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

Company 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 and 50+ early-stage assets; global staff of 4,000 and 80,000L manufacturing capacity in China.

• In-house clinical operations span 20 countries with 1,000 research centers; 66 NDA approvals and 164 INDs globally.

• Commercialization team of 1,600 in China and 20 overseas partners; products sold in 60+ countries.

Pipeline highlights and clinical progress

• Serplulimab approved for multiple indications in China and EU; ASTRUM-005 study shows 21.9-month OS vs. 7.2 for standard care.

• Global phase III studies for serplulimab in mCRC and gastric cancer; breakthrough designation for perioperative gastric cancer.

• HLX22 (HER2 mAb) in global phase III for gastric cancer; PFS expected to exceed 20 months, superior safety profile.

• HLX43 (PD-L1 ADC) shows ORR up to 70% in cervical cancer and 61.5% in esophageal cancer; global phase III trials planned.

• HLX07 (EGFR mAb) demonstrates 17.4-month median PFS in squamous NSCLC; phase II/III multinational studies to start this year.

Upcoming milestones and strategic focus

• Regulatory approvals expected for serplulimab in perioperative GC (China) and NSCLC (EU); BLA filings in US for SCLC.

• HLX22 data readout for HER2 low breast cancer (China); HLX43 pivotal phase III studies in NSCLC and squamous cancer.

• Multiple data publications and readouts at ASCO for ESCC, NSCLC, NPC, CC, and ovarian cancer.

• HLX07 pivotal studies in CSCC and first-line squamous NSCLC to launch this year.

• Focus on next-gen IO, ADCs with dual payloads, and immune cell engagement; leveraging AI for toxicity prediction.