Thank you everybody for coming today to our Interim Results Presentation for Hodgson China Meditech. We got a slightly different format today than we have in the past, there is a bit more brief summary focusing on some of the key things that are going on at the moment. As you will see in the presentation, the appendices are extensive, so much of the much of the detail – a lot of detail is in the back. But let’s start, first of all, on the latest update, including the financial updates as well as the key progress on the pipeline. So overall, probably the biggest thing that the market and investors and we, as a company, are focused on at the moment is our first NDA on fruquintinib. I'll give you a full update on that. It's going to plan. It is a -- as I said before, it's a very long and arduous process that the Company has spent another last 12 months working on, but we're getting very close. And I will update you on that in a more details. On fruquintinib also, at the back end of this year, probably November late November, we’ll see the top line results on the third line non-small cell lung cancer Phase III, so that’s the second indication for fruquintinib will report in November. So we’re obviously quite optimistic about that but we’ll talk about in a moment. On savolitinib where you see the word breakthrough, there is a lot going on. AstraZeneca is moving rapidly now in planning for the combinations with Tagrisso and savolitinib. I can give an update on that later. We have a fairly big piece of news that I think is probably the most important thing to update people on savolitinib. In the last couple of…

[Operator Instructions]

Thank you. [Cindy] from Bloomberg Intelligence, I have two questions. First on, while we’re waiting for the approval, can you just give us an update on your launch preparations and the reimbursement negotiations. And my second question is on savolitinib. In you press release you mentioned we’ll see some preliminary data for Phase II in c-MET amplified gastric cancer. And can you just specify when -- at which meeting we’ll see the data? Also, is that a Chinese study? If so, will you able to use the data to engage with USFDA for breakthrough therapy discussions? Thank you.

So for fruquintinib, obviously, Eli Lilly is our commercial partner in China. So we do everything in terms of the development, in terms of the manufacturing. But in terms of actually commercializing fruquintinib, it will be Eli Lilly that commercializes it. Now Eli Lilly is very well prepared. They've built a team of medical reps that are now waiting, ready to go. They've appointed several, I would say, very experienced industry veterans on the commercial side to be responsible for the launch of fruquintinib. So yes, I'd say they are ready. They are involving us in all of this commercial planning as much as they can, obviously. But yes, subject to approval, I think we’ll be very ready to launch fruquintinib. On the pricing and on the negotiation of the pricing, this is something that comes later. It will be launched initially as an out-of-pocket drug. So patients will pay out-of-pocket but very soon after launch, we will start to engage with the regulatory authorities around reimbursement and how to broaden the availability of this product to patient populations in China, so that's on fruquintinib. On savolitinib, you asked about got gastric cancer. We've presented some very preliminary data from our gastric cancer Phase II studies, one in Korea and one in China. And that data has been very encouraging. And we continue in c-MET gene amplify gastric cancer patients to be very encouraged by the data that we see. So much so that we are working closely with AstraZeneca to talk about what's the next step for gastric cancer on savolitinib. In my opinion, there is an exciting next step for gastric cancer and savolitinib in those c-MET gene amplified patients. As far as when is the data, the Phase II data going to be presented, it’s a little bit out of my hands, because the main study is an investigator led studying Korea, at Samsung Medical Center. It’s a huge study that covers not just c-MET but many other molecular or genetic mutations in gastric cancer. So when that study is published is a bit out of my control. But I can say the data is starting to look very interesting, and if that’s the case, I would imagine -- you could imagine that it could be a scientific conference in 2019 sometime, maybe in ASCO or before that.

Thank you. Mike Mitchell from Panmure Gordon. The investments in the -- from the U.S expansion is I think very strong. Could you tell us a little bit more about what you’d be expected to establish in terms of the U.S operations, international operations? And also just that given your comments on the inflationary pressure in China does that percentage will give you optionality in the future?

I think the optionality is good. As a company, we’ve always been focused globally. So why grow -- and the team created this portfolio of clinical drug candidates with global potential in mind, not just China. So it's absolutely essential that we build out our capability globally, or particular in United States and Europe, to bring our assets through developing ourselves. Historically we’ve relied on partners, AstraZeneca being the one example. But I think, going forward, as a company with bigger, with stronger; we have more resource; we have more capabilities; our assets are further along. A de-risk. It’s now time for us to take on that work ourselves. And so building this clinical regulatory team in New Jersey has been a big strategy for the Company. And we’ve been able to appoint some really good people, actually there is one thing in the back here, Enrico Magnanelli formerly from Gilead, who has joined as our Head of International who's going to be helping our clinical regulatory team in the U.S. get established and look for opportunities to bring our assets outside of China. So yes, it’s an important step for the company but it's one that is long overdue.

