共价抑制剂 Wayrilz(rilzabrutinib)

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新药周观点:复宏汉霖PD-L1ADC优异数据披露,后续BD值得期待-20250907
Guotou Securities· 2025-09-07 13:35
Investment Rating - The report maintains an investment rating of "Outperform the Market" [4] Core Insights - The report highlights the promising data disclosure of PD-L1 ADC HLX43 by Fuhong Hanlin at WCLC 2025, indicating its potential as a superior treatment option for patients with advanced non-small cell lung cancer (NSCLC) who have failed standard therapies [2][3][18] - The report suggests that there are multiple upcoming catalysts in the sector, including academic conferences, business development (BD) opportunities, and negotiations for medical insurance and innovative drug directories [2][18] Summary by Sections Weekly New Drug Market Review - From September 1 to September 7, 2025, the top five gainers in the new drug sector were: - Saintno Pharmaceutical (+62.01%) - Chuangsheng Group (+47.26%) - Jakes Pharmaceuticals (+40.69%) - Hualing Pharmaceutical (+30.90%) - Yiming Oncology (+28.26%) - The top five decliners were: - Frontier Biopharmaceuticals (-10.47%) - Kemia (-9.09%) - Zai Lab (-5.62%) - Ascentage Pharma (-4.57%) - Yundin New Medicine (-4.56%) [1][14] Weekly Focused Stocks - The report recommends focusing on several companies with upcoming data disclosures, including Fuhong Hanlin, Baillie Tenheng, and Kangfang Biopharmaceuticals, which are expected to provide significant updates [2][18] - Potential heavyweights for overseas licensing include differentiated GLP-1 assets from companies like Zhongsheng Pharmaceutical and Gilead Sciences, as well as upgraded PD-1 products from Kangfang Biopharmaceuticals [2][18] Weekly New Drug Industry Analysis - Fuhong Hanlin's PD-L1 ADC HLX43 has shown excellent efficacy in treating NSCLC, with an overall objective response rate (ORR) of 37.0% and a disease control rate (DCR) of 87.0% in the overall NSCLC population [19][20] - The data indicates that HLX43 has the potential to expand into frontline treatment and combination therapy [2][18] New Drug Approval and Acceptance Status - This week, three new drug applications were approved, including: - Fuhong Hanlin's new drug for NSCLC - Merck's Letermovir tablets - Sanofi's Tislelizumab injection - Eleven new drug applications were accepted for review [24][25] Weekly New Drug Clinical Application Status - Twenty new drug clinical applications were approved this week, with fifty-eight applications accepted for review [27]