复宏汉霖ADC新药获FDA孤儿药资格认定;英科医疗全资子公司拟7000万美元参与投资基金丨医药早参
Mei Ri Jing Ji Xin Wen·2025-10-20 23:14

Group 1 - The innovative ADC drug HLX43 developed by Fuhong Hanlin has received orphan drug designation from the FDA for the treatment of thymic epithelial tumors (TETs) [1] - The orphan drug designation provides various benefits, including tax credits for clinical trial costs, exemption from new drug application fees, and seven years of market exclusivity post-approval, which can accelerate the drug's development process [1] - This milestone indicates international recognition of HLX43's potential as a breakthrough treatment in the TETs field, potentially shortening its global development timeline and addressing the treatment gap for ADC therapies in this disease area [1] Group 2 - Zai Lab announced that its self-developed drug, JAK inhibitor Jika Xixin tablets, has achieved the primary efficacy endpoint in a Phase III clinical trial for active ankylosing spondylitis, demonstrating statistical significance (p<0.0001) [2] - Currently, only three JAK inhibitors have been approved in China for treating active ankylosing spondylitis, indicating a competitive market landscape [2] - The achievement in the Phase III trial brings the drug closer to approval, and as a key product for Zai Lab, it is expected to generate significant revenue upon market entry [2] Group 3 - Yingke Medical announced that its wholly-owned subsidiary plans to invest $70 million in the Warburg Pincus Global Growth 15 fund, which aims to raise $17 billion [3] - This investment is expected to enhance the integration of capital and industry, fostering business synergy and resource complementarity, thereby improving overall competitiveness and profitability [3]