Good afternoon. This is Yang Huang, China Healthcare Analyst at JP Morgan. Welcome to the, I believe, if I'm not mistaken, the last session for today. And thank you for continuing to stay here and join the session. And we have Henlius to give us the latest update. And Dr. Jason Zhu, the CEO and the Executive Director of Henlius, will do the honor of presentation. Dr. Zhu.
Good afternoon. Thank you, everyone, for your attention. I understand this is the last presentation, but I think, I hope it is the last, but it's not the least. Thank you very much. So Henlius is actually the public company listing in Hong Kong. So we are the biopharma company. So far, we have four products approved by the US FDA. We have seven products approved by the China NAPA. We have four products approved by the EU EMA countries. So we got 30-plus ongoing clinical trials. We got 50-plus early-stage assets. We actually got a global staff, 4,000 staff, global employee. And also, we have the manufacturing facility with the 80,000 liters based in China. So far, our products actually benefit more than 950,000 patients globally. So Henlius, we have five core global competencies.
First of all, we have an in-house clinical operation team that is across the world in China, US, Australia, Japan, and also we're covering 1,000 clinical research centers spread across 20 countries. We have R&D capabilities, 50-plus early-stage molecules, 70% of them aimed to be first best in class, 15% of them first in class to be aimed, including the ADC, IO, multi-specific modality , peptide, small molecule inhibitors as well, so we have the regulatory affairs in-house as well, so that's why, as of today, we have done 66 NDA approvals approved globally. Just last year, we got four BLA approved by FDA. We got 164 IND approved globally, and also, in terms of manufacturing, so far, we have manufactured more than 1,150 commercial GMP batches, GMP certified by multiple regulatory authorities, which is including FDA, EMA, as well as NMPA from China.
Also, we got a global commercialization team, 1,600 oncology commercialization team professionals in China, 20 overseas sales partners. Products are sold in more than 60 countries and regions. Let's look at our late-stage clinical pipeline. Serplulimab is obviously, we aim to be the best in class, particularly around the lung cancer area. We firstly got this product approved in the year 2022 in China with the indication small cell lung cancer. Also, later on, we got a couple of indications approved in China, including esophageal cancer, including non-small cell lung cancer. Last year, February, we got this small cell lung cancer approved in the EU countries and also later on launched in the UK, India, and some Southeast Asia countries. This approval is actually based on ASTRUM-005 study, as you can see in the right hand.
The ASTRUM-005 studies, in terms of the hazard ratio, is 0.6. And also, for the four-year OS rate, our four-year OS rate is 21.9 months versus the standard of care 7.2. If you look at the peers assets, their four-year OS rate is 13 months. So there is a strong comparison in that. So after that, we actually kick off a couple of very innovative design studies, so-called very brave design studies. That is around a phase II study we call ASTRUM-015 in the first line MSS, mCRC, metastatic CRC patients. So that design, we actually got a very good result. The PFS, you can see, it is an add-on standard of care design. We do the serplulimab add-on, the bevacizumab add-on chemo. The PFS is 16.8 months comparing to the standard of care, which used to be 10 to 11 months.
That design actually enabled us to move further. We launched global phase III studies, mainly focused on Asia, Japan, Southeast Asia, and China. So far, this study has completed recruitment, 600 patients completed recruitment. We are waiting for the result next year in terms of the OS. Also, phase III registration trial we done in the perioperative treatment of the gastric cancer, which met the primary endpoint and grant breakthrough designation. Also, partly reviewed from China NMPA. That is the first perioperative regimen for gastric cancer to replace the adjuvant chemotherapy. That means the patient doesn't have to be suffering from any of the chemo in the adjuvant therapy for those gastric cancer patients. The second asset, currently, we are running the global phase III, covering US, China, Japan, Europe, Latin America.
That asset is talking about HLX22, which is a novel epitope HER2 mAb. That asset, we are trying to succeed in comparing to Keynote-811. As you can see, that is a dual epitope strategy. The strategy enables us to boost HER2 internalization by 40% to 80. That internalization enhancement enables us to have a much lower safety concern, especially talk about IO, especially talk about diarrhea, grade 3 diarrhea. As you can see, we actually compare our phase II study to the rest of the study, Keynote-811, HERIZON studies. Keynote-811, they actually provide a patient with PFS around 10 months as a median. HERIZON, which is disclosed recently this year in the phase III design, is 12.4 months. Our PFS is not reachable at the moment, but I think it is definitely more than 20 months plus.
So these data disclosures enable us to move to the global phase III, which is currently ongoing. And the global phase III is actually a randomized control study with 600 patients trying to be recruited. So the design is actually HLX22 plus the standard of care versus Keynote-811. That means we want to beat KEYTRUDA in this particular population. And so far, I think the doctor, the leading PI from different countries, like Japan, like Latin America, like the US, they also pretty much want to join this study. One of the reasons is because they understand the safety profile for the HLX22 is way better than the rest of the peers. So they are very confident to move ahead. So far, we completed about 40% of the patient recruitment as a target already. So HLX43 is the PD-L1 ADC.
