原始出處紀錄
重大申請已受理
CNTB: Simcere 針對 AD 的 rademikibart NDA 獲中國 NMPA 受理
Simcere 為 Connect 在大中華地區的獨家授權合作夥伴，已提交 rademikibart 用於成人和青少年異位性皮膚炎的 NDA 並獲得 NMPA 受理。此受理使公司有資格獲得剩餘最高約 $110 million 的開發、監管和商業里程碑付款，以及大中華地區銷售額的階梯式低雙位數權利金。未報告美國監管行動。
關鍵事實
來源摘錄
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