摘要：2025年3月24日，复宏汉霖（2696.HK）发布2024年度业绩，于业绩期内实现营业收入约人民币57.244亿元，较去年同期增长约6.1%，净利润达8.205亿元，同比增长50.3%，净利润率达14.3%，同比增长41.6%。这是继2023年首次取得全年盈

2025年3月24日，复宏汉霖（2696.HK）发布2024年度业绩，于业绩期内实现营业收入约人民币57.244亿元，较去年同期增长约6.1%，净利润达8.205亿元，同比增长50.3%，净利润率达14.3%，同比增长41.6%。这是继2023年首次取得全年盈利之后，公司连续第二年实现全年盈利。核心产品商业化销售的持续扩大成为业绩盈利的重要驱动力，产品销售收入合计约人民币49.335亿元，同比增长8.3%。此外，公司全年研发投入达到人民币18.405亿元，同比增长28.4%。

公司加速创新管线突破并高效拓展全球布局，释放更多增长潜力，推动公司可持续高质量发展。截至目前，复宏汉霖已有6款产品在中国获批上市，4款产品在国际获批上市，触达50多个国家和地区，广泛覆盖亚洲、欧洲、拉丁美洲、北美洲和大洋洲，惠及全球超75万患者。业绩期内，公司在全球范围内完成25项上市注册申请递交，并获得17项批准，覆盖中国、美国、欧盟、加拿大、印尼等多个国家和地区，加速产品全球化进程。同时，公司秉持差异化的创新研发策略，构建了约50个分子的多元化管线，覆盖单抗、多抗、抗体偶联药物（ADC）、融合蛋白等丰富的药物形式，并持续深化AI等前沿技术和平台赋能，破解临床之需并促进创新成果转化落地。

复宏汉霖董事长张文杰先生表示：“公司持续实现全年盈利增长，充分验证了我们在战略布局和商业运营效率上的不断提升，为可持续发展奠定了坚实基础。秉持‘以患者为中心’的理念，复宏汉霖将继续聚焦临床未尽之需，充分发挥一体化平台优势，进一步优化精益运营管理体系，助力公司迈向更高质量发展。”

复宏汉霖执行董事、首席执行官朱俊博士表示：“过去一年里，我们锚定创新和国际化两大抓手，全面加速海外市场拓展，成为中国生物医药企业出海领导者，同时打造多元化创新管线，并积极拥抱前沿技术，不断激发创新活力，释放持续增长动能。面向未来，我们将继续以创新为引领，在国际化征程上阔步前行，为全球患者提供更多高品质治疗方案。”

连续盈利聚势增长，全球拓局致远新篇

深化创新管线布局，破解临床未尽之需

2024年，复宏汉霖聚焦未被满足的临床需求，在以抗体技术为核心的创新领域持续推进，致力于加速更多潜在“First-in-Class”和“Best-in-Class”分子进入临床开发阶段。公司持续搭建并优化抗体偶联药物（ADC）技术平台和T细胞衔接器（T Cell Engager， TCE）技术平台，并充分运用以AI为代表的前沿技术，为创新研发提供有力支持。

与此同时，公司持续优化生产运营与质量管理体系，为未来发展筑牢根基。截至目前，公司已建成48,000升商业化产能，稳定供货中国、东南亚、北美、欧洲、中东及拉丁美洲等地区。随着松江基地（二）项目的推进竣工验收，公司将进一步强化产能布局，为未来发展提供更强支撑。质量管理方面，公司商业化生产基地及配套体系已通过近百项各国药监机构及国际合作伙伴的核查或审计，获得中国、欧盟、美国、印尼及巴西等多个PIC/S成员国的GMP认证。此外，松江基地还通过ISO 14001环境管理体系和ISO 45001职业健康安全管理体系双认证，标志着其在环境可持续管理及员工健康安全管理方面达到国际先进水平，为公司全球化生产与供应体系再添权威认证。

展望未来，复宏汉霖将继续秉持"以患者为中心"的理念，以创新为基石，以全球化为驱动，持续提升商业化运营能力、并强化产能建设，为全球患者提供更多可及、可负担的优质治疗方案，继续向着成为具有全球竞争力的生物制药企业稳步迈进。

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，已有6款产品在中国获批上市，4款产品在国际获批上市，4个上市申请分别获中国药监局、美国FDA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。

Henlius 2024 Annual Results: Steady Revenue Growth with a Net Profitof RMB820.5 million， Up by 50.3% YoY

Shanghai， China， March 24,2025 – Henlius (2696.HK) announced its 2024 annual results. During the reporting period，Henlius’ total revenue reached approximately RMB5.7244 billion， representing an increase of 6.1% YoY. The net profit reached RMB820.5million， a 50.3% YoY growth， with a net profit margin of 14.3%， up by 41.6% YoY. This marks Henlius' second consecutive year of full-year profitability following its first profitable year in 2023. The increasing commercial sales of core products have been a key driver of profitability， with total product sales revenue reaching approximately RMB4.9335 billion， an increase of 8.3% YoY. Additionally， the company’s annual R&D expenditure reached RMB1.8405 billion， representing an increase of 28.4% YoY.

