Good day, everyone, and thank you for attending Our Medicines twenty twenty one Interim Results Conference Call hosted by ICA Investor Relations, the company's Investor Relations advisor. Today's call is being recorded. On the call today are Doctor. Lee Chen, Founder, Chief Executive Officer, Chief Scientific Officer and Executive Director and Mr. George Lin, Chief Financial Officer and Executive Director.
Doctor. Lee Chen will start the call with an overview of the company's highlights, including clinical trials and recognitions, followed by a pipeline update. And Mr. George Lin will give his thoughts on the numbers and the updated guidance before we open up the call for Q and A. Management will be available to answer your questions during the Q and A session that follows.
During the presentation, we will be able to submit your questions in in written format in Zoom's chat box or Q and A channel. Alternatively, you could virtually raise your hand on Zoom for an opportunity to speak with the management team during the Q and A session. For your information, this call may contain forward looking statements. For details, please refer to the disclaimer on today's presentation deck. With that, I will now turn the call over to Doctor.
Chen. Please go ahead. Thank you.
Thank you. Good afternoon, good morning and good very early morning. Thank you very much for participating Farmedicine's interim results report. Huomedicine is a clinical stage company working on the innovation solutions for the diabetes and the neurodegeneration diseases. This is the area we are set forth to work on because we are facing an aging world and much needed cares in the diabetes neurodegeneration area.
This require innovations and then come up with new standard and a new medicine. In the next slide, I give you the overview of recent progress on our endeavor to discover the world's first in class glucokinase activator for diabetes. And this is the dorlaglutin and its NDA has been filed to the China regulators and then for the indication of monotherapy for drug naive type two diabetes patients and add on to metformin for the metformin failed type two diabetes patients. This is a very important milestone not only for Huami Medicine, but also for the medical care community that in the diabetes care, upon the approval of this drug by the regulatory agency in China, it's become the first in class new diabetes drug. This is going to be the tenth class of the drug, but with five very important characteristics that are going to change the healthcare in the diabetes.
First of all, this drug have a very novel concept by treating diabetes for the underlying cause of the disease through rescuing the early phase insulin secretion. This is a very important fact that the Type two diabetes is initiated by lots of the first phase insulin secretion functions and then developing to the disease as we prolong with new with the drug indication. The second area will be the new mechanism of action using the allosteric activation process to regulate glucokinase enzyme. That is very important to provide a sustained efficacy and a safety profile and making doraglietin as the cornerstone therapy for diabetes care. Of course, it is a novel chemical entity and also with a new formulation, most importantly, explaining the novel benefit in improving the beta cell function and the reduction of insulin resistance, and which is very important for the sustained glycemic control and remission in the diabetes.
So those five characters differentiated with the new drugs people really talking to, especially for the Me too class, where they only have the novel chemical entity. However, the novel concept, novel mechanism of action, novel formulation and additional benefit to the clinic use will be very important for this first in class novel antidiabetics. And after the submission of our NDA to the NPA in China, the regulatory agencies have the subsidiary divisions in CDE, CFDI, CPC and the CFDCs are all engaged in full blown inspections and a reviewing process. And hopefully, that will go through this process and then get the drug approved in the near future. In respect to preparation for the approval of NDA and also the launch of this new drug, our manufacturing capability, currently run by CRO and CDMOs, has fully validated and is ready for commercial production.
Adding on this, in anticipation in the future market growth and product needs, we have established a new manufacturing company at the Lingang Shanghai area and to run these operations in 2025 timeframe and provide drug supplies in China and the rest of the world. We have also established the commercial team, which will engage in our product distribution management and in market entry. In China, as you know, it's very important to have an efficient drug distribution network that be able to send our drug to the different regions and provinces and cities. And this work has been established with our internal team in partner with the major distribution channel companies. And then we are also working on the market entry, dealing with the drug in price and then the NIDL entries together with our payers, medical and the marketing team engaging on the product launch readiness.
