原始来源记录
重大申请已受理
CNTB: Simcere 针对 AD 的 rademikibart NDA 被中国 NMPA 受理
Simcere 是 Connect 在大中华区的独家授权方，已提交 rademikibart 治疗成人和青少年特应性皮炎的 NDA 并获得 NMPA 受理。该受理使公司有资格获得高达约 $110 million 的剩余开发、监管和商业里程碑付款，以及大中华区销售的分级低双位数特许权使用费。未报告美国监管行动。
关键事实
来源摘录
EX-99.1 2 cntbq32025earningsrelease.htm EX-99.1 Document Exhibit 99.1 Connect Biopharma Reports Third Quarter 2025 Financial Results and Provides Business Update – Recruitment ongoing for Phase 2 Seabreeze STAT studies for acute exacerbations in asthma and COPD; expect to report topline data from both studies in 1H26 – – New Drug Application for rademikibart for the treatment of atopic dermatitis submitted by Simcere, the Company’s exclusive licensee in Greater China, was accepted by China’s NMPA – – Completed termination of American Depositary Receipt program and directly listed our ordinary shares on Nasdaq – – Presented positive data at ERS 2025 supporting the potential of rademikibart to deliver differentiated efficacy and safety in patients across a broad range of baseline type