2025年12月30日，复宏汉霖（2696.HK）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（IND）申请均已获得国家药品监督管理局（NMPA）受理。以上三款产品皆拟用于实体肿瘤的治疗。

复宏汉霖执行董事、首席执行官

朱俊博士表示

三个创新项目同时获得IND受理，是我们持续构建和完善前沿创新平台、系统化创新能力的阶段性战略成果。三个分子分别代表复宏汉霖在免疫细胞衔接器、小分子和融合蛋白赛道的积极探索，展现了我们在蛋白药物前沿治疗领域的自主研发实力与创新视野，也充分验证了公司的CMC（化学、生产和控制）体系在支持多抗、ADC等复杂分子从临床前开发到商业化生产全过程中的关键能力，为后续高效推进全球产业化落地提供了坚实保障。未来，我们将继续以患者为中心，在科学、技术等维度同步发力，加速拓展和夯实我们的创新管线，为全球患者带来更好的治疗方案。

平台化研发体系，驱动创新“加速度”

创新成果的集中涌现，标志着复宏汉霖系统化、平台化的创新研发体系正持续高效地产出具有差异化价值的候选药物。目前，从早期靶点筛选、验证，候选分子设计与优化，到系统性地临床前开发，公司已搭建起包括PD(L)1为核心的免疫检查点抑制剂平台、免疫细胞衔接器平台（如多特异性TCE平台）、Hanjugator ADC 平台、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，不仅保障了单个项目的研发质量与效率，更关键的是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，从而能够持续、高效地将前沿科学发现转化为具有临床价值的候选药物。

聚焦未满足的临床需求，此次进入临床阶段的三款分子各具潜力，剑指当下肿瘤治疗中的难点与前沿方向：

• HLX3901是一款拥有自主知识产权的创新型靶向Delta样配体3（DLL3）双表位、CD3 和CD28 的四特异性抗体药物。该分子能够通过同时激活CD3 和CD28 来增强T 细胞对表达DLL3 肿瘤细胞的杀伤裂解能力，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，有望为小细胞肺癌（SCLC）等难治性肿瘤患者带来突破性的治疗方案。HLX3901的成功开发，是公司AI驱动的智能药物设计与TCE平台技术成功结合的典范，该平台通过精巧的分子设计，兼具持久的特异性T细胞激活、攻克低T细胞浸润肿瘤及显著降低CRS风险等多重优势，旨在克服第一代TCE在实体瘤治疗中的主要障碍。

• HLX97 是一款新型、潜在同类最优的口服组蛋白乙酰转移酶(KAT6A/B）抑制剂。KAT6A/B是乳腺癌等实体瘤治疗中极具潜力的靶点，其异常与多种血液肿瘤和实体瘤的发生发展密切相关。HLX97通过精准抑制KAT6A/B的活性，能够调控肿瘤细胞的增殖、分化与凋亡，具有“快速起效/快速清除”药代动力学特性和高选择性，旨在最大化药物抗肿瘤活性的同时减轻产品的血液毒性，有望为乳腺癌等肿瘤患者带来新的治疗选择。依托深刻的生物学洞察，复宏汉霖构建了覆盖成熟靶点与新兴靶点的差异化开发能力，实现了小分子与大分子药物领域的深度融合与优势互补，为打造中国首创及同类最优的创新产品组合提供了核心引擎。

• HLX316是一款基于蛋白工程平台开发的靶向B7同源物3（B7H3/CD276）的人唾液酸酶融合蛋白。B7H3是一种免疫检查点蛋白，在多个上皮癌（包括肺癌、乳腺癌、结直肠癌、胰腺癌、前列腺癌和卵巢癌等）中过表达，且与肿瘤进展和预后不良相关，但其在正常组织中的表达水平很低。肿瘤高唾液酸化会衔接白细胞上的抑制性 Siglec 受体，从而削弱先天性和适应性免疫效应功能，导致 ICI 耐药性。通过酶促作用去除末端唾液酸并浓缩其在 B7H3 阳性肿瘤细胞中的活性，HLX316可解除糖免疫检查点抑制，并恢复肿瘤微环境内的先天性和适应性抗肿瘤功能。HLX316有潜力靶向PD-1/PD-L1以外的免疫抑制生物学机制，拓宽免疫治疗在实体瘤中的应用范围，突破现有治疗方案局限。

以患者为中心：创新管线持续拓展，临床价值稳步兑现

复宏汉霖已前瞻性地构建了一个多元化、高质量的创新管线，包含约20个临床阶段分子，并由约40个早期分子组成强大的早期储备，广泛覆盖肿瘤、免疫及炎症性疾病等治疗领域。其中，H药 汉斯状（斯鲁利单抗，抗PD-1单抗）、HLX43（PD-L1 ADC）、HLX22（新表位HER2单抗）、HLX07（抗EGFR单抗）等核心创新产品已在临床开发中展现出令人鼓舞的疗效与安全性，持续释放爆款分子的巨大价值。

