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科创板2家创新药企迎来重大新突破
Zheng Quan Ri Bao·2025-07-03 08:45

Group 1 - Baili Tianheng announced that its drug Iza-bren (BL-B01D1) for nasopharyngeal carcinoma achieved its primary endpoint in a Phase III clinical trial, marking it as the first dual antibody ADC to complete such a study globally [2][3] - The drug was licensed to Bristol-Myers Squibb for an upfront payment of $800 million, with a potential total deal value of up to $8.4 billion, representing the highest transaction for a single asset in the ADC field [2] Group 2 - Dize Pharma received FDA approval for its drug ZEGFROVY® (Shuwotini), which is indicated for adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, following disease progression after platinum-based chemotherapy [3][4] - Shuwotini has been recognized with four breakthrough therapy designations in China and the U.S., making it the only drug to achieve "BTD Grand Slam" for treating EGFR exon 20 insertion NSCLC [4] Group 3 - The breakthroughs by Baili Tianheng and Dize Pharma reflect the rising strength of China's biopharmaceutical industry, showcasing a shift from being "followers" to "leaders" in innovative drug development [5] - As of now, 10 domestic innovative drugs have been approved for marketing in the U.S., with four of them coming from companies listed on the STAR Market [5] - Recent policies from the National Healthcare Security Administration and the National Health Commission aim to support the high-quality development of innovative drugs through various measures, injecting vitality into China's innovative drug sector [5]