News | September 9, 2026

Henlius Open Day 2026: Systematic Global Expansion Drives C-MNC Vision, Innovation Fuels New Peaks

Henlius successfully hosted its Open Day 2026 event with great fanfare. The company's management team gathered together with leading experts and scholars from across the industry to engage in in-depth discussions centered on Henlius's "Globalization 2.0" strategy, the global value of biosimilars, the latest advancements in innovative R&D, future strategic planning, and cutting-edge technology and therapeutic modalities.

Dr. Zhu Jun, Executive Director and Chief Executive Officer of Henlius, stated: "With 4 products approved by the U.S. FDA, 5 approved by the European Commission (EC), and 8 approved by China's NMPA, we have now benefited over 1.1 million patients worldwide. These are not just numbers—they are the fulfillment of our 'patient-centric' commitment. For Henlius, 2026 marks a pivotal year in which our globalization and innovation-driven development continue to advance in depth. From the global footprint of our biosimilars to the steady progress of our innovative pipeline, from the ongoing build-out of our worldwide R&D, manufacturing, and process systems to the expansion of our commercialization capabilities into overseas markets—Henlius is further strengthening the value chain that bridges scientific innovation to product delivery, and global assets to global patients. Looking ahead, Henlius will continue to deepen its efforts in antibody drug R&D, transitioning from 'product going global' to 'system going global,' driving China's innovative pharmaceuticals onto the world stage. We remain committed to making affordable, high-quality biologics accessible to patients around the globe, and to accelerating our journey toward becoming a C-MNC ."

Biosimilars Set Sail for Global Markets at the Right Moment A Three-Phase Roadmap to Worldwide Commercialization
Ms. Cao Ping, Chief Business Development Officer and Senior Vice President of Henlius, shared the company's development milestones and the global competitive advantages of its biosimilars. In her remarks, she stated: "Leveraging our robust CMC and quality control capabilities, Henlius has overcome high-barrier technical challenges such as glycan characterization of biosimilars, achieving a high success rate of 'filing-to-approval' and earning recognition from overseas regulatory authorities through the strength of our products. The company continues to make strides in globally scarce therapeutic areas, including cetuximab and pertuzumab, building a unique competitive moat. With our proven track record of reliable delivery, Henlius has consistently earned deep trust from international industry giants such as Sandoz and Organon. By leveraging the commercialization networks of our global partners, we continue to amplify the commercial value of our biosimilars, providing a steady stream of cash flow to fuel our innovative business pipeline."

Mr. Darius Panaligan, Chief Commercial Officer of Henlius International Markets, presented the company's strategic blueprint for global commercialization: "The global pharmaceutical market is poised for significant opportunities, with prescription drug spending projected to exceed US$2 trillion. Henlius is advancing its global expansion through a three-phase approach: establishing direct market access in the U.S. from 2026 to 2027, expanding into the EU and other high-value markets from 2028 to 2030, and emerging as a global biopharmaceutical leader beyond 2030. We have already built core capabilities in international markets spanning commercial alliances, affiliate commercial operations, market access, commercial strategy, and medical affairs, while developing differentiated strategies tailored to North America, Europe, Latin America, Asia-Pacific, and the Middle East & Africa. We firmly believe that through affordable innovation and trusted quality, Henlius will achieve its strategic goal of transitioning from China to the world and becoming a C-MNC."

Dr. Du Jing, Partner at Boston Consulting Group (BCG), delivered a systematic assessment of the global value proposition of biosimilars. She observed: "The global biosimilar industry is currently experiencing a critical inflection point, as a wave of blockbuster originator drugs approach patent expiries, reinforced by sustained policy tailwinds in both the U.S. and Europe. Market forecasts indicate that the global biosimilar market could surpass US$240B by 2035. With China's inherent cost and efficiency advantages across R&D and manufacturing, the international expansion of Chinese biosimilars is gaining significant momentum. As a frontrunner in China's biosimilar landscape, Henlius has built a differentiated competitive position in the global market through a dual-track strategy that combines partnership-driven overseas expansion with independent commercialization, zeroing in on high-value blockbuster drugs and high-barrier blue-ocean opportunities."

Identifying Unmet Medical Needs: Making Strides in Lung Cancer, Gastrointestinal Malignancies, and Prostate Cancer
Henlius remains closely aligned with key innovation trends in the biopharmaceutical industry, empowering cutting-edge R&D through AI technologies to sharpen its competitive edge. At the event, Dr. Yuan Jijun, Chief Scientific Officer of Henlius, systematically outlined the company's latest early-stage R&D progress and strategic upgrades. He noted that the company has successfully upgraded its technology platforms beyond the three established in 2025, actively expanding its innovation platform matrix to encompass Tri-TCE, Hanjugator™ ADC, multispecific antibodies, and HAI Club, among others, to match the growing demands of its pipeline. To date, multiple product candidates developed from the Tri-TCE and ADC platforms have entered Phase I clinical studies and have demonstrated early potential for best-in-class therapeutic profiles. Concurrently, the ADC platform is advancing both internal and external collaborations in novel toxin discovery and site-specific conjugation technologies, while the multispecific antibody pipeline is extending into non-oncology indications, including autoimmune diseases, thyroid eye disease, and inflammatory bowel disease.

Dr. Yuan emphasized that a single therapeutic mechanism is insufficient to address the complexity of solid tumors, and that synergistic iteration across platforms is key to achieving breakthroughs. The in-house HAI Club AI platform is now deeply integrated into the entire R&D workflow, from target discovery to preclinical candidate compound (PCC) confirmation. Leveraging proprietary local experimental data and internally developed algorithm iterations, it has significantly shortened R&D cycles, improved success rates, and effectively reduced immunogenicity risks. Through a dual-pronged strategy of internal discovery and external collaboration, the company is continuously advancing approximately 10 innovative molecules into the clinic each year, committed to delivering safer and more effective treatment options for patients.

Dr. Wang Qingyu, Chief Medical Officer of Henlius, delivered a presentation titled "The Full Landscape of Innovative Drug Clinical Development," providing a systematic overview of the company's pipeline and clinical progress in lung cancer, gastrointestinal tumors, prostate cancer, and other therapeutic areas. "In lung cancer, Henlius has built a comprehensive portfolio and is exploring combinations of HLX43 (PD-L1 ADC) with serplulimab, HLX37 (PD-L1×VEGF BsAb), HLX48 (c-MET×EGFR BsADC), and HLX903 (EGFR-TKI). In GI tumors, serplulimab and HLX22 are driving clinical research, with serplulimab pioneering a chemotherapy-sparing adjuvant approach in the perioperative treatment of gastric cancer. In prostate cancer, HLX3902 (STEAP1×CD3×CD28 TsAb) is now in clinical stage. Moving forward, Henlius will continue to strengthen combination development, build on serplulimab backbone drug role, and expand HLX37's application in combo therapies."

The Open Day 2026 also featured expert sessions on gastric cancer, prostate cancer, and SCLC, exploring treatment landscapes, unmet needs, and clinical pain points to guide innovative R&D direction.

From biosimilars to first-in-class therapies, and from major markets to global expansion, Henlius is driven by globalization and innovation to break new ground. In 2026, under the theme "Global Reach, Collaborative Innovation", Henlius will accelerate translation from technology to clinical value, advancing dual transformations in both innovative technology and international collaborative ecosystems. Henlius is poised to continue writing a new chapter in the global narrative of China's biopharmaceutical industry, accelerating its growth into a globally influential, innovation-driven biopharmaceutical company with worldwide impact.

Source: Shanghai Henlius Biotech, Inc