Hello, good morning, everyone. Welcome to the H.C. Wainwright twenty-sixth Annual Global Investment Conference. I am Yip from the H.C. Wainwright research team. For our next presentation, we have Gyre Therapeutics, and with us today, we have Gyre's CEO, Han Ying. Han, great having you with us. Please go ahead with your presentation.
Great. Thank you very much, and good morning, everyone. Gyre Therapeutics, we develop anti-fibrotic therapies for chronic organ disease. Currently, Gyre Therapeutics has three commercial drugs, and then our lead candidate, hydronidone, the F351, is currently in pivotal phase III trials right now. The top-line results will be announced in early 2025. We have a phase II program on acute liver injury, which we saw encouraging results with the initial patients. We also have a phase I program on pulmonary hypertension, and also we have a clinical program, which is going into a clinical soon. That's the summary of our company.
The structure of our company. We are a U.S. NASDAQ company controlled by a GNI Group, a Japan company, that controls 85% of Gyre Therapeutics. We also control 65% of a subsidiary, Gyre Therapeutics China, in Beijing. That's the structure of our company. This is the summary of our three commercial products. The first one is pirfenidone, indication for pulmonary fibrosis, the idiopathic pulmonary fibrosis, IPF. This year, we acquired a generic nintedanib, which is also for the indication of IPF. Only two drugs currently are approved for IPF, so therefore, Gyre is a company that owns two IPF commercial drugs in the world. The third one, it's our internal program, and this product was approved in July this year.
It's for thrombocytopenia, and we will plan to commercialize the nintedanib and also avatrombopag later this year. So this is the highlight of our company, how we differentiate from other pharmaceutical companies in the same area, and also how we manage our operation risk. So number one, we have a proven track record. We developed the pirfenidone actually from research all the way to commercialization, so that really established our team, our presence in the industry, and also our expertise. And second, we are financially sustainable. Like I said, we have three commercial products. And the third, our innovation focus and also our strategic direction is on organ fibrosis. And also, we do not target the metabolic pathway, but instead, we target the chronic inflammation pathway.
The chronic inflammation, as you know, it's a very important mechanism for many, many organ disease in humans, so therefore, this is a very important mechanism to target. And then we also have a de-risk R&D approach. We, for example, the Hydronidone, our Pivotal 3 candidate, this one was a derivative of Pirfenidone, and then, we improved the safety profile and also enhanced the efficacy, and also owned the global right. So in this, in this way, we avoid the the very high risk in the early drug discovery and drug development. So this is our, our risk management from the R&D, perspective.
And also, we have a rigorous and efficient clinical trial execution team, and this allow us to quickly advance our program in the clinical setting, and then, so we can quickly move faster than other companies in the same field. And then, like I said, you know, we have two drugs covering the IPF area. And then a little bit about our pipeline. So the commercial, like, as I mentioned, we have already have three commercial products as shown in this commercial product pipeline. And then I want to spend a little bit of more time on this early-stage development pipeline. So F-351 , the indication we target is NASH-associated...
Sorry, the first, I want to mention the HBV-associated liver fibrosis. That's our pivotal three trials in China. And then the result will be announced in early 2025. And then in the U.S., we target the NASH, or we call it the MASH, associated liver fibrosis. And then in the U.S., we have already completed the IND, the phase I trial. We are submitting the phase II right now in the U.S. So this program, anticipating we will see very encouraging results soon on the HBV fibrosis, and also we're going to advance in the MASH-associated fibrosis. And then the F573, which is a caspase inhibitor, this one, it's currently in phase II right now.
We did the initial 16 patients and saw encouraging results, but we are going to hopefully announce some results when we finish more patients later part of this year. The F-230 is a program we collaborate with Eisai from Japan, and this one we target pulmonary arterial hypertension. This one, we just received the IND approval, and we're going to start enrolling patients soon. F-20, F-528 , that is also a we own the global patent on this, on this drug, and this one is gonna target the COPD. It's we have already completed the preclinical validation, and this program we're gonna bring to clinical trials hopefully in the near future. And then about the 351 Hydronidone, this one, first I want to discuss our results in the HBV-associated liver fibrosis. This result has already published.
We completed this phase II proof-of-concept trial in patients with HBV-associated liver fibrosis. You can see in the three different doses, we saw very statistically significant efficacy, particularly in the 270 milligram per day dose, both in the liver fibrosis improvement and also in the liver stiffness measurement. We have more results on this trial study, and then you're welcome to look at it. It's available online right now. Currently, our phase III, we have already completed the patient enrollment in the early 2024. So the last patients will be complete in October, so it's only just a few weeks away from now.
And then the top-line results will be analyzed and then announced in early twenty twenty-five. And then, as I said, we also completed the phase I study in the U.S., and now we are planning to submit the phase I of the phase II for MASH-associated liver fibrosis in the U.S. So that's about our lead program. So this is the critical milestones right now. So we have in China we are basically we have already started preparing the NDA, but then the phase III top-line results will be announced soon. And then in the U.S., we completed phase I of the F351, and then we are preparing the submission of the phase II protocol soon.
To summarize about Gyre Therapeutics, we have three commercial drugs, and also we have a lead candidate in HBV-associated liver fibrosis, and then the results will be announced in early 2025. We have a phase II program that is ongoing right now. We saw some encouraging results. We have one phase I program for the F230, in collaboration with Eisai from Japan. Also, we have a preclinical program on the F528. That's our summary of our company, and this is what highlights our competitive advantage. We are a commercial stage company.
