease progresses to later lines， treatment options become more limited and increasingly depend on prior treatment response， performance status (e.g.， ECOG score)， and specific molecular subtypes3-4. Later-line options5-7 such as regorafenib， fruquintinib， and TAS-102 offer limited clinical overall benefits， underscoring a critical unmet need for more effective and combination-ready therapies. Immunotherapies targeting the CD47-SIRPα signaling pathway have entered clinical trials in colorectal cancer and other solid and hematologic malignancies. Notably， its combination regimens have shown potential synergy in specific molecular subtypes of cancer8-9. As next-generation CD47-SIRPα-targeted therapies continue to advance， further clinical validation is warranted to establish their efficacy and optimal combination strategies.
HLX701 is a next-generation SIRPα-Fc fusion protein in-licensed from FBD Biologics Limited (“FBD”)， a subsidiary of HanchorBio， and is being advanced under a collaboration agreement between the parties. This molecule is an engineered fusion protein combining a human SIRPα immunoglobulin (IgV) domain with the crystallizable fragment (Fc) region of human Immunoglobulin G4 (IgG4). It binds to CD47 on tumor cells with high affinity， effectively blocking the inhibitory CD47 "don't eat me" signaling， thereby promoting macrophage-mediated phagocytosis of tumor cells and enhancing anti-tumor activity. It further activates T cells via antigen presentation， ultimately achieving synergistic engagement of both innate and adaptive immunity.
Notably， nonclinical and early clinical data suggest that HLX701， while binding selectively and with high affinity to tumor CD47， exhibits minimal binding to CD47 on normal cells such as red blood cells (RBCs). Consequently， it neither induces RBC agglutination nor promotes macrophage-mediated RBC phagocytosis， thereby demonstrating a lower potential to cause common hematological adverse events， including anemia and thrombocytopenia， in clinical settings. In animal models， HLX701 has shown additive or synergistic antitumor activity when combined with chemotherapy， immune checkpoint inhibitors， epidermal growth factor receptor (EGFR) inhibitors， or anti-angiogenic agents across multiple tumor models， including colorectal， gastric， breast， and lung cancers. Currently， a Phase 1 dose-escalation study of HLX701 monotherapy is ongoing in both China and the U.S.， and Ib/2a studies of HLX701 in combination with various agents are also underway in China.
Among them， the company's self-developed anti-PD-1 monoclonal antibody (mAb)， serplulimab， is the world's first anti-PD-1 mAb approved for first-line treatment of small cell lung cancer (SCLC)， and the first and only anti-PD-1 with positive results from a phase 3 registrational trial in the perioperative treatment of gastric cancer (GC). To date， it has been approved in over 40 countries and regions， including China， Germany， the UK， India， and Singapore. HLX43 is a potential best-in-class pan-tumor ADC targeting PD-L1 that integrates dual mechanisms: immune checkpoint blockade and payload-mediated cytotoxicity. It has shown broad therapeutic potential in preclinical and early clinical studies， with an encouraging safety profile and preliminary efficacy in non-small cell lung cancer (NSCLC)， cervical cancer (CC)， and esophageal squamous cell carcinoma (ESCC)， with ongoing validation in other solid tumors such as cervical cancer (CC) and esophageal squamous cell carcinoma (ESCC). HLX701 represents a key asset in Henlius' immuno-oncology pipeline. Its differentiated molecular design holds promise for an improved safety profile and the potential to synergize deeply with Henlius' existing pipeline assets， thereby paving the way for next-generation immuno-oncology treatment strategies.
Guided by unmet clinical needs and its antibody platform strength， Henlius will pursue novel targets with high potential， actively explore frontier technologies， and seek partnerships for premium， innovative assets to bring more quality， affordable treatment options to patients worldwide.
About HLX701-CRC201银河国际游戏平台官网
发布于：北京市开云体育官方网站 - KAIYUN
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