$康乃德生物(CNTB)$ Atopic Dermatitis (AD): • Achieved primary and key secondary outcomes at Week 16 in both global Phase 2b and China pivotal/stage 1 trials with > 475 patients with moderate-to-severe AD • Efficacy observed with both 300mg Q2W and 300mg Q4W doses in the global Phase 2b trial and in China pivotal trial • Showed continued and sustained improvement with Q4W dosing efficacy comparable to Q2W dosing through Week 52 in the China pivotal trial Asthma • Rapid, significant and sustained improvement in lung function observed in 24-week global Ph2b trial • Strong trends observed towards reduction in exacerbations • Significant improvements in asthma control observed through Week 24 • Overall safety data show rademikibart generally well tolerated and consistent with blocking IL-4Rα signaling 2024-2025 Led by Simcere, Connect’s Greater China partner: NDA submission and potential approval in AD Supported by highly compelling clinical efficacy and safety data in AD and asthma trials Anticipated catalysts and potential approval 1H’2024: Anticipated asthma End-of-Phase 2 meeting with FDa
特应性皮炎(AD):
•在第16周,在全球2b阶段和中国都取得了主要和关键的次要成果
475名以上中度至重度AD患者的关键/1期试验
•在全球2b期试验和
中国关键审判
•Q4W给药效果与Q2W相当,表现出持续和持续的改善
中国关键试验第52周给药
气喘
•在24周的全球Ph2b中观察到肺功能的快速、显著和持续改善
试验
•观察到减少恶化的强烈趋势
•在第24周观察到哮喘控制有显著改善
•总体安全性数据显示,rademikibart总体耐受性良好,与阻断IL-4Rα一致
信号
2024-2025
由Connect大中华区合作伙伴Simcere牵头:
NDA提交和AD中的潜在批准
支持者
非常
引人入胜的
临床疗效
和安全数据
在AD和
哮喘试验
预期的
催化剂和
潜在批准
2024年1月:
预期哮喘2期会议结束
带FD