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Shanghai Henlius Biotech (2696) investor relations material
Shanghai Henlius Biotech 44th Annual J.P. Morgan Healthcare Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.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.
Next Shanghai Henlius Biotech earnings date
Next Shanghai Henlius Biotech earnings date
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