So as we're moving along, you can see in the next slide, our medicine is also building up our product pipeline and R and D focus with doraglutin as a cornerstone therapy and then adding on the existing anti diabetic medicines to create a portfolio of the drugs that with different indications in the Type two diabetes care treatment, which is a part of the agreement with our Pfizer with our payer colleagues that upon we achieve approval for the new indications, with the new milestone payment that will be received by Huami Medicine and then Bayer will be also responsible for commercialize and then promote those products into China market. On top of the anti diabetic medicines using dorogilatin and other combinations, and then we're also expanding our capability in the areas of neurodegeneration, metabolic diseases using Boragayatan platform and additional ProJEC mGORE5 and the Fructokinase inhibitors. And we are very pleased to let you know that following the Phase III study, the seed work and the subject who engaged in the dream study has come to the end. And the top line data will be presented by our leading investigators in the sixth China Biomed Innovation and Investment Conference to be held in September 2527 in Studio China.
And this is very important milestone to demonstrate that after drug elastin treatment, our subject can sustain, maintain their blood glucose level without further drug treatment. And then this reach to a very important control aspect and also be leading the change of the standard of diabetes care. And we are looking forward to CEO and Sudou at that time. Now with moving forward on the diabetes and Medicare, and we have discovered the connections about the diabetes glucose homeostasis in connection with glutamate homeostasis. And then, MGOR5 as the group mate regulator is actually contributing to the neurodegeneration diseases, not only as in the PD LID we have been studied, but also recently discovered in the Alzheimer diseases.
Addition to this, we also have discovered that GLP-one has a natural connection to from the pancreatic and intestinal function to the central nerve system that regulates the neuro degeneration process. We call the neuroendocrine regulation. The next slide I'm showing that in the clinical studies that we have demonstrated dorogliaetin involved within the GLP-one regulation in the type two diabetes patients. We're actually showing that the type two diabetes patients upon receive GLP-one have received dorkliotin have a significant increase of the total GLP-one, which is very important in the signaling pathway to managing not only the peripheral network, but also important in the central neural system management. On top of this, we also see the synergistic effect of the DPP4 inhibitors with dorogliafone, which significantly increased the active GLP-one.
The active GLP-one is very important in the regulation of beta cell function and insulin secretions. So this funding certainly is very important to support our future expansion in the disease indication and the diabetes care and neurodegeneration pairs. In next slide, we're going to briefly show you why we take diabetes and as a major area that Huar Medicine put us the last ten years of work on. Actually, if you look at what's happening in the diabetes field even till today, the current treatment paradigm for type two diabetes is not satisfactory because it cannot contain the disease progression, it cannot prevent diabetes complication. And we have to focus on the diabetes complication because it's causing much more medical care expenditures because that we cannot control the blood glucose.
In order to better control blood glucose, ADA and CFDA are the two major diabetes academic and society and community provide guidelines to regulate the blood glucose fluctuation using timing range and also asking the physicians to use SGLT2 or GLT1 receptor agonist to control the diabetes complications. Now with this, we can see in the next slide the impact of the diabetes in the global medical expenditures and also the costs in China related to the diabetes and the diabetes complication. And all those complications is clearly related to the timing range for the blood glucose post meal and under the fasting below the range. And the timing range lost in the diabetes is the very important factor to lead to the diabetes complication and the dorogliaison is here to correct that. That is dorogliaison through regulating the gluco homeostasis and then put the blood gluco fluctuation into the healthy range so that we can prevent the diabetes complication and then contributing to the global market.
Next slide was showing that why we think glucokinase activator can address the underlying cause of the diseases and become the cornerstone therapy for the treating the diabetes. Diabetes have four major factors that are contributing to the disease onset: genetically, environmental inflammation as an epigenetic factor and also insulin resistance. At the end of the day, they all contribute to the final common denominator, which is lost the beta cell secretory function for beta cell mass. And that is in the clinic, we lost the first phase insulin secretion. With existing therapy, metformin or GLP1 plus metformin or insulin plus metformin cannot rescue this defect because in this process of the beta cell secretory dysfunction, GK played a major role in this whole process.
That is, if we do not fix and repair glucokinase as the glucosensor function, we will not be able to address the underlying cost of the Type two diabetes, which will lead to the complications and unsuspend treatment. So next slide basically showing that over the years, after 17 clinical studies and many preclinical studies, we have demonstrated doraglietin as a dual acting glucokinase allosteric activator, be able to remodel the glucosomeostasis because it improves the beta cell secretory function and immediately acting upon the pancreatic islet function. On the right side, you can see the most recent study from the godfather of glucokinase, Franz Machinski, showing in the study using the islet from type two diabetes patient that thoraglutin dose dependently improve the insulin secreting function in the type two diabetes patients. And then there's further evidence in supporting that glucokinase activator doriglietin acted on glucosinor decay in the pancreas and also driving the insulin secretion to the next level where this will help to repair the glucose sensing function for the type two diabetes patients. So next slide, basically showing and updating you what we have discussed and shared at ADA on the most recent work that adorably attending the cis study will be able to effectively not only control the blood glucose, A1c and the two hour postprinuclear glucose, but also controls very well in the beta cell function improvement and a reduction of insulin resistance.