Henlius has accelerated breakthroughs in its innovation pipeline and efficiently expanded its global footprint， unlocking further growth potential and driving sustainable， high-quality development. Up to date， Henlius has secured approvals for 6 products in China and 4 internationally， reaching over 50 countries and regions across Asia， Europe， Latin America， North America， and Oceania， benefiting over 750,000 patients worldwide. During the reporting period， the company completed 25 marketing applications and secured 17 approvals around the world， covering key markets such as China， the United States (U.S.)， the European Union (EU)， Canada and Indonesia， accelerating its global expansion. Additionally， Henlius has maintained a differentiated innovation strategy， building a pipeline of about 50 molecules， including monoclonal antibodies (mAbs)， polyclonal antibodies (pAbs)， antibody-drug conjugates (ADCs)， and fusion proteins. The company leverages cutting-edge technologies such as AI to address unmet clinical needs and enhance the translation of innovative achievements.

Mr. Wenjie Zhang， Chairman of Henlius， said: "Henlius has consistently achieved year-round profit growth， which fully validates our continuous improvement in strategic planning and business operational efficiency， laying a solid foundation for sustainable development.Adhering to patient-centricity， Henlius will continue to focus on unmet clinical needs， fully leverage the advantages of its integrated platform， further optimize the lean operation management system， and drive the company towards higher quality development."

Dr. Jason Zhu， Executive Director and Chief Executive Officer of Henlius， said: "Over the past year， we have anchored our strategy in innovation and globalization， accelerating overseas market expansion and solidifying our position as a leader among Chinese biopharmaceutical companies going global.By building a diversified innovation pipeline and embracing cutting-edge technologies， we have consistently fuelled innovation and unlocked sustainable growth momentum. Moving forward， we will continue to be driven by innovation， advancing our global journey to deliver more high-quality treatment options for patients worldwide."

Harnessing Momentum through Profitability， Charting New Horizons in Global Expansion

The company's core product on breast cancer， HANQUYOU， maintained robust growth. In 2024, the global sales revenue of HANQUYOU was approximately RMB2.8100 billion， with domestic sales of RMB2.6924 billion and overseas sales revenue of RMB117.6 million up by 27.0% YoY. HANQUYOU is a China-developed monoclonal antibody biosimilar receiving approvals in China， the U.S.， and Europe， making it the most widely approved Chinese mAb biosimilar across multiple countries and regions. In 2024, the product received approvals for marketing in countries and regions including the Philippines， Brazil， the U.S.， and Canada， with successful shipments made to Saudi Arabia and the U.S. Its commercial supply network now covers countries and regions such as China， Southeast Asia， North America， Europe， the Middle East， and Latin America. To date， HANQUYOU has gained marketing approvals in over 50 countries and regions， including the U.S.， the U.K.， Canada， France， Germany， Switzerland and has been included in the national medical insurance catalogues of countries such as China， the UK， France， and Germany， benefiting over 240,000 patients globally. Additionally， in August 2024, Henlius entered into a strategic cooperation with Convalife Pharmaceuticals for HANNAIJIA (neratinib)， an oral small molecule anti-tumour drug， further enriching its breast cancer treatment portfolio. Neratinib is used for extended adjuvant therapy in early-stage HER2-positive breast cancer and can be used sequentially with HANQUYOU to further reduce the risk of recurrence for patients with early-stage HER2-positive breast cancer within 5 and 10 years after surgery， providing a new treatment option for patients.

Focusing on lung cancer and gastrointestinal tumours， HANSIZHUANG， recognized for its breakthrough efficacy and differentiated advantages， has been approved for marketing in over 30 countries and regions， including China， Europe and Southeast Asia， benefiting more than 100,000 patients. In 2024, HANSIZHUANG recorded a totalsales revenue of RMB1.3126 billion， representing an increase of 17.2% YoY， with domestic sales of RMB1.3089 billion. HANSIZHUANG is the world's first anti-PD-1 mAb approved for the first-line treatment of small cell lung cancer. In December 2024, it was approved for the treatment of non-squamous non-small cell lung cancer (nsNSCLC)， marking its third approved indication in lung cancer following squamous NSCLC and extensive-stage small cell lung cancer (ES-SCLC). Furthermore， HANSIZHUANG has been included in 118 provincial/city-level commercial medical insurance programs across China， further strengthening its market competitiveness. In terms of overseas expansion， the company continues to collaborate with partners including Intas， KGbio， and Fosun Pharma to promote the globalization of HANSIZHUANG. To date， HANSIZHUANG has been licensed out to more than 100 countries and regions including the U.S.， Europe， Southeast Asia， the Middle East， and North Africa. In the first quarter of 2024, the company efficiently completed the first shipment of HANSIZHUANG overseas， marking its entry as the first domestically produced anti-PD-1 mAb in Southeast Asian countries， offering new treatment options to patients worldwide. In February 2025, it was approved in the EU for the first-line ES-SCLC treatment， becoming the first and currently the only anti-PD-1 mAb in the EU for this indication， further benefiting more patients worldwide.

