The US FDA Approves Supplemental BLA Filing for
The Addition of Samsung Biologics in Korea for Commercial
Manufacturing of Trogarzo
Date of events
2022/02/23
To which item it meets
paragraph 53
Statement
1.Date of occurrence of the event:2022/02/23
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:
On August 27, 2021, TaiMed formally submitted to the US Food and Drug
Administration (FDA) a supplemental BLA filing for the addition of Samsung
Biologics in Korea for commercial manufacturing of Trogarzo.
For the last few years, TaiMed have been working diligently with Samsung
Biologics Laboratories (SBL) to qualify Trogarzo commercial manufacturing
using 15,000L bioreactors at their site in Incheon, Korea. All the drug
substance and drug product process performance qualification batches were
successfully executed and placed on ongoing stability studies.
The FDA now have officially approved the SBL site for Trogarzo commercial
manufacturing with a 3-year drug product shelf-life.
Because SBL employs large 15,000-L stainless steel bioreactors for
production, the upfront development cost was high, but the future production
cost per unit will be significantly lower than that from WuXi Biologics'
2,000L single-use bioreactors. This project has taken 3 years, and the total
investment including several batches of mass production was about USD$50
million. The production at SBL will substantially improve our gross profit
margin as well as ensure long term stability of Trogarzo commercial supply.
Separately, due to COVID-related travel restrictions and manpower
constraints, the FDA has rescheduled the inspection of TaiMed's own Trogarzo
testing facility in Taiwan to April, 2022.
6.Countermeasures:None
7.Any other matters that need to be specified:
New drug development requires long process and large investment with no
guarantee in success, which therefore may pose substantial investment risks.
Investors are advised to exercise caution and conduct thorough evaluation.
