IMMUNOTECH-B(06978) has not yet submitted any new drug application for EAL, and plans to submit it in the near future.

IMMUNOTECH-B (06978) announces that, based on recent communication with the China National Medical Products Administration (NMPA) Drug Evaluation Center (CDE), CDE has agreed to allow the group to submit a conditional approval application for its core product candidate drug EAL. The company advises that after the submission of the new drug application, the application and submitted materials will be rigorously reviewed and evaluated by CDE. If the results are deemed to not meet the evaluation criteria, CDE may terminate or reject the application at any time. The company emphasizes that the submission, timeline, content, and final approval of any such application may or may not materialize, depending on various factors such as further communication with regulatory agencies, progress of registration verification, and compliance with regulatory requirements for conditional approval. As of the date of this announcement, the group has not yet submitted any new drug marketing application for EAL but plans to do so in the near future. Once the application is accepted for review by CDE, the company will promptly make an announcement.