公司深耕未满足的临床需求，不断扩充由高潜力分子组成的早期管线储备，多款产品于近期取得里程碑进展，HLX37（创新抗PD-L1/VEGF双特异性抗体）已获得IND批准用于晚期实体瘤治疗并高效完成首例患者给药；HLX701（新型SIRPα-Fc融合蛋白）凭借潜在更优的安全性，即将启动在国内的II期临床研究；潜在FIC分子HLX79（人唾液酸酶融合蛋白）在国内启动治疗活动期肾小球肾炎的II期临床试验，更多临床前候选分子如HLX3902（STEAP1xCD3xCD28三特异性TCE）、HLX49（HER2xHER2双抗ADC）、HLX48（EGFRxcMET双抗ADC）、HLX105（抗体融合蛋白）在内的多个前沿分子也将加速迈向临床，为公司创新管线不断注入新鲜血液。

未来，复宏汉霖将继续坚持“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。

关于复宏汉霖

复宏汉霖（2696.HK）是一家国际化的创新生物制药公司，致力于为全球患者提供可负担的高品质生物药，产品覆盖肿瘤、自身免疫疾病、眼科疾病等领域，已在全球获批上市10款产品，5个上市申请分别获中国药监局和欧盟EMA受理。自2010年成立以来，复宏汉霖已建成一体化生物制药平台，高效及创新的自主核心能力贯穿研发、生产及商业运营全产业链。公司已建立完善高效的全球创新中心，按照国际药品生产质量管理规范（GMP）标准进行生产和质量管控，不断夯实一体化综合生产平台，其中，公司商业化生产基地已相继获得中国、欧盟和美国GMP认证。

复宏汉霖前瞻性布局了一个多元化、高质量的产品管线，涵盖约50个分子，并全面推进基于自有抗PD-1单抗H药 汉斯状的肿瘤免疫联合疗法。截至目前，公司已获批上市产品包括全球首个获批一线治疗小细胞肺癌的抗PD-1单抗汉斯状（斯鲁利单抗，欧洲商品名：Hetronifly）、自主研发的中美欧三地获批单抗生物类似药汉曲优（曲妥珠单抗，美国商品名：HERCESSI，欧洲商品名：Zercepac）、国内首个生物类似药汉利康（利妥昔单抗）、地舒单抗生物类似药Bildyos和Bilprevda，以及帕妥珠单抗POHERDY。公司亦同步就19个产品在全球范围内开展30多项临床试验，对外授权全面覆盖欧美主流生物药市场和众多新兴市场。

Henlius Marks Innovation-Driven Milestone with Three Concurrent IND Acceptances

Shanghai, China, December 30, 2025 – Henlius (2696.HK) announced that the Investigational New Drug (IND) applications for three differentiated innovative candidates have been accepted by the National Medical Products Administration (NMPA). These products include HLX3901, a DLL3xDLL3xCD3xCD28 tetra-specific T-cell engager (TCE) developed from its proprietary TCE platform; HLX97, a potential best-in-class (BIC) oral small-molecule inhibitor targeting KAT6A/B; and HLX316, a potential first-in-class (FIC) B7H3-sialidase fusion protein. All are these innovative products intended for the treatment of solid tumors.

Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius, stated, "The simultaneous acceptance of INDs for three innovative projects marks a significant milestone in our ongoing efforts to build and enhance cutting-edge innovation platforms and systematic R&D capabilities. These molecules represent Henlius' active exploration in the fields of immune cell engagers, small molecules, and fusion proteins, demonstrating the company's independent R&D capabilities and innovative vision in cutting-edge protein-based therapeutics.It also fully validates the critical role of our CMC (Chemistry, Manufacturing, and Controls) system in supporting the entire development process of complex molecules, such as multispecific antibodies, antibody-drug conjugates, from preclinical stages through to commercial manufacturing. This provides a solid foundation for efficiently advancing global clinical development and industrialization. Moving forward, we will remain patient-centered and continue to drive progress in science and technology, accelerating the expansion and strengthening of our innovation pipeline to deliver better treatment options for patients worldwide."

Platform-Powered R&D: Accelerating Breakthroughs

The accelerating pace of innovation at Henlius can be attributed directly to its platform-based R&D system, which is designed to steadily deliver a stream of differentiated, high-potential drug candidates. The company has built a multidimensional innovation platform matrix that supports the entire R&D continuum—from early target discovery and candidate optimization through systematic preclinical development. This integrated infrastructure includes a PD(L)1-based checkpoint inhibitor platform, an immune cell engager platform (e.g.multispecific TCEs), the proprietary Hanjugator ADC platform, and the AI-powered, all-in-one early-stage R&D platform HAI Club. More than ensuring quality and efficiency in individual programs, this interconnected platform system provides the sustainable capability needed to build a globally competitive mid‑to‑long‑term pipeline. It enables Henlius to consistently translate cutting‑edge science into high‑value clinical‑stage drug candidates.

