Shanghai, China, August 26, 2024 – Henlius (2696.HK) announced its 2024 interim results. During the reporting period, Henlius’ revenue reached about RMB2.7461 billion, representing an increase of 9.8% YoY, and recorded a net profit of RMB386.3 million, up by 61.0% YoY. The solid and sustained profitability is due to increasing commercial sales of the company’s core products, which reached approximately RMB2.4794 billion. HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac^® in Europe) and HANSIZHUANG recorded sales of RMB1.4743 billion and RMB677.8 million, respectively. Meanwhile, the company accelerates the expansion of its global commercial footprint, unleashing the potential of overseas markets to promote its long-term high-quality development.

‍‍‍Up to date, Henlius has 6 products launched in China, 3 approved for marketing in overseas markets, 24 indications approved worldwide, benefiting over 600,000 patients and reaching 48 markets in Asia, Europe, Latin America, North America and Oceania. During the reporting period, the company submitted approximately 80 drug registrations, and received more than 60 approvals in China, the U.S., EU, Canada, Indonesia and Japan. Meanwhile, the company stays focused on differentiated innovation to accelerate the development of products in its pipeline. Currently, its product pipeline covers more than 50 molecules and 14 R&D platforms with the forms of drug covering mAb, pAb, antibody-drug conjugate (ADC), fusion protein, and small molecule drug, etc.

‍Wenjie Zhang, Chairman and Executive Director of Henlius, said:" In the first half of 2024, we have received impressive results based on our well-established commercial strategy and layout. Following the first time full-year profits in 2023, we achieved sustainable profitability and steady growth, opening a new chapter of high-quality development. Looking forward, we will further promote differentiated innovation and proactively respond to external changes. Meanwhile, we will continue to advance lean management and operations to solidify our leading position, progressing towards an innovative global biopharmaceutical company with a focus on high-quality development."

Jason Zhu, Executive Director and Chief Executive Officer of Henlius, said:" Innovation and globalisation are two core strategies propelling us along the journey of addressing unmet clinical needs. In the first half of 2024, we have been actively expanding our global footprint with significant milestones achieved on our way of going abroad. Meanwhile, our innovation landscape has rapidly expanded, further strengthening our differentiated innovations. In the future, we will adhere to patient-centricity and stay committed to providing high-quality and innovative therapies to benefit more patients worldwide."

Global Expansion: Swift Overseas Commercialisation & Vast Market Opportunities

In the first half of 2024, Henlius continued to efficiently drive the integrated development of research, production, and commercialisation, while constantly improving commercial operational efficiency. Through multi-faceted measures such as improving product accessibility and exploring diversified business models, the company fostered the commercial growth of its core products, achieving sustained high-quality profitability. Furthermore, the company has achieved notable milestones in its global market expansion endeavors, with approvals and successful commercialisation across various markets infusing fresh momentum into the growth of its overseas presence. During the period, Henlius’ five products reached total sales revenue of approximately RMB2.4794 billion, up by 15.2% YoY. HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac^® in Europe), HANSIZHUANG (serplulimab), and HANBEITAI (bevacizumab) recorded sales of RMB1.4743 billion, RMB677.8 million and RMB86.7 million, respectively. In addition, the company received sales revenues of RMB227.0 million and RMB13.6 million based on the collaboration with partners for HANLIKANG (rituximab) and HANDAYUAN (adalimumab), respectively.

Henlius' core oncology product HANQUYOU maintains a positive growth momentum. During the reporting period, HANQUYOU has recorded a global sales revenue of RMB1.4743 billion, up by 15.5% YoY. To date, HANQUYOU has been approved in 48 countries and regions around the world, covering Asia, Europe, Latin America, North America, and Oceania, making it the China-developed monoclonal antibody (mAb) biosimilar with the most marketing approvals, benefiting more than 200,000 patients. From which, HANQUYOU recorded domestic sales of RMB1.4062 billion, representing growth of 13.5%, further expanded its market share in China. Due to its differentiated clinical advantages and international recognised quality, HANQUYOU has been widely used in clinical practice and achieved rapid market acceptance, making it the leading brand of trastuzumab in China. Moreover, Henlius has proactively pursued overseas commercialisation of HANQUYOU, overseas revenue from product sales recorded RMB68.2 million approximately, up by 79.1% YoY. In April 2024, it received marketing approval from the U.S. Food and Drug Administration (FDA), making it a China-developed mAb biosimilar approved in China, the EU, and the U.S. In June 2024, HANQUYOU made its first delivery to Saudi Arabia，poised to be the first Chinese mAb to enter the Middle Eastern market. As of August 2024, the overseas commercialisation of HANQUYOU managed to include the markets of the U.S., Canada, the Philippines, Brazil, Uzbekistan and Turkmenistan, bringing more benefits to patients.