In the next slide showing in the DUMB trial, where add on metformin to treat metformin failed patients that blood glucose control has done very well, at the same time with the improvement of the beta cell function and the reduction of insulin resistance, the root cause of type two diabetes. Next slide is basically showing that in the combination study of dorabeaten with sitaclifatin and empaglutfosin, which showing that in both combinations, doragliptin adding to silagliptin or empaglutfosin improved the beta cell functions over either simple drugs. Next slide showing the benefit of improving the beta cell function at least to the improvement of the Glucose reduction. And you can see that in the combinations, the glucose reduction is also in not only in the total glucose of the AUC represented and also the Cmax of blood glucose, which where it's very important to contribute to what we call the timing range in the study. So with this, you can see that doraglutin as an important therapy, target the ongoing cost of the Type two diabetes and be able to informally contribute to modifying the disease conditions.
And therefore, in the next slide, we're basically showing that with this cornerstone therapy and then we'll be able working with metformin, SGLT2, DPP4, GLP1 or insulin to treat type two diabetes with different patient populations and indications and also bring us into the new territory of the NASH and the Type one diabetes as we indicated that the discovery work and then clinical design work has been initiated. And then the areas that we've been working on will offer a much important indication and in the disease treatment community. So in the next slide, and you can see that we have continuing a lot of work to do. Our partner Bayer, we have an anniversary for announced our collaborations and then we are marching toward a next milestone that the NDA approval and the product launch. And obviously, we have joint efforts for many medical community educations and then KOL discussions to how to position this drug into China market and then best help the patients in China.
And also, we are optimizing our manufacturing capabilities, working with Wuxi STAs, TigerMed, D Sino and so to improve our capabilities and a cost of goods for the door agreement and then bring a better benefit to the company and investors. We are also working on the new drug discovery. As I mentioned that mTOR5, NAM and SANS are the very important regulators in the neurodegeneration diseases in PD LID and potentially AD. And then the preclinical work and the basic science discoveries has been conducted within pharma medicine and our academic collaborators. And then hopefully, in the near future, I can report you a breakthrough paradigm for managing the neurodegeneration diseases through ultimate homeostasis.
And fracokinase is a very important enzyme in the metabolic diseases and dyslipidemia. And pharma medicine has a long time investigations in the fracokinase area and are now very engaging the pharco kinase inhibitor discovery in collaboration with partners and so on, we hope to bring you the benefit in this area. Now we are very well positioned financially. We have a very strong balance sheet with RMB800 million in cash, right, in cash and also additional milestone payment will be received upon the NDA approval and the product launch in 2022. So with this, I would invite my dear colleague and company's CFO, George Lin, to give you an update on the financial review.
George?
Great. Thanks, Doctor. Chen. As it's customary, this section will be very short. I think you guys have heard this through before.
So very quickly, let me take you through our cash balance and our spend for the last this last reporting period. So to be very specific, we had cash balance RMB 846,900,000.0 of cash at the June versus just slightly over RMB1 billion last period sixthirtytwenty twenty. The total cash decreased $185,000,000 of which most of the amount was in operating activities. As some of you know, we did move into a new headquarters and we'll explain some of the expenses, but the remaining expenses fairly nominal around $10,000,000 was for that. You can see the financing activities $5,800,000 and exchange rates as the renminbi strengthened also caused a net exchange rate change of about $5,000,000 Next slide.
