First, please allow me to introduce the experts, Professor Yi-Long . I think you all know him very well, and he is the mentor for the PhD students, IASLC Outstanding Scientific Award receiver, and he is the Guangdong Lung Cancer Institute head, and also he is very famous for the chest lung cancer chair. Also, we are very pleased to have Dr. Weiguo Su from HUTCHMED. I think you all know him very well. Let's start with Dr. Su.
Thank you, Yingqi. Good afternoon, dear investors. It is my pleasure to have the opportunity to talk with you, HUTCHMED, savolitinib combined with osimertinib in NSCLC, our two major studies. Yingqi mentioned for these two studies, has announced in this year's ESMO 2026. Firstly, let's do a very quick review. Savolitinib journey, in 2010, we initiated this project. We approved this project. It is for NSCLC treatment.
Last year, in 2025, in China, it was approved in the second line EGFR mutation and also MET amplification NSCLC treatment of patients based on the phase III research result. For this June, it was approved for the gastric cancer treatment for phase III. For this year, for the ESMO 2026, one is SANOVO, one SAFFRON studies. SANOVO is a Chinese study led by Professor Wu and completed. I personally think this is very significant and very innovative and groundbreaking potential research. Also for this research, later on, Professor Wu will give a very brief, detailed introduction. Also for the SAFFRON research led by AstraZeneca, and this year, Professor Lu in ESMO 2026, he did presentation. SAFFRON has achieved a very successful result. For this result is correlated to China phase III. It is aligned with our China data.
Later on, we will show you the figure. For these two studies to prove MET, no matter for high expression or amplification in terms of EGFR mutant patients, EGFR TKI treatment, it will breathe poor prognosis, or for the MET high expression, will greatly reduce EGFR TKI therapeutic result. Simultaneously, to blockade EGFR and MET signal pathway will benefit our patients better. I think for the savolitinib has experienced a decade, more than 10 years research journey. I think for the MET and EGFR mutant patients prognosis, I think it has a better understanding for those segment patients. So I'd like to give floor to Professor Wu. Professor Wu will give more details on the SAFFRON and the SANOVO data interpretation and the clinical significance of those datas.
Thank you, Dr. Su.
We know the savolitinib from the early stage research, and then it will step into the global commercialization and to cover front line, second line, and multiple indications. Like Dr. Su said, we will invite Professor Wu to help us to interpret the data of the SAFFRON and the SANOVO. Later on, we will have roundtable discussion. We will invite two experts to tell us the outlook for the clinical application. Finally, we will have a Q&A session. For investors, please use Zoom to raise your hands to raise your questions. Now, let's give floor to Professor Wu.
Good afternoon. I come from Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital. I am Professor Yi-Long . In this October, in Madrid, Spain, in ESMO 2026, on behalf of Guangdong Provincial Research Team, I did a presentation in the ESMO 2026.
I give the presentation about savo combined with osi in frontline treatment, after the biomarker selection, frontline patients treatment for this research. For the enrolled patients, they must have met two requirements. First requirement, they have EGFR mutant patients. They are missing 19 and 21 mutation. For the second requirement, for the OR biomarker, we use IHC to identify those patients. They are MET overexpression. For the MET overexpression, we have two definitions. One definition, first of all, we will look at the strong expression for IHC, above 3+, above 90% tumor cell. They have a very demonstrated strong stain. The second definition is the IHC 2+. IHC 2+, we use very normal method, H-score. H-score is above 220, and for the tumor cells demonstrating strong staining below 90%. People do not know what the IHC meaning.
Two meanings is the numbers and the grade of the expression. For the two requirements, it will give H-score. As we all know, since IHC 3 to IHC 2, and so, how about we make the judgment in order to give a right, accurate judgment? So, we do not only look at the strong staining, and also we need to look at the quantity. Then we use H-score. H-score must be above 220. There are 320 patients to be enrolled, and according to 19 and 21 IHC 3+ and IHC 2+, and whether it has the brain metastasis, we allow brain metastasis patient to be enrolled, randomized. There are two groups of patients. One is savolitinib combined with osimertinib, and the other is placebo combined with osimertinib. This is the most classic and most recognized placebo with contrast arm.