Hi, I am Christian Glennie with Stifel. Just I guess a follow up on that point, on potential of getting fruquintinib into global markets. And so what do you think in terms of the potential combination studies you’re thinking of in terms of what modalities there or mechanism being particularly attractive? And therefore, when you think about those combinations and those companies that ultimately have those other products, so it would be in combination how you look to structure, it’s straight forward that would supply the product and you’ll investigate a combo and then see where that gets you, or something maybe a bit more for more?

What I'm going to do is I'll answer the part about how we structure it and then I will hand it over to Weiguo who is on the phone for him to answer what areas are we interested in, what combination opportunities are we interested in. So to start with the structure that we will look at for collaboration is -- well, it’s easier if you’re going to combined it with something that we've already got. So fruquintinib in combination with savolitinib would be for us a no-brainer. And there are probably two or three other combination opportunities with our own assets that would be quite interesting. But as we've said in this presentation, probably the biggest area is looking at, and I'll let Weiguo talk about that. How we would do it is we would find the right partner and probably in a relatively non-exclusive manner provide product. The partner provide product. We work on the safety run-ins to ensure that these products are combinable. We may do small exploratory expansions to see that does the combination provide benefit in the patient populations that we’re looking for. And then maybe you go into a more exclusive collaboration, once you’ve designed and defined your registration strategy and you start investing in registration. These collaborations could be for just China or they could be global collaborations, and I would imagine there would be many of those types of collaborations. These are very common in the industry. These days, I think particularly as company start looking for innovative combinations of their assets with other assets, you've got to be fairly flexible and you’ve got to make sure that both parties have the same objective. So maybe I'll hand it over to Weiguo Su to address which combination areas are we interested in.

So good morning, Weiguo here calling in from Hong Kong. So with regard to -- I mean specifically for PD1 combinations, as you know VEGFR is obviously very important over 30 tumor types haven't being approved in indications haven’t been approved for these type of therapies. So specifically for PD-1 combination, a lot of promising data already produced and published in over the last two to three years. So what we are thinking, I think, it will be will it treat China and outside China differently, simply because the competitive situation. So inside China, I think, it's wide-open. We probably will go and there is chance for well established indications such as kidney cancer and liver cancer for that matter. So we may go for a bit more mature indications with better proof-of-concept, but still a window of opportunity to get in there and really move fast towards registration. So we take that route while the opportunity still exists. Outside China, as I already alluded to, kidney cancer is a bit late and even liver cancer given Roche got breakthrough therapy designation just two weeks ago with otezo plus bev combination. And data from other combinations, pembro plus lenvatinib, for instance, also looking pretty strong. So it's a bit -- and we feel it's a bit late there. We might explore other indications, perhaps maybe in GI, for instance, gastric, colorectal area where everyone is at the same start -- pretty much at start line. And PD1s or PDL1s, therapies have not really succeeding on large scale for that matter. Another area would be also of course angiogenesis, plays a very important role as the GYN; these are indications, breast cancer, ovarian cancer, even cervical cancer as well. So this is an area immunotherapies have not done very well, but angiogenesis is extremely important. So perhaps the combination will lead to some breakthroughs there as well. So in all, we’ll probably take a balanced approach. In China, we would love to identify a few indications perhaps with more proof-of-concept data with a bit more mature, but there is still an opportunity in China for rapid registration. But outside China, we’ll take some more risk and explore areas where PD1 monotherapies or PDL1 monotherapies have not done very well. While we also understand that angiogenesis is very, very important and this probably include GI, GYN, and maybe also GU, aside from kidney I think that bladder cancer, urothelial cancer. I think all of this -- perhaps worth exploring. So outside China, we’ll be more exploring but inside China, we would take on some of the more mature indications and try to move rapidly towards registration.

And then just one follow-up, if I can, on Savolitinib and particularly on the MET exon 14 skipping, a sense for the percentage of patients if you know that yet in terms -- of these patients that have that phenomenon. And then what potential read across -- is this something you shared with Astra and what potential read across that have in terms of their plans for development?

