TaiMed received the official approval letter from US FDA for the pre-approval inspection (PAI) of TaiMed cGMP monoclonal antibody facility

 TaiMed received the official approval letter from
US FDA for the pre-approval inspection (PAI) of TaiMed
cGMP monoclonal antibody facility

1.Date of occurrence of the event:2022/05/25
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 today received the official approval letter from the US FDA of the
 pre-approval inspection (PAI) of the company's new cGMP monoclonal antibody
 manufacturing and testing facilities in Taiwan.  The PAI was conducted on
 April 18 - 22, 2022 by the Agency and resulted in no Form 483 observations.
 This excellent outcome demonstrates TaiMed's competence and readiness in
 full-scale clinical and commercial contract manufacturing.  With its
 4 x 2,000L single-use bioreactors, full downstream purification and
 state-of-the-art QC testing facilities, the company announced previously
 that it is entering the CDMO business in addition to supporting its own
 monoclonal antibody development programs.
 TaiMed will participate in the BIO International in San Diego in June and
 the Taiwan Biotechnology Exhibition in Taipei in July to promote its CDMO
 services and meet with clients.
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.