Shanghai Henlius Biotech (2696) 44th Annual J.P. Morgan Healthcare Conference summary

Corporate overview and global footprint

• Four products approved by US FDA, seven by China NMPA, and four by EU EMA; over 950,000 patients benefited globally.

• 30+ ongoing clinical trials, 50+ early-stage assets, and 4,000 global employees.

• Manufacturing capacity of 80,000 liters in China; 1,600 oncology commercialization professionals in China and 20 overseas sales partners.

• Products sold in over 60 countries and regions.

Clinical pipeline highlights and trial progress

• Serplulimab approved for multiple indications in China and EU; global phase III studies ongoing with key data readouts expected next year.

• HLX22, a novel HER2 mAb, in global phase III trials; shows superior safety and efficacy compared to Keynote-811 and HERIZON studies.

• HLX43 (PD-L1 ADC) demonstrates high ORR in solid tumors, especially non-small cell lung cancer and cervical cancer; global phase III trials to start this year.

• HLX07 (EGFR mAb) shows promising PFS in squamous non-small cell lung cancer; phase II/III multinational studies to begin this year.

Upcoming milestones and regulatory plans

• Anticipated regulatory approvals for serplulimab in perioperative gastric cancer in China and non-small cell lung cancer in the EU.

• BLA filings for serplulimab in the US for small cell lung cancer (extensive and limited stage) planned this year.

• HLX22 data readout for HER2 low breast cancer (China) and HLX43 pivotal phase III studies for non-small cell lung cancer expected.

• Multiple data publications and readouts at ASCO for various indications, including ESCC, NPC, and ovarian cancer.