For the placebo, to make our research and make our positions and patients, they do not know. The patients actually, they use what kind of drug in order to make sure the justification of the drug and the fair of the research. So, we also look at the resistance and the intolerable toxicity progression time, and we call it PFS. Secondly, we will adopt because independent PFS and toxicity and safety and efficacy. A lot of people ask a question, why we will use the PFS for the research since we use the placebo contrast? No matter what kind of medicine we use without, I think this is a recognized method adopted. Here, we selected 1,896 patients, among which 144 patients, they have EGFR mutant patients. We tested MET IHC.
Actually, the randomization patients is 326, among which 162, they come to our research group, and 166, they are in the placebo arm. As you can see, until we got the data, cutoff date is July 31st, 2026. As you can see, in savo combined with osimertinib, 37.7% patients are doing ongoing treatment. For the placebo group, only 24.4% patients, they accept ongoing treatment. This is the result, very beautiful result. As you can see, according to our research statistic, IHC 3+, according to outstanding, this is the most strong indication. For IHC 3+, 30.4%. As you can see today, if we look at follow-up time, this duration is relatively long, and for the other follow-up, maybe it is around 10 months or more than 10 months. As you can see, we follow up longer time to observe the result.
As you can see, the result is very stable. The result is more persuasive. Also, if we look at median PFS, the disease progression is 24.8 months, above two years, and to osimertinib is 10.2 months, and reduce the death rate by 55%, and the P-value below 0.01. As you can see, 24 months is 43.7%, and for the three years, as you can see, 26.9%-14.4%. The data is very good. As you can see, we across different population. H-score two patients, we also recruit H-score 2 patients, and also we can see 0.56, P is 0.01, and the median PFS is 24.9. OS osimertinib is 24.8. As you can see, for those two lines, we can see from the beginning to the two process, as you can see, the two curves have a very wide gap.
As you can see, it's very clear difference, not a difference at certain point. This is its significance. As you can see, this is the median follow-up, 38.7 months. You know the OS. OS is the primary endpoint. The secondary endpoint in our research, secondary point, we attach great importance as well. As we can see, so far, it's 40.5 and 34.9. HR is 0.48. As you can see, by three years, well, as you can see, the 20% gap, 67.4% versus 47.4%. This is also a good result, which means in our research, in terms of PFS and OS, this is a very important two endpoints and a secondary important endpoint. We have achieved good result.
In terms of toxicity, if you look at this table, for the savolitinib in terms of the toxicity versus osimertinib combined, as you can see, there are some similarities and differences. Similarities, it will hurt our liver and our renal, and also it has peripheral edema. For the upper limb and the lower limb, this is the commonality. As you can, for the MET, in terms of the toxicity, above three is 7.2 versus 38.4%, and for the severe is 54.9, 28.7. As you can see, for the leading to dose discontinuation is 14.8, not very high. This data is acceptable. We can conclude in terms of the safety, the safety for our non-savo and osi are consistent with known profiles. There is no new unpredicted toxicity. This is the SANOVO in the first line.
This is SAFFRON in second line, where in Shanghai Chest Hospital, Professor Lu, he delivered a presentation. For the patients, previously, they used third generation, and they have the drug failure. Let's look at the combo, how does combo perform? As we know, for the enrollment of the patients, they must meet two requirements. One requirement is overexpression, 3+ above 90%, IHC 3+ above 90%. I think it's aligned with our core standards, but also it has another requirement, the FISH amplification above 10% for those enrollment patients. As you can see, the requirements are similar and different from savolitinib. In SAFFRON, the stratified by Asian or non-Asian, the baseline brain metastasis line of treatment is second line, third line. As you can see, it's one-to-one randomized. There are 324 patients, and we use osimertinib combined with savolitinib.
Contrast group is pemetrexed combined with carboplatin or combined with cisplatin, and as you can see, for the four cycles. As you can see, the primary endpoints is PFS, but for the PFS, we use independent data to do the evaluation because this is not a blind test. That is why we must have the test value, so we comply with our requirements and guidelines to conduct our research. As you can see, this is the PFS, 7.6 months, osi plus savo, and for platinum, pemetrexed is 5.4%, so HR is 0.55. As you can see, to reduce the death rate by 45%, so in 12 months, 36% versus 10%. As you can see, this is a very wide gap, wide difference, and it is very, very important in terms of the statistical significance, in terms of the OS, 17.8 months versus 12.9 months.