So everything on savolitinib is working in tandem with AstraZeneca. So we don't do anything independently, this is all joint -- it’s a joint steering committee, we work together on everything we do. So the exon 14 skipping program, while in China. We are running that clinical trial with the sponsor of that clinical trial we’re doing it in collaboration with Astra. As far as the as the proportion of patients that are MET exon 14 skipping, it varies in various different subsets of non-small cell lung cancer. But in general, it’s 1% or 2%. It’s a very small subset. It’s difficult to find them. But when you talk about 1.7 million new non-small cell lung cancer patients a year, 1% or 2% is actually 30,000 patients a year, so it's -- particularly in China where non-small cell lung cancer is such a very large problem. So I think it's a material and relevant patient population. And as far as how we see savolitinib performing in that area, we’re very encouraged. Our PIs are very encouraged. AstraZeneca is very encouraged. And we intend to capitalize on this as quickly as we can. And we’re also -- it's wonderful to see the Chinese regulatory authorities identifying great efficacy. And while there is no breakthrough therapy designation structure in China today, they are essentially saying take that Phase II data and make it big enough, deliver that level of efficacy and we will treat it essentially as breakthrough therapy and approve it based on that. So it's very encouraging from a regulatory standpoint in China and from an efficacy standpoint in the patients that we’re seeing to this point.

Can I follow-on from what Mike and Christian would be talking about when we look at fruquintinib, there is just obvious opportunity there. Is having Lilly on board an asset or a liability as you look forward?

As we look forward -- actually, we retain the rights on fruquintinib outside of China. So Lilly still has an option on the global rights, which expires after the third line non-small cell lung cancer study reads out in November. So probably January their global option will expire. I do not expect them to take that up. They have Cyramza, which is VEGFR2 antibody that worked on pretty hard over the years. And there is a bit of overlap between fruquintinib and Cyramza. I doubt that they will take up fruquintinib. So in terms of are there an assets or not outside of China, subject to them not up-taking of the global option then it's neither here nor there, it's all us. And actually that's where, as Weigou has just said, our interest is in combinations, it really go up and develop fruquintinib ourselves outside. That's why we are building our own clinical regulatory team in the U.S. to start this work and to get this work going. So I think outside of China, there is no impact of Eli-Lilly. Inside the China, looking forward, this is an area that we have deep discussions with Eli-Lilly on around lifecycle indications on fruquintinib. You've got the first indication hopefully close to approval in colorectal cancer. But you can see there are 30 different solid tumor types for which VEGFR inhibitors are approved around the world. In China, it’s a fraction of that, maybe a dozen. So there's a lot of solid tumor indications in China that a high quality VEGFR inhibitor is going to do very well in. And it's in that area that it's difficult for us to be on the same -- have the same objectives as Lilly for us, it move us rapidly as we can in these lifecycle indications to maximize the potential sales and profits and use of this drug in China, whereas Eli-Lilly may have a different philosophy towards it. So in China, I can't really tell, to be honest with you at this stage of the game. I would hope that we would not be held back. And that fruquintinib would be given every opportunity to become as big as it can be. We think fruquintinib can be an enormous therapy in China. Outside of China I am less concerned, because it’s more in our control.

Just talking about MET monotheraphy exon 14, it’s a single arm study. What’s the Chinese FDA are asking for comparisons?

So basically for MET exon 14 patients, actually that study, that Phase II study is chemo refractory MET exon 14, so you cannot, it’s not ethical to knock free those patients with chemo to start with. And so they are chemo refractory MET exon 14 skipping patients. Then post failure on chemo, really there's nothing left for them. So putting them on savolitinib is ethical, and it’s in those patients that you’re seeing that fantastic efficacy. Now ultimately that's not the patient population that we would seek to get approval in. You obviously want to become the first line therapy for MET exon 14. But in this case, this study is around chemo refractory patients. So we do that, we get it approved then we’ll have another study, which will be first line. And that will be how you get it approved in absolute first line.

And then just looking at epitinib, also savolitinib, fruquintinib outside of China quiet positive. But with epitinib and maybe Tagrisso being positive in brain met. What’s your thoughts kind of outside the China with that…

I think epitinib, our primary focus is get epitinib right in China, because EGFR mutation positive non-small cell lung cancer; around 50% plus of non-small cell lung cancer patients in China are EGFR mutation positive. In the west, it’s between 10% and 15%. So it’s a much smaller sub-segment of non-small cell lung cancer is EGFR mutation positive. So China is by far in a way the biggest reservoir of EGFR mutation positive patients. And so our real primary focus on epitinib is for China at the moment. As you say, Tagrisso does have -- it does metabolite that can penetrate the blood-brain barrier and provide benefit to patients, but it's a very expensive drub. So epitinib would probably be something at a much lower level, but we’ll see. I think our focus is squarely on China for the moment and we’ll at global at a later day.

Okay, thank you.

Okay, great. Well, that’s the hour up, and thank you all very much for coming. Thanks very much for the questions. And I think we will call it here, we have probably some of the line, but we’ll call it. Okay, thanks very much for coming.