Trastuzumab biosimilar(Shanghai Henlius Biotech, Inc.)

SHANGHAI, March 24, 2025 /PRNewswire/ -- 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 RMB820.5 million, 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 In 2024, Henlius continued to deepen its focus on high-incidence cancer areas such as breast cancer, lung cancer, and gastrointestinal tumours, with core products driving steady revenue growth and achieving the goal of sustained profitability. During the reporting period, Henlius' 6 products recorded total sales revenue of RMB4.9335 billion, up by 8.3% YoY. Among these, HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe), HANSIZHUANG (serplulimab, trade name: Hetronifly® in Europe), HANBEITAI (bevacizumab) and HANNAIJIA (neratinib), achieved sales revenues of RMB2.8100 billion, RMB1.3126 billion, RMB197.1 million and RMB45.3 million, respectively in 2024. Additionally, based on agreements with partners, the company received total revenues of RMB550.4 million and RMB40.1 million for HANLIKANG (rituximab) and HANDAYUAN (adalimumab), respectively. 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 total sales 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, to enhance commercial 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. 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 HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANDAYUAN (adalimumab), HANBEITAI (bevacizumab), HANSIZHUANG (serplulimab, trade name: Hetronifly® in Europe), the world's first anti-PD-1 mAb for the first-line treatment of SCLC, and HANNAIJIA (neratinib). What's more, Henlius has conducted over 30 clinical studies for 19 products, expanding its presence in major markets as well as emerging markets. SOURCE Henlius WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED