Medigen Biotechnology Corp. has applied to the Taiwan Food and Drug Administration (TFDA) for Phase I/II clinical trial of allogeneic natural killer cells (Magicell-NK). New drug name or code: Allogeneic natural killer cells (Magicell-NK).

Indication: The application of Phase I/II clinical trial of allogeneic natural killer (NK) cells submitted to the Taiwan Food and Drug Administration (TFDA) involves the use of company's proprietary and independently developed allogeneic natural killer cell expansion technology, Magicell-NK. This technology utilizes blood from donors, which is cultured, activated, and expanded ex vivo to prepare natural killer cell products. These products are then administered back into the patients and will be used as adjuvant therapy post-surgery, in combination with chemotherapy, for pancreatic ductal adenocarcitnoma (PDA) or bile duct cancer patients, aiming to prevent recurrence and increase survival time.

Planned development stages: Phase I/II clinical trial. Current development stage: Application submission/approval/disapproval/each of clinical trials (include interim analysis): Submitted an application for Phase I/II clinical trial to TFDA. Accumulated investment expenditure incurred: Due to considerations of commercial strategy, disclosure is temporarily withheld.

Upcoming development plan: Phase I/II clinical trial will commence upon obtaining approval from the TFDA and the Institutional Review Board (IRB). Estimated Completion Time: Expected to be completed in 2029, the actual schedule will be adjusted according to the progress of execution. Expected Obligations: company will bear the expenses related to clinical trials and related registration fees.