2026年3月9日，复星医药子公司复宏汉霖（2696.HK）宣布，公司潜在同类首创（FIC）靶向B7-H3的唾液酸酶融合蛋白HLX316的新药临床试验（IND）申请已获得国家药品监督管理局（NMPA）批准，拟用于晚期/转移性实体瘤的治疗研究。此次IND获批标志着复宏汉霖在肿瘤免疫调控与糖免疫检查点领域的创新探索迈出关键一步。

双重免疫逃逸精准破局

HLX316是一款基于蛋白工程平台开发的靶向B7同源物3（B7-H3/CD276）的人唾液酸酶融合蛋白。HLX316针对癌症中两种关键的免疫逃逸途径，即B7-H3过表达和肿瘤高唾液酸化。B7-H3是一种免疫检查点蛋白，在肺癌、乳腺癌、结直肠癌、胰腺癌、前列腺癌和卵巢癌等多种实体肿瘤中过表达，其与肿瘤进展和预后不良相关，但在正常组织中的表达水平很低。肿瘤高唾液酸化可以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，导致免疫检查点抑制剂（ICI）耐药性。HLX316通过酶促作用去除末端唾液酸，并浓缩其在B7-H3阳性肿瘤细胞中的活性，从而解除糖免疫检查点抑制，恢复肿瘤微环境内的先天性和适应性免疫介导的抗肿瘤功能。

通过靶向表达B7-H3 的肿瘤细胞及其微环境发挥唾液酸酶活性，HLX316有潜力同时缓解蛋白和聚糖介导的免疫抑制，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。临床前研究显示，HLX316对肿瘤细胞具有强效的B7-H3 定向去唾液酸化作用，且具有良好的耐受性。

体系化创新驱动多元差异管线

HLX316为公司基于与Palleon战略合作开展的创新项目之一。Palleon由联合创始人、诺贝尔奖获得者Carolyn Bertozzi教授共同创立，其在糖生物学领域的突破性发现促成了公司技术平台的开发。双方将依托各自在糖生物学与肿瘤免疫领域的技术积累，加速推进创新融合蛋白药物的全球研发进程。HLX316的IND获批，是公司创新引擎持续加速运转的又一体现。依托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、免疫细胞衔接器及AI驱动的一站式早期研发平台HAI Club，公司正系统性构建覆盖多抗、ADC、融合蛋白及小分子抑制剂在内的多技术路径创新体系。

在这一创新框架下，多款差异化分子已进入密集推进阶段。HLX37（PD-L1×VEGF双特异性抗体）IND获批并完成首例患者给药；HLX701（SIRPα-Fc融合蛋白）已启动II期临床研究；基于自研T细胞衔接器（TCE）平台开发的DLL3xDLL3xCD3xCD28四特异性TCE HLX3901、HLX97（KAT6A/B抑制剂）与HLX316同步获得IND受理。与此同时，HLX3902（STEAP1×CD3×CD28三特异性TCE）、HLX49（HER2×HER2 ADC）、HLX48（EGFR×cMET ADC）、HLX105（抗体融合蛋白）在内的多个前沿项目也正加速向临床转化，形成梯度清晰、技术多元的早期产品矩阵。

复宏汉霖正在打造具备持续输出能力的创新管线体系。随着核心产品进入全球关键性临床阶段，并逐步迈向注册与商业化，复宏汉霖已从“创新突破”迈入“体系化创新”的新阶段。展望未来，公司将持续深化全球化2.0战略布局，在保持稳健现金流支撑研发投入的同时，加速差异化创新资产的全球开发与转化，推动更多具有国际竞争力的产品走向欧美成熟市场，朝着2030年“迈向全球的生物制药企业”的愿景稳步前行。

关于复宏汉霖

复宏汉霖（2696.HK）是一家国际化创新生物制药企业，致力于为全球患者提供高品质、可负担的生物药，产品覆盖肿瘤、自身免疫疾病、眼科疾病等领域。自2010年成立以来，公司已构建涵盖全球研发、临床、注册、生产及商业化的全产业链平台，拥有全球员工近4,000人，并在中国、美国和日本等多地设有运营及分支机构。依托生物类似药形成的稳健现金流反哺创新研发，复宏汉霖正稳步迈入“全球化2.0”阶段，持续打造可复制、可持续的全球增长模式。截至2026年初，公司共有10款产品在全球60个国家和地区获批上市，其中7款已在中国获批。在欧美主流生物药市场，复宏汉霖亦取得多项里程碑式突破，已有4款产品获得美国FDA批准、4款产品获得欧盟EMA上市授权，充分体现了公司在研发体系、质量管理及生产能力方面已全面对标国际最高标准。

在创新驱动方面，复宏汉霖依托上海、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的抗PD-1单抗，正加速全球布局，已在全球40余个市场获批上市；同时，多款潜力创新资产，包括PD-L1 ADC HLX43及新表位HER2单抗HLX22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。

IND Application for Potential First‑in‑Class B7‑H3–Targeting Sialidase Fusion Protein HLX316 Approved in China

Shanghai, China, March 9, 2026 — Shanghai Henlius Biotech, Inc. (2696.HK) announced that the Investigational New Drug (IND) application for HLX316, a potential first‑in‑class (FIC) B7‑H3–targeting sialidase fusion protein, has been approved by the National Medical Products Administration (NMPA) of China. The approval enables the initiation of first‑in‑human (FIH) clinical studies of HLX316 in patients with advanced or metastatic solid tumors, representing an important translational milestone in the development of glyco‑immune checkpoint–modulating therapies.

