Okay. All right. Hello, everyone. Good afternoon and welcome to the HC Wainwright 27th Annual Global Investment Conference. My name is Matt Keller. I'm a Vice President in the Equity Research Department. It is now my pleasure to introduce our next company and our next presenter. With us, we have David Zhang, the SVP Corporate Development of Gyre Therapeutics. David, the floor is all yours.
Thank you. My name is David Zhang. I'm in charge of Corporate Development as well as investor and shareholders relations at Gyre Therapeutics. At Gyre Therapeutics, we are a commercial stage pharmaceutical company dedicated to fibrosis-first therapies across different organs that are affected by chronic disease. We are China-rooted, but with a global ambition. Just a bit of a quick cautionary note that the statements we make are forward-looking and there are risks and uncertainties contained. Please read the notes. At Gyre, when we founded our company in 2002, it was one single mission, that is to confront the pulmonary fibrosis in a country where few people even know of this disease. Through a pioneering effort by our initial team, our efforts bore fruit. In 2011, we received the first-in-class approval for our pirfenidone.
Later on, we branded it as ETUARY® in China as a first-in-class approval drug, as well as designated as an orphan drug. Through persistent patient education, physician education, as well as patient management, in addition to national advocacy, we have built ourselves a dominant market share in China for the last 10 years, or at least a decade. As of the end of last year, we still maintain about 50% of the market share in the IPF market, but over 90% of the market share in pirfenidone space. There are only two globally approved treatments for IPF. One is our pirfenidone. The other one is called nintedanib. We are very happy and proud of what we achieved for the IPF space. As of the end of last year, we have about 600 employees across the globe. About 400 of those are in commercial activities.
We have treated about over 150,000 patients in the last 10 years, or a little bit more. We maintain a coverage of over 3,000 hospitals and pharmacies. If you really look at it, the Gyre story is one of sustainable growth. We have been EBITDA positive since 2017 and growing at a 32% compounded rate each year. Our revenue last year was a small dip due to the economic condition, but we are looking at continued growth in the future years. Just to put it into context, our drug price, at least in the case of pirfenidone, is approximately one-tenth to one-twelfth of the price that we normally would be charged in the U.S., at least a few years back when pirfenidone didn't come off the patent yet. That's why we're looking at the U.S. market as our next frontier.
We really believe we have a nice pipeline, which I'm going to get into. Last but not least, very importantly, we have an integrated platform where we have two state-of-the-art GMP-certified manufacturing facilities currently running at a low capacity, completely ready to scale when our next drug is approved. Building on our previous success with pirfenidone, Gyre purposely built hydronidone, or internally we call F351, to tackle fibrosis directly with more potency and an improved safety profile. Hydronidone is really a pirfenidone 2.0 from our perspective. In the last month, in May, we announced Phase 3 top-line result for chronic hepatitis B or CHB in China. The result is very promising with statistically significant fibrosis regression, which we'll get into later on. In the U.S., we're looking to apply for the Investigational New Drug, IND, very shortly, hopefully very shortly, to focus on MASH-advanced fibrosis.
Beyond F351, we have a very diversified pipeline in place. In addition to the pirfenidone, which is lung-focused, we're also looking to expand into additional indications such as radiation-induced lung injury or RALI, as well as pneumoconiosis. These are additional indications built on the strong reputation and the foundation of pirfenidone, which we have been dealing with for the better part of the last 14, 15 years. Pneumoconiosis is at the latest, it's already approaching the completion of Phase 3. We are entering into the oncology space with RALI for pirfenidone, and we're looking to do an adaptive approach with Phase 2 and Phase 3 clinical trial. For F573, which is in acute-on-chronic liver failure disease, we are looking to complete the enrollment for Phase 2 clinical trial this year. We are also very excited about our F528 program, which is COPD.
It's a market in China that's pretty large, and we're all very excited with this space. In addition, we're also looking at diabetic kidney disease or DKD. That's another area that we are continually exploring with our Phase 1 clinical trial and potentially other drugs in a number of different spaces. Before I get into the specifics on our hydronidone or F351, I'd like to highlight two strategic commercial moves that we made recently. In 2024, we acquired the generic rights for nintedanib. As I mentioned previously, that's another approved treatment or one of the two approved treatments. One is pirfenidone and the other one is nintedanib. Currently, we are able to offer both treatments to our physician network, expanding our offerings in the spectrum of the treatments. In addition, we acquired the rights to Contiva or Evotrauma PEG.
