The global commercial strategy for HENLIUS's key oncology drug is progressing rapidly, with its value increasingly recognized in international markets.
At the recent "First Gastric Cancer Perioperative Immunotherapy Innovation Conference," Zhu Jun, Executive Director and CEO of HENLIUS, stated in his address: "HENLIUS has long been deeply committed to high-incidence disease areas such as oncology. Today, we have successfully brought a perioperative immunotherapy regimen for gastric cancer directly to patients. In the past, gastric cancer patients bore a heavy burden of chemotherapy; now, perioperative patients can achieve 'high-quality chemotherapy de-escalation,' moving towards a new stage of long-term survival."
During the conference, the ASTRUM-006 study garnered widespread attention. This randomized, double-blind, placebo-controlled, multicenter Phase III clinical trial addresses the clinical challenges of poor tolerance and low completion rates associated with traditional post-operative chemotherapy. Targeting the immunologically favorable population with PD-L1 CPS≥5, the study employs a pre-operative regimen of immunotherapy combined with chemotherapy to achieve tumor killing and immune activation. Post-operatively, it innovatively implements a "chemotherapy-free" approach. This strategy not only significantly improves survival benefits but also achieves the dual goals of reducing treatment-related toxicity and improving patients' post-operative quality of life and treatment adherence. Furthermore, it lowers the medical economic burden associated with chemotherapy and its necessary supportive care.
Based on the groundbreaking results of the ASTRUM-006 study, serplulimab (H drug) received approval in China this June for the perioperative treatment of gastric cancer. It has become the world's first and only anti-PD-1 monoclonal antibody approved for this specific use, filling a long-standing clinical gap in this field. Currently, serplulimab is approved for marketing in over 50 countries and regions worldwide, including China, the United Kingdom, the European Union, and several Southeast Asian nations and emerging markets. It has been included in the national health insurance or public payment systems in more than 10 countries, such as the UK, Austria, Denmark, Germany, Ireland, Italy, Spain, and Sweden, gaining access to mainstream local healthcare systems. It is poised to become the next domestically developed innovative drug to achieve global annual sales exceeding 10 billion RMB.
A representative from HENLIUS indicated that the company is comprehensively advancing its Globalization 2.0 strategy. This involves a strategic leap from a singular "product going global" model to a full industrial chain "system going global" approach. The company will continue to deepen its differentiated pipeline of cutting-edge therapies and build a sustainable, replicable model for international growth. Aligned with its 2030 vision, HENLIUS aims to usher in an era as a C-MNC (China-headquartered Multinational Corporation) biopharmaceutical enterprise. Its goals include striving for the global launch of over 20 products, with more than 15 of them entering markets in Europe and the United States.
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