Business
Connect Biopharma Reports Full Year 2022 Financial Results and Provides Business Update
CDE’s Pre-NDA Feedback Confirms CBP-201 for Atopic Dermatitis on Track for NDA Submission in China by End of First Quarter 2024 SAN DIEGO and TAICANG, SUZHOU,
About this update from Connect Biopharma Holdings Limited
[{"type":"text","content":"CDE’s Pre-NDA Feedback Confirms CBP-201 for Atopic Dermatitis on Track for NDA Submission in China by End of First Quarter 2024 SAN DIEGO and TAICANG, SUZHOU, China, April 11, 2023 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (Nasdaq: CNTB) (Connect Biopharma or the Company), a global clinical-stage biopharmaceutical company developing T cell-driven therapies to treat inflammatory diseases, today announced financial results for the year ended December 31, 2022 and recent corporate highlights. “Based on feedback from China’s Center for Drug Evaluation (CDE), we are on track with our timeline and look forward to advancing our lead drug candidate CBP-201 for moderate-to-severe atopic dermatitis (AD),” said Chief Executive Officer and Co-founder of Connect Biopharma Zheng Wei, Ph.D. “We plan to submit a New Drug Application (NDA) by the end of the first quarter of 2024, which could lead to potential regulatory approval in China as early as 2025. We also remain encouraged by the CBP-201 results from our China pivotal trial and post-hoc analyses from the global Phase 2b data presented last month at the American Association of Dermatology (AAD) Annual Meeting. We remain confident in the efficacy profile of CBP-201, which showed rapid and sustained improvements and has the potential to be an effective new treatment for AD. Beyond AD, we continue to focus on treating other inflammatory-mediated diseases, including ulcerative colitis and asthma, both of which also have the potential to address large patient populations with persistent unmet medical needs.” Recent Corporate Highlights Presented two abstracts from CBP-201 clinical development program in patients with moderate-to-severe AD at the AAD last month. Specifically, data from post-hoc analyses of the CBP-201 global Phase 2b trial showed rapid and sustained improvements across all body regions. Also, the results for the Primary Analysis Population from the ongoing CBP-201 China pivotal trial showed rapid and sustained improvement with no efficacy plateau at week 16.Completed full enrollment for the CBP-201 Phase 2 global trial in patients with moderate-to-severe asthma with Type 2 inflammation.Announced positive topline data on Stage 1 of the ongoing CBP-201 China pivotal trial in AD on the primary analysis population of 255 patients.Reported results from Phase 1 single as...