Argenx heeft een licentie overeenkomst gesloten met Zai Labs om haar succes medicijn Vyvgart in China te vermarkten.
Onderstaand een selectie uit het transcript mbt de 1e kwartaal call van Zai Labs.
? Michael Yee
Thanks. Good morning and we had two quick questions. On efgartigimod, I know that you guys are waiting for approval. Can you give us an update on your expected timing and ramifications and your expectations for getting that in for NRDL, what the timelines are for that, and what our expectations should be for NRDL for 2024 and how that would work with the timing of approval?
?
Hi, Michael. It is Josh. Good to hear from you. I am going to direct the questions to our executives this morning. So, I will start on efgartigimod directed to me, and then Rafael can talk a little bit about your question on LUNAR. On efgartigimod, as you know, there is not a PDUFA date in China for reviews or approvals. What I can say is we are in discussions with the regulators that they are going well, and we are looking forward to a potential approval. Once we have that, we are prepared to move quickly to launch, as we mentioned. In my comments, we have planned to have about 100 sales reps at launch ready to promote the product, and we will be moving quickly then toward developing packages and strategies for NRDL. We need an approval sometime over the summer to, I think, fit into that window, but again, we will keep you updated as we continue to go through. Everything is going well, and we are excited about the opportunity.
Die 100 verkopers staan dus in de startblokken.