As you can see, the reduced death rate by 30%. As you can see, the 70% versus 53% osi plus savo in second line treatment achieved a great success in terms of PFS, OS achieved good results in the endpoints. It is also international multicenter, and including European patients, U.S. patients, Asian patients, plus PFS and OS value. As you can see, we deliver keynote speeches simultaneously. We issue the results in the New England Journal of Medicine. It is a successful research. As you can see, according to our forecast, we can say, no doubt, it will become the regulatory. We will file for the regulatory approvement, and it will become a routine standard for care. This is about the toxicity.
Likewise, just now I showed the first line treatment, some similarities, grade above 3, 64%, and as you can see, the two figure are very close. For the serious, 41%, not very great difference. It is once again, the combo in terms of the safety. The safety is quite consistent, no matter for the front line and the second line treatment. This is my today's presentation. Thank you.
Thank you, Professor Wu. Thank you for your introduction. Also, I'd like to congratulate on the savolitinib in terms of SANOVO and SAFFRON and the groundbreaking data. Congratulation on your presentation. Now we're going to move to our roundtable interaction. Here, we can see it's important in the NSCLC. Let' s start from SANOVO.
I'd like to ask Professor Wu several questions, so f or recent years, as you can see, the MET overexpression during the patient is, well, a ccording to the literature, in the front line, mutation or MET overexpression, the proportion is very high. Some people say 10, 20, 50, but it seems that there's no unified figure. My question is for Professor , what was the actual proportion of patient with MET overexpression during the patient screening process of the SANOVO study? Do you think MET testing has the potential to become a routine screening item in front line EGFR mutant lung cancer to help our doctors to choose tailored treatment regimen?
It's a great question. As we all know, we know the MET gene abnormal, there are three aspects. One is mutation, gene mutation. We know the exon 14 skipping, and the other is amplification. You know the amplification in the EGFR is a bypass.
Once the bypass activated, it will cause the disease. The third is overexpression. Before we did our research, people did not think overexpression is not a good biomarker. Why this time we emphasize on the expression? This is because we have laid a good foundation beforehand. For the first, when we use a MET inhibitor, capmatinib, back then, we have already did the contrast of the expression and amplification. So the MET overexpression can indicate its value. More importantly, before, we always use MET amplification as our biomarker in our previous study. Later on, we have noticed that amplification in the clinical prevalence, it is not very good in terms of the testing. Testing is troublesome because you must use FISH and other methods in a clinical practice. At present, firstly, we will use gene sequencing method.
Secondly, we will use IHC to help us to do the testing. We never choose FISH as our preferred one. If we cannot find other methods, then we will use FISH. So far, we will not use FISH as our preferred one. So it is quite restricted in the clinical practice. Because of that reason, we are very boldly, we use overexpression to become our option, because MET overexpression, it is very simple to be tested, and we are able to get to the proportion. So what is the proportion? If the number is very low, we do not think it is very meaningful. So among 1,000 patients, 449 have EGFR mutation, and for 2+, 3+. As you can see, it is 58%. As you can see, this figure, the figure is big and high. But I think for this figure, we should have need to identify that figure.
From SANOVO, to SAFFRON, so IHC 3+ is around 20%, it is very stable. IHC 2+ because of two reasons, I think this figure need to be identified later on. But at least in terms of SANOVO, among 1,000 patients successfully tested, the proportion is 58%. So it is a big population, it is prevalence, and I think this is a good result. In my presentation in the ESMO 2026, in a panel discussion, the Lung Cancer Association, he is specialized in IHC. He commented, he said before, they want to use IHC as the biomarker to do the selection, but they failed. But today, we are the first one to use IHC clinically practice. It is very successful versus the other method. It is simple, it is cost-effective.
Thank you, Professor Wu. Follow-up question.