Scientific Rationale: Targeting Dual Immune Evasion Pathways

HLX316 is an engineered human sialidase fusion protein targeting B7‑H3 (CD276), developed based on an innovative protein engineering platform. The molecule is engineered to address two major immune evasion mechanisms commonly observed in solid tumors: B7‑H3 overexpression and tumor hypersialylation.

B7‑H3 is an immune checkpoint protein that is overexpressed in many solid tumors—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).

Through its enzymatic activity, HLX316 removes terminal sialic acids and preferentially enriches its activity in B7‑H3–positive tumor cells, thereby relieving glyco‑immune checkpoint–mediated immunosuppression and restoring innate and adaptive antitumor immune functions within the tumor microenvironment.

By exerting sialidase activity specifically in B7‑H3–expressing tumor cells and their microenvironment, HLX316 has the potential to simultaneously alleviate protein‑ and glycan‑mediated immune suppression, expand the applicability of immunotherapy in solid tumors, and overcome the limitations of existing treatment modalities. Preclinical studies have demonstrated that HLX316 induces potent B7‑H3–directed desialylation of tumor cells with a favorable tolerability profile.

Systematic Innovation Driving a Diversified and Differentiated Pipeline

HLX316 is one of the innovative programs arising from the strategic collaboration with Palleon Pharmaceuticals. Palleon was co-founded by Nobel laureate Carolyn Bertozzi, whose pioneering discoveries in glycobiology enabled development of the company’s therapeutic platform. By leveraging the complementary strengths of both parties, HLX316 is advancing toward global clinical development. The IND approval of HLX316 further reflects the accelerated momentum of Henlius’ innovation engine. Leveraging its PD‑(L)1–centered immune checkpoint inhibitor platform, immune cell engager platforms (including multispecific T‑cell engager technologies), Hanjugator ADC platform, fusion protein technologies, and the AI‑powered one‑stop early discovery platform HAI Club, Henlius is systematically building a multi‑modal innovation ecosystem spanning multi-specific antibodies, ADCs, fusion proteins and small‑molecule inhibitors.

Within this framework, several differentiated assets are advancing through early‑stage development. HLX37 (anti-PD-(L)1/VEGF bispecific antibody) has received IND approval and completed dosing of the first patient. HLX701 (novel SIRPα-Fc fusion protein) has initiated a phase 2 clinical study in China. In addition, HLX97, a potential best-in-class KAT6A/B inhibitor, and HLX3901, a DLL3xDLL3xCD3xCD28 tetra‑specific T‑cell engager (TCE) developed from Henlius’ proprietary TCE platform, received IND acceptance concurrently with HLX316.

In parallel, several other programs are progressing toward clinical development, including HLX3902 (STEAP1 × CD3 × CD28 trispecific T‑cell engager), HLX49 (HER2 × HER2 bsADC), HLX48 (EGFR × cMET bsADC), and HLX105 (a fusion protein). Collectively, these programs form a well‑tiered and technology‑diverse early‑stage pipeline.

Henlius is building a sustainable innovation pipeline with long‑term value creation capabilities. As core products advance into global pivotal clinical stages and progressively move toward registration and commercialization, the company has transitioned from “breakthrough innovation” to a new phase of “systematic innovation.” Looking ahead, Henlius will continue to deepen its Globalization 2.0 strategy, while maintaining robust cash flow to support R&D investment, accelerating the global development and translation of differentiated innovative assets, and bringing more internationally competitive products to mature markets in Europe and the United States, steadily advancing toward its vision of becoming a global biopharmaceutical company by 2030.

About Henlius

Shanghai Henlius Biotech, Inc. (2696.HK) is a global, innovation-driven biopharmaceutical company committed to delivering high-quality, affordable biologic therapies to patients worldwide. The Company focuses on major disease areas including oncology, autoimmune diseases, and ophthalmic diseases. Founded in 2010, Henlius has established an integrated, end-to-end biopharmaceutical platform encompassing global R&D, clinical operations, regulatory affairs, manufacturing, and commercialisation. The Company employs nearly 4,000 people globally and operates across multiple regions, including China, the United States, and Japan. Leveraging the stable cash flow generated from its biosimilar portfolio to support innovation, Henlius is steadily advancing into its “Globalisation 2.0” phase, building a scalable and sustainable global growth model. As of early 2026, Henlius has achieved regulatory approvals for 10 products across 60 countries and regions worldwide, including seven approvals in China. The Company has also reached multiple milestones in major biopharmaceutical markets, with four products approved by the U.S. Food and Drug Administration (FDA) and four products authorized by the European Medicines Agency (EMA), reflecting its globally aligned R&D capabilities, quality systems, and manufacturing standards.

Driven by innovation, Henlius has built a diversified, 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 than 50 early-stage innovative assets, approximately 70% of which are expected to be best-in-class, with over 30 clinical trials ongoing globally. Henlius’ core product, serplulimab (trade name: Hetronifly in Europe), is the world’s first anti–PD-1 mAb approved for first-line treatment of small cell lung cancer and has been approved in more than 40 markets worldwide with an accelerated globalisation process. In parallel, multiple high-potential innovative assets—including the PD-L1 ADC HLX43 and the novel epitope anti-HER2 mAb HLX22—are advancing through global pivotal clinical development. Supported by a biologics manufacturing network with a total capacity of 84,000L 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.

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(复星医药 动态宝)