KELUN PHARMA(SZ:002422)2026-01-15 18:30Summary of Sichuan Kelun Pharmaceutical FY Conference Company Overview - Company Name: Kelun-Biotech - Industry: Biopharmaceuticals - Focus Areas: Oncology, immunology, metabolism, and other therapeutic areas - Shareholders: Kelun Pharmaceutical (largest), MSD (second largest and major collaborator) [2][3] Pipeline and Product Development - Pipeline Programs: Over 30 programs, including: - 4 approved products with 7 indications - 2 products at NDA stage - Over 10 programs in clinical development - Employee Count: Approximately 2,000, with 900 in R&D, 500 in manufacturing and quality control, and 500 in sales and marketing [3][4] - Key Products: - TROP2 ADC (sac-TMT): Approved for three indications in China, including lung cancer and breast cancer - HER2-ADC (trastuzumab botidotec): Approved for HER2-positive breast cancer - Cetuximab: Approved for RAS wild-type colorectal cancer - PD-L1 for nasopharyngeal carcinoma (NPC) [4][5][11] Clinical Studies and Approvals - Clinical Studies: Initiated five pivotal studies for breast cancer, six for lung cancer, and one for gastrointestinal cancer [5] - Expected Approvals: Anticipation of more product approvals and label expansions in 2026, including a small molecule RET inhibitor [3][6] - Global Studies: MSD is initiating 16 global phase three studies for various cancers [9] Market Position and Strategy - National Reimbursement Drug List (NRDL): Three core products included in NRDL 2025, effective January 2026 [7] - Commercialization Strategy: Full-fledged commercialization team established with access to Class III hospitals and key opinion leaders [6] - Partnerships: Collaborations with MSD, Ellipses, Wonderworld Bio, and Keratin Bio to enhance pipeline value and global market reach [7][8] Innovation and Future Plans - OptiDC Platform: Focus on optimized drug conjugate technology, with plans to expand into non-oncology areas [12][15] - Research Focus: Development of novel payloads, linkers, and ADC designs, including bispecific antibodies and non-toxin-based drug conjugates [14][15] - Growth Plans: Prioritizing differentiated pipeline programs, expanding drug development and commercialization capabilities, and enhancing global partnerships [15][16] Key Performance Metrics - Efficacy Data: - TROP2 ADC demonstrated significant improvements in progression-free survival (PFS) and overall survival (OS) in clinical trials [10] - HER2-ADC showed improved PFS and overall response rate (ORR) compared to T-DM1 [11] This summary encapsulates the key points from the conference, highlighting the company's strategic focus, product pipeline, clinical advancements, and future growth plans.