Morning, InnoCare Pharma first half 2023 earnings call. This is Ziyi Chen, China healthcare analyst at Goldman Sachs. Before we kick off this session, I would like to highlight that this call is strictly for clients of Goldman Sachs and InnoCare Pharma only, and this conversation is not intended for the media and is off the record. Participants will be removed from the call if they cannot be properly identified, and this call is not for the purpose of sharing or receiving non-public otherwise confidential information. Attendees are public and market participants who may not receive and should not request non-public otherwise confidential information about issuers or securities about the market securities. So joined today, including company's Chairperson and CEO, Dr. Jasmine Cui, company CMO, Dr. Sean Zhang, IR Director, Ms. Lu Xia, and other management team.
And, before we hand it over to Jasmine to kick off, I would like to highlight that, if you have any questions during the call, please raise your hand, we can collect you into the call, or you can type your questions into the Q&A box. Management will, management team will be happy to answer that. Now, I'm gonna turn the call to Jasmine to get started. Jasmine, please.
Sure. Thank you, Ziyi, for the introduction. Hi, everyone. Good morning, good evening, and thank you for attending InnoCare's 2023 interim earnings call. InnoCare, our vision is to become a global pharmaceutical leader that delivers developed innovative therapy for the patients worldwide. Our product innovation focus on oncology and autoimmune disease therapeutic area. This slide highlights our first half year of 2023 achievement and progresses. In the commercialization, we achieved a total revenue of CNY 378 million, representing a 53.5% year-on-year growth. And Orelabrutinib sales increased 47.8% this year compared to last year.
Primarily due to orelabrutinib market penetration and hospital coverage after the NRDL inclusion and, of course, our highly experienced commercial team in hematology. Our second drug, orelabrutinib, approved for the urgent clinical use in Thailand and also get market approval this half year, the first half year in Hong Kong, and followed by be able to access for urgent clinical use in the Big Bay Area. In the middle panel highlights our progress of our internal R&D pipeline. In orelabrutinib, we have made several progresses. First of all, the first half year in April, we get market approval for relapsed refractory MCL, and which is the first and only BTK inhibitor got approved in China for the MCL indication. Also the r/r MCL was approved in Singapore.
In the US, we have finished the registrational trial for MCL and patient enrollment, and we are anticipated to submit NDA in the mid of coming year. In China, the first-line CLL, SLL registrational phase three trial finished patient enrollment as well, and we are going to submit NDA in about six months time from now. The first-line DLBCL, MCD subtype and the registrational trial phase three are ongoing. In the autoimmune disease side of orelabrutinib, we started the phase three trials for ITP, which is a registrational trial, and based on the excellent POC phase two results. For SLE, previously, we reported phase two A positive result, and this first half of the year, we initiated phase two B.
The enrollment have 20-30 patients and going very aggressively, and we anticipate to finish full enrollment by middle in the coming year, and interim result by end of 2024. In the MS site, we previously reported 12-week results. We get, over 90%, 92% relative new T1 lesion reduction, at 80 mg, compared to placebo arm. Here, we reported a 24-week result, which we saw consistently and the leading, efficacy, 92.3% in relative new T1 lesion reduction and at the 24 weeks. Another, other asset, we also made progresses and our BCL-2 inhibitor, first in man achieved in the first half of the year, and we got excellent efficacy, safety readout in the first few patients.
Our TYK2 inhibitor, ICP-332, we initiated the phase 2 atopic dermatitis and we are almost finished. Patient enrollment will be finished in a couple of weeks. The readout, the result will come out by end of this year. ICP-488, phase 1 healthy volunteers finished, and now we started cohort enrollment in cirrhosis, and we also initiated the phase 2 trials. For solid tumor-wise, aside ICP-723, the TRK inhibitor, we are aggressively pushing on the registrational trial. By far, we have 20-30% patient enrolled. We anticipate the NDA submission by end of next year, and also this IND also approved for pediatric use. FGFR inhibitor ICP-192, the registration trial for cholangiocarcinoma is ongoing.
