2026年6月17日–复宏汉霖（HK2696）(2696.HK)宣布，基于自主创新型免疫细胞衔接器(Immune cell engager)平台开发的第二款创新T细胞衔接器(T cell engager，TCE)HLX3902(STEAP1×CD3×CD28三特异性抗体)已获得中国国家药品监督管理局(NMPA)批准，拟用于转移性去势抵抗性前列腺癌及其他晚期实体瘤的治疗。此前，HLX3902已获澳大利亚临床许可，公司计划在中国及澳大利亚同步开展临床研究，评估其在前列腺癌等晚期实体瘤患者中的安全性、耐受性和疗效。
HLX3902是由复宏汉霖（HK2696）研发的拥有自主知识产权的创新型靶向STEAP1、CD3和CD28的三特异性抗体药物，能够同时激活CD3和CD28来增强T细胞对表达STEAP1肿瘤细胞的杀伤能力，并通过对T细胞激活第一信号(CD3)和第二信号(CD28)的优化，增强T细胞的激活、增殖和存活能力，延长抗肿瘤免疫应答的持续时间，使其在低T细胞浸润的环境中依然展现出优异的抗肿瘤活性。
临床前研究显示，HLX3902可诱导靶点依赖性的T细胞活化及细胞毒性，在低效应细胞/靶细胞比下优于传统CD3双特异性TCE。重复抗原刺激模型表明，其CD28共刺激信号可增强T细胞活化、增殖及记忆T细胞扩增，从而维持持久杀伤作用。体内C4-2/hPBMC及阿比特龙耐药PDX/hPBMC模型中，HLX3902抗肿瘤活性显著增强，伴随T细胞浸润和功能提升。此外，在食蟹猴研究中，HLX3902展现了良好的耐受性和可控的安全性。
HLX3902作为潜在首个靶向STEAP1的三抗TCE分子，进一步体现了公司多特异性免疫细胞衔接器平台从技术构建向临床验证阶段的持续推进与能力兑现。此前，基于该平台开发的首个创新分子HLX3901(DLL3xDLL3xCD3xCD28四特异性TCE)亦在临床前研究中展现出同类最优的治疗潜力，并已完成首次人体临床试验的首例患者给药，实现从技术构建向临床验证的关键跨越。
目前，复宏汉霖（HK2696）已搭建起包括免疫细胞衔接器平台(如多特异性TCE平台)、PD(L)1为核心的免疫检查点抑制剂平台、Hanjugator ADC以及AI驱动的一站式早期研发平台HAI Club在内的多维创新平台矩阵，在保障单个项目的研发质量与效率的同时，为打造具备全球竞争力的中长期创新管线提供了可持续的系统能力支撑。未来，公司将持续秉持“以患者为中心”的研发理念，依托平台化、系统化的创新体系，加速推进具有全球竞争力的差异化创新管线布局，为全球患者提供更可及、更有效的治疗选择。
关于前列腺癌和靶向STEAP1的T细胞衔接器
前列腺癌(Prostate Cancer,PCa)是男性最常见的恶性肿瘤之一，也是男性癌症死亡的第五大原因1,2。早期患者可通过手术或放疗获得良好控制，但一旦发展为转移性去势抵抗性前列腺癌(metastatic castration-resistant prostate cancer,mCRPC)，治疗选择有限，预后较差，临床仍存在未满足的治疗需求3。STEAP1(six transmembrane epithelial antigen of the prostate1)在超过85%的前列腺肿瘤中高表达，而在正常组织中几乎不表达，是高度特异性的治疗靶点3。
前列腺癌通常呈“免疫冷肿瘤”特征——T细胞浸润稀少、抗原呈递能力低、免疫抑制因子丰富——限制了PD-1等免疫检查点抑制剂的疗效4-6。靶向STEAP1的T细胞衔接器(T-cell engager,TCE)可同时结合T细胞上的CD3和肿瘤上的STEAP1，重定向T细胞杀伤肿瘤，在多种模型中显示出抗肿瘤活性7,8。然而，现有TCE主要依赖CD3介导的一级激活信号，实体瘤微环境中缺乏共刺激信号的T细胞易耗竭，限制持续抗肿瘤效应。引入CD28共刺激信号可通过“双信号”激活机制增强T细胞持久活性并改善功能维持。
在创新驱动方面，复宏汉霖（HK2696）依托上海、美国等多地协同布局的研发体系，构建了多元化、平台化的创新技术矩阵，覆盖免疫检查点抑制剂、免疫细胞衔接器(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方向。目前，公司拥有50余项处于早期阶段的创新资产，其中约70%具备同类最佳(Best-in-Class)潜力，并在全球同步推进30余项临床研究。核心产品H药汉斯状(斯鲁利单抗，欧洲商品名：Hetronifly)作为全球首个获批一线治疗小细胞肺癌和首个获批胃癌围术期适应症的抗PD-1单抗，正加速全球布局，已在全球50个市场获批上市；同时，多款潜力创新资产，包括PD-L1ADC HLX43及新表位HER2单抗HLX22(通用名：dulpatatug)正全面推进全球关键性临床研究。依托通过中、欧、美三地GMP认证的生产体系，复宏汉霖（HK2696）已建成总产能达84,000升的生物药生产平台，形成覆盖全球六大洲的稳定供应网络。未来，复宏汉霖（HK2696）将始终坚持以患者为中心，聚焦未满足的临床需求，持续推动创新成果向临床价值与患者可及转化，在全球生物医药创新生态中创造长期而稳健的价值。
STEAP1×CD3×CD28Tri-specific TCE HLX3902Receives China Clinical Approval,Promising Breakthrough in“Cold Tumour”Therapy June 17,2026–Shanghai Henlius Biotech,Inc.(2696.HK)announced that its second Innovative（IIPR） T cell engager(TCE),HLX3902—a tri-specific antibody targeting STEAP1×CD3×CD28developed on the company’s proprietary immune cell engager platform,has been approved by the National Medical Products Administration(NMPA),for the treatment of metastatic castration-resistant prostate cancer(mCRPC)and other advanced solid tumours.Recently,it has also received clinical trial authorization in Australia.To accelerate the evaluation of HLX3902's preliminary efficacy and safety in humans,the company plans to initiate multi-regional clinical trials(MRCT)simultaneously in China,Australia,and other regions to evaluate HLX3902’s safety,tolerability,and preliminary efficacy in patients with advanced solid tumours，including prostate cancer.
