TaiMed Announces its Marketing Partner Received Refusal to File Letter for Trogarzo Intramuscular Method of Administration sBLA from the US FDA. New drug name or code: TMB-355(ibalizumab),(trade name: Trogarzo). Planned development stages: Trogarzo IV Infusion: Marketing approval by the U.S. FDA and European, Medicines Agency.

Trogarzo IV Push: Marketing approval by the U.S. FDA (sBLA). Trogarzo IM Injection: Disapproval. Current development stage: Application submission/approval/disapproval/each of clinical trials (include interim analysis): Trogarzo IV Infusion: Approval of Biologics License Application (BLA) Trogarzo IV Push: Approval of supplemental Biologics License Application (sBLA).Trogarzo IM Injection: US FDA has issued a refusal to file letter (RTF) regarding the theratechnologies?

supplemental Biologics License Application (sBLA) for an intramuscular (IM) method of administration for the maintenance dose of rogarzo. Upon preliminary review, the FDA determined that the sBLA was not sufficiently complete to permit a substantive review. The RTF states that the sBLA did not contain the data required to establish the pharmacokinetic bridge between the IM and the intravenous infusion route of administration of Trogarzo.

Once disapproved by competent authority or each of clinical trials (include interim analysis) results less than statistically significant sense, the risks & the associated measures the Company may occur: Trogarzo IV push administration has been approved by the FDA for marketing and sales, significantly improving the weakness of the IV infusion administration, which was time-consuming and inconvenient. The administration time for IV push is equivalent to that of IM injection. Therefore, the impact of IM disapproval on Trogarzo sales is limited.

After obtaining official approval or the results of statistically significant sense, the future strategy: Trogarzo IV Infusion:Available in the U.S. market since April 2018. It will be gradually extended to other countries and regions. Trogarzo IV Push: The administration of Trogarzo by intravenous push shortens the administration time from 30 minutes to 90 seconds and eliminates the need for an IV infusion bag.

These improvements significantly improve the convenience for both the physician and the patient. The clinical trial, regulatory application, and all other related costs are borne by Theratechnologies, and the terms in the original license agreement remain unchanged.