Record-breaking Profits! Henlius Achieves Annual Profit for the First Time

In a significant milestone for Henlius, the pharmaceutical company has announced its first-ever annual profit, surpassing 500 million yuan. This remarkable achievement can be attributed to the continuous growth in sales revenue of their flagship products, Zercepac® and Serplulimab®, as well as the company's focus on cost reduction and operational efficiency. Let's delve into the details of this groundbreaking success.

Henlius's Success Story:

On March 4, 2024, Henlius released a positive profit forecast, estimating that the company's annual profit for the reporting period would exceed 500 million yuan based on unaudited comprehensive management accounts and preliminary evaluation data available to the board of directors. This achievement marks the first time that Henlius has achieved an annual profit, following their initial half-year profit in 2023. The company's success can be primarily attributed to the sustained growth in sales revenue of their core products, Zercepac® and Serplulimab®, as well as their refined management approach focused on cost reduction and operational efficiency.

Rising Sales of Core Products:

Zercepac® and Serplulimab® have emerged as star products for Henlius, driving their success in the pharmaceutical market. Zercepac® is China's first domestically developed biologic drug, a HER2-positive early-stage breast cancer treatment, as well as a treatment for metastatic breast cancer and metastatic gastric cancer. It has obtained market approvals in over 40 countries and regions, including China, the United Kingdom, Switzerland, Australia, and Thailand, making it the domestically produced biologic drug with the most international market approvals. In the first half of 2023, Zercepac® received acceptance of its U.S. market application by the FDA, and its Canadian market registration application was also accepted by Health Canada. These developments are expected to expand Zercepac®'s presence in the mainstream biopharmaceutical markets of Europe and the United States.

Serplulimab®, on the other hand, gained approval in March 2022 and is currently approved for the treatment of microsatellite instability-high (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 the world's first-line treatment for small cell lung cancer with an anti-PD-1 monoclonal antibody. In December 2023, Serplulimab® submitted a market registration application for its fifth indication, the first-line treatment of non-squamous non-small cell lung cancer (nsNSCLC), to the National Medical Products Administration (NMPA) in China. The approval for this indication is expected in the second half of 2024. Serplulimab® has also made significant progress in international markets, with its approval in Indonesia and its application acceptance in the European Union.

Expansion and Diversification:

Henlius's success is not solely reliant on its flagship products. The company has been strategically expanding its product pipeline to include a diverse range of molecules, such as monoclonal antibodies, bispecific antibodies, antibody-drug conjugates (ADCs), fusion proteins, and small molecule drugs. With approximately 80% of its products being developed in-house, Henlius has established a strong foundation for innovation and differentiation.

In 2023, Henlius accelerated the international multicenter Phase III clinical trials of several products, including H drug, HLX11 (a biosimilar of pertuzumab), HLX14 (a biosimilar of trastuzumab), and HLX04-O (an anti-VEGF monoclonal antibody). These products are either already on the market or in advanced clinical stages, and the company aims to gain market approvals in the United States, the European Union, and other countries and regions.

Henlius's achievement of record-breaking profits and its first-ever annual profit of over 500 million yuan is a testament to the success of its core products, Zercepac® and Serplulimab®, as well as its commitment to cost reduction and operational efficiency. With a diversified product pipeline and ongoing international expansion efforts, Henlius is well-positioned to continue its growth trajectory and make a significant impact in the global pharmaceutical market.