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$康乃德生物(CNTB)$ 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

全部讨论

04-02 15:54

所以到底需不需要做3期临床啊?

03-28 21:29

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。
理解下来最少延迟1到2年以上提交上市申请