Well, for the first-line options are highly diverse, including osimertinib plus chemo, Johnson & Johnson's RYBREVANT combo, upcoming ADCs will be expanded in the frontline treatment. Do you believe savolitinib plus osimertinib has already demonstrated a strong compactness in the frontline setting based on SANOVO's data and oral convenience?
Well, like we all know, starting from the year 2022, we have already been aware that in lung cancer, we are able to choose a gene-targeted drug to treat the lung cancer. We can achieve a good result. For example, we use EGFR testing from generation 1 to generation 3. As you can see, we are able to extend OS and PFS. But later on, we find the mutations have the similar characteristics. In terms of the lung cancer, as you can see, there is a large commonalities. If there is a target, we select a targeted therapy.
Well, in terms of the survival, the survival can be extended. Based on this fact, as you can see, in the overall, in our research, the PFS achieved 22.5 months. This is a very good result, outstanding result, as you can see. In OS, we can achieve 40% result versus existing MET polo, FLAURA2. As you can see, we are able to achieve the same level, but pay attention to the details in contrast group. When we, versus FLAURA, if you look at the PFS shortened. That is why, according to our forecast, FLAURA2-MARIPOSA are specifically for the MET driver patients. We cannot achieve a good efficacy because it is a broad treatment. Now, this is all function. For the HR, SANOVO is 0.48, but for the other two is 0.7% in clinical research. HR is above 0.7%.
We think it is not very clear advantage, but it is below 0.6. This is outstanding. This is a clinical significance. As you can see, for the SANOVO is 0.48 in terms of HR. In terms of the safety, we think SANOVO has achieved a good safety. Also for the AE discontinuation of the drug. The final question is the side effects. Side effects leads to discontinuation. For the side effects will lead to a discontinuation. If you look at SANOVO is 14.8%, around 15%. For the MARIPOSA is 40%-50%, FLAURA 48%, nearly 50%. SANOVO is more safer. SANOVO has a potential to become the frontline SOC.
Thank you, Professor. You mentioned about the MET testing. I also want to ask the question. When the physician have the MET plan, will test the MET in order to missing the frontline targeted window?
I think this is a good question. If you look at China population testing, this is a progressive process. At the very beginning, we only do one mutation testing. People ask, "Why? Why do we do mutation test?" This is around more than 10 years ago. The cost was really high because for the patients, they do not have this kind of necessity to be tested, but we ask them to take the medicine, so it will cause them to have the mutation. In the lung cancer, first of all, we need to do tests. Firstly, when we do tests, in advance, including MET overexpression in Guangdong Lung Cancer Institute, when we recruit all the patients, we will test them. We test them first.
When the medicine is approved nationwide and accepted, of course, it will be listed in our guidelines and national drug list. Well, like I have answered your question in question one, it is a simple method, it is a cost-effective method. Of course, it has its potential to become a routine testing method.
Thank you, Professor Wu. After talking about SANOVO, now I would like to talk about SAFFRON. What was the proportion of MET alterations during the screening process of the SAFFRON study? Is this patient segment relatively common among the EGFR-resistant population?
Before, our old concept was, if, so for the post-resistance, if we look at MET amplification, it is around 25%-30%. It was an old concept. For the SAFFRON research result, we noticed that the population is over 30%, from 30% to reach 35%. Why it is a high population? This is because it including MET amplification.
As you can see, MET overexpression. As you can see, the figure grow. If you achieve, plus MET amplification, it is 25%-30%. This is our research. So, when we versus the previous two research for the overexpression, MET overexpression, we can cover more population.
Very clear. Thank you, Professor Wu. My follow-up question is, SAFFRON is the world's first phase III study to achieve statistically significant PFS and OS benefits following EGFR TKI resistance. Where does its core differentiated advantage lie against ADCs, bispecifics, and does it possess standard of care potential clinically? For the SAVO combined with OSI, does it have the potential of SOC?
Well, for the combo, we use including the osi plus chemo or ADCs. Every year, you know, one or two research studies will be released. I remember the first relief of the FLAURA2.
