TaiMed Biologics : The US FDA completed a pre-approval inspection (PAI) of TaiMed cGMP monoclonal antibody facility with no observation

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Provided by: TaiMed Biologics Inc.
SEQ_NO	1	Date of announcement	2022/04/20	Time of announcement	20:45:42
Subject	The US FDA completed a pre-approval inspection (PAI) of TaiMed cGMP monoclonal antibody facility with no observation
Date of events	2022/04/20	To which item it meets	paragraph 53
Statement	1.Date of occurrence of the event:2022/04/20 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: The US FDA completed a pre-approval inspection (PAI) of TaiMed Biologics' brand new cGMP monoclonal antibody facility on April 20th, 2022. There is no 483 observation (inspectional observation). The positive outcome adds further assurance for its newly-established Contract Development and Manufacturing (CDMO) business. 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.