On August 21, Henlius (2696.HK) was invited to participate in the 2025 Evercore China Biotech Summit. Organized by the leading independent investment bank Evercore, the summit gathered leaders from the biopharmaceutical industry, investment institutions, and innovative companies across Europe, the U.S., and the Asia-Pacific region to explore trends in global drug development and investment opportunities. Dr. Jason Zhu, Executive Director and CEO of Henlius, reviewed the company’s 15-year journey and shared its strategic blueprint for the future. Henlius is evolving from its "1.0 era" focused on biosimilars to the "2.0 era" of innovation-driven globalization, building itself into a competitive international biopharma.
Dr. Zhu highlighted that since its founding in 2010, Henlius has remained committed to its patient-centric mission and achieved breakthroughs in key markets such as China, the U.S., and Europe. To date, six products have been approved in China and four have gained approvals overseas, covering more than 50 countries and regions including the U.S., Europe, and India, benefitting over 850,000 patients. He emphasized that Henlius has gradually developed five core capabilities—early-stage R&D, clinical development, international-standard CMC, global regulatory expertise, and commercialization networks—that are driving the company into its "2.0 era". With a diverse pipeline spanning monoclonal antibodies, bispecifics, ADCs, fusion proteins, and small molecules, Henlius is focused on "biosimilars + innovation + globalization". The company is strategically advancing differentiated innovations in high-incidence cancers such as lung, breast, and gastrointestinal cancers, aiming to develop more potential first-in-class therapies.
HLX43 is Henlius' innovative broad-spectrum anti-tumour ADC with dual mechanisms of checkpoint blockade and cytotoxic payload delivery. Preclinical studies demonstrated marked efficacy and good tolerability across multiple tumour types resistant to PD-1/PD-L1 antibodies, including non small cell lung cancer (NSCLC), cervical cancer, and esophageal squamous cell carcinoma (ESCC). According to the abstract released for WCLC, the phase 1 study of HLX43 showed sustained high response rates in advanced solid tumours, particularly in heavily pretreated NSCLC patients who failed checkpoint inhibitor (CPI) therapy. Notably, in the EGFR wild-type non-squamous NSCLC (nsNSCLC) subgroup, HLX43 achieved an ORR of 47.4%, while maintaining a favourable safety profile. Importantly, HLX43 demonstrated consistent efficacy across PD-L1 positive, negative, and unknown subgroups, highlighting its biomarker-independent potential.
Henlius' self-developed anti-PD-1 monoclonal antibody serplulimab is the world's first PD-1 inhibitor approved for first-line treatment of extensive-stage small cell lung cancer (ES-SCLC), with approvals in nearly 40 countries including China, the UK, Germany, India, Indonesia, and Singapore. To date, serplulimab has been approved for squamous NSCLC, ES-SCLC, ESCC, and nsNSCLC. Globally, Henlius is conducting more than 10 clinical studies of serplulimab-based immunotherapy combinations, covering high-incidence indications such as perioperative gastric cancer, limited-stage SCLC, and metastatic colorectal cancer.
In breast and gastrointestinal cancers, Henlius is advancing HLX22, a novel epitope HER2 expected to complement existing therapies and bring more options to HER2-positive patients. HLX22 received orphan drug designation from both the U.S. FDA and the European Commission in 2025 for gastric cancer. Its global phase 3 head-to-head study (HLX22-GC-301), comparing HLX22 plus chemotherapy with or without pembrolizumab against standard of care (trastuzumab + chemotherapy ± pembrolizumab), is ongoing in China, Australia, the EU, Japan, the U.S., and South America. The first patient has been dosed in China, Japan, Australia, and South Korea, and trial approvals have also been obtained in Chile, Brazil, and Argentina. Recently, Henlius also launched a phase 2 trial of HLX22 plus T-DXd in HER2-low, HR-positive breast cancer, with the first patient dosed in China.
From "1.0" to "2.0", Henlius is accelerating growth with continuous innovation and a globalization strategy. With solid commercialization foundations and forward-looking pipeline development, the company is steadily advancing toward becoming an innovation-driven global biopharmaceutical enterprise. "Our goal is not only to bring medicines to more countries, but also to deliver the values, standards, and responsibilities of China's innovations to the global market," Dr. Zhu emphasized. "Henlius will continue to uphold international standards and create greater value worldwide with high-quality original biologics from China."