#United States #San Francisco #Henlius Biotech #Jason Zhu #Globalisation 2.0

Henlius Unveils Globalisation 2.0 Strategy at JPM 2026

The J.P. Morgan Healthcare Conference (JPMHC), a pivotal event for global health industry leaders, took place in San Francisco from January 12 to 15, 2026, bringing together over 8,000 attendees including innovators and investors in the pharmaceutical sector. At the forefront of this prestigious conference, Dr. Jason Zhu, the CEO of Shanghai Henlius Biotech, Inc., presented the company’s ambitious Globalisation 2.0 strategy along with a comprehensive innovation blueprint designed for mid- to long-term growth in the biopharmaceutical landscape.

A Vision for Global Reach by 2030

During his keynote, Dr. Zhu articulated Henlius' vision targeted toward 2030, which emphasizes becoming a leading global biopharmaceutical entity. Currently, the company enjoys regulatory approvals for ten products, spanning 60 markets, and has positively impacted the lives of over 950,000 patients worldwide. Looking ahead, Henlius plans to bolster its portfolio with more than 20 new products, including at least 15 products for the U.S. and European markets. Continuing its commitment to innovative therapies, Henlius plans to advance products within oncology, autoimmune diseases, and central nervous system disorders using advanced technologies like antibody-drug conjugates (ADCs).

Five Core Capabilities for Sustainable Growth

In order to effectively implement its Globalisation 2.0 strategy, Henlius has established five key capabilities:
1. Integrated Research & Development (R&D): Henlius has a solid pipeline of over 50 early-stage assets, with about 70% identified as best-in-class, driving its innovation landscape.
2. Global Clinical Operations: The company manages a robust clinical team across several regions, successfully conducting clinical trials in over 20 countries with a presence in more than 1,000 research centers.
3. Regulatory Excellence: Henlius has garnered 164 Investigational New Drug (IND) approvals and 66 New Drug Applications (NDA), showcasing its strong proficiency in navigating international regulatory frameworks.
4. Manufacturing Expertise: The company has completed over 1,150 GMP-approved production batches, ensuring a reliable supply of quality products across the globe.
5. Commercialization Network: With a dedicated oncology commercial team of approximately 1600 professionals, Henlius has successfully partnered with over 20 international commercial players, distributing its products in about 60 countries.

Development Plans for Key Innovation Assets in 2026

Henlius' commitment to innovation includes a detailed plan for its leading products:

• - Serplulimab (trademarked as Hetronifly® in Europe): Expected milestones include achieving accelerated approvals for gastric cancer treatment in China and filing for FDA approvals for small cell lung cancer.
• - HLX22: A novel HER2-targeted therapy anticipated to reach Phase 2 data readout in 2026.
• - HLX43: A PD-L1 ADC which will initiate pivotal trials in multiple oncology settings.
• - HLX07: Focused on first-line treatment paths for specific lung cancers, reflecting Henlius's focus on complex cancer therapies.

Building a Next-Generation Pipeline of High-Potential Assets

Henlius doesn't just aim for immediate gains; it is also invested in long-term innovation through a multi-faceted R&D ecosystem. The company expects to file over 40 new clinical trial applications in the coming years, supported by an integrated innovation platform that includes multiple therapeutic avenues such as immune checkpoint inhibitors and T-cell engagers. Henlius is pushing forward with strategic development across a mix of first-in-class (FIC) and best-in-class (BIC) candidates, positioning itself firmly on the cutting edge of biopharmaceutical advancements.

Conclusion

The unveiling of Henlius' Globalisation 2.0 strategy at JPM 2026 marks a significant step in the company’s ambition to not only broaden its product offerings but also enhance its global presence significantly by 2030. Henlius stands ready to make a lasting impact on the biopharmaceutical landscape, with a strong focus on innovation, regulatory compliance, and sustainable growth. As Dr. Zhu emphasized, their integrated efforts across various platforms will enable smooth transitions from concept to market, ensuring that Henlius continues to deliver essential therapies to patients worldwide.