For the loss before tax, $165,300,000 in the first half of twenty twenty one versus Remind of $173,500,000 in the same period last year. Our research and development expenses were approximately $98,000,000 in the first half of twenty twenty one versus $112,300,000 So $98,000,000 of $165,000,000 is from R and D. Most of the decrease was due to the completion of the two Phase III trials in 2020 that amounted to a total of about $28,000,000 an increase in $2,800,000 for CMC work related principally to the chemical and process search for our fructose kinase inhibitor, I can tell you that this is a fraction of the cost that Pfizer has actually spent on this program, and we are moving very quickly on finding a lead candidate for this. So that's very, very exciting. And an increase of $3,000,000 for dorazaglietin nonclinical studies, as you all know, principally related to the NDA filing and also FTC efficacy studies in combination along with animal studies for cognitive disorder as Doctor.
Chen was talking about neurodegenerative. Next slide. So the R and D expenses, an increase of $10,200,000 for others. This was primarily attributable to the allocation of rental fee moving out and then moving into our new headquarters as we had discussed. And you can see the comparison here from the previous year, which is $112,000,000 So we actually decreased that from in this period.
Next slide. And administrative expenses, again pretty much the same this year compared to last year, $63,500,000 in the first half of twenty twenty one versus $64,200,000 in the first half of twenty twenty, decrease in labor costs attributable to share based payments of about 4,000,000 under the accelerated amortization method and a decrease of $4,700,000 as we got very favorable rates going forward with our new headquarters even though it's much larger space and brand new. Again, we're hoping that this also extends to our further lingam showing the Shanghai government support of our company. And then adjusted for the increase of $2,600,000 in D and A mainly due to again new headquarters, more meetings compared to the last year which was locked down. This year we're definitely moving about and especially with the commercialization team and also additional work related to Dream, etcetera.
A lot more activity has increased. So that's the financial situation. I'll summarize it up with the next slide with a summary. Again, we have global rights dorazoglietin. That includes the composition of matter, process, formulation and then multiple products in an FDC with other OADs.
Those FDC patents and formulation go all the way out to some of them to 02/1939. We have a commercialization partner we've considered to be the best and for the last twenty years was number one in China with Bayer. We've met our primary endpoints and submitted our NDA, which was accepted in April 2021. As a reminder to people, the technical rule is two hundred working days. So we're presuming about one year from a timeline perspective as kind of a target as people know that MPA can do what they do, but this is what we've been giving guidance.
First in class drug to significantly and sustainably reduce HbA1c, which targets, right, the underlying cause. So that's the first novel concept. And I think what's really exciting as Doctor. Chun mentioned, for the first time ever in Type two diabetes, we'll get to see some controlled sustained rate of glucose control without our drug after treatment of our drug, which is going to be a new indicator and will cause people to think how exactly are we leaving this very lengthy, lasting effect on patients. That's very, very exciting for us.
The combination with DPP4 and SGLT2 is very exciting, especially with the new data on SGLT2. So that's going to definitely have a long term space, especially as it relates to heart. DPP4, our excitement with the GLP1 secondretion with our drug combined with DPP-four could be a very formidable potential oral GLP-one competitor. So that's exciting. And then our drug is suitable for Type two patients with chronic kidney disease across all stages.
So very, very large market and in anticipation of our commercialization, as Doctor. Chen mentioned, we've established a new drug manufacturing company to support really the commercial supply that we expect to receive once the drug gets rolling starting within the third year. We can expect third or fourth year, we could expect up to 1,000,000,000 pills of requirements as kind of our current modeling. Who knows whether that will be, but that's our current anticipation and we must be prepared for it. And then of course, very strong balance sheet of renminbi $846,900,000 cash as of 06/30/2021.
So with that, that concludes our presentation. We're open for Q and A.
This concludes our prepared remarks. We will open the call up for Q and A. Dear investors and analysts, feel free to submit your questions in written format in Zoom's chat box or Q and A channel. Alternatively, you could virtually raise your hand on Zoom for an opportunity to speak with the management team during this Q and A session. So now we will open the floor up for questions.
So first, we have an investor, Lumen Gao. His first question is, latest progress in H and M three zero three, comparison against sulfonylering and BTP4 inhibitor and H and M O304 comparison against alpha glucosinib inhibitor?
Very interesting questions. I think one of the questions that you're talking about in the comparison against supplementary urea and the DPP-four inhibitors and then those are the previous discussions and prior the Bayer collaboration. And after the Bayer collaboration, our pipeline has been updated geared toward the common interest in our future pipeline and milestone development. So we are currently focusing on developing the our combination with DPP4 inhibitors and also not developing a direct comparison with the araglugocytes. The decision from the araglugocytes and the araglugocytes is a major product from Bayer and then it has been a big sales in China over the last ten years before they entered into the new procurement regime.
