'Invossa' US Clinical Trial Resumption Kolon "Focusing on Administrative Litigation Domestically" (Comprehensive)

[Asia Economy Reporter Cho Hyun-ui] Kolon Life Science, which dramatically revived with the decision to resume the Phase 3 clinical trial of the osteoarthritis gene therapy 'Invossa K Injection (Invossa)' in the United States, appears to be focusing on administrative litigation domestically instead of reapplying for clinical trials. Previously, the Ministry of Food and Drug Safety (MFDS) had canceled the sales approval of Invossa with a stricter stance than the U.S. due to controversy over its components. Following the U.S. clinical trial resumption decision, some speculated that Kolon Life Science might seek to restore its reputation by reapplying for sales approval. However, Kolon seems to believe that the administrative litigation has become more favorable with this decision, and the reapplication period is uncertain.

◆ U.S. Phase 3 Clinical Trial to Resume Soon = A Kolon Life Science official stated on the 13th regarding domestic sales commencement, "It will be decided based on the outcome of the ongoing administrative litigation." This means that regardless of the U.S. FDA's decision to resume clinical trials, the commencement of domestic sales will be determined through the ongoing administrative litigation, and they will focus on this.

On the 11th, the U.S. Food and Drug Administration (FDA) lifted the clinical hold on Invossa's Phase 3 trial in the U.S. and allowed the resumption of the Phase 3 trial involving patient administration. The FDA sent an official letter containing this information to Kolon TissueGene, a Kolon Life Science subsidiary responsible for development and approval tasks in the U.S. The FDA stated, "All clinical hold issues have been satisfactorily resolved," and "clinical trials may proceed."

This measure allows Kolon TissueGene to resume clinical trials approximately 11 months after the FDA decided to place a clinical hold on Invossa in May last year. The exact resumption date has not yet been determined. Kolon explained, "The FDA recognized the validity of the clinical trial data submitted by Kolon TissueGene and acknowledged that the Phase 3 trial may continue based on this."

◆ A Ray of Hope for Resale Through Administrative Litigation = While the biggest hurdle has been overcome in the U.S., the domestic situation remains challenging. The MFDS canceled the product approval last year following the controversy over Invossa's components, and Kolon Life Science filed an administrative lawsuit in July last year. An industry insider predicted, "With the FDA's decision to resume clinical trials, Kolon, which is undergoing administrative litigation, may be in a more advantageous position." Apart from the administrative litigation, the procedure to regain product approval is also valid. However, since there remains a possibility that sales may resume immediately depending on the administrative litigation outcome, it is known that Kolon is not currently considering reapplying for product approval. An MFDS official explained, "To resume domestic sales of Invossa, product approval must be obtained again," and added, "The FDA's clinical trial resumption cannot invalidate the MFDS's cancellation of product approval."