Well I was the person who disclosed the person. In the discussion, I asked a question to everybody. Now, we have an oral drug, and when patients take the drug, the patients, he can walk normally and he can have a good life quality, who can live in a normal life. However, if we use intravenous injection to these patients every week, this patient need to go to hospital to receive the injection. His family members need to accompany this patient to go to the hospital. As you can see, actually, the patient's life quality has been decreased. I asked a question back then. When I raised the question, well, the New England Journal of Medicine also gave me a medicine, gave me a comments and feedback, and also I released this in that journal.
In terms of the amivantamab plus lazertinib, clinical practice, it can achieve 80% efficacy because of the side effects, because patients need to go to hospital to receive the injection. But today, if we use the osimertinib plus savo, those are oral drugs, so the patients do not need to visit hospital weekly. As you can see, the life quality has been greatly improved. Also for the savo and osi, it does not have any side effects, other cost for the chemotherapy, and also, for example, the patients need to live in the hospital. As you can see, the cost is high in terms of accessibility and easy to use. Well it enjoys its advantage. The third key factor, well if you look at HR 0.68, below 0.7.
As you can see, for the combo, the HR, and for the MARIPOSA-2, HR is 0.73. By comparison, in the future, for the convenience and low side effects, and also plus its low cost, it will become our routine option.
Thank you. After asking Professor Wu, my question is for Mr. Su. For Citi, we know combining the exciting data from the SANOVO study, does AstraZeneca have opportunities for global regulatory filings or initiation of overseas clinical trials? Mr. Su?
Thank you for your question. I would like to answer your question. For AZ, in terms of the ESMO data release, we also have investors meeting back then, and we also did introduction during the meeting. They mentioned they are working with regulatory bodies to discuss opportunities for global regulatory filings.
Well, if you look at SAFFRON global research after the ending of the filing, once savolitinib goes to the market, it is more accessible by the patients in the frontline treatment. Savolitinib will be accessed by some patients in the first line. Whether Chinese data can support global filing, can be approved globally, I think we will talk and discuss to regulatory bodies. For AZ, we have this plan, but the plan is under negotiation.
Thank you. My second question is from a commercialization perspective. How to evaluate the global market potential of savolitinib? What are the company's expectations regarding the future peak sales?
Well, from a commercialization perspective, for AZ is responsible for the commercialization in China. If you look at indications, some indications have been approved. An exon 14 skipping indication.
In China, there are more products, highly competitive market in China in terms of MET exon 14 drug. But we have a second line combined with osimertinib, savolitinib, and also, as you can see, it has been approved. Also for the third line, gastric cancer to be approved. Also for the SANOVO research, it is expected to be approved in the frontline and will cover larger population, and the duration of care will be longer. So I would like to talk about following perspectives. From the perspective of AZ, savolitinib combined with osimertinib, I think it is a very valuable combo regimen. Well, like I mentioned, no matter in the second line, in the future, in the frontline, for the patients, and more than savolitinib sales, since it combined with osimertinib.
On one hand, it will benefit AZ to consolidate osimertinib market share, because in China, there are a lot of generation three TKI to be approved and to be get access to the market. So for the osimertinib, has been challenged by our competitors' products in terms of market share. But for the SANOVO research, specific to EGFR mutation and MET overexpression, it will help and benefit AstraZeneca's osimertinib market share in Chinese market, specific to our patients, and we are able to prolong the drug duration. As you can see, the PFS is doubled. Well, it does not only benefit the sales of savo, but also help to consolidate osimertinib's market share in China. Plus, savolitinib globally, well, it has the global filing and apply for the approval globally based on the SAFFRON research.
I personally believe, well, it has the clinical significance, but also it will have a big potential for commercialization. Well, it will achieve the $1 billion potential market.
Thank you. Thank you, Mr. Su. What is the current status of regulatory filings and the registrations for the SANOVO and SAFFRON studies in China and globally? What is the plan and timeline for anticipated approvals?
SAFFRON global filing is responsible by AstraZeneca. Later on, I will show you a PowerPoint. At present, for the U.S. FDA, we applied in September, by the end of this year, and we think we will get the result. For the EU and Japan, well, we released our news in the EU and Japan. We applied and have been accepted. We have filed and be accepted.
According to our forecast, in 2027, 12 months, 6- 12 months, it will be approved. For the EMA and the PMDA filing, according to their schedule, it will be approved, I think overseas. I think the earliest one is in the U.S. market. For the SANOVO NDA application, it will be completed soon. You can anticipate in the near term, we will release the news and the NDA in China, filing for Chinese market.
