Xin Hua Cai Jing·2025-07-03 10:01Group 1 - Baili Tianheng announced a significant breakthrough in its clinical trial for Lankang Yilong Monoclonal Antibody, achieving the primary endpoint in a Phase III trial for recurrent or metastatic nasopharyngeal carcinoma [2] - 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, marking the highest transaction for a single asset in the ADC field globally [2] - The company is currently conducting over 40 clinical trials in China and the US for various tumor types with Lankang Yilong Monoclonal Antibody [2] Group 2 - Dizhe Pharmaceutical's Shuwotini tablet received FDA approval for adult patients with locally advanced or metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations [3] - Shuwotini has received four breakthrough therapy designations (BTD) in China and the US, and it was granted "priority review" status by the FDA, which accelerates the review process for drugs that show significant safety or efficacy breakthroughs [3] - A total of 10 domestic innovative drugs have been approved for market entry in the US, with four of them coming from companies listed on the STAR Market [3] Group 3 - The breakthroughs achieved by Baili Tianheng and Dizhe Pharmaceutical reflect the rising strength of China's biopharmaceutical industry, showcasing the transition from "follower" to "leader" in innovative drug development [3] - This development signifies a shift from "following and copying" to "independent innovation," positioning China as a core player in global innovative drug research and development [3]