We are a profitable company, but we also want to replicate our success by taking the clinical program that's already validated in China into the US. So we want to maximize the value of our products globally. That's it. Thank you very much for your attention.
Thank you. Perhaps maybe we can discuss your studies with liver fibrosis in HBV patients. As you've seen, there's already phase II data in China, and then phase II- A is expected to... is in planning phase for the US. So in terms of study design, trial size, what do you see overlap between two studies, and what would be the major differences?
That's a very good question. The phase II study, well, in the phase III study, we enrolled a lot more patients. The total patient in the phase III -A, like I said, is 248 patients. But basically, it's still a confirmative trial, so we want to clinically further validate the result from the phase II. So we anticipate the result from the phase III would be, because we use the same clinical endpoint, so it will be similar, hopefully, you know, similar to our phase II results. Yeah.
Right, and I suppose in terms of patient demographics, where do you plan to have clinical sites for the US study? Would trial sites in Europe be included or elsewhere in the rest of the world? And also, to that end, would data from the study conducted in China do you anticipate data from those studies be included in discussions with the FDA?
You raise a very insightful questions, you know, regarding the trial plan in the U.S. We are discussing with KOLs, both from China right now, because, you know, some of the KOLs, in fact, they are coming to San Diego to deliver a conference in November. So we're gonna hold a KOL meeting in San Diego between the China KOL and also US KOLs to really discuss the trial design is important, but also, like you said, the patient demographic, you know, selection and also how we will try to. Are we going to also enroll some patients in China as well? So these are all being considered at this moment in how we're gonna do it.
In my humble opinion right now, I think we probably also want to, you know, have some patients in China, but are they going to be in the same trial design or different? That's something we are still discussing with the KOL right now. That's a very important question, yeah.
I see. And then perhaps, if we can switch gears a little bit, a little discussion about the MASH program. This, that's- we can see that it's primarily gonna be focused in the US. So, from a mechanism standpoint, what are some parallels between 351 and 230 ? You know, clearly, they both involve the liver, but different, very different diseases. So, do they employ the same mechanism of action of these two compounds?
Like I mentioned earlier, so our strategy is we want to start from the compound that's already demonstrated a clinical efficacy. So therefore, the compound we selected, for example, you mentioned F230 or F528 or F351, they all have a different mechanism of action. But, however, just because, you know, we happen to... I mean, one thing, the way we do it is we also want to diversify our risk by not targeting the same one. F351 is targeting the TGF-beta pathway, but then, for example, the F528, that target different mechanism. But however, altogether, this compound, they all target chronic inflammation.
Our focus, we want to target the chronic inflammation, but perhaps not through the same molecular pathway. Yeah. Yeah, so that's our strategy. Yeah.
Maybe perhaps a bigger picture question for MASH. As you mentioned, 351 has a unique targeting TGF-beta, and as we've seen, the first drug approved for MASH by Madrigal, you know, in recent months, and then with the emergence of use of GLP-1 and weight loss and also a lot of studies in MASH as well. How do you see 351 potentially fit in a therapeutic treatment combination? Do you see 351 as a fibrotic specialist in conjunction with other compounds that could improve metabolic measurements?
Yeah, that's a great question. Basically, you know, the this organ disease progression, that involves metabolic pathway, as well as chronic inflammation. You know, it's basically when the acute tissue repair fails, that induce the further damage and also the chronic inflammation. And then the chronic inflammation induce even further damage. So therefore, I think both the metabolic pathway and also the chronic inflammation are integral part of this whole disease progression scenario. But whether we combine these two and how we combine these two, it's still unknown at the moment. For example, there are a lot of drugs right now are being developed targeting the metabolic pathway, like the GLP, GIP, and also 89bio yesterday had a really fantastic result on the FGF21.
So we saw companies are currently doing either a combination or a dual-specific agonist, or tri-specific, or even a quadruple-specific agonist. So these are, you know, but this raise a question, I echo with the CEO of 89bio's opinion. It's unknown right now. We don't know. We use simply combine two drugs. It you know you probably you know know how to manage it. But when you have a dual-specific or tri-specific these mechanisms, what's something we don't know right now, what's going to be the toxicity, the adverse event?
And also, the two pathways, are we going to do the two pathways equal, or how are you going to control the level of each pathway? That's, you know, still unknown right now. I think there's going to be a lot of exciting results coming up in the coming years. But then coming back to how we combine the drugs targeting inflammation with the drug targets, metabolic pathways, that's something we are discussing with our KOL right now, you know, how we do that.
At the same time, we already started testing in animal models on the 351, a combination with, for example, I probably shouldn't reveal, you know, which specific drug, but we are testing several drugs right now in the metabolic pathways in combination with our 351 in animal models right now.
Okay, just one last question from me as we look forward to the phase II-A study, and-
That's phase III-A.
phase, phase III-A.
Yeah.
How can you highlight what are some key design elements of this study? You know, what are the primary endpoints? How many patients? Just a really quick overview.
This one, unfortunately, I don't have the Chief Medical Officer with me today, so I wouldn't be the best person to. But, however, I'm going to get back to you after, you know, consulting with our Chief Medical Officer. Yeah.
Understood. Well, thank you so much for your presentation. Does anyone have any questions for Han? All right.
Great. Okay.
Thank you very much.
Thank you all. Thank you very much.