HANSIZHUANG is the world’s first anti-PD-1 mAb approved for the first-line treatment of small cell lung cancer (SCLC), has been launched in China, Indonesia, Cambodia and Thailand. During the reporting period, HANSIZHUANG has recorded a sales revenue of RMB677.8 million, representing an increase of 21.8% YoY. Up to now, it has been approved for 4 indications, broadly covering high-incidence tumours including lung cancer and gastrointestinal cancer, benefiting over 7,5000 patients. 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), and expected to be approved in the second half of 2024. On the other hand, overseas sales revenue and licensing of HANSIZHUANG recorded RMB75.2 million approximately. 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, making it the first China anti-PD-1 mAb successfully approved for marketing in Southeast Asia. In the first quarter of 2024, Henlius has finished the first international shipment of HANSIZHUANG, opening a new chapter in benefiting patients worldwide with this product. HANSIZHUANG’s Marketing Authorisation Application (MAA) for ES-SCLC has been validated by the European Medicines Agency (EMA), which is expected to be approved in 2024. The company has also submitted marketing applications for HANSIZHUANG in Singapore and Malaysia to further promote the product in Southeast Asia. Moreover, Henlius steadily advances 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, and plans to submit the Biologic License Application (BLA) of the product in the U.S. in early 2025.

In the first half of 2024, Henlius achieved a number of milestones in business development. Regarding HLX78 (lasofoxifene), the company expanded its collaboration with Sermonix in all of Asia. Additionally, Henlius reached cooperation with Convalife to commercialise neratinib (trade name: HANNAIJIA), which is indicated for extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer, to follow adjuvant trastuzumab-based therapy, further enriching the company’s product pipeline for breast cancer treatment and creating synergy with HANQUYOU. Meanwhile, the company joined hands with international partners such as Accord, Eurofarma, KGbio and Organon to accelerate overseas commercialisation of its products. In the first half of 2024, HANLIKANG, the first biosimilar launched in China, has been approved to be marketed in Peru, which made it the company’s third self-developed and manufactured product breaking into global markets. Furthermore, the marketing application for HLX14 (denosumab biosimilar) has been accepted for review in European Union (EU) in May 2024, and expected to be approved in 2025. The company also plans to submit marketing applications for HLX14 in the U.S., and for HLX11 (pertuzumab biosimilar) in China and the U.S. in the second half of 2024.

Synergistic Growth: Accelerating Innovation & Ensuring Manufacturing Meets International Quality Standards

In the first half of 2024, Henlius hase been continuously advancing its differentiated R&D pipeline with the vision of offering high-quality and affordable innovation products, proactively exploring novel modalities and diverse disease areas. Guided by unmet clinical needs, the company has accelerated the clinical researches of a number of innovative products including HANSIZHUANG (serplulimab), HLX22 (anti-HER2 mAb), HLX42 (EGFR-targeting ADC) and HLX6018 (anti- GARP/TGF-β1 mAb). During the reporting period, the phase 3 international multicenter clinical study (ASTRUM-015) of serplulimab in combination with bevacizumab and chemotherapy indicated for the treatment of metastatic colorectal cancer (mCRC) has been permitted by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and completed dosing of the first subject in China. Meanwhile, a phase 3 international multicenter clinical study of Henlius’ novel anti-HER2 mAb, HLX22, in combination with trastuzumab and chemotherapy for the treatment of HER2-positive advanced gastric cancer has been approved by the U.S. FDA. The latest results for innovative products such as HANSIZHUANG and HLX22 have been presented to global academic community, including Cancer Cell, Med, AACR, ASCO, ASCO GI, ESMO GI, and ENCALS, gaining wide recognition. Moreover, the company has completed the first patient dosing for clinical trials of HLX42, the potential first/best-in-class EGFR-targeting ADC, and of HLX6018, the company’s first novel product in chronic inflammatory diseases area. In addition, the company has received the IND approval for the clinical trial of novel anti-TIGIT fc fusion protein HLX53 in combination with HANSIZHUANG plus HANBEITAI for the first-line treatment of locally advanced or metastatic hepatocellular carcinoma (HCC) from the NMPA, and has completed the first patient dosing for a phase 2 clinical trial.

While boosting innovation, Henlius is steadily consolidating international high quality manufacturing capability to accelerate its global commercialisation layout, translating the R&D efforts into social impact and commercial results. The company currently has three manufacturing facilities: Shanghai Xuhui Facility, Songjiang First Plant and Songjiang Second Plant. Regarding Songjiang Second Plant, the company has completed construction and validation of drug substance (DS), drug product (DP) and prefilled syringes system (PFS) line of the two major manufacturing buildings in the Phase I & II project, and main structural framework was topped out in the Phase III project. Currently, the commercial capacity of the company is 48,000 litres, enabling stable supply to markets beyond China, including Europe, Southeast Asia, Latin America and Middle East. Additionally, the company has always been upholding the highest quality standards, allowing its products to go global. As of now, Henlius’ commercial production facilities and supporting quality management system have also passed nearly one hundred on-site inspections and audits conducted by the NMPA, the EMA, the FDA, the EU Qualified Person (QP), as well as Henlius’ international business partners, and have been GMP-certificated by China, the EU and U.S. regulatory agencies. The company also adopted a series of lean operation projects, optimised production processes, utilized digital technology to empower supply chain, inventory and quality management, putting "affordable innovation, trustworthy quality" into practice.

Focusing on patients unmet clinical needs, Henlius will further strengthen its commercialisation capabilities as a biopharma, improve the operation efficiency of its integrated biopharmaceutical platform, and expand its global presence, enabling high-quality innovative outcomes to benefit more patients worldwide.