TaiMed Biologics : Enrollment of Phase III Clinical Study Is Complete for Trogarzo Intramuscular Injection (IM)

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Provided by: TaiMed Biologics Inc.
SEQ_NO	3	Date of announcement	2022/04/27	Time of announcement	21:46:35
Subject	Enrollment of Phase III Clinical Study Is Complete for Trogarzo Intramuscular Injection (IM)
Date of events	2022/04/27	To which item it meets	paragraph 53
Statement	1.Date of occurrence of the event:2022/04/27 2.Company name:TaiMed Biologics Inc. 3.Relationship to the Company (please enter "head office" or "subsidiaries"):Head Office 4.Reciprocal shareholding ratios:N/A 5.Cause of occurrence: TaiMed reached an agreement with Theratechnologies on May 18, 2021 to officially start a phase III clinical trial of Trogarzo IM injection to further expand the use of the drug in multi-drug resistant patients in the United States and Europe. The clinical trial, regulatory application and other related costs are all borne by Theratechnologies, and the terms in the original license agreement remain unchanged.. The enrollment of the Phase III clinical study of Trogarzo IM is officially complete per study protocol. The clinical trial data are expected to be available by the end of the third quarter of 2022 after statistical analysis. A supplemental biologics license application (sBLA) for Trogarzo IM will be submitted to the US FDA in the fourth quarter of 2022 if the primary endpoint is met. 6.Countermeasures:None 7.Any other matters that need to be specified: New drug development requires a long process and sizeable investments with no guarantee of success, which therefore may pose substantial investment risks. Investors are advised to exercise caution and conduct thorough evaluation.