In terms of license and collaboration sites, ICP-B04, tafasitamab plus lenalidomide. In Mainland China, we finished the patient enrollment already, and the NDA submission is anticipated in the second quarter of 2024. In collaboration with Keymed with two antibodies, the bispecific antibody ICP-B02, CD3/CD20, and we have finished 6-7 cohorts. We observed excellent efficacy with IV dosing as well as subcutaneous cohorts. The CCR8 antibody in phase 1 dose escalating ongoing. Platform-wise, our Guangzhou manufacturing facility is producing majority, over 90% of commercial products, orelabrutinib, as well as all the other clinical materials for our internal product. The Beijing Biological CMC facility started to operate.
And also, we removed the VIE in the Hong Kong Exchange and our entity were transformed from biotech to biopharma. So all the employees in the company now focusing our concerted effort on company's 2.0 objectives, and continue our corporate culture of cost-effective, strong execution, as well as innovation. This is our pipeline for liquid cancer. As mentioned, orelabrutinib approved several indications in China, in Singapore, and et cetera. And we have a few indications ongoing and registrational ongoing, including the one in the U.S. for MCL. And the other asset that we just mentioned, the ICP-B04 tafasitamab plus lenalidomide, and we'll submit NDA in the next six months, and as well as our bispecific monoclonal antibody and the small molecule glue and such.
This is our comprehensive coverage for hematology oncology, from multiple myeloma to AML to leukemia. So our cornerstone product, orelabrutinib, approved, and tafasitamab approved in certain areas and also will be approved in mainland China. And around that, you know, number of our other small, large molecule compounds will be cover different indications in the different hematology oncology disease areas. And to make us a leader in the hematology. And just to mention, orelabrutinib sale this first half year is CNY 321 million. It's a, it's a, a 47.8% increase comparing to the same period last year, and primarily due to NRDL inclusion, increased the market penetration, hospital coverage, and also because our indication expansion. I just mentioned the first half of the year, we got MCL approved in China.
This is considered to be a large indication in China, in the NHL. It's the second largest, in addition to DLBCL. For DLBCL, it's a large indication. We have a variety of strategies to cover that. From first line, orelabrutinib, with excellent safety profile, for combo with R-CHOP, with CD20, to tafasitamab in combo with lenalidomide, the CD19 antibody, with improved ADCC, ADCP function for the second line and above, as well as our molecular glue, E3 ligase modulator, and highly selective and can overcome lenalidomide cause resistance, and will be used for MM and NHL, as well as bispecific antibody. And our subcutaneous formulation improve the safety and convenience and for the late line of patients. And this is orelabrutinib in hematology, and actually, the efficacy, safety continuously improves.
And with time, this on the left is the efficacy reported in the first half of the year, with 47 months follow-up. Still again, with excellent ORR and CR, especially on CR, is very outstanding, 30% CR within 47 months of treatment. And below also listed of the MCL, and we continuously to follow, continuously showing good efficacy, as well as just approved MCL and with ORR of 58.9% and estimate the 12-month PFS/OS is 82.8%, as well as 91%. So on the right side is continuously showing good safety profile, particularly in the off-target related adverse effects, such as the diarrhea and the grade 3/4 AST, and secondary malignancies and major hematologic.
And orelabrutinib continuously shows very good safety profile. This is our second product in hematology, tafasitamab. I just mentioned, we'll submit the NDA in mainland China in the second quarter of 2024, hope to get approved in the first quarter of 2025. And the below shows the, this is approved in U.S. and Europe for the second line and above, and DLBCL patients. And you can see it has a very good ORR CR, especially understanding efficacy, duration of response, as well as overall OS, is out rate of our other treatments for DLBCL. Our third drug, we come out to the good surprise, is the BCL-2 inhibitor, ICP-248. We started the first patient in the first half of the year.
So far, we have enrolled four patients, and in the three evaluable patients, we see first two PRs with undetectable MRD, and indicating deep remission of the disease. And this is our first dose, 100 mg. And the patients, the first two patients actually have been multiple lines of prior treatment, and they all failed the BTK inhibitors. So we saw actually CR in the first evaluation of imaging. And so on the right-hand side shows our ICP-248 has great synergy with orelabrutinib in antitumor. So the synergy with you know orelabrutinib indicates you know we have a strong scientific basis for the combo of orelabrutinib with ICP-248, pursuing the CLL especially for the fixed duration of treatment, as well as MCL, potentially for DLBCL as well.
