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信达生物(1801.HK):IBI363肺鳞癌更新MPFS数据进一步延长
Ge Long Hui· 2025-06-12 00:18
Core Viewpoint - The company has presented additional follow-up data for IBI363 and IBI343 at the ASCO conference, showing promising results that enhance confidence in their development, leading to an upward revision of the target price to HKD 95 and a reaffirmation of the "buy" recommendation [1][5]. Group 1: IBI363 Data Insights - The mPFS for the IBI363 3mg/kg dose group in IO-treated sq-NSCLC has been extended to 9.3 months, an improvement from the previously reported 7.3 months, indicating strong efficacy [2][3]. - In the EGFR wild-type adenocarcinoma (EGFRwt Ad-NSCLC), the mPFS remains consistent at 4.2 months, outperforming docetaxel's mPFS of 2.5-4 months [2]. - The company plans to initiate a Phase III registration clinical trial for IBI363 in 3L+ sq-NSCLC, with the 3mg/kg dose expected to be used [2]. Group 2: IBI343 and Other Data - IBI363 combined with bevacizumab shows a 15.1% cORR and a 4.7-month mPFS, with a notable 31.3% cORR and 7.4-month mPFS in the population without liver metastasis [3]. - The overall mOS for IBI363 monotherapy is reported at 16.1 months, with subgroup analysis showing mOS of 14.4 months for liver metastasis patients and 17.0 months for those without, both significantly higher than the 9.3 months for fruquintinib in 3L CRC [3]. - In melanoma, the IBI363 1mg/kg Q2W dose group shows mPFS of 5.7 months and mOS of 14.8 months, significantly better than real-world data [4]. Group 3: Financial Projections - The company forecasts peak sales of approximately HKD 2.5 billion for IBI363 and HKD 1.5 billion for IBI343 in China, adjusted for risk [5]. - Projected net profits for the company are estimated at HKD 430 million, HKD 850 million, and HKD 1.89 billion for the years 2025, 2026, and 2027, respectively [5].