Zhi Tong Cai Jing·2025-12-11 02:53Core Viewpoint - Rongchang Biologics (09995) experienced a significant stock increase, with a rise of over 7% during trading, closing at 81.5 HKD, with a transaction volume of 310 million HKD. This surge is attributed to the presentation of clinical trial data for their PD-1/VEGF bispecific antibody RC148 at the ESMO-IO conference in London, highlighting its promising efficacy in treating non-small cell lung cancer [1][1][1]. Group 1: Clinical Trial Data - The clinical trial data for RC148, presented at the ESMO-IO conference, showed a remarkable overall response rate (ORR) of 66.7% and a disease control rate (DCR) of 95.2% when combined with docetaxel at a dosage of 20 mg/kg every three weeks [1][1][1]. - Subgroup analysis revealed that patients with PD-L1 positive status (TPS≥1%) had an ORR of 80%, indicating significant efficacy across different patient groups [1][1][1]. - The median follow-up time for the trial was approximately 7 months, with a median progression-free survival (mPFS) of 8.3 months, further supporting the drug's potential effectiveness [1][1][1]. Group 2: Regulatory Approvals and Market Potential - RC148 received FDA approval to initiate Phase II clinical trials in the United States, marking a significant step in its global clinical development [1][1][1]. - Earlier in August, RC148 was also approved in China for clinical research in monotherapy and combination therapy for advanced solid tumors, showcasing its rapid progress in clinical development [1][1][1]. - The global business development (BD) activity surrounding PD-1/VEGF therapies is intensifying, with companies like Kangfang Biologics and 3SBio already pursuing international licensing agreements, indicating a competitive landscape and potential for RC148 to capitalize on this trend [1][1][1].