So, we're very excited about the combo, about this compound and also the potential of the combo for the global market. The fourth product is our CD3/CD20 antibody, and this is, you know, CD3 as a T-cell invader with, you know, CD20 against the B-cells. So, we have finished the IV dosing of a phase 1 cohort and the first sub-Q cohort, and we observed good efficacy in both IV and SC cohorts in the follicular lymphoma, as well as DLBCL patients, and with very good efficacy and safety and no DLTs observed by far. So the sub-Q formulation improved the safety and convenience. So we have high expectation for the bispecific antibody, for DLBCL and a number of other HL indications as a mono and combo therapies.
So this is our molecular glue compound, ICP-490, and from MOA, it can be used as a targeted therapy for multiple myeloma, and it is very potent and can overcome the lenalidomide causing resistance. And also, from mechanistic point of view, it can be an immune modulator, and it can synergistically with a number of antibodies such as CD20, CD19, CD38, to increase the efficacy and potentially the effect by immune response for a number of indications in NHL as well as MM. So shifting to our autoimmune diseases, we have three compound covering T-cell pathway, two JAK2 inhibitors, and also BTK inhibitor for B-cell pathway.
So we just mentioned the number of indications we're pursuing for orelabrutinib, SLE in phase 2B, MS completed the phase 2, and ITP, and in phase 3. And NMOSD is another indication now in phase 2 trials, and we are also evaluating CSU and et cetera. And the TYK2 inhibitors, ICP-332, we call it the JH1 domain inhibitor, and it's being evaluated in phase 2 for atopic dermatitis, and we are getting the results by end of this year. And also for JH2 inhibitor for NASH, we are evaluating in the cirrhosis patient in phase 1 and phase 2. And also we are evaluating other indications for the T-cell pathway inhibitors.
So first of all, it's ITP, just mentioned, ITP actually is a quite severe disease and pretty prevalent in Chinese patients. And the BTK inhibitor can cure the disease by multiple mechanisms. So in the phase 2 trial, we saw 40% of patients met the primary endpoint at a 50 mg once a day dosing. So the phase 3 trials has been approved by CDE and has been initiated in China with a 50 mg qod dosing. And this is orelabrutinib in the front line for BTK inhibitors get approved for autoimmune diseases, and we are considering global market as well. So the second indication, SLE, previously, we reported the 3-month phase 2A result. We saw dose-dependent increase of SRI-4 response.
We also saw the trend of a reduction in proteinuria levels, and also other biomarkers improvements. So, so far, globally, this only BTK inhibitor saw the, you know, excellent efficacy in the phase 2 trials. We initiated 100, across 200 patients, phase 2B trial, for 48 weeks, and interim, we will finish enrollment next year, by middle of next year. Interim will be, come out by end of 2024. So, on the MS, so previously we reported, the MS, multiple sclerosis study, is a global study involving five countries. And the 12 week is a primary endpoint, we saw a really excellent reduction of the T1 new lesion at the 12 weeks.
Here we report the 24-hour results, and from the graph you can see on the top, and from 4-24 weeks, the T cell, the lesion, T1 lesion get really controlled, well controlled by different doses. If you compare the 80 milligram dose with the placebo plus 50 milligram, you know, 12 weeks, power curve, we saw 92.3% improvement. And so no matter if the 12-week or 24-week data, is all leading, you know, best in class for BTK inhibitors, as well as leading efficacy comparing to other therapies of MS. In terms of safety, the liver enzyme elevation has been, you know, we mentioned it before. Here is the data in the whole trial, 158 patients.
So we saw one patient at a 50 mg BID, we still call it SAE. And also we saw another patient in the 50 mg QD with medium level of elevation of ALT, AST. And so, if you consider any elevations, you know, at about threefold of the normal level, we saw one patient in the placebo group. So this is very common, actually, the moderate elevation of ALT, AST in the placebo group. And the 80 mg, actually, treatment is 24 weeks, comparing to placebo. 12 weeks treatment, we see actually is comparable, the same as the placebo. And the 50 mg QD and the BID increased to 2-3 other cases, in addition to the two cases we saw in the previous graph.
