SHANGHAI, March 20, 2026 /PRNewswire/ — Henlius (2696.HK) today announced its annual results for the year ended December 31, 2025. During the reporting period, the Company recorded revenue of RMB 6.6666 billion, representing a year-on-year increase of 16.5%, and net profit of RMB 0.8270 billion. Total R&D investment reached RMB 2.4919 billion, an increase of 35.4%. Amid continued investment in innovation, pre-R&D profit grew to RMB 2.3425 billion, up 26.2% year-on-year. This marks the third consecutive year of profitability and sustained growth of revenue since the Company first achieved full-year profitability in 2023, demonstrating resilient and sustainable profitability, alongside high-quality growth.
In 2025, Henlius continued to strengthen its global growth momentum, with global product revenue reaching RMB 5.7746 billion, up 17.0% year-on-year. Driven by sustained ex-China revenue growth from its core products—serplulimab (trade name: Hetronifly® in Europe) and HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe)—as well as the accelerating realisation of licensing payments from strategic partnerships, the Company’s ex-China business expanded significantly. Ex-China product revenue exceeded RMB 200 million in 2025, doubling year-on-year, while ex-China product profit increased to RMB 93.9 million. To date, Henlius has achieved approval for 10 products across 60 countries and regions worldwide, including 7 products approved in China, 4 products approved by the U.S. FDA, and 4 products authorized by the European Commission (EC), benefiting more than one million patients globally.
Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius, commented: “2025 marked not only a pivotal year for Henlius as we advanced into the era of Globalisation 2.0, but also a year in which our innovation pipeline began to deliver meaningful progress. With continued growth in our ex-China business and ongoing pipeline breakthroughs, we remain firmly committed to a first-principles approach to biopharmaceutical innovation—focusing on deeply understanding and addressing fundamental clinical needs. Looking ahead, Henlius will continue to leverage its integrated platform and global operating capabilities to bring more biologics with quality to patients worldwide, delivering on our long-term commitment to patients through robust innovation.”
Product Revenue Reaches New High, Driven by a Synergistic Commercial Portfolio
In 2025, the synergistic contribution from Henlius’ innovative biologics and biosimilars drove total product revenue to a new high.
The Company’s flagship product, serplulimab (trade name: Hetronifly® in Europe), continued to deliver global commercial momentum. During the reporting period, it recorded global sales revenue of RMB 1.4926 billion, representing a year-on-year increase of 13.7%. It received approvals in 2025 in Europe and multiple emerging markets for first-line treatment of extensive-stage SCLC (ES-SCLC), as well as in Indonesia and Thailand for squamous non-small cell lung cancer (sqNSCLC). It has also been included in public reimbursement systems in seven EU countries, including Germany, Italy, and Spain. To date, serplulimab has been approved in over 40 countries and regions worldwide, with continued progress in lung and gastrointestinal cancers, including the potential to set multiple new cancer treatment standards. As the first anti–PD-1 mAb approved globally for first-line treatment of small cell lung cancer, serplulimab is also the first perioperative gastric cancer treatment globally to replace adjuvant chemotherapy with immunotherapy monotherapy. In addition, its international multi-centre phase 3 trial for first-line treatment of metastatic colorectal cancer (mCRC) has completed patient enrolment, with the potential to become the first immunotherapy for first-line treatment of microsatellite stable (MSS) mCRC. With its global commercial potential and differentiated clinical value continuing to expand, Henlius aims to position serplulimab as the next China-developed innovative biologic to surpass RMB 10 billion in annual global sales.
Focusing on broader clinical needs, clinical development and regulatory progress for serplulimab advance with full acceleration across China, the European Union, the United States, Japan, and other emerging markets. In China, the product has been granted Breakthrough Therapy Designation by the National Medical Products Administration for perioperative treatment of gastric cancer. The corresponding marketing application has been accepted and granted priority review, with approval anticipated in the first half of 2026. In parallel, a New Drug Application (NDA) for limited-stage SCLC (LS-SCLC) is planned for submission in China in 2026. In the EU, additional indications—including squamous and non-squamous NSCLC and esophageal squamous cell carcinoma (ESCC)—are expected to receive approval in 2026. In the United States, the bridging study for first-line ES-SCLC has completed enrolment, with a Biologics License Application (BLA) submission planned for 2026.
In 2025, Henlius’ breast cancer franchise maintained strong growth momentum. During the reporting period, global sales revenue from breast cancer products reached RMB …