复星医药：首款国产皮下复方制剂复宏汉霖帕妥珠/曲妥珠单抗双靶HLX319获批临床
2026年4月1日，复星医药子公司复宏汉霖（2696.HK）宣布，公司自主开发的帕妥珠单抗曲妥珠单抗固定剂量皮下给药复方制剂HLX319的新药临床试验（IND）申请已获得中国国家药品监督管理局（NMPA）批准，拟用于HER2阳性早期/局晚期乳腺癌的新辅助和辅助治疗以及转移性乳腺癌的治疗。此次IND获批不仅是公司在突破复杂剂型技术壁垒上的重要里程碑，更是复宏汉霖长期深耕乳腺癌领域、全面践行“全域全程全球”战略布局的集中体现。
深耕HER2乳腺癌领域，优化患者治疗体验
乳腺癌是全球第二以及女性最高发的恶性肿瘤1，其中HER2过表达的乳腺癌约占乳腺癌总数的15%-20%2。在HER2阳性乳腺癌治疗领域，复宏汉霖已全面布局治疗基石方案曲妥珠单抗（汉曲优®，美国商品名：HERCESSI™，欧洲商品名：Zercepac®）和帕妥珠单抗HLX11（美国商品名：POHERDY®），早期强化辅助治疗药物奈拉替尼汉奈佳®以及创新新表位抗HER2单抗HLX22（通用名：dulpatatug*）、HER2双表位ADC HLX49等多元管线，覆盖乳腺癌治疗全程。
HLX319为复宏汉霖按照中国、欧盟等生物类似药法规自主开发的Phesgo®生物类似药，由活性成分曲妥珠单抗、帕妥珠单抗和辅料透明质酸酶组成。Phesgo®为一款固定剂量的曲妥珠单抗和帕妥珠单抗皮下复方制剂，该产品于2020年首次获批，目前已在中国、美国和欧盟等地上市。与传统的静脉输注方案相比，Phesgo®疗效和安全性相当，但采用固定剂量皮下给药，无需按体重调节，在5-8分钟内即可完成帕妥珠单抗和曲妥珠给药，极大方便了临床应用。然而，由于开发稳定的大分子合剂具有一定难度，以及皮下给药系统及核心辅料透明质酸酶的专利限制，目前尚无国产复方皮下制剂批准上市。
HLX319中的帕妥珠单抗和曲妥珠单抗分别采用复宏汉霖自主研发的HLX11和汉曲优®。作为首个国产曲妥珠单抗，汉曲优®已在中欧美等全球50多个国家和地区获批上市，广泛覆盖欧美主流市场和众多新兴市场。HLX11于2025年11月获FDA批准上市，用于HER2阳性早期乳腺癌的新辅助/辅助治疗、HER2阳性转移性乳腺癌的治疗，成为美国首个且唯一**的帕妥珠单抗生物类似药。目前，HLX11的上市许可申请亦已获得NMPA、加拿大卫生部（Health Canada）与欧洲药品管理局（EMA）受理。根据《生物类似药研发与评价技术指导原则（试行）》中逐步递进的原则，全面的药学比对研究、非临床研究结果显示HLX319与原研Phesgo®高度相似。
AI赋能突破给药壁垒，
全自研“单抗+酶”展现平台优势
作为破局皮下给药系统的核心环节，HLX319采用的辅料透明质酸酶来自公司具有自主知识产权的透明质酸酶Henozye®，能够在给药部位局部、可逆性水解皮下组织中的透明质酸，暂时降低皮下基质阻力，从而提升可注射体积并促进大分子药物在皮下组织中的分散和吸收效率。目前，Henozye®已作为药用辅料在CDE完成备案并公示（登记号：F20250000716）并已完成美国药物主文件（DMF）注册。同时，基于该酶开发的注射液也已获得NMPA临床试验批准，以进一步评估其在受试者中的安全性、药代动力学及免疫原性。
HLX319的成功开发，充分整合了复宏汉霖在曲妥珠单抗、帕妥珠单抗等多款产品中积累的成熟研发经验，以及公司在创新技术领域的前瞻战略布局。自2020年起，公司率先布局AI for Science系列平台建设，通过计算生物学、机理模型和机器学习等前沿技术与丰富的试验数据相结合，构建了覆盖蛋白分子结构建模、分子设计与改造、成药性评估、工艺开发、制剂处方开发等关键流程的AI辅助模拟计算平台HAI PBD，显著提升了产品的研发效率。Henozye®的开发周期较传统方法大幅缩减，可以适配多种不同种类的蛋白分子，在单抗、双抗、多抗、融合蛋白及ADC等复杂分子中均体现出良好的相容性，在各类缓冲体系和环境条件下均展现出卓越的稳定性，极大降低了皮下共制剂开发的门槛、提高了复杂剂型开发成功率，显著拓宽了各种药物分子的应用场景。
未来，复宏汉霖将持续深耕乳腺癌、肺癌、消化道肿瘤等核心疾病领域，通过不断强化化学、制造与控制（CMC）体系的核心技术优势，同时依托下一代肿瘤免疫、免疫细胞衔接器、Hanjugator™ ADC及HAI Club等多维创新平台，加速构建具备全球竞争力的产品管线，为全球患者提供更多高质量、可负担的治疗选择。
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EC批准，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。
Enhancing Treatment for Breast Cancer: China’s First Subcutaneous Pertuzumab/Trastuzumab Combination HLX319 Approved for Clinical Trial
April 1, 2026 – Shanghai Henlius Biotech, Inc. (2696.HK) today announced that the Investigational New Drug (IND) application for HLX319, the company's self-developed, fixed-dose subcutaneous injection of pertuzumab and trastuzumab, has been approved by the China National Medical Products Administration (NMPA). The product is intended for neoadjuvant/adjuvant treatment of HER2-positive early or locally advanced breast cancer, as well as for the treatment of metastatic breast cancer. This represents a key milestone in Henlius' breakthrough in complex formulations and demonstrates its deep commitment to breast cancer and the implementation of its full-course, all-domain, global breast cancer treatment ecosystem.
