News from Taimed Zhongyu (4147-TW) announced today (14) that the European Union’s medical certification authority EMA has notified the foundry of Trogarzo, a new AIDS drug, to South Korea’s Samsung Biologics (SBL), and will conduct an inspection in two weeks. If the inspection is approved, the production capacity will be increased. Enlarged, the overall gross profit margin is also expected to grow simultaneously.
The new AIDS drug Trogarzo developed by Zhongyu has been co-founded by South Korea’s Samsung Biologics (SBL) in 2019. It is currently produced in a 2000L bioreactor. The two parties have recently expanded the production of Trogarzo and changed its production capacity to the 15000L bioreactor at the Samsung plant in Incheon. At present, all batches of process performance verification (PPQ) have been completed and entered the stability test stage.
Zhongyu said that the European Union's medical certification authority EMA will go to the plant for inspection in two weeks. If the inspection is passed, the Trogarzo bioreactor will be expanded from 2000L to 15000L, which will help increase the gross profit margin.
In terms of Trogarzo sales, Zhongyu pointed out that with the gradual control of the new crown epidemic in the United States, the inventory adjustment of the US marketing partner Theratechnologies has also come to an end. The second quarter began to restart the sales, and the expected revenue performance is expected to recover at the same time. In addition, the Trogarzo intravenous bolus dosage form has the opportunity to be launched in the United States at the end of this year and the first quarter of next year.
In terms of the European market layout, Zhongyu said that it has completed the price setting of health insurance drugs with the German competent authority. In addition, if the epidemic in Europe gradually slows down in the future, it will expand the market to France.
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