公司第八款自研产品实现海外获批上市，全力驱动全球化突破

汉达远®首次海外获批，加速惠及新兴市场国家

2026年9月，复宏汉霖(2696.HK)宣布，公司商业合作伙伴Getz Pharma (Private) Limited(“Getz Pharma”)收到相关注册证书，复宏汉霖自主开发和生产的汉达远®(阿达木单抗)获得巴基斯坦药监局(Drug Regulatory Authority of Pakistan, DRAP)批准上市，商品名为Adaliget®，获批原研阿达木单抗在当地的所有适应症。汉达远®成为继汉曲优®(曲妥珠单抗，欧洲商品名：Zercepac®，美国商品名：HERCESSI®)、H药 汉斯状®(斯鲁利单抗，欧洲商品名：Hetronifly®)、汉倍优®(帕妥珠单抗，欧美商品名：Poherdy®)和汉贝泰®(贝伐珠单抗)等产品后，复宏汉霖第八款海外获批上市的产品。

行稳致远，触达患者需求

根据2023年全球疾病负担(GBD)研究，2023年度全球仅类风湿关节炎和银屑病的患者已有约5,000万人，且这一患病群体仍在持续扩大。1 阿达木单抗是全球最为畅销的药物之一，在全球范围内已获批用于类风湿关节炎、强直性脊柱炎、银屑病、葡萄膜炎等十余项自身免疫疾病适应症，获得北美、欧洲多个权威临床实践指南一致推荐，然而在很多新兴市场其渗透率仍有待提高。

基于双方于2022年达成的授权和供货许可协议，Getz Pharma致力于将汉达远®推向包括巴基斯坦在内的亚非欧11个新兴市场国家，此次获批将有助于双方携手将汉达远®带给更多本地患者。

汉达远®是复宏汉霖自主开发的阿达木单抗生物类似药，也是公司首款治疗自身免疫疾病的产品，于2020年12月正式获得中国国家药品监督管理局(NMPA)批准上市，并由复星万邦负责中国市场的推广，于2026年7月被纳入中国《国家基本药物目录(2026年版)》。

精耕品质，拓展全球可及

此次汉达远®在巴基斯坦获批主要基于DRAP对一系列研究数据的审查，相关申报资料主要基于该产品递交NMPA上市注册申请(NDA)的资料。复宏汉霖针对汉达远®开展了一系列的头对头比对研究，包括药学比对研究、非临床比对研究和临床比对研究，研究结果证明汉达远®在质量、安全性和有效性等方面与原研药高度相似。

汉达远®的研发、生产和质量控制环节遵循国际最高标准。为国内首个针对中国银屑病患者开展III期临床研究的阿达木单抗生物类似药。公司生产基地及配套的质量管理体系的质量管理体系已通过约百项由NMPA、欧洲药品管理局(EMA)、美国食品药品监督管理局(FDA)、PIC/S成员印尼食品药品监督管理局(BPOM)和巴西国家卫生监督管理局(ANVISA)、欧盟质量受权人(QP)及公司国际商业合作伙伴进行的多项实地核查及审计。

除汉达远®之外，复宏汉霖于2024年12月与Getz Pharma扩大合作，授予后者汉曲优®在巴基斯坦的商业化独家权益。未来，公司将继续坚守国际化质量标准，携手Getz Pharma等合作伙伴，持续推动更多生物药在全球上市进程，为不同市场的患者带来更多治疗选择。

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，拥有全球员工超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。截至目前，公司共有10款产品在全球60余个国家和地区获批上市，其中8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、5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50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，已在全球超50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(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。

关于Getz Pharma

Getz Pharma (Private) Limited于1995年成立于巴基斯坦伊斯兰共和国，主要从事各种药品的配方开发、生产和销售。截止目前，Getz Pharma (Private) Limited在南亚、中亚、东南亚、中东和非洲地区超过45个国家开展业务，在全球拥有8000多名员工。

Henlius HANDAYUAN Received DRAP Approval in Pakistan

- Henlius’ 8th self-developed product breaking into global market

- HANDAYUAN's first approval beyond China to benefit patients in emerging markets