And the Bayer team consider Doroglia ten as a super acobos and they would like to replace the Acapos in the market and then really considering how Acapos and Dorothea will eventually working together is a separate approach where we're considering in the longer term doroglitan while moving to the disease prevention to prevent the prediabetics, IGT patients developing into the diabetes. And that's where I think the arkabos, arfaglucosidase inhibitor will be beneficial in working with doraglietin. Thank you. And the second progress in the global license out, there is several discussions ongoing with companies around global license out and George has been working very hard on this. George, do you have a comment on this?
No, nothing material to report except for what Doctor. Chen said is that we continue to have conversations with various parties, including road and belt countries. I think just to give people a sense of kind of some of the navigation roads is having done our Phase three registrational trials in China. China has never had a first in class drug and so it's not a reference country for most of these other countries. But as people saw with the COVID and vaccine, we're seeing new precedent.
And so from that perspective, we are getting some traction in these other countries. And so we will continue having these discussions. We expect with more data and more time as we see with things like green, there will be more creative ways to potentially get accelerator approval in some of these other more mature markets that have very high impediments. But that's pretty much all we can disclose right now.
Okay, great. We have Matthew. Hi, Matthew. I see your question here. This is a question I want to know how quick the manufacturing capability can scale up and then what's the cost curve might looks like.
This is the manufacturing, as you all know, we have been working with Wuxi PharmaTech STA and DesaiNo in the drug development stage. And then based on the MAh process and the current China Drug Administration Law, our drug launch is based on our CDMO partner, Wuxi, DesaiNo. And their capability at this moment is getting up to Bai Yi by 800,000,000. I got to get this thing straight. 800,000,000, that's the current capacity, which was projected at the third year in the commercialization.
And in fourth year, and then we'll get into 1,000,000,000 pills and that's where our new manufacturing sites will enter into. And then this will be in the investment of the land and then in the equipment at this moment. And then that will be involved in the investment in the next couple of years for establishment of this new facility.
Thank you, Doctor. Chen. We have another question coming from investor Lu Veng Gao. His question is any progress in Dorsigliacin global license out?
I think we have answered that already.
Yes, I think Li Zheng Qu has a question, right? A hand raised.
Yes,
it's from Goldman.
Also another one. Okay.
Hi, can you hear me?
Yes. Yes.
Thank you for taking my question. I have Lucille. Maybe just first follow on the manufacturing side. How do we plan to the construction? What's the CapEx for this one?
The detail of the CapEx plan was in the development. I think overall, that's a RMB1.9 billion investment total over the next five years.
You say RMB1.9 billion? In terms
of which a substantial amount would be subsidized through loans by the government as well, right, Doctor. Chen? Just up to 50% to 60%.
So how do we plan to fund the USD1.9 billion for the manufacturing side?
The finance, as George mentioned, that one is from the government subsidized loan bank loans and then the VATS and then some investment from the Huam Medicine global.
And also Bayer Mausman specifically linked to manufacturing as we validate the manufacturing as well.
The milestone payment from Bayer?
As it relates specifically to manufacturing, yes.
How much is that?
We haven't disclosed that, but it won't be an issue once we are building that. As Doctor. Chen said, this is over a five year period of time, which is very actually back end loaded. In terms of the land, it's not a significant amount. And then the actual factory being built, a lot of that will be funded by the government.
And by then, we would have to give visibility as to the actual need.
Okay. Because maybe just being another angle, we have about RMB800 million cash, right? So we have a CapEx of RMB1.9 billion for the manufacturing side. Just want to get a little color, how do we plan to use our cash on hand? If that's the case, do we plan to maybe raise additional money either through debt or through equity?
We just want to have a little more color on this.
But yes, I guess one of your key assumptions is this rent won't be approved and we won't have revenue, we won't get any milestones, so we need to raise money through equity. And that's not our operating basis, right? If you look at our Bayer contract a year ago, we have over $3,000,000,000 of milestones still to be collected, of which some are off of clinical development, but others are based off of sales milestones. And then we also get revenue as well. So some of this will be equity and potentially.
