Biopharma · FDA Approvals · Stock
Connect Biopharma Holdings Ltd is a clinical-stage biopharmaceutical company dedicated to transforming care for asthma and chronic obstructive pulmonary disease (COPD). The company is advancing rademikibart, a next-generation antibody designed to target interleukin-4-receptor alpha. It is currently conducting clinical …
Assets on file: rademikibart
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rademikibart · NCT07705737 registry update
countries: {'total_sites': 2, 'us_sites': 2} → {'total_sites': 3, 'us_sites': 3}
rademikibart · NCT06940141 registry update
status: ACTIVE_NOT_RECRUITING → COMPLETED
Connect Biopharma reports Phase 3 topline results for rademikibart in atopic dermatitis
The 8-K discloses topline results from a Phase 3 52-week study of rademikibart in moderate-to-severe atopic dermatitis conducted by partner Simcere in China. A separate Phase 1 IV pharmacology study topline was also released. These data releases constitute the regulatory/clinical milestone event.
CNTB: Simcere NDA for rademikibart in AD accepted by China NMPA
Simcere, Connect’s exclusive Greater China licensee, submitted and received NMPA acceptance of its NDA for rademikibart in adult and adolescent atopic dermatitis. The acceptance triggers eligibility for up to ~$110 million in remaining development, regulatory and commercial milestones plus tiered low double-digit royalties on Greater China sales. No U.S. regulatory action is reported.
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