So the conclusion is, the 80 mg QD has excellent efficacy and also safety profile, comparable, similar to the placebo. And we are going to move forward with the 50 mg QD dosing for the further clinical evaluation. And for all cases, the elevated enzyme levels were reversible, come back to normal and with no symptoms from the patient. So the fourth indication is AD, atopic dermatitis. This is TYK2 inhibitor 332. We finished the phase 1 in healthy volunteers, and it gets pretty good results, and it's highly selective for TYK2 against, you know, JAK, JAK to experimentally 400 for the selectivity.
So the phase 2 trial is 80 and 100 milligram QD doses, and we are finishing patient enrollment very soon, and the results come out by end of the year. And so last one is ICP-488, it's JAK2 inhibitor of TYK2, and for the treatment of cirrhosis. We finished the phase 1 healthy volunteer, and now we move to a cirrhosis cohort in the expanded phase 1 study, as well as we are initiating the phase 2 study for cirrhosis. So the TYK2 inhibitor, no matter the JAK1, JAK2, can cover numerous other indications. So we are starting from one indication first and set out goals and to get a POC before we move to other indications.
So for solid tumor strategy, our strategy is, you know, giving the right medicine to right patients at the right time. So one approach is benefit a patient more by precision medicine. If the person carry a gene mutation fusion, you know, we have a drug for that, that give very good response. For example, our ICP-723, and we are in the registrational trial at 80 mg, and we saw a really good OR response, 80%-90%. So the trial is still ongoing. We are, you know, aggressively finishing it, try to submit NDA next year. And the ICP-192, and we are doing registrational trial for carcinoma at a 20 mg. So far, we also observe pretty good efficacy.
Another approach is benefit more patients by combo with the different therapies. So we have two ways. Here, as an example, we have more than two compounds. Here, just as an example, ICP-189 is a SHIP2, is a first-in-class inhibitor, and it's the immunotherapy. And also ICP-B05 is anti-CCR8 antibody. Both are in phase 1 dose escalating, and we're considering combos with other targeted therapy and the immunotherapy, and for covering different indications. So, ICP-723, the second generation of the TRK inhibitor, that can overcome acquired resistance of a first generation of TRK.
We finished the phase 1, and we get excellent safety, efficacy readout, and then no DLT observed from 1 to 20 milligrams, and the registrational trial is 80 milligrams. And so far, we are already finished 20-30% patient enrollment, and so far, we observe 80%-90% ORR. We also saw 1 patient and gave a very good response in the R/R treatment resistant patient. And IND for pediatric patient already get accepted, approved, and we are also exploring RAS mutations for this compound. On the right hand, you see a young adult, and he got a big tumor on the left side of the face. After 15 days treatment with the ICP-723, and the tumor get, you know, almost completely disappear.
So ICP-192, just mentioned, is the FGFR inhibitor. It's an irreversible inhibitor, and we finished the phase 1 from 2-26 milligrams, no DLT observed. And right now, the registrational trial is on 20 milligrams for cholangiocarcinoma. We are also exploring multiple other indications with FGFR mutations, and overall, in the solid tumor, 7.1% solid tumor carrying FGFR mutations. So, ICP-189, we just mentioned, is a SHIP2 inhibitor, and we have finished those escalation from 10-120 milligrams, and we observed excellent safety, basically no any SAEs, and it's a medium safety profile. At the 20 milligram, we confirmed the PR in the cervical cancer and in the QOD dosing.
Right now, we are doing a combo with EGFR, with the erlotinib in the US, and EGFR, a combo study, for small lung cancers, small cell lung cancers. And also, we plan to do combo with PD-1 and other things, and cover different indications. So this is our pipeline, autoimmune disease and solid tumor. We just touch on, and I'm not going to go over it with it. So, anticipated milestones and catalysts in next 12 months. And for liquid cancer, we mentioned that we will have three C NDA package, first line, CLL, SLL, and will be in 6 months, the package submission. And also the tafasitamab will be 6 months from now, submit NDA package in Mainland China.
And also in US, we have around, maybe 12 months, submit NDA to FDA in the US. And other, liquid cancer, we just mentioned ICP-248, ICP-248 and 2.8, just the first dosing, and we saw, the CR for the patient failed multiple, line of treatment, failed, BTK inhibitor treatment. So the BCL-2 inhibitor is our, you know, we, internally discovered for sequential treatment with BTK inhibitor, also for combo with the BTK inhibitors and others. So autoimmune disease, we just mentioned orelabrutinib, we are in, phase 3 for ITP, registrational trial, and phase 2b for SLE. And we hope, you know, after with the result, discuss, you know, the registrational strategy. And MS, we are, working with FDA, seeking our path forward.
