On March 21, 2023 Henlius (2696.HK) reported its 2023 annual results. During the reporting period, Henlius’ revenue reached about RMB5.3949 billion, representing an increase of 67.8% YoY, and recorded a net profit of RMB546.0 million (Press release, Henlius Biopharmaceuticals, MAR 21, 2024, View Source [SID1234641360]). This is the first time for Henlius to achieve full-year profits following the company’s achievement of its first half-year profits in H1 2023. The full year of profitability is due to increasing commercial sales of the core products and expanding sales volume. Henlius’ products achieved total sales of approximately RMB4.5535 billion in 2023, up by 70.2% YoY.
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Up to date, Henlius has 5 products launched in China, 2 launched in overseas markets, 19 indications approved worldwide, benefiting over 560,000 patients and reaching more than 40 markets in Asia, Europe, Latin America and Oceania. Besides, over 50 marketing applications of its products have been accepted for review in countries and regions including China, the EU, the U.S., Canada, Singapore and Thailand. Meanwhile, the company stays focused on differentiated innovation to accelerate the development of products in its pipeline. In 2023, the company’s R&D expenditure reached approximately RMB1.4336 billion.
Wenjie Zhang, Chairman and Executive Director of Henlius, said: "Henlius achieved remarkable performance and recorded full-year profits for the first time. Through unwavering innovation and outstanding execution, we have established a solid foundation for high-quality development and have been continuously improving the efficiency of our integrated biopharmaceutical platform, enabling the company to accelerate its development. Furthermore, we’ve boosted efficiency in operations and management across the business, driving steady and strong growth and inspiring us to build an innovative global biopharmaceutical company with high-quality development."
Jason Zhu, Executive Director, Chief Executive Officer and Chief Financial Officer, said: "Under the dual-drive strategy of ‘biosimilars and novel biologics’, Henlius continues to accelerate both domestic and overseas market expansion, stick to lean operations, promote high-quality and synergistic product development, increase profitability and further advance its comprehensive capabilities. In the future, we will adhere to patient-centricity, further optimize our innovation layout, expand the global distribution of high-quality biological drugs, and make greater contributions to improving human health and well-being."
Achieving strong growth in commercial performance and making new breakthroughs in overseas expansion
In 2023, Henlius has made achievements in product commercialization, business models construction, market layout optimization and overseas market expansion. Its five products achieved total sales revenue of approximately RMB4.5535 billion. HANQUYOU (trastuzumab, trade name in Europe: Zercepac), HANSIZHUANG (serplulimab), and HANBEITAI (bevacizumab) recorded sales of RMB2.7370 billion, RMB1119.8 million and RMB119.4 million, respectively. In addition, the company received sales revenues of RMB540.5 million and RMB58.6 million based on the collaboration with partners for HANLIKANG (rituximab) and HANDAYUAN (adalimumab), respectively.
Henlius’ core oncology product HANQUYOU continues to unleash strong growth momentum. During the reporting period, HANQUYOU has recorded a domestic sales revenue of RMB2.6444 billion, up by 56.1% YoY. Due to its advantages of 150mg/60mg dual dosage and preservative-free formulation, HANQUYOU further expanded its market share in China, benefiting over 180,000 Chinese patients to date. Overseas revenue from product sales recorded RMB92.6 million approximately, up by 162.3% YoY. As one of the pioneers of domestic biopharmaceuticals going global, HANQUYOU has successfully been approved for marketing in over 40 countries and regions, including the United Kingdom, Germany, Spain, France, Italy, Switzerland, Australia, Singapore, Argentina, Brazil, etc., becoming the China-developed biosimilar with the most marketing approvals. Meanwhile, the product’s accessibility has been further improved. It is now reimbursed nationally in countries including China, the UK, France, and Germany. In 2023, the overseas commercialization of HANQUYOU managed to include the markets of Thailand, the Philippines and Brazil, and its marketing applications in the United States and Canada have also been accepted and expected to be approved for marketing in 2024.
Henlius’ innovative product HANSIZHUANG, the world’s first anti-PD-1 monoclonal antibody (mAb) approved for the first-line treatment of small cell lung cancer (SCLC), has been launched in China and Indonesia. In 2023, HANSIZHUANG has recorded a total sales revenue of RMB1119.8 million, representing an increase of 230.2% YoY. Up to now, it has been approved for 4 indications and in 2023, it was approved for the treatment of extensive-stage small cell lung cancer (ES-SCLC) and esophageal squamous cell carcinoma (ESCC), benefiting over 60,000 Chinese patients to date. Additionally, the 5th NDA of HANSIZHUANG for the first-line treatment of non-squamous non-small cell lung cancer (nsNSCLC) has been accepted by the National Medical Products Administration (NMPA). On the other hand, Henlius continues to expand HANSIZHUANG’s global footprint, which now covers more than 70 countries and regions including the U.S., Europe, Southeast Asia and MENA. In December 2023, HANSIZHUANG was approved for marketing in Indonesia, becoming the first China anti-PD-1 mAb successfully approved in Southeast Asia. Furthermore, the company submitted marketing applications for HANSIZHUANG in Thailand, Singapore, Malaysia to further promote the product in Southeast Asia. In March 2023, HANSIZHUANG’s Marketing Authorization Application (MAA) for ES-SCLC has been validated by the European Medicines Agency (EMA). Moreover, Henlius has initiated a head-to-head bridging trial in the United States to compare HANSIZHUANG to standard of care atezolizumab (anti-PD-L1 mAb) for the first-line treatment of ES-SCLC to further support the Biologic License Application (BLA) in the U.S. Henlius is also advancing HANSIZHUANG-based tumour immuno-combination therapies and has initiated over 10 clinical trials worldwide.
