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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]
港股新药(513780)获融资买入0.32亿元,近三日累计买入0.84亿元
Jin Rong Jie· 2025-07-31 00:23
Group 1 - The core point of the article highlights the financing activities of Hong Kong New Drug (513780) on July 30, with a financing buy amount of 0.32 billion yuan, ranking 660th in the two markets [1] - Over the last three trading days from July 28 to July 30, Hong Kong New Drug received financing buys of 0.13 billion yuan, 0.39 billion yuan, and 0.32 billion yuan respectively [1] - On the same day, the company had no short selling activity, with both short selling and net selling at 0.00 shares [1]