We mentioned about ICP-332, by end of the year, we'll have data read out for the AD, and ICP-488 for cirrhosis by later this year. Solid tumor, we mentioned ICP-189. We're finishing phase 1, and we're starting combo with the EGFR and the two precision medicine drug candidate, ICP-723 and ICP-192, for submission of re-- finish registrational trial and submission for NDA. So, we consider ourselves finish the company phase 1, and from start to end of last year, and we get, you know, drug launched in the market, and the company successfully IPOed in Hong Kong and in STAR Market.
And also we build up a strong pipeline, and a team, experienced the R&D drug innovation team, and also platforms from discovery all the way to commercialization. So if we look forward in the next 3-5 years, we saw at least the 6 drugs will be marketed in the, you know, in a commercial stage. And this including our already approved orelabrutinib for hematology, and will be approved in mainland for tafasitamab, and also 723 and 192, in the relatively later stage of registrational trial. And also, if we move 3-4 years from now, we see number of indications of orelabrutinib for autoimmune disease, and will be approved. And also, the BCL-2 inhibitor, 248, and the two TYK2 inhibitors with high possibility success for number of indications.
And this, we listed our top eight products. Of course, we have a rich pipeline and others that we feel something hopefully will also get registered within the time frame. And so by then, we will be a recognized leader in the hematology and a strong competitor for autoimmune diseases and the solid tumors. And in our internal R&D, in addition to above drug candidates, we are very carefully positioning our future drug and in the R&D stage. And so we hope those are the, you know, first in class or very unique in the indications therapeutic areas. And we are also set up very unique research platforms to get differentiated assets.
And also our drug innovation platform from research clinical development to manufacturing commercialization platform will be more completed, it will be more powerful. And also we hope and we're striving to get 3-4 products get into globalization, including out licensing, partnership, and launching common drugs ourselves and et cetera. And by then we anticipate a significant increase of the revenue and a significant growth of our Our company in the stock market as well. So we're really confident.
We have a really good pipeline, rich pipeline, we have a strong team, we have our established platform from research to commercialization, and we do have, you know, cash enough for the next few years to develop our own assets, potentially for, you know, for licensing activity as well. So this is our financial numbers, and the total revenue, just to mention, is CNY 378 million, and increased 53.5%. And the drug sales, CNY 321 million, increased 47.8%. And our R&D cost increased around 30% because the increase of clinical trials, especially the global clinical trials, to CNY 358 million.
But this is still a reasonable number for our R&D costs. We have been really cost effective. So as such, our loss for the period for Hong Kong FRS, and exclude the exchange rate of USD, RMB, and, you know, RSU, so around CNY 206 million, and is around a 10% decrease from last year. Our cash and cash equivalents, and comparing to last year, we increased more than CNY 2 billion, and primarily from the success of our IPO of STAR Market in September last year. And we have CNY 8.7 billion cash and cash equivalent enhanced now. I will stop here and welcome any questions you may have.
Thank you, Jasmine. That's really comprehensive for the introduction of first half results. Now, we're going to start with the Q&A sessions. Again, just a reminder to investors dialing into the call, if you have any questions, you can either raise your hand, you know, you can ask a question directly to the management team, or, you can also type your question into the Q&A box. We're going to read it out and for the management to answer that. So I'm probably going to start with two questions first. You know, we basically got a lot of questions from investors. So one is on the orelabrutinib sales. In the second quarter, we saw the drug booked about CNY 170 million sales, versus first quarter is CNY 150 million.
You know, slight increase, but first quarter, we actually know, there was COVID, the factory also Chinese New Year. So, investors feel like, you know, second quarter, sales looks a bit weak. We're also looking into some of the competitors, numbers. Brukinsa, in China, also, second quarter versus first quarter is not growing. So does that mean the overall BTK market is getting to a stage that, it might not be able to push the penetration further? Or is there any temporary one-off things happening in the second quarter that are leading to the relatively weak sales numbers? That's the first question.