Thank you, Professor Su. My final question. I'd like to ask you to give us a summary. Abnormal MET expression is widely prevalent across a variety of solid tumors, generally dictating poor prognosis. Will we consider expanding into other tumor types in the future, including the EGFR wild-type population? Professor Wu, could you please help to answer the question first?
I think this is a great question.
If you know the MET, abnormal MET expression research history, around 20 years ago, back then, we worked together with the U.S., and we did a research of the transformation during our research for abnormal MET expression, apart from EGFR TKI resistance. Back then, in the clinical research, we noticed, for the cells, they did not have any mutation, but still they had abnormal MET expression for this translational research. Also, in our tissue sample, we proved that research. 15 years ago, I wrote an article, and I said the future of the MET and three research directions. First direction is today, in the SAFFRON and such. At the very beginning, when there is a MET application, when we detected it, then we use the combo to treat this type of patients. The other is for the EGFR mutation, and at the very beginning, we used the combo.
Today, the SANOVO has already proved that. The third research direction is without EGFR mutation. EGFR without EGFR mutation. At the beginning, we used the MET to do the treatment. For the MET inhibitor, it was approved in the application in China. China is the only to approve the first MET abnormal expression can be used to treat a first-line treatment. According to my forecast, as you can see, the research are following those three directions, according to the SANOVO design. At the very beginning, if you look at the resistance, I think in the future, in the very beginning, if there is no mutation, we are able to use this kind of treatment. Last year, we did a research. It is a phase II study. We are lacking of phase III research.
If Su is brave enough, like before, we are able to initiate the phase III research, and I think this is a very good research. On top of that, if you look at the MET overexpression, in the SANOVO, it is the first time we emphasize on the MET overexpression. It will cause a ripple effect, because for the global medical conference, if you start a question, then a lot of people will following on to research the questions. Like the gastric cancer and for other carcinoma, likewise, physicians around the world will do the research. If we can achieve success in the lung cancer, we are able to cover other diseases. Also in China, we have done some tests. Well, for different tumors, and we put them together, and we use a targeted treatment.
Well, in China, we have the traditional, yes, for the different diseases, we can use the same method to treat, or we can use different methods to treat same diseases. I think we can use the similar Chinese concept to treat the lung cancer or the oncology. For our researcher, we need to be bold enough to do this kind of research.
Thank you, Professor Wu. Very interesting. My question is, I'd like to ask Dr. Su to answer the question. From commercialization point of view, SAFFRON research plus SANOVO research, two researchers have proved that MET abnormal or MET overexpression, this is a marker of the prognosis for the patients with poor prognosis in a clinical study. How can we tailored and precisely select patients, like IHC 3+ above 90% H-score below 220?
We know one thing, h igher MET expression cause to lower prognosis and lower PFS and OS. For the same target with different targets, like EGFR mutation and the MET overexpression are two targets. Since we identified the prognosis related to MET and to blockade MET can benefit our patients better. From this perspective, I think we're able to cover other population. Professor Wu, who is expert and who has been studying MET for over 20 years. So, for the EGFR wild-type NSCLC patients, EGFR wild-type NSCLC, MET overexpression level is also very high. In our study of SANOVO, we selected many patients with EGFR wild-type high MET expression, and the positive confirmation rate is very similar, very high. For this segment of patients, they may consider use savo as a standard of care so that the efficacy can be further improved.
I think it's valuable for us to explore this direction. Apart from lung cancer, Professor Wu also mentioned about gastric cancer and other tumors. For the MET abnormal, MET overexpression, a lot of solid tumors have high expression. For the gastric cancer, we have more knowledge. And when research initiated a research, well, in the intestinal cancer, to explore the standard of care for the savolitinib for the MET high expression can improve the efficacy of SOC. I believe with the approval of the savo, of the savolitinib to be approved globally and accessibility, I think the test of MET, test of tumor, well, the bar is higher. Well, in China, the same for the IHC. IHC testing is more convenient.
