It’s a good part of the terms were, I think, in excess of expectations. But I think the company had an opportunity back in 2020 and 2021 to partner sooner, which I think would have helped competitiveness, especially in a world where Daiichi partnered with AZ and created a much bigger competitor in the HER2-targeted space. And so I think we’re always in the position of wanting to move forward on ourselves because we can, realizing there’s interest from a number of parties to work with us on specific assets or a broader collaboration and just understanding how that partnership could allow us to create more value than we could ourselves and sometimes it’s in accelerating or broadening or picking up some timing. I’m also aware of a year ago in the ADC space, if you ask us who we compete with, it would be CGEN, AminoGen, Ambrex.
Quickly a year later, those have almost turned into Pfizer, AbbVie, and J&J. So we just need to be cognizant of, I think something we could have done with zani to put it in a better position didn’t and I think we’ve made a nice recovery of that with our relationship with Jazz. But I think we just always think about how a partner can help us move our development forward in a broader, more accelerated way that might be something we can’t do on our own. And quite frankly, the interest there is now in ADCs and T-cell engagers broadly, and our platforms to create other agents beyond that. There’s some interesting optionality for us to make those decisions, to go alone ourselves longer, to partner specific assets, to partner some assets, and keep U.S. rights and partner next to U.S. bases, do something broader around a series of ADCs as Daiichi did with both AstraZeneca and Merck.
And I think it’s our duty as management to make sure that we’re actively understanding what those options are and inviting partners to let us know how they could work with us to make us, put us in a better position from a competitive standpoint. And we’ll continue to have those discussions, and as with Jazz, only make the right deal at the right time with what we think is the right partner and make sure we exceed our own expectations of what that transaction looks like and helps us, if I can give that guidance.
Operator: Thank you. One moment…
Jon Miller: Yeah. That make sense. Thank you.
Operator: One moment for our next question. Our next question comes from the line of Derek Archila from Wells Fargo. Your line is open.
Unidentified Analyst: Great. Hey, guys. Thanks for taking our questions. This is Adam [ph] on for Derek today. So, maybe just on the rolling BLA submission for zani in second-line BTC, can you walk us through what has already been submitted, what remains to be submitted and the timing around those steps? And then with the accelerated approval path, would this potentially put approval sometime in late 3Q, early 4Q of this year? If so, is there an opportunity to launch in the U.S. before 2025? Thanks.
Ken Galbraith: Yeah. Thanks for the question. I could provide the guidance that Jazz has provided. So, they started the rolling submission before the end of last year. They haven’t been specific about which modules were started with. One of the obligations prior to completing the submission was to get the confirmatory study in BTC up and running. And if you go on ClinTrials, you’ll see it was there starting last week. So, you can see the nature of the confirmatory study. You can see that they’re starting to actively recruit at sites and we continue to see more sites filled with that. They’ve guided that they will complete the rolling submission during the first half of this year, and when they’ve done that, we’ll let them announce that they’ve done that.
Obviously, we would need to wait for the submission to get accepted to understand if it qualifies for prior review, which we would expect it would, but that’s something we need to wait for determination and that would obviously determine the PDUFA date. As you’ve seen with some recent submissions, some of those happen on a more accelerated basis, well in advance of the PDUFA date. And this is clearly an area where, in this patient population, second-line biliary tract cancers, there is no HER2-targeted therapy and we expect the data set, while small, was very compelling. And so, we would hope that would be a subject of a timely review, but that’s obviously up to Jazz to provide the guidance as to when the submission is complete and for FDA to provide guidance on the nature of the review and the PDUFA date and then undertake the review.
So we’re quite comfortable with Jazz’s execution on this and their speed, and I think, they’re prosecuting this in the right way in the U.S., and with respect to China, BeiGene has guided that they will complete their submission in the second half of this year, and then, obviously, we have the Phase 3 readout from the first-line GEA study with zani, which topline data will be available this year and a positive subject of supplemental BLAs and more global filing for zani around the world beyond DTC.
Unidentified Analyst: Great. And then, maybe just one on the HERIZON readout in late 2024. Just for clarity, will this include data from all 914 patients or will this only be data from the original 714 patients target enrollment? Thanks.
Ken Galbraith: Yeah. So, the PFS endpoint is still based on the original patient population, which was 714 patients and there was a predefined number of events to look at the PFS endpoint and that has not changed from the original design that was made available some time ago. We just did add 200 patients to the patient population for the OS endpoint readout only and the requirement there is to ensure that those patients are fully enrolled before the PFS endpoint is unblinded. So, the PFS number of events will be based on the 714 patients and the events. If there are — obviously, the safety will include all the patients. Efficacy will be based on the 714 patients and number of events for PFS and the other 200 patients will be important only for the OS endpoint.
Unidentified Analyst: Okay. Great. Thank you.
Operator: Thank you. [Operator Instructions] And there appears to be no further questions in the queue. I’d like to turn the conference back over to Ken for closing remarks.
Ken Galbraith: That’s great. Thank you. Thank you for your time and attention, everyone. I think we’re making really good progress in 2024 and we expect a really exciting rest of 2024 year. We really invite you to join us at AACR and have a look at our posters. I think there’s some high quality signs there in a number of areas and we’re really excited to be able to report that to you at AACR and look forward to seeing you all at, again, future medical meetings or investment conferences. As required, I’m providing more progress at our next quarterly earnings update or before then. So, thank you for your time and attention and look forward to talking to you again.
Operator: This concludes today’s conference call. You may disconnect your lines. Thank you for participating and have a pleasant day.