This is our attempt to get into the hepatology space or liver space where we are preparing our eventual launch of hydronidone for chronic hepatitis B. What we try to do here, what we try to demonstrate is that we are able to balance short-term execution as well as long-term planning here. We recently announced our hydronidone phase 3 clinical result for CHB in China. As you can see, we met the primary endpoint with a treatment delta of approximately 23% with a p-value of 0.0002 on an ITT basis, and all with central blinded pathology review. We also met the key secondary endpoint with greater than one grade inflammation improvement with a net delta treatment of at least 15% with a very satisfactory p-value.
What really differentiates hydronidone is truly the safety and tolerability profile where we see a 4.88% of the serious adverse event compared to 6.45% of the placebo. No discontinuation occurred due to the adverse event. On that basis, we received the breakthrough designation in China, which positions us to apply for new NDA for new drug approval on an expedited basis. Potentially, this is going to be our second first-in-class approval in a span of 14 years. In the U.S., we're looking to file an IND to enter the phase 2 or advanced liver fibrosis for MASH. The trial will initiate pending regulatory review. Again, here's the safety profile. We're extremely happy with the favorable safety profile. No SAE is determined to be associated with our drug. There's no discontinuation as well. Overall, we're extremely pleased with the improved safety profile with hydronidone.
In China, our focus is on the CHB market. It's a huge potential market with 2.6 million targeted unmet needs of patients. We believe the overall market is approximately 5 million people. This is based on the data we reviewed. In China, approximately 7 million people have cirrhosis, and 70% of those people derive their cirrhosis due to CHB. We believe these patients are our future target patients. For the moment, we're looking at the most severe stage of patients who are diagnosed and who are likely to go through to be treated with hydronidone. Just to put it in perspective, when we started with pirfenidone, our unmet market is approximately one-tenth of the market size we're looking at with CHB.
In the U.S., we are looking to enter the MASH market because the MASH market, we believe, for our there's about 650,000 patients in this space, which will be seven times larger than the CHB space. Our hydronidone is purposely built to target the advanced fibrosis, which is complementary to all our other metabolic drugs, including GLP-1s, THR-beta, as well as FGF21. Our hydronidone is going to focus specifically on the fibrosis where other drugs' starting point is metabolic. It's a substantial market for us. We have completed a Phase 1 study a few years back on healthy volunteers. Our preclinical data indicates the effectiveness of hydronidone in treating fibrosis patients in MASH. Additionally, we believe the biological pathway for liver fibrosis is similar, or if not the same, for CHB as well as MASH.
Where our focus is going to be, as you can see in this chart, most of our other metabolic drugs are currently focused on the F2 and F3, where the starting point is metabolic, where our focus is at the latest stage in the F3-F4 stage, which is close to cirrhosis and liver cancer. This is the space where we believe the drug will be most effective. We estimate there's approximately 450,000 patients in that space. We hope to initiate our clinical trial after consultation with FDA. What makes Gyre different? We look at it as four pillars of success factors. Number one is we have a strong and diversified pipeline. Our lead asset, hydronidone, has the potential, again, to become a first-in-class therapy in China for CHB. In the U.S., we're looking at MASH.
In addition to that, we're looking at other indications as well as fortifying our existing pirfenidone franchise. Number two is really what we are most proud of, we are looking at this China validation strategy to be our stronghold. Why? Because we understand the market. We can enroll patients faster with cost efficiency. What we would like to do is achieve faster validation in the China market and then bring it across the pond to the U.S. to expand globally. We are currently building a team where we are very pleased that we are going to establish our foothold in the U.S. and potentially grow globally. Hydronidone, we're looking to file the IND soon and focus on advanced fibrosis. We hope to, with the team in place, do the clinical trial soonest.
Last but not least, our commercial execution in China, the capability will afford us the stability that you do not normally see in an early-stage biotech. We are able to, with development, continue to maintain our market leadership and continue to build on those positions with our team. This commercial execution forms the baseline that gives the company the potential upside for our investor in the long run. Last but not the least, we have the end-to-end, from discovery to development, from manufacturing to commercialization. We own the whole value chain. We can quickly scale if we need to once the drug is approved with cost efficiency and with the knowledge we built previously. Again, we have two GMP-certified state-of-the-art factories ready to move with our, hopefully, the potential approval of hydronidone in China. We hope that, and in the US, we're building the team.
Overall, I think our story is a story of sustainable growth and is a story of optionality and upside for our investors.
Great. Fantastic presentation. I want to take a moment to say thank you to David and the entire Gyre team for the presentation today. If you have any questions, since we are out of time, we encourage you to follow up with David or the team after this session. Thank you again from HC Wainwright. Thank you for the attendance this year. Appreciate it. Thank you, David.
Thank you.