Deepening Expertise in HER2, Enhancing the Treatment Experience for Breast Cancer Patients
Breast cancer is the second most common malignancy worldwide and the leading cause of cancer in women1. HER2‑positive breast cancer accounts for approximately 15‑20% of all breast cancer cases2. In the field of HER2‑positive breast cancer therapy, Henlius has built a comprehensive portfolio covering the full treatment continuum. Its pipeline includes foundational regimens HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S, Zercepac® in Europe) and HLX11 (pertuzumab, trade name: POHERDY® in the U.S.), the extended adjuvant therapy HANNAIJIA (neratinib) ,novel epitope anti-HER2 mAb HLX22 (dulpatatug*) and HER2 dual-epitope ADC HLX49.
HLX319 is a biosimilar of Phesgo® developed by Henlius in compliance with Chinese and EU biosimilar guidelines. It contains the active ingredients trastuzumab and pertuzumab, along with a proprietary recombinant human hyaluronidase (rHuPH20) excipient. Phesgo®, as a fixed-dose subcutaneous combination, first approved in 2020 and now marketed in China, the U.S., and the EU, allows trastuzumab and pertuzumab administration in 5–8 minutes without weight-based dose adjustment, offering comparable efficacy and safety to intravenous regimens and greatly facilitating clinical use. However, due to the technical complexity of developing stable large-molecule co-formulations, as well as patent constraints related to subcutaneous delivery systems and hyaluronidase excipient, no domestically developed subcutaneous combination product has yet been approved in China.
The pertuzumab and trastuzumab used in HLX319 are Henlius’ self‑developed HLX11 and HANQUYOU, respectively. To date, HANQUYOU has been approved in more than 50 countries and regions worldwide, covering major markets in Europe and the United States as well as numerous emerging markets. HLX11 was approved by the FDA in November 2025 for the neoadjuvant/adjuvant treatment of HER2-positive early breast cancer and for HER2-positive metastatic breast cancer, making it the first and only pertuzumab biosimilar approved in the U.S.**. Its marketing authorization applications have also been accepted for review by the NMPA, Health Canada, and the European Medicines Agency (EMA). In accordance with the stepwise approach recommended in China’s biosimilar guidelines, comprehensive pharmaceutical comparability studies, non-clinical studies have demonstrated that HLX319 is highly similar to the reference product Phesgo®.
AI-Powered Delivery Breakthrough: Self-Developed "mAb + Enzyme" Platform Demonstrates Core Competitiveness
As the key component enabling the subcutaneous delivery system, the hyaluronidase excipient in HLX319 is based on Henlius' proprietary hyaluronidase, Henozye®. It works by locally and reversibly degrading hyaluronic acid in the subcutaneous tissue, temporarily reducing resistance and allowing larger injection volumes while improving the dispersion and absorption of large molecule drugs. Currently, Henozye® has been filed as a pharmaceutical excipient with China’s Center for Drug Evaluation (CDE; Registration No.: F20250000716) and as a Drug Master File (DMF) with the U.S. FDA. A IND application for the hyaluronidase injection was also recently approved by the NMPA to further evaluate its safety, pharmacokinetics, and immunogenicity in clinical study.
The successful development of HLX319 highlights Henlius' integrated R&D capabilities, built upon extensive experience with trastuzumab, pertuzumab, and other biologics, as well as its forward-looking strategy in innovative technologies. Since 2020, the company has been advancing its AI for Science platforms including HAI PBD, which integrates computational biology, mechanistic modeling, machine learning, and extensive experimental data. This AI-assisted platform spans key processes from protein modeling and design to process and formulation development, significantly boosting R&D efficiency. Compared with conventional approaches, Henozye® enables a substantially shortened development cycle and demonstrates strong compatibility across diverse modalities, including monoclonal antibodies, bispecific and multispecific antibodies, fusion proteins, and antibody-drug conjugates (ADCs). Its excellent stability across various buffer systems and environmental conditions significantly lowers the barriers to subcutaneous co-formulation development, enhances the success rate of complex formulations, and expands the potential applications of diverse therapeutic modalities.
Moving forward, Henlius will continue to deepen its focus on core disease areas such as breast cancer, lung cancer, and gastrointestinal cancers. By consistently strengthening its technical capabilities in Chemistry, Manufacturing, and Controls (CMC) and leveraging a multi-dimensional innovation platform—including next-generation immuno-oncology platform, immune cell engager, Hanjugator™ ADC, and HAI Club—the company aims to accelerate the development of a globally competitive product portfolio, delivering more high-quality and affordable treatment options for patients worldwide.
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 approved by the European Commission (EC), 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.
To learn more about Henlius, visit https://www.henlius.com/en/ and connect with us on LinkedIn at https://www.linkedin.com/company/henlius/.
参考文献及注释
1.https://www.who.int/news/item/01-02-2024-global-cancer-burden-growing--amidst-mounting-need-for-services.
2.Kang S,Lee SH,Lee HJ,et al.Pathological complete response,long-term outcomes,and recurrence patterns in HER2-low versus HER2-zero breast cancer after neoadjuvant chemotherapy. Eur J Cancer.2022 Sep 29;176:30-40.
* 药品通用名处于pINN状态
**U.S. FDA官网，访问日期：2026年3月31日
