China-based Henlius (HKG: 2696) has announced its annual results for 2022, revealing that revenues reached RMB 3.214 billion (USD 466.5 million), representing a remarkable increase of 91.1% year-on-year (YOY). This growth was driven by the successive commercialization of various products, with the company currently having launched five products in China and one product approved in overseas markets, totaling 18 indications approved worldwide.
Focus on Differentiated Innovation and R&D Investment
Henlius remains committed to achieving differentiated innovation to accelerate the development of its product pipeline. In 2022, the company’s research and development expenditure reached approximately RMB 2.183 billion (USD 316.9 million), underscoring its dedication to advancing new therapies and enhancing its market position.
Sales Performance Amidst Epidemic Challenges
Despite the impact of epidemic restrictions in China, Henlius generated sales revenues of RMB 2.675 billion (USD 388.3 million) last year, marking a 79.0% increase YOY. This strong performance provided a significant impetus for R&D, manufacturing, and commercialization efforts. Notably, Henlius’s core anti-tumor product, Hanquyou (trastuzumab), achieved domestic sales of RMB 1.695 billion (USD 246 million), reflecting a 95.4% increase YOY.
Launch of Hansizhuang and Regulatory Progress
The programmed death-1 (PD-1) inhibitor Hansizhuang (serplulimab) was launched in China in March 2022, generating total sales revenue of RMB 339.1 million (USD 49.2 million) within nine months of its launch. The molecule has been approved for three indications locally and is currently under review by the European Medicines Agency (EMA) as a first-line treatment for extensive-stage small cell lung cancer (ES-SCLC). Henlius plans to submit a Biologics License Application (BLA) for Hansizhuang in the US in 2024, and a New Drug Application (NDA) for the drug as a first-line treatment in esophageal squamous cell carcinoma (ESCC) has been accepted by China’s NMPA.
Growth in Collaborations and Licensing Revenue
In 2022, Henlius achieved a new high in business collaborations, obtaining overseas licensing and other revenue worth RMB 539.3 million (USD 78.2 million), an increase of 188.3% YOY. The company partnered with Organon, Abbott, Getz Pharma, Eurofarma, and Fosun Pharma to accelerate the overseas commercialization of products such as Hansizhuang, Hanquyou, Hanlikang, Handayuan, Hanbeitai, HLX11, and HLX14. Upfront payments from overseas licensing totaled RMB 1.5 billion (USD 217.7 million), with underlying deals valued at up to USD 1.446 billion.
Future Outlook for Henlius
Looking ahead, Henlius will continue to strengthen its commercialization efforts, improve innovation efficiency, and optimize long-term planning for its three manufacturing facilities, evolving towards a sustainable and integrated biopharmaceutical enterprise.-Fineline Info & Tech