HLX3902is an Innovative（IIPR） trispecific antibody with proprietary intellectual property,capable of simultaneously engaging CD3and CD28to enhance T-cell-mediated killing of STEAP1-expressing tumour cells.By optimizing both the primary(CD3)and co-stimulatory(CD28)signals,HLX3902promotes T-cell activation,proliferation,and survival,prolonging antitumor immune responses even in tumours with low T-cell infiltration.
Preclinical studies demonstrated that HLX3902induces target-dependent T-cell activation and cytotoxicity,outperforming traditional CD3-based bispecific TCEs at low effector-to-target ratios.Repeated antigen stimulation models further confirmed that CD28co-stimulation enhances T-cell activation,proliferation,and memory T-cell expansion,sustaining long-term cytotoxic effects.In vivo,HLX3902showed significant antitumor activity in both C4-2/hPBMC and abiraterone-resistant PDX/hPBMC models,accompanied by increased T-cell infiltration and functional activity.In cynomolgus monkeys,HLX3902demonstrated favourable tolerability and a controllable safety profile.
As a potentially First（FFBC）-in-class STEAP1-targeting trispecific T-cell engager,HLX3902further validates the continued evolution of Henlius’multispecific immune cell engager platform from technology Construction（ROAD） to clinical translation.Previously,HLX3901,the Company’s First（FFBC）-in-class DLL3×CD3×CD28×CD28tetravalent T-cell engager developed on the platform,demonstrated best-in-class potential in preclinical studies and has successfully completed First（FFBC）-in-human dosing,marking a key transition from platform establishment to clinical validation.
Henlius has established a Diversified（DHC） innovation platform matrix,encompassing PD(L)1-centered immune checkpoint inhibitors,immune cell engagers(including multispecific TCEs),Hanjugator ADCs,and the AI-driven one-stop early R&D platform HAI Club.This platform-driven approach ensures high-quality and efficient project development while supporting the creation of a globally competitive mid-to long-term innovation pipeline.Henlius remains committed to a patient-centric R&D philosophy and a systematic,platform-based innovation Strategy（MSTR） to advance differentiated,globally competitive therapies,providing bROADer access to effective treatments for patients worldwide.
About PCa&STEAP1-Targeting TCE Prostate cancer(PCa)is one of the most common malignancies in men and the fifth leading cause of male cancer death.1-2Early-stage disease can be effectively managed with surgery or radiotherapy;however,once it progresses to metastatic castration-resistant prostate cancer(mCRPC),treatment options are limited and prognosis is poor,highlighting a critical unmet need for novel targeted therapies.3STEAP1(six transmembrane epithelial antigen of the prostate1)is highly expressed in over85%of prostate tumours while minimally expressed in normal tissues,making it a highly specific therapeutic target.3
Due to its characteristic“immune cold”tumour microenvironment—low T cell infiltration,insufficient antigen presentation,and abundant immunosuppressive factors—traditional immunotherapies such as PD-1inhibitors show limited efficacy.4-6STEAP1-targeted TCEs are designed to redirect T cells toward tumour cells by simultaneously engaging CD3on T cells and STEAP1on tumour cells.This approach has demonstrated potent antitumor activity in multiple preclinical models and shows selectivity for tumours with high STEAP1expression.7-8Existing TCEs primarily rely on CD3-mediated primary T-cell activation;however,in solid tumour microenvironments,limited immune cell infiltration and absence of co-stimulatory signals often lead to T-cell exhaustion,restricting sustained antitumor responses.By incorporating a CD28co-stimulatory signal,the TCE can mimic the physiological dual-signal mechanism of T-cell activation,enhancing the durability and functional persistence of T-cell responses within the tumour microenvironment.
Driven by innovation,Henlius has built a Diversified（DHC）,platform-based technology ecosystem through coordinated R&D efforts across Shanghai,the United States,and other regions.Its innovation platforms span immune checkpoint inhibitors,immune cell engager technologies(including multispecific T cell engagers),antibody-drug conjugates(ADCs),and AI-enabled early discovery platforms.The Company currently has more than50early-stage Innovative（IIPR） assets,approximately70%of which are expected to be best-in-class,with over30clinical trials ongoing globally.Henlius’core product,serplulimab(trade name:Hetronifly in Europe),is the world’s First（FFBC） anti–PD-1mAb approved for First（FFBC）-line treatment of small cell lung cancer and for perioperative gastric cancer.Up to date,it has been approved in50markets worldwide with an accelerated globalisation process.In parallel,multiple high-potential Innovative（IIPR） assets—including the PD-L1ADC HLX43and the novel epitope anti-HER2mAb dulpatatug(HLX22)—are advancing through global pivotal clinical development.Supported by a biologics manufacturing network with a total capacity of84,000L and GMP certifications from regulatory authorities in China,Europe,and the United States,Henlius has established a stable global supply system serving six continents.Guided by a patient-centred mission,Henlius remains focused on addressing unmet medical needs and translating scientific innovation into meaningful clinical value and patient access,contributing sustainably to the global biopharmaceutical ecosystem.
