CStone 2026 Interim Results: Accelerating Pipeline 2.0 Execution and Sustained Global Commercial Momentum
PR Newswire
SUZHOU, China, Aug. 27, 2026
CS2009 Achieved Key Clinical Validations for Efficacy and SafetyAs of August 2026, updated data further confirmed the favorable safety profile of CS2009 and demonstrated strengthened efficacy across multiple key cohorts compared with the data presented at ASCO in May 2026. With expanded patient enrollment and longer follow-up, improvements were observed in both the objective response rate (ORR) and duration of response (DOR):Compelling monotherapy efficacy in first-line non-small cell lung cancer (NSCLC)At the 30 mg/kg dose level, CS2009 achieved an ORR of 100% and a disease control rate (DCR) of 100% in patients with PD-L1 TPS ≥50%. In the broader PD‑L1 TPS ≥1% population, the ORR was 70.8% and DCR was 91.7%.Monotherapy efficacy in Immunotherapy (IO)-pretreated NSCLC and IO-nonresponsive "cold tumors" further validates CTLA-4 activity and efficacyIn second-line NSCLC patients (all previously treated with IO plus chemotherapy), CS2009 monotherapy (30 mg/kg dose level) yielded an ORR of 38.5% and a DCR of 84.6%; In patients with heavily pretreated metastatic colorectal cancer (mCRC), CS2009 monotherapy (30 mg/kg dose level) achieved an ORR of 20% and a DCR of 93.3%; In patients with heavily pretreated soft tissue sarcoma (STS) and non-clear cell renal cell carcinoma (nccRCC), CS2009 monotherapy delivered ORR of 38.5% and 42.9%, respectively.CStone will present additional more mature Phase I/II clinical data for CS2009 in patients with advanced NSCLC and mCRC via two rapid oral presentations at ESMO 2026 in October. The Company also expects to reach consensus with global regulatory authorities including the U.S. Food and Drug Administration (FDA) and the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA), on the global Phase III registrational trial protocol in the fourth quarter of 2026.Pralsetinib Delivers Strong Sales GrowthFollowing its effective inclusion in the National Reimbursement Drug List (NRDL) on January 1, 2026, pralsetinib's in-market sales volume increased by almost 500% year-over-year in the seven‑month period ending July 2026.Solid Cash PositionAs of June 30, 2026, cash and cash equivalents and time deposits totaled RMB1,560.2 million.SUZHOU, China, Aug. 27, 2026 /PRNewswire/ -- CStone Pharmaceuticals ("CStone," HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and development of therapies for oncology, immunology, inflammation, and other key disease areas, today announced its 2026 interim results and recent business highlights.