Okay, Ziyi, thank you. Actually, this question also being asked early today, and our first quarter is CNY 161 million, and the second quarter actually is CNY 170 million, increased 13%. And, you know, we think the second quarter is not really that weak, is we are still, you know, competitors. Yeah, maybe flat in the first and second quarter, and we are still increasing the about 13%-14%. And, in the second quarter, you know, after Chinese New Year and we sort of made a strategy that we changed our geographic, you know, sales sales region and positioning ourselves to add more sales rep.
Actually, it's starting from late of the second quarter until the, you know, the June, July. And so, in general, I think, you know, the first two quarters, we get CNY 200, CNY 321. And, you know, we feel in the third, fourth quarter, and in general, it's always the case. You know, last year we, from first two quarter, we increased quite a bit and to, you know, to this first two quarters. We're also confident in the last two quarters, and we hope also increase. You all know with any prohibition now from last month and have the, you know, efficiency affected a little bit with the meeting postponed, canceled and stuff like that.
But even that, we are still, you know, confident to, you know, move forward with the, with the last 2 quarters. And actually, we didn't automate much, and we feel, and in this environment, the cash is really important. Our sales cost decreased a lot, actually, this first half a year. We feel net profit is very important, and so we are going to continue striving for, you know, reduce, reduce the cost and increase profit of our commercial team.
Great. Thank you. Thank you for the color. Well, just a follow-up to that, in terms of the guidance this year. I think at beginning of the year, company gave a guidance about, you know, potentially CNY 800 million-CNY 900 million or CNY 1 billion in sales this year, for orelabrutinib. Do you have updated guidance for that, or you still think the guidance is achievable? And also, over the next few years, how should we think about the potential sales ramp-up trajectory for orelabrutinib? You know, let's say, in three years' time, where the drug sales can be landed, in your view?
Right. Actually, we give a, a objective for our sales team, another really for the market guidance. So we never give market guidance. So we always put, you know, the high objective for our team and for make up, you know, their, their bonus, their objectives and such, and obviously the high number. So last year, we did CNY 566 million, and this year, even, you know, we do CNY 800 million. This still a lot of increase. And we did plan in the second quarter, I just mentioned, that we changed the structure of our sales team and try to get more sales rep. You know, you need more labor to get, you know, significantly higher. So we are still in the middle of a ramp up.
We plan to ramp up around 90-100 sales rep, but we finished around half of it, and we will see whether there's a need later over the year to add more sales rep. Right now, because the meeting was postponed and et cetera, and we slowed down a little bit the activity for adding additional manpower. Again, we are looking both parameters, the top line as well as the ROI, return of investment. We are very cautious, and we have, we want to make sure all our strategies will pay off. So if we add people, we want to make sure we still keep our profit and while we are getting the higher revenue.
If, you know, because of some effect of, you know, the recent environment, and we'd rather keep our profit unchanged and even reduce a little bit of the revenue. So that's our thoughts. We still feel the cash and the profit is very important for the sales, for the commercial team.
Got it. That makes a lot of sense, actually, reading into the first half prints of a lot about the company, looks like everyone consistently value cash and a profit more than the top line in this type of environment.
Right.
Well, I think another question probably you also got asked a lot is anti-corruption probe in China, the ongoing ones. And 'cause this is really now leading to a bit of disruption to sales reps and a doctor's interaction, and also in terms of some of the marketing activities, like, many conferences who got delayed or canceled. So, we're trying to also understand a bit from InnoCare's view that how this is gonna be evolving, and how do you feel like the overall feedback from the front-line salespeople, and how you're actually managing the discussion or communication with doctors in this type of tough time. So trying to get a sense from you about how InnoCare is being positioned in this kind of policy changes.
Right. So, Ziyi, you are right. And this policy, I think in long run, we really welcome this kind of anti-corruption policies, and we feel that's where China can get, you know, really the novel medicine, encouraging the growth development of novel medicine. This year, you probably know, early this year, the NRDL have some policies, really favorable policies to sort of reduce the price cut and also other, you know, a number of other things to encourage the new medicine launch to the market. We think anti-corruption is another move that's really favorable to the innovative companies like InnoCare and to the innovative medicine, back to the really normal track for the sales and be sort of mitigate the gap with the global market.
