TaiMed Biologics : EMA Approves Supplemental BLA Filing for The Addition of Samsung Biologics in Korea for Commercial Manufacturing of Trogarzo

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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.