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<Resume> IMMUNOTECH-B (06978.HK) Core Candidate EAL Listing Application Rejected
IMMUNOTECH-B (06978.HK) announced that it has received a "Notice of Disapproval Regarding the Application for Conditional Approval of EAL? from the Center for Drug Evaluation (CDE)...
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<Resume> IMMUNOTECH-B (06978.HK) Core Candidate EAL Listing Application Rejected
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IMMUNOTECH-B (06978.HK)  -0.670 (-29.386%)   announced that it has received a "Notice of Disapproval Regarding the Application for Conditional Approval of EAL? from the Center for Drug Evaluation (CDE). The notice stated that "existing clinical trial data indicate that EAL?has shown a trend of benefit in the immunologically defined population, and confirmatory clinical trials are required in this population. As the results of confirmatory clinical trials in the immunologically defined population have not been submitted, a comprehensive evaluation of the product's benefit-risk profile cannot be conducted, and the marketing authorization application cannot be supported."

The current notice of disapproval only relates to the conditional approval application. The company will actively proceed with preparations for subsequent confirmatory clinical studies and will re-submit the marketing application for its core candidate EAL?under the regular approval process upon completion of the relevant studies.

The company has applied for the resumption of trading in its shares on Wednesday (29th). (de/d)(HK stocks quote is delayed for at least 15 mins.)



This article was automatically translated by AI, the Chinese version should be considered the authoritative version. AASTOCKS.com Limited does not guarantee its accuracy or completeness and accepts no liability for any damages or losses arising from the use of this translation.

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