Henlius Reports 2026 Interim Results: Serplulimab Becomes First Anti-PD-1 mAb Approved for Perioperative Gastric Cancer
核心洞察
Henlius reported first-half 2026 revenue of RMB 3.5882 billion, up 27.3% year-over-year, with net profit of RMB 430.4 million, up 10.3%.
Serplulimab received NMPA approval in June 2026 as the world's first and only anti-PD-1 (搜索) monoclonal antibody for perioperative gastric cancer (搜索) treatment.
Ex-China product sales surged 159.4% year-over-year to RMB 105.3 million, reflecting accelerating global commercialization under the company's Globalization 2.0 strategy.
Shanghai Henlius Biotech, Inc. (2696.HK) announced its interim results for the 2026 fiscal year on August 21, reporting revenue of RMB 3.5882 billion, a 27.3% increase year-over-year, and net profit of RMB 430.4 million, up 10.3% year-over-year. The company reported non-IFRS profit of RMB 572.3 million, a 46.7% year-over-year increase, and adjusted EBITDA of RMB 904.1 million, rising 35.2% year-over-year.
Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius, stated: "2026 marks a pivotal year of acceleration in Henlius' journey toward becoming a C-MNC. In the first half of the year, our core products continued to generate tangible value through global commercialization, while multiple differentiated pipeline assets entered critical stages of value validation."
Global Commercialization and Core Portfolio Growth
As of the reporting period, Henlius has 10 products approved in over 60 countries and regions across Asia, Europe, Latin America, North America, and Oceania, benefiting over 1.1 million patients worldwide. Global product sales revenue amounted to RMB 2.9386 billion, up 14.9% year-over-year. Notably, sales revenue from ex-China markets increased significantly by 159.4% year-over-year to RMB 105.3 million, while product profit from ex-China markets reached RMB 59.5 million, more than four times that of the same period last year.
In the breast cancer (搜索) therapeutic area, global sales revenue reached RMB 1.6983 billion during the reporting period. The four marketed products collectively delivered strong volume growth, with HANQUYOU (trastuzumab), HANBEIYOU (pertuzumab), HANNAIJIA (neratinib), and fovinaciclib generating sales revenues of RMB 1.4844 billion, RMB 7.7 million, RMB 195.5 million, and RMB 10.7 million, respectively.
In the first half of 2026, HANBEIYOU received sequential marketing authorizations from the European Commission and China's NMPA, marking it as the first and only Chinese-developed pertuzumab biosimilar approved across all three major markets—China, the U.S., and the EU. In combination with HANQUYOU, it establishes the first Chinese-developed dual HER2 (搜索)-targeted regimen combining trastuzumab and pertuzumab approved in China, the U.S., and the EU, spanning the treatment continuum from neoadjuvant setting to first-line treatment of advanced disease.
Serplulimab: A First-in-Class Regulatory Milestone
Serplulimab (Hetronifly in Europe) recorded global sales revenue of RMB 0.5975 billion in the first half of 2026. In June, the product received approval in China for the perioperative treatment of gastric cancer (搜索) through a priority review pathway, becoming the first and only anti-PD-1 (搜索) monoclonal antibody globally to be approved for this indication and thereby addressing a significant unmet need in this treatment setting.
In terms of international expansion, serplulimab has secured marketing approvals in over 50 countries and regions. During the reporting period, it obtained approvals for three additional first-line indications—non-squamous non-small cell lung cancer (搜索) (nsqNSCLC), esophageal squamous cell carcinoma (ESCC), and squamous non-small cell lung cancer (sqNSCLC) in the EU—and has been incorporated into the national healthcare or public reimbursement systems of 12 European countries, including the United Kingdom, Germany, Italy, Spain, and Sweden.
HANBEITAI (bevacizumab), another key oncology product, generated sales revenue of RMB 0.2182 billion in the first half of the year, up 87.6% year-over-year, with a decision on its Biologics License Application expected in the second half of 2026.
Innovation Pipeline and R&D Investment
R&D expenditure reached RMB 1.4507 billion during the reporting period, representing a 45.7% year-over-year increase. The company has established multiple technology platforms—next-generation IO, Hanjugator ADC, multi-specific T-cell engager (TCE), and AI—with more than 50 early-stage pipeline molecules in reserve, covering therapeutic areas including oncology, immunology and inflammation, neuroscience, and metabolism diseases.
As a potential best-in-class broad-spectrum anti-tumor PD-L1 ADC, HLX43 has demonstrated encouraging preliminary efficacy and a favorable safety profile across multiple solid tumors, including NSCLC. Its phase 2 and phase 2/3 international multi-center studies in NSCLC are advancing across regions including China, Europe, the United States, Japan, and Australia. To date, the company has initiated more than ten clinical studies of HLX43 as monotherapy or in combination regimens, with over 1,500 patients enrolled globally.
Dulpatatug (搜索) (HLX22), a novel-epitope monoclonal antibody targeting HER2 (搜索), is making steady progress in an international multi-center phase 3 clinical study featuring a head-to-head comparison against the current first-line standard of care for HER2-positive gastric cancer (搜索). First patient enrollment has been completed across a broad geographic footprint, including China, the U.S., Europe, Japan, Australia, South Korea, and Latin America.
Globalization 2.0 and Strategic Collaborations
Since the start of 2026, the company has announced three major international strategic collaborations in succession. In high-value mature markets, the company entered into an agreement with Eisai Co., Ltd., granting Eisai exclusive commercialization rights for serplulimab in Japan. To accelerate its presence in emerging markets, the company formed a strategic collaboration with Abbott to expand serplulimab's commercial footprint across Asia-Pacific, Africa, Central Asia, and Eastern Europe. To maximize the global potential of its biosimilar portfolio, the company established a broad-based strategic partnership with Sandoz, covering up to ten biosimilar products.
On clinical development and regulatory affairs, the company received 32 new clinical trial approvals and 25 marketing authorizations worldwide during the reporting period, covering nearly 50 countries and regions. To date, the company has completed more than 1,400 GMP commercial production batches and successfully passed over 100 on-site inspections and audits conducted by regulatory authorities worldwide and international collaborators, with a 100% pass rate.
Looking toward 2030, Henlius aims to bring 10 new products to markets worldwide, with over 5 expected to reach European and U.S. markets, accelerating its journey toward becoming a China-headquartered multinational biopharmaceutical company (C-MNC).