As you can see, we have so far recruited 500 patients already, mainly in the solid tumor. It's not mainly. It's 100% in the solid tumor for sure. And more than 60% of the patients with the non-small cell lung cancer, as you can calculate, is about 300 patients already recruited in the non-small cell lung cancer area. And the right hand, the waterfall plots, you can see, is based on the RP2D cohort we pick up. So for the squamous non-small cell lung cancer, for anything more than later line than the third line, all of those patients have received the chemotherapy refractory. And also, all of those patients received the IO therapy as well. The squamous is at 2.0 milligrams per kg. The ORR is more than 33%. And also, for the docetaxel, so failed patients, we have achieved the ORR 38.5% as well.
For the non-squamous non-small cell lung cancer, which basically is covering two parts, two categories. One is the EGFR mutation. The other one is the EGFR wild type. So for the EGFR wild type patient, you can see we have achieved the ORR rate 47.4%, which is the best in disease potential. And also, we have dosed the patient in cervical cancer, 2 milligrams, 2.5 milligrams, 3 milligrams. It shows a very, very consistent dose dependency efficacy model. So in the 3.0 milligram, the efficacy has reached 70% as an ORR, which is quite significant. And also, for the esophageal, it's the same things. We have observed a very consistent dose dependency from 2.5 to 3.0. So the 3.0 cohort, we have observed the ORR at 61.5%.
So as that, I think we want to perceive HLX43, PD-L1 ADC as a high potential pipeline in a pure best in class, best in disease. So this year, I think, is a critical year for Henlius. I think we're going to kick off a couple of global phase III trials in non-small cell lung cancer. The first line and the second line. So the first line is for the non-AGA patient. The second line is for both, for the non-squamous, non-AGA second line, and also for the squamous second line. And we're going to kick off the global phase III. As you can see, we also have the data generated from the ESCC last year. And we have the data generated from the CC last year as well.
And this year, I think we're going to have the data readout for the NPC, for the GC, and hopefully for the TNBC as well. So HLX07, which is the novel EGFR mAb. So this 07, the reason why I want to present here is because we do see a huge potential in the treatment of the squamous non-small cell lung cancer. We pick up a very small sample size, which is 27 patients. However, the median PFS is really encouraging, which is reaching at 17.4 months. That's comparing to the Keynote-407 or HARMONi-6. We have a very good confidence. So over the next 12 months, I think we're going to kick off the phase II/3 multinational studies versus standard of care. Also, the first patient in is going to be planned this quarter this year.
This is the clinical milestone we're going to expect in this year. First of all, for the serplulimab, for the regulatory approval part, we're going to have the accelerated approval for perioperative GC from China as a new indication in addition to the current four approved indications already. We're going to expect approval for non-squamous non-small cell lung cancer as well as the squamous non-small cell lung cancer in the EU countries. We're going to file our BLA for the US for the extensive-stage small cell lung cancer first-line. We're going to file the BLA for the U.S. for the limited-stage small cell lung cancer this year as well. For the study progress, we have extensive-stage small cell lung cancer Japan bridging studies. Enrollment is going to be complete this year.
The primary endpoint is going to be readout this year as well. For HLX22, other than the current ongoing global phase III GC studies, I think we're going to have the data readout for the HER2 low breast cancer China-only studies phase II. That is a design on the add-on design. That means we actually do the combination with the T-DXd. And we're going to see if we can better improve in terms of the efficacy, in terms of the safety part preliminary. For the HLX43, I think this year for the study initiation, we're going to have a global pivotal phase III study for second-line non-squamous EGFR wild-type for the third-line non-squamous non-small cell lung cancer, also for the second-line squamous non-small cell lung cancer.
And also, study initiation. We got two POC studies to be initiated, which is the HR-positive breast cancer as well as the TNBC. Data publication, ASCO is supposed to be a big piece for us, ESCC. And also, ASCO is going to be the non-small cell lung cancer as well as the NPC. The ASCO is going to be the data readout for the CC later on data as well as the ovarian cancer. So data readout combination, we're going to have the combination data readout for the preliminary POC data driven from HLX43 plus the serplulimab and plus the HLX07 in the non-small cell lung cancer, in the small cell lung cancer as well as the mCRC patient.
HLX07, which is our EGFR mAb, we're going to kick off the CSCC pivotal studies, which is going to enable us to launch the first indication in a very quick way. And also, we kick off the first line squamous non-small cell lung cancer phase II/3 MRCT trials this year. So coming back to the research stage, what is our strategy? I think we still want to focus pretty much on the next generation IO. So what's going to happen? How do we improve the clinical response to those immune checkpoint resistant disease? So we got seven assets waiting there. And also, Henlius ADC platform, which we want to provide a larger therapeutic window, also overcome potential drug resistance. And also, we want to have a combination of the toxin with multiple MOA. That means a dual payload or even multiple payload in one asset.