But as Doctor. Che mentioned, the first two the first three to four years of supply comes from our CMOs, which is Wuxi, STA, and Desano, right? And then we've got Zhou Zou as a backup, which we've indicated in the press release. Where the factory really comes into play is actually to, I think, Matthew's question is that it would significantly drop our COGS, and especially by that time, ideally, the drug supply would be needed for ex China as well, which then would come from this factory. So it's not like today we need to come up with 1.9 or tomorrow we need to come up 1.9.
I think that's kind of like a big number that Doctor. Shen has in his budget, but we actually would not need a lot of that payment until probably the fourth or fifth year. And a lot of it is funded initially by the government. They have our plans as well, which is why they would either agree to let us be in Mingtang, which is in the same area as Tesla rather than anybody else.
Got it. So what do you think
the CapEx? $129,000,000 is the total investment and then I think the CapEx is around half of that. So and then 70% of that will be in the loans and environment subsidy. So that's where the plans are going. Obviously, what Jordan mentioned is that additional milestone bonuses, not bonus payment from the buyer related to the drug approval product launch and also our capacity in the manufacturing, and also part of the income set in line with the development of this manufacturing capability.
And then you may ask, why do we need to have this own manufacturing capability? This is really the pure factory, right, for the solid dosage, not only for the dura gliadin, but also for the fixed dose combinations that come in line in the time of 2025, '20 '20 '6. And additional research and development and also process development going to be engaged in the future manufacturing needs. So overall, I think with the that's one part. The other part is the security for the drug supply chain.
We, as the primary drug providers and once we get launched, we will need multiple sites to manage the drug supply. ESino is one of them and then we need yearly internal capability to have the sub drug supply around 50% of the overall drug supply, at the same time, really be able to using our internal practice to drive down the overall cost of this cost of goods. So that will bring us additional benefit and then the profitability will be significantly improved when this manufacturing factory is get online.
Understood. Yes, that was helpful. So maybe just follow-up on the latest update on the regulatory side. So what's the latest status now and when do we expect a potential approval?
The latest update is that the regulatory agency, as I listed, is all very busy doing their work. First of all, we have getting the CDE's request with different type of documents for their internal review. And also we get CFPI, which is the drug site, manufacturing site inspection, clinical site inspection, central labs and also the research and development facility inspections ongoing. And then this is also part of this drug approval process. On top of this, and there are the drug name validation approval from a CPC and the methodologies for validating our quality control and analytical matters and so on is also under the evaluation of a national issue for our metric measurements.
So on the yard, all the activities is currently ongoing. With the China new regulations and then from the effective from last July, he said for our drug, there is a expected taving feedback, the regulatory feedback approval in two hundred working days, roughly a year, a calendar year period of time. Now the caveat is whether the COV will pose a pressure for the regulatory agencies conducting the work in the five area. I think the site inspection certainly is something that maybe impacted, but so far, everything is moving smoothly. So that's we continue expecting that the drug getting approval sometime next year.
And then we'll update with you guys when we have more definitive answers on the base.
Great. So what's the commercial preparation right now in collaborative industry supplier?
Commercial collaboration is very important as a as biomedicine transition from R and D biotech into a biopharma, as everybody talked about. Internally, we need to have our commercial team established to manage the national distributor companies who move our drug from our fuel factory to the each province or cities. So that's one thing. The team is in place and in partnership with the four major national distributors is ongoing discussions. And then the second area is working with the experts and then KOLs and then determining our price and then NACL strategies and then those sort of things with the team now within biomedicine and then working with Bayer and then developing that to prepare for launch.
The third thing, obviously, used to be part of Biomedicine's work and then now is the major efforts from Bayer is the marketing and the medical education. And we're at BEAR and now join for us with Hao Medicine on the medical education conferences, meetings with KOLs and discussing the market entry and then best practice treatment waste or gluten in the clinic. So those are the three areas that are ongoing. However, with the buyers' major efforts is in the marketing, is down the medical education and preparing the sales force and getting engaged for the commercialization.
Thank you. So maybe just last one from me. What's our data presentation or publication plan for our two Phase three study, the one or two?
I can tell you that we are we have submitted our manuscript to the leading journals. And now we see the reviewers' comments and we are doing the revision. So this is one very important progress, obviously. And then there are additional publications on the pipeline related to the AI driven data mining, additional learnings from the subgroup analysis and as well as the additional clinical trials, where we have this metformin add on, we have this sipaglitin add on, we have emaglitin gluclosing add on, these are all add on trials. We have learned very important information on the pharmacokinetic and then pharmacodynamic relationship, which help us to better position Boraglia ten to the patients with more precision and with more personalized approach.
