Summary of Shanghai Henlius Biotech FY Conference Call Company Overview - **Company Name**: Shanghai Henlius Biotech (SEHK: 02696) - **Industry**: Biopharmaceuticals - **Key Products**: Four products approved by the U.S. FDA, seven by China NMPA, and four by EU EMA - **Clinical Trials**: Over 30 ongoing clinical trials and more than 50 early-stage assets - **Global Workforce**: Approximately 4,000 employees - **Manufacturing Capacity**: 80,000 liters facility in China - **Patient Impact**: Products have benefited over 950,000 patients globally [2][3][26] Core Competencies - **Clinical Operations**: In-house team operating across China, U.S., Australia, Japan, with 1,000 clinical research centers in 20 countries [3] - **R&D Capabilities**: 50+ early-stage molecules, with 70% aimed to be first best in class and 15% first in class [3] - **Regulatory Affairs**: 66 NDA approvals globally, including four BLA approvals by FDA last year [3] - **Manufacturing**: More than 1,150 commercial GMP batches certified by multiple regulatory authorities [3] Product Pipeline Highlights - **Serplulimab**: Approved for small cell lung cancer in China and EU, with ongoing studies for additional indications [4][5] - **Clinical Data**: Four-year overall survival (OS) rate of 21.9 months compared to standard care of 7.2 months [5] - **HELIX-22**: A novel HER2 mAb with a dual epitope strategy, currently in global phase three trials [7][9] - **Safety Profile**: Better safety compared to competitors, with ongoing recruitment of 600 patients [9] - **HELIX-43**: PD-L1 ADC targeting solid tumors, with significant efficacy data reported [10][11] - **Efficacy Rates**: ORR of 47.4% for EGFR wild type patients and 70% for cervical cancer at 3.0 mg/kg [11] Upcoming Milestones - **Regulatory Approvals**: Expecting accelerated approval for perioperative gastric cancer and additional indications for non-small cell lung cancer in the EU [14][15] - **Clinical Trials**: Initiating global phase 3 trials for various non-small cell lung cancer indications [12][16] - **Data Readouts**: Anticipated data from multiple studies at ASCO, including non-small cell lung cancer and ovarian cancer [17] Strategic Focus - **Next Generation Immuno-Oncology**: Emphasis on improving clinical responses to immunotherapy-resistant diseases [18][19] - **AI Technology**: Investment in generative AI for toxicity prediction and efficient screening [19] - **Biosimilars and Innovative Compounds**: Plans for 10 biosimilar launches and five innovative compound launches in the next five years [26][27] Financial Outlook - **Revenue Growth**: Projected double-digit growth with $0.7 billion in revenue for 2024 [26] - **Global Expansion**: Vision to launch over 20 products globally by 2030, with overseas revenue expected to exceed domestic contributions [26][27] Funding Strategies - **Revenue Utilization**: Leveraging sales revenue from biosimilars to fund innovative compound trials [27] - **Partnerships**: Open to licensing discussions and new collaborations to support development [27][28]