The US FDA completed a pre-approval inspection (PAI) of TaiMed cGMP monoclonal antibody facility with no observation
· Issued by TaiMed Biologics Inc.
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Today's Information
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.