Focusing on unmet clinical needs, the three molecules target key challenges and emerging frontiers in cancer therapy:

HLX3901 is a novel, proprietary tetra-specific antibody targeting DLL3 dual enpitope and the T-cell co-stimulatory receptors CD3 and CD28. Its bispecific engagement of DLL3 enhances precise tumor targeting, while concomitant activation of CD3 (Signal 1) and CD28 (Signal 2) potentiates T‑cell cytotoxicity, activation, proliferation, and persistence against DLL3‑expressing tumors. Developed through the synergistic integration of AI‑driven molecular design and the company’s T‑cell engager (TCE) platform, HLX3901 exemplifies a next‑generation TCE engineered to overcome key limitations of earlier constructs in solid tumors—achieving sustained and specific T‑cell activation, better efficacy in the tumor microenvironment (TME) with low TIL density, and a reduced occurrence of cytokine release syndrome (CRS). It holds significant promise as a breakthrough therapeutic for refractory cancers such as small cell lung cancer (SCLC).

HLX97 is a novel, oral KAT6A/B inhibitor with best-in-class potential.  KAT6A/B represents a promising therapeutic target in breast cancer and other solid tumors, with its dysregulation closely related to the pathogenesis of multiple hematologic and solid malignancies. By precisely inhibiting KAT6A/B activity, HLX97 modulates tumor cell proliferation, differentiation, and apoptosis. It exhibits a fast‑on/fast‑off pharmacokinetic profile and high selectivity, aiming to maximize anti-tumor efficacy while minimizing hematologic toxicity. With its favorable therapeutic profile, HLX97 holds promise as a new treatment option for patients with breast cancer and other relevant tumor types. Based on deep biological insight, Henlius has developed a differentiated R&D capability that spans both validated and emerging targets. By combining the strengths of both small and large molecules, the company is synergistically advancing a pipeline of first-in-class and best-in-class therapies.

HLX316 is an engineered human sialidase fusion protein targeting B7H3 (CD276), developed based on an innovative protein engineering platform. B7H3 is an immune checkpoint protein that is overexpressed in many epithelial cancers—including lung, breast, colorectal, pancreatic, prostate, and ovarian cancers—and is associated with tumor progression and poor prognosis, while exhibiting limited expression in normal tissues. High levels of sialylation on tumor cells engage inhibitory Siglec receptors on leukocytes, suppressing both innate and adaptive immune effector functions and contributing to resistance to immune checkpoint inhibitors (ICI). By enzymatically removing terminal sialic acids and concentrating its activity in B7H3‑positive tumors, HLX316 releases glyco‑immune checkpoint inhibition and restores innate and adaptive anti‑tumor immunity in the tumor microenvironment. HLX316 has the potential to target immunosuppressive mechanisms beyond PD‑1/PD‑L1, thereby broadening the applicability of immunotherapy in solid tumors and overcoming the limitations of current treatments.

Patient‑Centric Focus: Pipeline Continues to Expand as Clinical Value Materializes

Henlius has established a forward-looking, diversified, and high-quality innovation pipeline, comprising about 20 clinical-stage candidates and a discovery- and preclinical-stage portfolio of about 40 molecules across key therapeutic areas such as oncology, immunology, and inflammatory diseases. Core innovative assets—including serplulimab(anti‑PD‑1 mAb), HLX43 (PD‑L1 ADC), HLX22 (novel epitope HER2 mAb), and HLX07 (anti‑EGFR mAb), are key value drivers for the company, continuing to build compelling clinical profiles as they progress.

Rooted in addressing high-unmet medical needs, Henlius is systematically strengthening its early-stage pipeline with promising candidates. Recent pipeline progress includes several key milestones: HLX37 (anti-PD-L1/VEGF bispecific antibody) has received IND clearance for advanced solid tumors; HLX701 (novel SIRPα-Fc fusion protein) will initiate a Phase 2 clinical trial  in China based on a potentially improved safety profile; and the potential first-in-class asset HLX79 (human sialidase fusion protein) has also entered a Phase 2 trial in China for active glomerulonephritis. Additionally, multiple preclinical candidates—including HLX3902 (STEAP1xCD3xCD28 trispecific TCE), HLX49 (HER2xHER2 bsADC), HLX48 (EGFRxcMET bsADC), and HLX105 (a fusion protein)—are advancing toward the clinic, injecting sustained innovation momentum into the company’s pipeline portfolio.

Looking ahead, Henlius will remain dedicated to its patient‑centric approach to drug development. Leveraging its integrated, platform‑based innovation engine, the company will accelerate the advancement of a differentiated, globally competitive pipeline, delivering more accessible and effective treatment options to patients worldwide.

About Henlius

Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases and ophthalmic diseases. To date, 10 products have been approved for marketing across multiple countries and regions, and 5 marketing applications have been accepted for review in China and the EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP.

Henlius has pro-actively built a diversified and high-quality product pipeline covering about 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as the backbone. To date, the company's launched products include HANSIZHUANG (serplulimab, trade name: Hetronifly in Europe), the world’s first anti-PD-1 mAb for the first-line treatment of SCLC, HANQUYOU (trastuzumab, trade name: HERCESSI in the U.S., Zercepac in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANLIKANG (rituximab), the first China-developed biosimilar, denosumab Bildyos and Bilprevda, and pertuzumab Poherdy. What’s more, Henlius has conducted over 30 clinical studies for 19 products, expanding its presence in major markets as well as emerging markets.

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(复宏汉霖)