In 2024, as part of its commitment to provide affordable and high-quality biomedicines for patients worldwide， Henlius has achieved remarkable success in the international market， and successfully realized the "Closed-loop Internationalization 1.0". Following HANQUYOU and HANSIZHUANG， China's first biosimilar， HANLIKANG， was approved for marketing in several Latin American countries including Peru， while HANBEITAI received its first approval in Bolivia， becoming Henlius' fourth product approved overseas. Moreover， the marketing applications for HLX14 (denosumab biosimilar) have been accepted in both the EU and the U.S.， and the marketing applications for HLX11 (pertuzumab biosimilar) have also been accepted in China and the U.S.， infusing new momentum into the company's global development. In 2024, the company achieved new milestones in business collaborations. Henlius has expanded its collaborations in emerging markets with Getz for HANQUYOU and with Abbott for five biopharmaceuticals. It has also entered into an out-licensing partnership with Dr. Reddy’s for HLX15, a biosimilar of daratumumab， accelerating the global expansion of the product. Besides， the company partnered with Sermonix on HLX78 (lasofoxifene)， an investigational novel endocrine therapy for breast cancer， for the Asian region， and collaborated with Palleon to advance glycan-editing therapies， further enhancing its pipeline. Additionally， the company established a strategic partnership with SVAX to set up a joint venture in Saudi Arabia， enhancing the accessibility of advanced biologics across the Middle East， North Africa， and Türkiye (MENAT) countries.

Deepening Innovation Pipeline to Address Unmet Clinical Needs

In 2024, Henlius focused on unmet clinical needs， driving innovation in antibody technology to accelerate the development of potential "First-in-Class" and "Best-in-Class" molecules into clinical stages. The company optimized its ADC and T cell Engager (TCE) platforms， leveraging advanced technologies such as AI to enhance R&D capabilities.

In clinical development， Henlius actively progressed the development of HANSIZHUANG， HLX22 (anti-HER2 mAb)， HLX43 (PD-L1 ADC) and other products. The company has initiated a range of clinical trials to support global regulatory submissions for a wide variety of indications for HANSIZHUANG. The phase 3 stage of the international multi-centre clinical trial (ASTRUM-015) of serplulimab in combination with bevacizumab and chemotherapy in first-line treatment of metastatic colorectal cancer (mCRC) has dosed the first patients in China， Indonesia and Japan， potentially making it the first anti-PD-1 mAb in non-MSI-H mCRC worldwide. The company is actively advancing an international multi-centre phase 3 clinical trial of HANSIZHUANG plus chemotherapy and concurrent radiotherapy in patients with limited-stage small cell lung cancer (LS-SCLC) and a phase 3 clinical trial of HANSIZHUANG plus chemotherapy as neoadjuvant/adjuvant therapy for gastric cancer (GC). Henlius is also conducting a bridging head-to-head trial in the U.S. to compare HANSIZHUANG with standard of care atezolizumab (anti-PD-L1 mAb) for the first-line treatment of ES-SCLC. HLX22, targeting HER2-positive advanced gastric cancer， received Phase 3 clinical trial approvals from China NMPA， U.S. FDA， Japan PMDA， Australia TGA etc.， and this international study has been initiated in multiple countries and regions worldwide and has completed its first patient dosing globally. In March 2025, the U.S. FDA granted orphan drug designation (ODD) to HLX22 for the treatment of gastric cancer. A phase 2 trial is also evaluating the potential of HLX22 in other HER2-expressing solid tumours in combination with trastuzumab and chemotherapy or in combination with trastuzumab deruxtecan (T-DXd). HLX43, the world's second and China's first clinical-stage PD-L1 ADC， has completed its first phase 2 clinical trial dosing in solid tumours. In addition， a phase 1b/2 trial of HLX43 in combination with the anti-PD-1 mAb serplulimab has been approved in China， aiming to exploit the synergistic effects of ADC and immunotherapy in advanced/metastatic solid tumours.

Meanwhile， the company continues to optimize its production operations and quality management system， strengthening its foundation for future development. To date， it has established a total commercial capacity of 48,000 litres， ensuring stable supply to countries and regions including China， Southeast Asia， North America， Europe， the Middle East， and Latin America. The completion of the Songjiang Second Plant will further enhance its production capabilities. In terms of quality management， the company's manufacturing facilities and production lines have successfully passed nearly a hundred inspections or audits conducted by various regulatory authorities and international business partners. It has obtained GMP certifications from China， the EU， the U.S. and multiple PIC/S member countries， including Indonesia and Brazil. Additionally， the Songjiang Facility has received ISO 14001 and ISO 45001 dual certifications， demonstrating its international leadership in environmental sustainability and employee health and safety， further strengthening its company's global production and supply capabilities.

Looking forward， Henlius will continue to adhere to its patient-centricity， driven by innovation and globalization， toenhancecommercial operations， strengthen production capacity and provide more accessible and affordable high-quality treatment options for patients worldwide， steadily advancing toward becoming a globally competitive biopharmaceutical company.

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.Up to date， 6 products have been launched in China， 4 have been approved for marketing in overseas markets， and 4 marketing applications have been accepted for review in China， the U.S. 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.

来源：金融界