Despite of that, in the short term, because the interpretation of the policy, everybody, you know, have a different understanding and a different geographic location, they have different emphasis. So there is a definitely disruption for our, you know, field medical education and sales activity. And the majority of the meetings, 90% of the meetings scheduled already canceled. And also, you know, the activity level reduced quite a bit. I heard from the field reduced to, you know, 70%. And so we hope, you know, this is the short-term pain and for long-term benefits. And so we will see. Hopefully, you know, all the activities will be back to normal, all the correct activities will be back to normal and the whole getting into the right track.
But definitely, we are quite sure there will be short-term disruption. And from late July to now, the activity is reduced significantly.
... Got it. Thank you for the color. Well, I think we're also encouraged to see, you know, they put out the safety data and the 24-week data on the multiple sclerosis. And if we're looking into data, there has been two cases of elevated liver enzyme. Well, but the interesting is that that was in the 50 milligram BID, QD group, you know, instead of a 80 milligram...
Yeah.
Right, QD. It's pretty interesting that looks like it's not a dose-dependent liver toxicity. How should we explain that? Well, you have been working on this for a while, so if there are anything about the potential mechanisms or any new findings, you can share your insights with investors.
Yeah, we also look at the data. Actually, only one case of SAE, and this case is very complicated in Ukraine, with a number of confounding factors in there. And the second case in 50 milligram QD actually is mild, it's not SAE. Just elevated AST or ALT and back to normal. And so, so we feel, you know, the MS patient, as we previously mentioned, and these two inherited, because of the disease, the liver is very sensitive, and all the other, many other MS drugs with different MOAs, and they also have, you know, almost majority of them all have, you know, liver issue or need specific detection after, after, you know, market, in the, in the field. And you...
So we also see, you know, 12 weeks placebo, and we see very, you know, the mild change, the threefold, you see also, 1 patient. So, we feel, you know, the compound, we have a good efficacy somehow, and you, you mitigate. Well, yeah, you reduce your, the, the, the liver incident, even it's mild, you know, change of AST, ALT, like 80 mg is actually better than the, than the placebo. And, and since a 24-week treatment, and you see all the cases here is much better than placebo. And, and so, we have been communicating with, FDA and, and, and also our, IDMC committee, our HAC committee, they are all supportive.
They are very excited about the efficacy, and they also see, you know, the, well, two cases with many other confounding factors. And, you know, the situation is Sanofi and Merck Serono, and they also see, I guess, also very few cases. And so, I guess they want us also identify, you know, definitely the confounding factors. We saw confounding factors in the one case, a lot of confounding factors, including, you know, cholestasis, and the patient had. And so they want to look into, you know, whether some biomarkers like actual alleles contributed to it. So we are making strategy to move forward.
We are also testing the very few cases with you know even mild elevation of AST, ALT, comparing to the placebo group, try to get you know whether we can identify a definitive factor that we can use exclusion in the enrollment. So so we are figuring out, and we're still doing some tests and for some patients. And since the study already finished, and we do need the protocol revision for retesting of some blood samples.
Got it. Then a quick follow-up to that is, you know, any updates on the FDA communication? So,
So-
What they are looking for and what, what we are looking for, you know, to, to moving forward with our potential phase 3 studies.
Yeah. We submitted all the phase 2 results to them, actually in late June, July. They came back, and they have questions, and we give it back again, and they have further questions. Yes, we are communicating with FDA quite frequently and back and forth, and also with all the recommendations to FDA from, you know, our expert, from IDMC, from HAG committee, and et cetera.
Got it. Well, since you're already talking to FDA frequently, do you have any clear guideline coming from FDA about, you know, let's say, what kind of data they need to see?
Yes, they do.
For FDA, yeah.
We are still trying rewriting protocol to gather, collecting more data from the existing patient.
Got it. Thank you. A question coming from investors, you know, would like to know, 'cause Jasmine, you mentioned about, you actually changed the sales strategy a little bit in June, July, adding more sales reps for better coverage. So the clients would like to understand company's consideration to adjust the sales strategy and increase number of staffs under current anti-corruption probes. 'Cause we start to hear more companies, instead of taking, talking about adding more sales reps, they are talking about cutting down their expenses. They're talking about, you know, being freezing their headcounts. So what has been the thinking logic behind your strategy change? Thank you.
