EMA Approves Supplemental BLA Filing for The Addition of Samsung Biologics in Korea for Commercial Manufacturing of Trogarzo
· Issued by TaiMed Biologics Inc.
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Today's Information
Provided by: TaiMed Biologics Inc.
SEQ_NO
3
Date of announcement
2022/04/13
Time of announcement
22:16:58
Subject
EMA Approves Supplemental BLA Filing for The
Addition of Samsung Biologics in Korea for Commercial
Manufacturing of Trogarzo
Date of events
2022/04/13
To which item it meets
paragraph 53
Statement
1.Date of occurrence of the event:2022/04/13
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 European Medicines
Agency (EMA) 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.
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. The production at SBL will substantially
improve our gross profit margin as well as ensure long term stability of
Trogarzo commercial supply.
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.