In 2023, the company achieved a number of milestones in business development, boosting new vitality in global expansion for its products. During the reporting period, Henlius earned approximately RMB841.4 million in overseas licensing and other revenues, an increase of 56.0% YoY. In 2023, the company reached commercialization collaboration with Boston Oncology for HANLIKANG in 16 Middle East and North Africa (MENA) countries. Moreover, the company expanded its collaboration with KGbio to commercialize HANSIZHUANG in 12 MENA countries. It also deepened collaboration with Intas to commercialize HANSIZHUANG in over 50 countries in Europe and India. Up to now, the company has collaborated with international partners such as Accord, Abbott, Eurofarma, Elea and KGbio to globalize its 8 products including HANLIKANG, HANQUYOU and HANSIZHUANG, covering mainstream biopharmaceutical markets in Europe, the United States, and numerous emerging markets, further expanding its global presence.
Charting innovation and improving global supply with enhanced quality and efficiency
As an innovative global biopharma company, Henlius has always been guided by clinical needs and collaborated with its global innovation centres and product development teams to continuously boost innovation and build up a high-quality, affordable and differentiated pipeline to effectively meet the needs of patients and the market. Currently, its product pipeline covers more than 50 molecules including mAb, antibody-drug conjugate (ADC), fusion protein, and small molecule drug, and has conducted over 30 clinical studies for 16 products worldwide.
In 2023, the company has accelerated many international multi-centre phase 3 clinical researches of HANSIZHUANG, HLX11 (pertuzumab biosimilar), HLX14 (denosumab biosimilar) and HLX04-O (anti-VEGF mAb), with plans to submit marketing applications worldwide in 2024. On the other hand, the latest clinical results for HANSIZHUANG, HLX208 (BRAFV600E small molecule inhibitor), HLX07 (anti-EGFR mAb), HLX22 (anti-HER2 mAb), HLX26 (anti-LAG-3 mAb), HLX42（EGFR ADC）and HLX43（PD-L1 ADC）have been presented to global academic community, including Nature Medicine, Cancer cell, 2023 ASCO (Free ASCO Whitepaper), 2023 ESMO (Free ESMO Whitepaper), 2023 ESMO (Free ESMO Whitepaper) Asia and gained wide recognition.
Moreover, the company is actively exploring novel targets and mechanisms, constantly expanding into more disease areas and molecular types, so as to accelerate the development of innovative medicines to address complex diseases. Henlius is promoting a number of potential first/best-in-class products, including HLX42 , HLX43 , HLX6018 (anti-GARP/TGF-β1 mAb) and HLX99 (polypharmacology) to enter into clinical/clinical registration filing stage. The company has successfully obtained breakthrough therapy designation (BTD) and fast track designation (FTD) for a number of products. The company is also accelerating the introduction of innovative products that have multiplier effects with its existing pipeline to drive growth, and has recently acquired the China rights of a novel endocrine therapy for breast cancer, lasofoxifene, which is currently in global phase 3 clinical development, bringing more effective and targeted solutions to more patients.
In 2023, Henlius continued building an integrated and comprehensive production platform, enhancing its global supply system to support the company’s worldwide commercial layout and to provide inclusive healthcare for patients. The company currently has three manufacturing facilities: Shanghai Xuhui Facility, Songjiang First Plant and Songjiang Second Plant. The current commercial capacity is 48,000 litres, enabling stable supply to markets beyond China, including Europe, Southeast Asia and Latin America. In 2023, the Songjiang Second Plant completed the construction and validation of two major buildings and the first engineering run. Henlius benchmarks the highest international standards to construct its quality management system. It has passed nearly one hundred on-site inspections and audits conducted by regulatory authorities and international business partners. Both Xuhui Facility and Songjiang First Plant have been granted with China and the EU GMP certificates. In 2023, the company’s manufacturing facilities successively obtained GMP certificates from PIC/S member Indonesia and Brazil for products including HANQUYOU, HANSIZHUANG, and HANLIKANG, and were granted EU GMP certificate for the production lines of HANSIZHUANG. Additionally, the Songjiang First Plant received the Pre-License Inspection (PLI) conducted by the U.S. FDA for the production line of HANQUYOU.
Adhering to patient-centricity, Henlius will further strengthen its commercialization capabilities as a biopharma, deepen its global strategic presence, drive high-quality innovation, and continue to improve the quality and efficiency of its manufacturing operations, so as to achieve a leap from rapid growth to high-quality development, enabling more high-quality innovative outcomes to benefit more patients worldwide.