A lot of patients, a lot of physicians, they may focus on the MET high expression, and they will increase the testing frequency, and also they may cover more tumors. From commercialization, MET high expression as a poor prognosis, SANOVO and SAFFRON researches, high expression of MET plus savolitinib to benefit our patients better. I believe on one hand, MET test will improve the SOC exploration in other types of tumors, well, like the gastric cancer and like the intestinal cancer. I believe for other types of tumors, we'll cover more cancers to do the research. And Professor Wu also mentioned about we need to be bold enough to register the research. I think we can discuss on this topic.
We need to discuss with AstraZeneca on this topic in terms of the feasibility. Also, we need to discuss, do we have enough data to support this kind of research? SANOVO is a Chinese clinical research, so it is Chinese patients to be recruited. SACHI is also a Chinese study. Also, we need to push to the global study so that we are able to cover more patients worldwide. AstraZeneca also talked to me. They are making the evaluation by using SANOVO data. Can this data be applied worldwide? I think maybe we can do one or two tests. This test will be very quick. So, we can do the bridging test. Maybe we do not need to have a lot of patients. In the U.S., we do a bridging test, and the research was successful.
I think for the SANOVO model, we can shift the model from China to the worldwide.
Thank you. Thank you for your excellent sharing. For the osimertinib and also for the market potential, we have a very deep understanding. For interest of time, we will have the Q&A session, and we will ask our investors to raise their questions. If the investors want to ask questions, you can raise your hands, and we will unmute. The first investor from Morgan, Mr. Liu.
Professor Su, Professor Wu, thank you for giving me this opportunity to ask you questions. I have noticed that in China, SACHI research, also the research, the data was good. It is perfectly to copy Chinese data to the global context. My question is, in terms of the comparison of the two studies, in terms of the clinical efficacy, any difference or similarities?
Also, in terms of clinical design, any differences which will lead to the different results? This is my question. Do you mean the other study, SACHI?
I think his question is Chinese SACHI.
In China, in the MET inhibitor, China developed very fast. In ESMO conference simultaneously, also have the question of the osimertinib plus lazertinib. As you can see, the design of the study has similarities and differences. I think the Chinese study design, according to my remember, we use FISH testing method, does not include MET overexpression method. In the future, in the clinical practice, in the application, FISH may have some restrictions and limitations. Secondly, so far, if we read the report and we know for the PFS, as you can see, the OS, the overall survival, has not have public data.
If the future, the OS can achieve a good result, I think the time is longer, but now the time is shorter. But if you look at the initial result, as you can see, the two lines are overlapped, unlike SAFFRON. As you can see, the two lines have a very wide gap. So, I think for the SACHI, it may has a very long follow-up time to prove. But in terms of the selection of biomarkers, unlike us, we can recruit more patients and to make it more accessible by more patients. I would like to add more information. One, if we talk about SACHI and SAFFRON results, as you can see, the results are consistent. SACHI refers to Chinese patients, but SAFFRON refers to global patients, including patients in E.U. and the U.S.
The biggest difference for the SACHI enrollment patients, generation one, two, three TKI failed patients. For the SAFFRON restricted to the generation three TKI, because SACHI started earlier in China for generation one TKI, covered more patients in China. Some patients are taking TKI. After several years, if you look at generation one and two TKI, less patients are using generation one and two TKIs. In terms of the population number are different. SACHI cover all TKI generation one, two, three TKIs, but SAFFRON only recruit generation three TKI failure patients. Secondly, biomarker selections are different. SACHI only use FISH, only recruit amplification patients. For the SAFFRON broad to FISH and IHC. As you can see, to expand the population. With more data support, we have broadened FISH and IHC patients. For those patients, they are able to be enrolled.
As you can see, this is the difference. But the results, the results between SACHI and SAFFRON, PFS is 7.8 months, are quite consistent. The results of two researches are quite consistent, are at the similar level.
Thank you. Very clear. Thank you. For the interest of time, last question from seller side. Changjiang Securities. Mr. Wang, please unmute.
