In a recent announcement, the "2026 China Top 100 Pharmaceutical Innovators" list has been released. HENLIUS (02696.HK) has secured its position on this prestigious list for the sixth consecutive year, solidifying its standing within the premier echelon of innovative pharmaceutical companies in China. This authoritative ranking is based on a comprehensive evaluation framework that assesses a company's innovation foundation, process, and outcomes. The assessment utilizes data on core and peripheral patents for novel drugs, the number of clinical trials conducted, and the quantity of approved and marketed innovative drugs to gauge overall innovation capability.
In recent years, HENLIUS has adhered to a principle-driven approach in its R&D, concentrating on addressing unmet clinical needs. The company's self-developed core innovative product, the anti-PD-1 monoclonal antibody HANSIZHUANG (serplulimab, European brand name: Hetronifly), is the world's first PD-1 inhibitor approved for first-line treatment of small cell lung cancer. It recently achieved another significant milestone by becoming the first anti-PD-1 monoclonal antibody globally approved for the perioperative treatment of gastric cancer. Concurrently, the international multi-center Phase III study of HANSIZHUANG for first-line treatment of metastatic colorectal cancer (mCRC) has completed patient enrollment, positioning it as a potential first-in-class immunotherapy for microsatellite-stable mCRC. To date, HANSIZHUANG has received marketing approvals in over 50 countries and regions, including China, the UK, the EU, Singapore, India, Switzerland, and Peru, covering nearly half of the global population. It has also been included in the reimbursement or public payment systems of more than ten European countries, enhancing global access to high-quality innovative biologics.
While vigorously advancing the global commercialization of its marketed products, the company is accelerating the strategic expansion of its cutting-edge innovation pipeline. Its core innovative asset, the novel-epitope anti-HER2 monoclonal antibody HLX22, has demonstrated significant potential in HER2-positive gastric cancer and may overcome the current limitations in first-line treatment. The PD-L1 ADC HLX43, characterized by high efficacy and low toxicity, is a potential best-in-class and best-in-disease broad-spectrum anti-tumor ADC candidate. Furthermore, the company boasts a portfolio of over 50 early-stage assets and is continuously strengthening its platform-based innovation system. This includes the development of a multi-dimensional technology platform encompassing next-generation IO platforms, the Hanjugator ADC platform, trispecific T-cell engagers, and the AI-driven, integrated early-stage antibody discovery HAI Club platform, thereby solidifying its long-term innovation foundation.
Looking ahead, HENLIUS will remain patient-centric, deepening its focus on critical disease areas such as oncology. The company is committed to accelerating the translation of its pipeline assets and frontier technology platforms into tangible outcomes, aiming to provide more affordable, high-quality biologic medicines to patients worldwide and persistently lead China's pharmaceutical innovation onto the global stage.
HENLIUS is an international innovative biopharmaceutical company dedicated to developing and commercializing high-quality, affordable biologic medicines for patients across the globe, with a portfolio spanning oncology, autoimmune diseases, and ophthalmology. Since its founding in 2010, the company has established a fully integrated platform covering global R&D, clinical development, regulatory affairs, manufacturing, and commercialization. It employs nearly 4,000 people worldwide and maintains operations and branches in China, the United States, Japan, and other locations. Supported by a stable cash flow from its biosimilar business, which in turn fuels innovative R&D, HENLIUS is steadily progressing into its "Globalization 2.0" phase, building a replicable and sustainable global growth model. To date, the company has secured marketing approvals for 10 products in over 60 countries and regions, with 8 approved in China. It has also achieved multiple milestone breakthroughs in major Western markets, with 4 products approved by the US FDA and 5 by the EU EC, demonstrating that its R&D system, quality management, and production capabilities are fully aligned with the highest international standards.
In terms of innovation, HENLIUS leverages a globally coordinated R&D network spanning Shanghai and the United States to build a diversified, platform-based technology matrix. This covers cutting-edge areas such as immune checkpoint inhibitors, immune cell engagers (including multi-specific TCEs), antibody-drug conjugates (ADCs), and AI-driven early-stage discovery platforms. Currently, the company possesses over 50 early-stage innovative assets, approximately 70% of which have best-in-class potential, and is advancing more than 30 clinical studies globally. Its core product, HANSIZHUANG, is accelerating its global footprint following its approval as the world's first anti-PD-1 mAb for first-line SCLC and is now marketed in 50 markets worldwide. Several other promising innovative assets, including the PD-L1 ADC HLX43 and the novel-epitope HER2 mAb HLX22 (generic name: dulpatatug), are advancing comprehensively into global pivotal clinical studies.
Supported by manufacturing facilities certified under GMP standards in China, the EU, and the US, HENLIUS has established a biologics production platform with a total capacity of 84,000 liters, forming a stable global supply network that reaches six continents. Moving forward, HENLIUS will steadfastly uphold its patient-centric mission, focus on unmet clinical needs, and persistently drive the translation of innovative achievements into clinical value and patient access, aiming to create enduring and robust value within the global biopharmaceutical innovation ecosystem.
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