Cloudbreak Pharma withdraws CBT-009 IND application for possible Phase 3 trial in China

Reuters03-19

Cloudbreak Pharma withdraws CBT-009 IND application for possible Phase 3 trial in China

Cloudbreak withdrew its Investigational New Drug application for CBT-009 in China after concluding it may be difficult to include China in a placebo-controlled multi-regional Phase 3 trial due to differing regional regulatory requirements.
The IND for CBT-009 was submitted to China’s Center for Drug Evaluation in December 2025 and was accepted in January 2026.
Management said it will reassess the clinical development strategy for CBT-009 and may hold further pre-submission consultations with the Center for Drug Evaluation or resubmit a clinical studies application after supplementary studies or protocol adjustments.
The R&D and IND application status of other core products CBT-004 and CBT-199 remains on track, and Phase 3 MRCT for CBT-001 is expected to be completed in Q3 2026.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Cloudbreak Pharma Inc. published the original content used to generate this news brief via IIS, the Issuer Information Service operated by the Hong Kong Stock Exchange (HKex) (Ref. ID: HKEX-EPS-20260319-12059382), on March 19, 2026, and is solely responsible for the information contained therein.

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Cloudbreak Pharma Inc. published t","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"02592":"拨康视云-B","BK1161":"生物科技"},"translate_title":"Cloudbreak Pharma撤回CBT-009可能在中国进行3期试验的IND申请","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"02592":0.9},"content_text":"Cloudbreak Pharma withdraws CBT-009 IND application for possible Phase 3 trial in China\n    \n\n\n          Cloudbreak withdrew its Investigational New Drug application for CBT-009 in China after concluding it may be difficult to include China in a placebo-controlled multi-regional Phase 3 trial due to differing regional regulatory requirements.\n        \n\n          The IND for CBT-009 was submitted to China’s Center for Drug Evaluation in December 2025 and was accepted in January 2026.\n        \n\n          Management said it will reassess the clinical development strategy for CBT-009 and may hold further pre-submission consultations with the Center for Drug Evaluation or resubmit a clinical studies application after supplementary studies or protocol adjustments.\n        \n\n          The R&D and IND application status of other core products CBT-004 and CBT-199 remains on track, and Phase 3 MRCT for CBT-001 is expected to be completed in Q3 2026.\n        \n\n\n\n\n\nDisclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. 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