Deyaa Adib: Thank you, Thane. So, to answer your question, the purpose of having this Phase 2 component of the Phase 2/3 design is to further optimize the dose that will be later on called the recommended Phase 3 dose. And this is essentially, if you go backwards in 2023, the FDA has initiated Project Optimus and it grows across the board in drug development to ensure that sponsors have identified the right dose moving forward that will offer patients maximum clinical benefit with the lowest risk in terms of adverse events. So, we are essentially complying with the FDA requirements to optimize the dose before we start the Phase 3 registration trial. So, this is our thinking about dose optimization.
Thane Wettig: And then one final comment, Dina, in addition to what Deyaa articulated, is we also plan on, again, pending concordance with the FDA, plan on treating all the patients in this dose optimization phase with the PET46 biomarker as well and then doing a post-hoc analysis to assess the correlation of CD46 expression and response to the ADC. And so that’s also an important component of the dose optimization part of the ongoing design.
Unidentified Analyst: Got it. Thank you so much.
Operator: Thank you. Our next question comes from Paul Choi with Goldman Sachs. You may proceed.
Paul Choi: Hi, thank you. Good afternoon and thank you for taking our questions. Just to follow-up on the prior question with regard to the Phase 2 monotherapy dose optimization. Your timeline calls for data potentially in 2026. I’m just curious if you — if there’s anything in terms of your insight from the monotherapy portion, particularly at the higher doses that might be able to accelerate that timeline for the Phase 2 dose optimization? My second question is just with regard to EVRENZO in China. You’ve maintained your updated timing for the CIA indication for second half of this year. But just to confirm your expectation for inclusion in the NRDL would be for no earlier than calendar 2026? If you could confirm that, that would be great. Thank you.
Thane Wettig: Thanks Paul. Regarding the kind of the 2026 timeline for FG-3246, now that we’ve taken a step back and that we’ve done a lot more thinking around this proposed Phase 2/3 design that we will discuss with the FDA, it’s probably a bit premature to talk about when we would see the totality of that dose optimization data set. Our goal would be to get this trial started as quickly as we can after discussion with the FDA and alignment with them and then begin execution. We think it will be a — it has the potential to be a rapidly enrolling trial. It’s not a huge cohort of patients in this dose optimization phase. And so our plan would be to get to execution as quickly as we possibly can. Deyaa, would you add anything to that?
Deyaa Adib: No. To your point, Thane, this will be a data-driven study and it will inform us in terms of not only dose optimization or the recommended Phase 3 dose, but also enabling us to select the patients who will make the best clinical benefit out of this ADC going into the Phase 3 component of the trial.
Thane Wettig: Great. And then Paul, I’ll ask Chris to comment on the updated CIA timing guidance.
Chris Chung: So, Paul, we updated the timing of the projected approval timeframe based on the current progress at the CD of the review of the technical filing. We are projecting a second half 2024. Although right now, we’re not in a position to comment on the regulatory review process. But to be conservative, we moved it to second half. To answer your specific question, would that mean that we would not have reimbursement for the indication of CIA until January 1st, 2026? The answer is yes. In order for us to qualify for NRDL starting January 1st, 2025, we would need to be approved by 2024 June 30th.
Paul Choi: Okay, great. Thank you.
Thane Wettig: Yes. And so Paul, we do believe that there’s still a chance to hit the approval timing that would allow us to have NRDL inclusion for the CIA indication in 2025, right? And so the team continues to work very closely with the CDE on the review. It’s just premature at this point in time to be able to handicap whether or not we’ll be able to achieve that. But please know that it’s a really important goal for us.
Paul Choi: Okay, great. Thanks for clarifying that. Thank you.
Operator: Thank you. I would now like to turn the call back over to Thane Wettig for any closing remarks.
Thane Wettig: Yes, guys, we appreciate your participation in today’s investor call and your continued interest in FibroGen and thank you for the questions. Enjoy the rest of your day.
Operator: Thank you. This concludes the conference. Thank you for your participation. You may now disconnect.
