HENLIUS: Earnings Exceed Expectations, Pipeline and Performance Set for Dual Gains

Deep News
Yesterday

HENLIUS has announced its full-year 2025 results, which surpassed market expectations. The company reported total revenue of RMB 66.666 billion, representing a year-on-year increase of 16.5%. Net profit reached RMB 8.270 billion. Annual research and development expenditure amounted to RMB 24.919 billion, a significant increase of 35.4% year-on-year. Despite the substantial increase in innovation investment, profit before R&D expenses reached RMB 23.425 billion, up 26.2% year-on-year. Since first achieving full-year profitability in 2023, the company has delivered three consecutive years of growth in both revenue and profit, demonstrating resilient profitability and high-quality growth capabilities.

The company's global product revenue rose to RMB 57.746 billion in 2025, a 17.0% increase year-on-year. Overseas revenue saw robust growth, exceeding RMB 200 million with a doubling year-on-year increase, as the value of overseas revenue from core products serplulimab and trastuzumab accelerated. Overseas product profit reached RMB 93.9 million. Domestically, trastuzumab generated revenue of RMB 2.809 billion, up 4.3% year-on-year. Serplulimab achieved revenue of RMB 1.440 billion, an increase of 10.0% year-on-year. Rituximab contributed revenue of RMB 590 million. Bevacizumab revenue was RMB 356 million, surging 80.8% year-on-year. Neratinib generated revenue of RMB 301 million. This sustained performance highlights the company's strong commercialization capabilities in breast cancer and lung cancer, with future strategic growth expected from the launch of major new products.

Progress on core products is advancing well, enhancing visibility in the broad international market. A Phase II trial for the core PDL1 ADC product in later-line non-small cell lung cancer is currently underway. As of February 2026, 140 patients had been enrolled globally, with 58 from overseas. In March 2026, the company announced the initiation of an international Phase II/III multicenter clinical study for this PDL1 ADC in squamous NSCLC. This study is planned to proceed to Phase III following discussions with the FDA, potentially becoming the first key registrational study for HLX43 in lung cancer. Another core asset, Dulpatatug (HLX22), is progressing through a Phase III trial for first-line HER2-positive gastric cancer. By February 2026, 282 patients were enrolled globally, including 80 from overseas, with key data readout anticipated in the first half of 2027.

A recent business development deal for its PD-1 antibody exceeded expectations. On February 5th, the company out-licensed the Japanese rights for its PD-1 to Eisai, with an upfront payment of $75 million and a potential total deal value nearing $400 million. The value is underpinned by the PD-1's potential in three major indications: first-line small cell lung cancer, perioperative gastric cancer, and first-line metastatic colorectal cancer. This PD-1 has the potential to become the first PD-(L)1 therapy combined with VEGF for first-line metastatic colorectal cancer, with results from a multi-regional clinical trial expected in 2027.

The early-stage pipeline is becoming increasingly robust. Assets such as a PD-L1xVEGF bispecific antibody, a DLL3xDLL3xCD3xCD28 T-cell engager, a B7H3-sialidase fusion protein, a KAT6 A/B inhibitor, a cMetxEGFR bispecific ADC, and a STEAP1xCD3xCD28 T-cell engager are rapidly advancing towards the IND application stage, strengthening the company's research pipeline.

Potential risks include product sales falling short of expectations, volume-based procurement risks, policy risks, clinical trial risks for innovative drugs, operational risks, and subjective estimation risks.

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