2026年1月20日，复星医药子公司复宏汉霖（2696.HK）宣布，公司创新型重组人SIRPα-Fc融合蛋白注射液HLX701已获国家药品监督管理局（NMPA）批准，开展一项联合西妥昔单抗及化疗治疗晚期RAS/BRAF野生型结直肠癌患者的Ib/II期临床研究。

HLX701是复宏汉霖自汉康生技（HanchorBio）控股子公司FBD Biologics Limited（简称“FBD”）引进，并由双方依据合作协议开发的下一代SIRPα-Fc融合蛋白。该分子是一种工程改造的人类SIRPα免疫球蛋白（IgV）结构域与人免疫球蛋白G4（IgG4）片段可结晶（Fc）区域蛋白结合的融合蛋白，能够以高亲和力结合肿瘤细胞上的CD47，有效阻断抑制性CD47抗吞噬信号，促进巨噬细胞对肿瘤细胞的吞噬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，最终实现先天免疫与适应性免疫的系统性协同。值得关注的是，临床前和早期临床研究显示，HLX701在选择性结合肿瘤CD47的同时，与红细胞（RBC）等正常细胞上的CD47结合亲和力较低，且不引起RBC凝集、不诱导巨噬细胞吞噬RBC, 因而HLX701在临床上引发贫血和血小板减少等常见副作用的可能性较低。

临床前研究显示，HLX701联合化疗、免疫检查点抑制剂、表皮生长因子受体抑制剂及抗血管生成药物等在结直肠癌、胃癌、乳腺癌、肺癌等动物模型中皆可产生协同抗肿瘤疗效。目前，HLX701单药剂量递增的I期临床研究正在中美同步开展，其联合不同药物的剂量递增及剂量扩展的Ib/IIa期临床研究也已在中国启动。

复宏汉霖已前瞻性地构建了一个覆盖肿瘤免疫治疗关键通路的多元化创新产品矩阵。其中，公司自主研发的 H药 汉斯状（斯鲁利单抗）为全球首个获批一线治疗小细胞肺癌（SCLC）的抗PD-1单抗，同时是全球首个且唯一胃癌围手术期III期注册研究成功的抗PD-1单抗，在中国、德国、英国、印度、新加坡等40多个国家和地区获批上市。HLX43为潜在同类最优（best-in-class）的创新型PD-L1 ADC，兼具免疫检查点阻断（IO）与载荷细胞毒性（ADC）的双重疗效，在临床前和早期临床研究中显示出广泛的治疗潜力，尤其在非小细胞肺癌（NSCLC）领域展现了令人鼓舞的安全性和初步疗效，并在宫颈癌、食管鳞癌等实体瘤中陆续验证。HLX701的广谱治疗潜力，使其有望作为免疫基石药物，与复宏汉霖现有的核心管线产品形成深度协同，为新一代肿瘤免疫治疗方案开辟路径。

未来，复宏汉霖将持续聚焦未满足的临床需求，立足于公司在抗体领域的累积优势，不断扩充创新潜力靶点，积极探索前沿技术与疗法，加强优质创新资产的合作，让优质可及的创新治疗方案加速惠及全球患者。

Henlius Receives NMPA Approval to Initiate Phase 1b/2 Clinical Trial of Novel SIRPα-Fc Fusion Protein HLX701 for Advanced RAS/BRAF Wild-type Colorectal Cancer

Shanghai, China, January 20, 2026 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that its novel recombinant human SIRPα-Fc fusion protein injection, HLX701, has received approval from the National Medical Products Administration (NMPA) to initiate an 1b/2 clinical trial in combination with cetuximab and chemotherapy, for the treatment of patients with advanced RAS/BRAF wild-type colorectal cancer.

HLX701 is a next generation SIRPα-Fc fusion protein in-licensed from FBD Biologics Limited (a subsidiary of HanchorBio) and being developed by each party under a partnership agreement. 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, HLX701 selectively binds to tumor CD47 with high affinity while exhibiting minimal binding to CD47 on normal cells such as red blood cells (RBCs) in preclinical and early clinical studies. It does not induce RBC agglutination or promote macrophage-mediated phagocytosis of RBCs, thereby demonstrating a lower potential to cause common hematological adverse events, including anemia and thrombocytopenia, in clinical settings.

Preclinical studies have demonstrated that, when combined with chemotherapy, immune checkpoint inhibitors, epidermal growth factor receptor (EGFR) inhibitors, or anti-angiogenic agents, HLX701 exhibits synergistic antitumor efficacy across various animal models, including those of 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 evaluating HLX701 in combination with various agents are also underway in China.

Henlius has proactively built a diversified innovative pipeline targeting key pathways in immuno-oncology. 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 the first-line treatment of small cell lung cancer (SCLC), and also the first and only anti-PD-1 with positive results from a phase 3 registrational trial in the perioperative treatment of gastric cancer. 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 broad-spectrum anti-tumor ADC candidate targeting PD-L1, which exhibits dual mechanisms integrating immune checkpoint blockade and payload-mediated cytotoxicity. It has shown broad therapeutic potential in preclinical and early clinical studies, particularly demonstrating encouraging safety profile and preliminary efficacy in non-small cell lung cancer (NSCLC), with ongoing validation in other solid tumors such as cervical cancer (CC) and esophageal squamous cell carcinoma (ESCC). The broad-spectrum therapeutic potential of HLX701 positions it as a potential backbone immunotherapy, with the capacity to synergize deeply with Henlius's existing core 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 on premium innovative assets, to bring more quality, affordable treatment options to patients worldwide.

(复星医药 动态宝)