Also, immune cell engagement, I think T cell engagement as well as the macrophage engagement, macrophage cell engagement, something we want to do and deep diving. Of course, we already have a couple of the assets in the clinical stage already, which I'm going to show you. I think we still want to focus on that. We're going to have more than five assets in this area, immune cell engagement. Henlius is pretty much spending money buying the GPU, doing the AI technology, just trying to have de novo generative power by the generative AI. We want to have the multiparametric toxicity prediction for efficient screen. These kind of things we are doing in a very intensive manner. Looking back to what's happening in the clinical stage already, that means last year we did quite a few IND.
The PD-L1 ADC is nothing new. We just want to make sure we have that. Currently, it is actually in the phase one stage. We have that. HLX97, which is a KAT6A/B inhibitor. I think we view that as a broader oncology asset. That means including the multiple oncology area, breast cancer, CRPC, non-small cell lung cancer. But our effort is trying to see how we mitigate those hematological side effects by designing comparing to the current leading compound in the industry. I think we have done a couple of pre-clinical models, seems to be confident, move ahead. T-cell engagement, we already have the one asset in the clinical stage currently in the dose escalation, which is DLL3, dual epitope trial specific asset.
The reason why we want to introduce CD28 is because we firmly believe the T cell exhaustion is the issue in the immunotherapy field. So the CD28 definitely is trying to provide a longer persistence of the activated T cell via this secondary T cell co-stimulatory T cell signaling stage. And also, by doing that, you can see T cell infiltration, the tumor-infiltrating lymphocytes are actually getting much more in the red bar comparing to the blue bar, which is the leading compound in the industry. So that's the strategy. I think we are very confident. So as of today, we're actually doing the dose escalation in the confident way. And HLX316, which is the first in class, we're doing the anti-B7-H3 antibody strategy. I think that's the first in class. Let's see what's going to happen.
So, 3902 is another T-cell engager, which we do as a STEAP1 x CD3 x CD28 . And again, I think we still believe CD28 as a co-stimulation signal not only produces a more rapid and active tumor effect, but also maintains the T-cell activation for a much longer persistent period of time. And that's the way to prevent T-cell exhaustion. That's the way really to provide some long survival treatment methodology for the patient. So again, I think we have observed a very, very exciting signal in the pre-clinical stage. And then the superior anti-tumor activity increased the T-cell infiltration as well as the persistence in the TME over the benchmark leading compound. And also, we have seen the more sustained cytotoxicity than a benchmark in the right lower panel. You can see we are more sustainable. We are more persistent.
Again, the 48 is something we call c-MET EGFR ADC because we firmly believe Amivantamab story. I think they are a very good compound, but we actually want to do an upgrade version, so we want to still retain the EGFR c-MET functionality, and at the same time, we have a low-dose strategy in this asset, and also, we want to have a better, much stronger bystander effect. That's why we introduced our new linker payload strategy, which is called ALPA003, and we firmly believe we need the bispecific antibody to do their job. At the same time, we also need a very low-dose strategy to allow a very strong bystander effect payload to penetrate into the different tumor tissue, and also, we have seen a very significant efficacy of the data comparing to our benchmark compound. Again, you can see this HLX48 reached HNSTD at 60 mg/kg.
It's a very, very safe signal, so HLX49, which is the best in class, we want to be the best in class HER2, HER2 novel paratopic ADC. One of the reasons is because of the HLX22. Again, this is the pre-clinical pipeline, which we're here. It's not really the pre-clinical because some of the blue flag already in the clinical and the yellow flag to be in the clinical within the next six months, so I think that's something we can expect this year, so strong growth trend in the next five years for Henlius. For all those light blue bar, that means Henlius starts our business in the biosimilar piece. But biosimilar actually gave us a very, very strong capability in terms of global clinical operation capability, global regulatory affairs capability, global manufacturer capability.
It starts from that, we actually move to the new area, which is the innovative compound. As of year 2024, we have $0.7 billion revenue sales generated. Last year, 2025, because we're the public company, we cannot discuss at the moment, but definitely double-digit growth is expected for sure in terms of the compound value. Over the next five years, I think you guys are going to see we're going to have another 10 biosimilar compound launch in the US, EU, and China market. We're going to have another five innovative compound launch in the global market as well. Again, Henlius 2030 vision as a global biopharma company, we're going to have more than 20 products launched globally and more than 15 compounds in the US and EU region.
And the portfolio expansion, we're going to have more ADCs, bispecific TCEs advancing to the market. And also broader footprint across oncology, autoimmune, metabolic, and CNS. Overseas revenue expected to exceed domestic contribution for sure. Thank you very much. We welcome any questions.
How much money do you need to push forward on these programs?
You're right. I think that's one reason I think we definitely done a couple of the strategy in terms of how we carry on this IND development. First thing, we can definitely leverage our sales revenue huge to generate from the global sales, especially from the biosimilar part, to sponsor the trials for the innovative compound. That's one channel. The second channel is definitely we are considering to have some of the licensing partnership discussion this year for a couple of assets.
And also, we are open to have some of the NewCo discussion to carry on this development. Thank you.