Professor Su, Dr. Su, Professor Wu, good afternoon. Thank you, Peng, for giving me this opportunity to ask questions. I have two questions. I will ask one by one. First question is about SAFFRON test. SAFFRON study versus other competitors' products, SAFFRON, MARIPOSA-2. If we versus these two studies, SAFFRON has achieved significant OS benefit. My first question is, I would like to ask two experts why SAFFRON can achieve significant OS benefit versus the competitor study? Why?
You asked me reason why SAFFRON are able to achieve OS benefit.
Why MARIPOSA cannot achieve OS benefit? I think this question is very hard for me to answer. But if you look at basic data, we can tell the reason a little bit. Firstly, if you look at MARIPOSA, this is a bispecific antibody inhibitor. On one hand, it is on the surface of the cell to do the inhibitor. But for the SAFFRON, apart from inhibitor, it can also enter inside the cell. As you can see, this is in-depth function. Also, please take a look HR value. HR value has a big difference. MARIPOSA, if you look at HR, is 0.7% around. But for the SAFFRON research, SAFFRON study is around 0.5%. For this kind of difference, at the very beginning, it is very clear. That is why it leads to the subsequent difference.
According to our experience, we clearly know that if we look at PFS and HR is around 0.8% in the future, it is very hard to achieve the similar OS. This is based on our existing experience. Second question, because of small differentiation, we need large sample size to help us to solve the difference. For the MARIPOSA, it is not around 1,000 sample size. As you can see, the sample size does not comply to OS sample. That is why the result is the difference. The result is not very much differentiated. Well, it is very hard to prove the difference of the OS. For this, for the HR value is around 0.8%. If we look at a subgroup, 1.5, the sample size is insufficient. It must use a larger sample size, b ut larger sample size will lead to a smaller differentiation.
So as you can see, the clinical significance is not very good. For example, among 1,000 patients, then the 10 patients will have this kind of issue. That is why today, the sample size. If you look at the mechanism, I have mentioned, it is large molecule and a small molecule of the antibody. Also, we need to look at the plus way overall expression. The small molecule has a very good HR value. From the above factors, you can explain the reason. Thank you.
Thank you for your comprehensive answer. My second question is about the SANOVO study. As we can see, for the SANOVO study versus other products like MARIPOSA, FLAURA2 studies. For poor prognosis patients accompanied by MET amplification, SANOVO can achieve a better clinical benefit, lower HR value. Could you please help me to answer this question?
SANOVO benefit study, well, I think what make me feel very proud, finally, we used overexpression as our selection of biomarker. A lot of people, they meet me and they say I am very smart and I use overexpression as biomarker. We designed two methods, IHC 3+, and then we will look at overall. This is because we are the first one to have the new test method, and we are very brave, and we do not know whether this biomarker is good or not. We are very cautious. We look small segment of patients, and we have a better knowledge, and then we select a biomarker. The biomarker has never been validated before. It is just like a gambling. Actually, you play a gamble, but we are very firm, and we success in our gambling.
As you can see, we are the first one to prove this concept, and also we have followers. The risks are smaller, and the successful possibilities are higher. Then versus other products apart from biomarkers, and in our presentation, we mention because this is the dual oral drugs, it is more convenient for patients. Well, for the patients, they ask me the question, "I want to use the oral drug." If there is no oral drug, so the patients do not want to do the chemo, and they ask the similar questions like those. As you can know, when we design our research, we meet our patients' needs, convenient, low toxicity, and the duration is long.
As you can see, we can meet all those requirements versus every week, every twice week, patients need to visit hospitals, family members like parents, wives, husbands, sons to accompany the patients to visit hospital. So the life quality is lower. We have a tailored and precise treatment, and we want to make it convenient. We want to make it more accessible, and also we want to give good benefit to our patients. As you can see, this is the big difference of our study with the future bispecific antibody drugs.
Thank you.
Thank you for your excellent answering, and also we look forward to the savolitinib progress and the highlight of the HUTCHMED in the future. I do not have any further questions. Give the floor back to our chairman.
Well, thank you.
Thank you, Professor Wu and Dr. Su. We also like to thank our investors for your questions. We are looking forward to the commercialization success of the savolitinib for our investors. If you have further questions, please welcome to contact Citi Asia Healthcare Research and HUTCHMED. Thank you for your time. See you next time. Thank you.
Thank you.
Thank you all.