Shanghai, China, September 2026 - Shanghai Henlius Biotech, Inc. (2696.HK) announced that the company’s business partner Getz Pharma (Private) Limited (Getz Pharma) has received the relevant registration certificates from the Drug Regulatory Authority of Pakistan (DRAP) for the approval of Henlius’ self-developed and manufactured adalimumab biosimilar HANDAYUAN under the trade name Adaliget®, covering all indications of the reference biological product approved in Pakistan. HANDAYUAN is Henlius' eighth product approved for ex-China marketing, following HANQUYOU (trastuzumab), HANSIZHUANG (serplulimab), Poherdy (pertuzumab), and HANBEITAI (bevacizumab).

According to the Global Burden of Disease (GBD) 2023 study, the total number of patients with rheumatoid arthritis and psoriasis in 2023 is over fifty million and the number continues to grow.1 Adalimumab is one of the world's best-selling drugs. It has been approved for over 10 autoimmune indications worldwide, including rheumatoid arthritis (RA), ankylosing spondylitis, psoriasis (Ps) and uveitis (UV), and it has been recommended by clinical practice guidelines for different autoimmune diseases in North America and Europe. In many emerging markets, however, market penetration of adalimumab has yet to increase.

Based on the licensing and supply agreement between the two companies in 2022, Getz Pharma is committed to bringing Adaliget® to 11 emerging markets in Asia, Africa and Europe, including Pakistan, and this approval will help both parties bring HANDAYUAN to more local patients.

HANDAYUAN is Henlius’ first self-developed monoclonal antibody in autoimmune treatment and was approved by the NMPA in December 2020. Fosun Wanbang is responsible for the commercial sales of HANDAYUAN in China. In July 2026, it was included in the China’s National Essential Medicines List (2026 Edition).

The approval of HANDAYUAN by DRAP of Pakistan is mainly based on the review of a series of studies. The relevant application materials are mainly based on the information in the New Drug Application (NDA) in relation to the product submitted to China’s National Medical Products Administration (NMPA). Henlius has taken multiple head-to-head comparisons between HANDAYUAN and the reference adalimumab, including analytical studies, non-clinical studies and clinical studies. The results showed that HANDAYUAN and reference adalimumab are highly similar in terms of quality, safety and efficacy.

The development, manufacturing facility for HANDAYUAN and the quality management system are in line with global standards. HANDAYUAN is the first adalimumab biosimilar evaluated in a Phase 3 clinical study among Chinese patients with Ps. Henlius’ manufacturing facilities along with their quality management systems, have successfully passed approximately 100 on-site inspections and audits conducted by NMPA, the European Medicines Agency (EMA), the United States Food and Drug Administration (FDA), PIC/S members Indonesia Food and Drug Administration (BPOM) and Brazilian National Health Surveillance Agency (ANVISA), and the EU qualified person, as well as multiple international business partners.

In addition to Adaliget®, Henlius and Getz Pharma expanded their collaboration in December 2024, granting Getz Pharma exclusive commercialization rights to HANQUYOU (trastuzumab) in Pakistan. Going forward, Henlius will continue to uphold international quality standards and work with partners including Getz Pharma to advance the approval and launch of more biologics worldwide, bringing more treatment options to patients across different markets.

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 over 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. Up to date, Henlius has achieved regulatory approvals for 10 products across over 60 countries and regions worldwide, including eight 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 five 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 50 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 for perioperative gastric cancer. Up to date, it has been approved in over 50 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 dulpatatug (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/index.html and connect with us on LinkedIn at https://www.linkedin.com/company/henlius/.

About Getz Pharma

Getz Pharma (Private) Limited was established in the Islamic Republic of Pakistan in 1995, which mainly specializes in the formulation development, manufacturing and marketing of a wide range of pharmaceutical products. It currently operates in more than 45 countries in South Asia, Central Asia, South East Asia, the Middle East and Africa and has more than 8,000 employees worldwide.