So, yes, there's a handful of papers now as in either drafting or in reviewing or in the preparation.
So we're going to see the detailed data from these two Phase III first in a publication rather than present at a medical conference. Is that the plan?
Yes. Obviously, well, we're going to have more data in the publications. And this is actually, as you know, in those leading journals. And then you can just publish the things you already disclosed, right? So there are things that we'll share with you.
Where I think the point that I gave you, Dorothy, is in the five characters as the first in class drug, the concept, the MOAs, the mechanisms of actions, right? And then the benefits in the DMPK for the renal impaired patients related to the structure and then additional efforts in the formulations and really be able to let the drug reach to the three target organ where GK stay there and then managing the glucoclonal stasis in a systematic work. All those aspects will gradually be released through the publication.
Thank you. That's all for me. Thank you.
Yes. Great. Thank you.
Thank you, Doctor. Chen. We have a question from Vinci Ip. The question is, any updates on the plans of U. S.
Phase I trial to test fixed dose combinations? Are we on track to find a global partner to co develop dorzadilatin?
Glutin? The global partner claim is ongoing as George and I has been discussed that we are working with the corporate partners that first of all really have the capability to help develop a door gap in the region and then has the muscle to launch that. On the other questions is that, as the Type one diabetes, we have identified the key investigators, the KOL, who we are working very closely to developing the protocols and then we'll soon announce our IND filing in the fourth quarter in U. S. That's the new indication.
And then what we believe in working with our KOLs is that because they work on the sensory function in the pancreas and in the intestinal and also working on the liver, be able to improve the glycogen storage. And in this way, it will reduce the post meal blood glucose and also reduce the hypoglycemia under the fasting conditions, especially for the Type one diabetes. For the Type one diabetes, the major need is not gather the blood glucose down, is to prevent the hypoglycemia. That means the blood glucose goes too low when you use insulin and then the current insulin pump will not be able to help to response quickly enough to maintain the blood glucose go below the standard. So with the improvement of the pancreatic and also the liver function, dorabilatin has the potential with the prevention of the hypoglycemia.
You have seen this anti hypoglycemia effect in the type two diabetes and also the mechanism of action has suggested that the improvement of the post meal glucose reduction has clearly related to the glucose uptake and the storage in the liver. So that's important for the Type one diabetes and we hope that we'll be able to come up with a new paradigm for the treatment of Type one diabetes in combination with doroglitan. At the same time, we'll have the opportunity to testing doroglitan in working on the Type two diabetes in combination with insulin in China. That's a two separate trial. And in both trials, we'll work on the subject has a relatively poor pancreatic beta cell functions, but we would like to understand on how Boraglia tends to improve the decay function in the pancreas and in the liver that able to restore the homo the static control and this is a very important aspect.
And then the timeline for the Type one work will be filed IND in U. S. And then initiate a study early next year.
Okay. Thank you, Doctor. Chen. Due to time constraint, we're going to take one last question from David Liu.
Hi, guys. I have a very quick question. I think last time when we talked, it was you guys mentioned there was a investigator initiated study regarding the study for clinical remission. Now in China, we're actively looking for that subpopulation where we're able to see that specific benefit from brusselatinib. I wanted to get an update in terms of when we'll be able to receive data from that and what further steps we will take after
we have
the data? Yes. So we have received the top line data from the investigators and because this is the investigator sponsored trial and then the investigator is planned to give a talk at one of the biomedical conferences in the Slide number five, I believe. If we can go to the Slide number five, the information for the conferences. This is the conference run by, right?
It is the six conferences. And in that conferences, we have engineered a fashion we called a global first release of the clinical data. So the DREAM study, that's the study you just mentioned and will be the first around the presentation in that session. And the investigator, Professor Ma Jianhua, will representing the other investigators from four other hospitals, gave a top comment. And this is basically, as George also mentioned, for the first time as the oral agents is able to show that after a period of treatment and then the patients who reach the glycemic control point and then sustain that for a year without further medication.
So that's very important conference that if you are interested, we can provide you with more detailed informations from IR network.
