Shanghai, China, March 4^th, 2024 – Henlius (2696.HK) released a positive profit forecast. Based on the preliminary assessment of the unaudited consolidated management accounts for the year ended 31 December, 2023 (the “Reporting Period”) and the information currently available to the Board, it is expected that the company will record a profit for the year of no less than RMB500 million for the Reporting Period. This is the first time for Henlius to achieve full-year profits following the company’s achievement of its first half-year profits for the six months ended 30 June 2023. The full year of profitability is primarily contributed by the continuous growth in sales revenue of the company's core products HANQUYOU and HANSIZHUANG, as well as cost reduction and efficiency improvement through refined management.

Wenjie Zhang, Chairman and Executive Director of Henlius, said: “2023 is a milestone as we reported a full-year profit for the first time. Benefiting from the efficient synergy and cumulative effects of an integrated industrial chain of R&D, manufacturing, and commercialization, the company has improved its decision-making efficiency and speed-to-market, achieving a leapfrog development. Looking ahead, we will continue to improve quality, make new breakthroughs in our journey of quality development, and reach out toward new horizons.”

Jason Zhu, Executive Director, Chief Executive Officer and Chief Financial Officer, said: “Henlius has always been guided by clinical needs and adheres to an innovation-driven development strategy. We maintain strategic focus and strengthen our own differentiated advantages under challenging circumstances, achieving milestone breakthroughs in various areas, and driving a rapid growth. Standing at a new starting point for development, we will draw a new blueprint for growth and collaborate with partners along the industry chain to benefit more patients.”

Hitting a record high by efficient and seamless collaboration

In 2023, Henlius further enhanced its self-sufficiency capabilities. Leveraging a forward-looking commercial layout and efficient market expansion, the company continuously advanced its product commercialization, improving product accessibility to maximize patient benefit. The competitiveness of the company’s two core products has continued to improve both domestically and internationally, which drives the revenue significantly and contributes to the high-quality development of the company.

HANQUYOU (trastuzumab, trade name in Europe: Zercepac^®; trade names in Australia: Tuzucip^® and Trastucip^®), the first China-developed monoclonal antibody biosimilar approved both in China and Europe, is indicated for the treatment of HER2 positive early breast cancer, metastatic breast cancer and metastatic gastric cancer. HANQUYOU has become the China-developed biosimilar with the most marketing approvals, covering over 40 countries and regions up to now, including China, the UK, Switzerland, Australia, Singapore, Thailand, Argentina, Brazil, and Saudi Arabia. With its differentiated advantages such as dual dosage of 150mg and 60mg, preservative-free formulation, the product has rapidly expanded its market share in China, benefiting more than 170,000 Chinese patients to date. Notably, the Biologics License Application (BLA) for HANQUYOU has been accepted by the U.S. Food and Drug Administration (FDA) in the first half of 2023, which makes HANQUYOU potentially the first Chinese biosimilar approved in China, the EU, and the U.S. Furthermore, its New Drug Submission (NDS) was accepted by the Health Canada in July 2023, further expanding the product’s footprint in major markets of biologics in the U.S. and Europe.

HANSIZHUANG (serplulimab), the first anti-PD-1 monoclonal antibody (mAb) developed by Henlius, was launched in March 2022. Up to date, it has been approved for the treatment of MSI-H solid tumors, squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC) and esophageal squamous cell carcinoma (ESCC). It is also the world's first anti-PD-1 mAb for the first-line treatment of small cell lung cancer (SCLC). In December 2023, the 5th NDA of HANSIZHUANG for the first-line treatment of non-squamous (NSCLC) was accepted by the National Medical Products Administration (NMPA), with approval expected in the second half of 2024. With its breakthrough efficacy and differentiated advantages in the relevant treatment fields, HANSIZHUANG has earned wide recognitions and has increasingly strengthened its market competitiveness and influence. To date, it has completed tendering process on the procurement platform in all provinces of Chinese mainland and has been included in over 70 provincial/city-level supplementary commercial medical insurances, benefiting more than 55,000 patients. Additionally, Henlius has collaborated with many world-renowned pharmaceutical companies to further expand HANSIZHUANG’s global footprint, which now includes the U.S., Europe, Southeast Asia, MENA, and India. In December 2023, HANSIZHUANG was approved for marketing in Indonesia, becoming the first China anti-PD-1 mAb successfully approved in Southeast Asia. On the other hand, 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 BLA in the U.S., which encourages more Chinese medicines to go global.

Accelerating the pace to meet the clinical needs in a multi-dimensional manner

Innovation is the cornerstone of Henlius for its sustainable development. We deliver on the commitment to patient centricity and continuously deepen and implement the differentiated innovation strategy to build a diversified and high-quality product pipeline and accelerate the translation of research results to market and practice. Currently, our product pipeline includes about 60 molecules across mAb, polyclonal antibody (pAb), antibody-drug conjugate (ADC), fusion protein, and small molecule drug, of which more than 80% are self-developed. In 2023, the company accelerated global multicentre phase 3 clinical studies for marketed or late clinical-stage products, including HANSIZHUANG, HLX11 (pertuzumab biosimilar), HLX14 (denosumab biosimilar) and HLX04-O (anti-VEGF mAb), with the first patients dosed in the U.S., the EU and other countries and regions. Meanwhile, the company is actively exploring novel targets and molecular mechanisms in more disease areas, promoting a number of potential first/best-in-class products, including the novel EGFR-targeting ADC HLX42 and PD-L1-targeting ADC HLX43, to enter into the phase 1 clinical research. The company has successfully obtained breakthrough therapy designation (BTD) and fast track designation (FTD) for a number of products, further accelerating its innovation layout.

As a global biopharmaceutical company, Henlius has continued to improve and enhance its large-scale production capabilities by establishing three production facilities, namely Xuhui Facility, Songjiang First Plant and Songjiang Second Plant, to form synergy and develop scale effects. The current commercial production capacity is 48,000 litres, enabling stable supply to markets beyond China, including Europe, Southeast Asia and Latin America. In 2026, the total production capacity is expected to reach 144,000 liters, laying a solid foundation for company's medium to long-term global commercial production and business development. In 2023, Henlius’ commercial production facilities and supporting quality management system have undergone/passed intensive on-site inspections and audits conducted by regulatory authorities and international business partners, including the U.S., the EU, PIC/S members Indonesia and Brazil, and Columbia, promoting the global launch of more products, thus benefiting more patients across the world.

Going forward,  Henlius will continue to strengthen its innovation capabilities, fully enhance productivity, improve commercialization efficiency, to consolidate positive growth, create diversified growth engines, and pursue a higher-quality development path.