Yes. Just to supplement that, yes, I mean, if you go on their website, they've already indicated the conference in states. And then as Doctor. Chen mentioned, those agglutin will be presented by our principal investigators. This is their trial.
Our trial ended at fifty two, fifty three week with both SEED and DAWN. DREAM study is their observation without our drug without any other drug for a fairly long period of time. And then they will finally be able to release that data after full validation.
Okay. Thanks.
Okay. Thank you very much. And in closing, on behalf of Quad Medicine entire management
team.
Sorry, is there
Yes, I had another further question. You got really quick, I'm sorry. So in terms of how do we plan to utilize the investigator sponsored
data going forward? Please the question again.
How do we plan to utilize the data from the Dream Study? Okay.
There's threefold of significance on this. First of all, as we have been looking into the literature, any oncidea biotics and so called blood glucocallory drug through the intensive blood glucocallory control and then be able to come for the blood glucocalloryc around six percent, which is within the safe healthy range, healthy people range. And then we saw that and then the blood glucose level rebound back to before the treatment. So that's the what we have learned. And in one of the slides showing that using metformin or using metformin plus GLP-one or insulin plus metformin, we cannot get this remission.
So that's very important for a new class of drug. And then when it fits the sensor, you're able to bring the benefit to conclude the disease progression. That's one thing.
Yes. I mean, Doctor. Chen, more specifically, right, what we talk about, we are the only drug that targets underlying cost, the root cause. And people ask for a biomarker, I can't think of a better biomarker than getting our drug and then stopping all drug treatment and then seeing the lasting effect for say one year, right? So that will definitely change the paradigm of how patients the medical doctors are.
So So this is one part, right? From the clinical practice in the type two diabetes area and then it's a very heterogenic disease in the specter of type two diabetes. And you get Caucasian type, you get Eastern type, you get IGT driven and impaired fasting, IFP driven and then Bose driven or you get obesity driven, right? The complications offers you a very different picture how to treat them. So with the C and then we see the signature of the subject who has performed well in the SEAT study, which means in the drug naive patients, they responded well in this fifty two week treatment by dorogilatin, right?
So that's one information. And then this group, right, the subgroup of those, roughly about sixty, seventy of those, are followed up by the investigators. So that means this group responded well and then continue to respond well. And then their disease get a control, they do not relapse. So that's very important to help us and then validating part of our algorithm we're developing for sub classification of type two diabetes patients and looking for a targeted therapy.
And that's number two. Number three is this is for the drug naive patients. There's also metformin treated tolerated patients. There's also metformin plus other therapy treated and the tolerated patients, right? So those sort of patients would probably require a different paradigm with metformin and then adding together with the existing therapy looking for a sustainability and then prevent the disease progression and so that we can eventually prevent the type two diabetes complications that 10 miserable diseases associated with the organ damage that come from diabetes.
So that's the three areas very important for us to decide what are the disease patients that dorogliaison can effectively treat and also achieve the prevention disease development into later. And then obviously, this is also telling us that for diabetes treatment, we will and the likelihood through combination with doraglietin with the existing therapy getting to the early stage relatively intensified blood glucose control and then making that available to the patients and then helping them to control and sustain the disease without further medication. So that were giving us a different standard of the IVs care.
Yes, I would just supplement that. Probably, Doctor. Chen, we should probably not speak any more about the principal investigators, what he's going to present because we don't know. So definitely try to attend this conference. And then as soon as this comes out, maybe just mechanics wise, as soon as it is published and it's as long as as soon as he's presented it and it becomes in the public domain, we will definitely put out a press release.
And then, there my understanding is the PIs are very excited about writing something for a medical journal and that will follow as well.
Okay, great. Thank you very much.
Great. That should be a very exciting milestone. Yes.
And then Doctor. Chen?
At the end of the day, it's basically showing how important to fix the sensor because in the past, a lot of therapy can control the blood glucose very well. But if you take the drug off, the disease relapses. And here, we see the sign of retain the drug effect and result of the drug. So that's exciting.
Okay, great. Thank you, Doctor. Chen. Thank you, George. In closing, on behalf of Swah Medicine's entire management team, we'd like to thank you again for your participation in today's call.
If you have any further inquiries in the future, please feel free to contact Qualmedicine's IR team or ICA. Thank you. This concludes today's call and you may now all disconnect.