... Yeah. Thank you. We changed from 3 large regions to 6. And so the reason is, actually, this strategy was made at the beginning of the year, the first quarter. And we plan to add, like, 90, over 90 sales reps to covering. Since we get more hospitals covered, we get more cities covered and also the county level, and we expand a lot. So we want to try sales reps covering more hospitals and areas, and to increase the sales. And so, you know, we made our strategy in the first quarter and with the goal to finish the enrollment by, you know, by middle of maybe third quarter and the second quarter, we did quite a bit. We enrolled, I think we added around 50. So you are absolutely right.
Since then, we are still now suspend the activity of adding more, we finished half of that. And, like we just mentioned, you know, InnoCare's tradition, we really be very careful about, you know, what's the profit, the top top revenue, and the profit. We balance that very carefully. And, you are right. Right now, we are still, you know, we finished the half of the expansion, and so we will see in the next month or two, hopefully, and we will see whether we still need to finish the rest of the half or that's good enough for now.
Got it. Thank you. And I think there's recently also been, you know, CDEs changing. It's not changing, but more providing a bit of updates for the new regulation on conditional approval. And how does that change could potentially affect your clinical strategy, for example, for ICP-192, you know, and or other assets are running potentially, we're thinking about conditional approval pathway, how does that gonna affect your clinical strategy?
Yeah. Actually, this is also moves sort of close to the regulation, you know, ICH globally. So, now, CDE, the policy is once, you know, the clinical value is the center of the whole approval. And, if there is a drug, no matter it's from, you know, where is it? It's from MNCs, from, you know, the domestic companies or where. As long as the phase three approval, a drug already, you know, have a phase three result or phase three approval, and then you, you are not qualified to do the single arm, the single-arm registration conditional approval. So, so this is very clear.
Either you need a very fast and to move forward, you know, get the conditional approval and while doing, you know, phase 3, or you start the regular, you know, phase 2, phase 3, the controlled trial, earlier. So now, you are absolutely right. Every clinical trials, we all, you know, before we, we decide, you know, what's the regulatory strategy, we always discuss back and forth, get all the competitors, competitors, compounds, and, and the timeline, and to give a best, best guess, you know, we are going to finish the phase 2 or not. So now, for our... You know, we have, a few, single-arm registration in oncology, but in autoimmune disease is basically, almost everything we are doing phase 3.
And for oncology and in general, we, you know, even we do the phase two conditional, we always start phase three, not too far away from the phase two, so we can make sure and we have, you know, in case the, the, the single arm has a problem, we also have, you know, the, the phase three come up very shortly. So, you are right, and this is, you know, the standard is higher and higher. In some way, I think it's also good to make sure the drugs are truly, you know, beneficial for the patients and don't, you know, by, don't have it by chance, you know, the efficacy.
Also, I think the Chinese regulatory agencies is much more closer to, you know, all the ICH Global, I think in the U.S. and, and other countries, and follow the same rules as well. You are right, now become, more and more closer to the, you know, global registration policy.
Got it. Well, here's another question from investors. Are you still looking for, actively looking for partnerships for, multiple sclerosis indication, BTK? Well, last time, when you communicate to investors, you mentioned about, have to wait until, there's a clear cut, you know, with the breakup with, Biogen, and now this is, pretty much done. Are we gonna reinitiate or is InnoCare's BD team is actively working on this kind of looking for partnerships?
Yes, this orelabrutinib, but, you know, we have the oncology arm, which works pretty well, and we are in the registrational NDA submission stage, and we also started the phase 3 for MCL, and we have plans to, you know, do the combo with BCL-2 inhibitor for the larger indications like CLL, SLL, DLBCL, and et cetera. Yes, we are looking for partners on that. For MS and, as we mentioned, we are communicating with FDA, and we are also, you know, we are developing different strategies with, you know, communicating with FDA, collecting more data and collecting more data for, you know, the liver related, you know, the liver elevation thing.
We are still looking, but we still want to make sure we know the path forward before we form the partnership. So that will be a different value. You know, we form partnerships with, you know, current studies or with future studies. We have a very clear path forward. We do, but I think we ourselves prefer to wait a little bit to, you know, to get the path forward clear.
Got it. Thank you. Well, in terms of what kind of partner you'll be looking for, are you still gonna be really searching in the big pharma space, or are you gonna be more open-minded about picking potentially global biotech, mid-sized pharma to work with?
Yeah. So, you know, actually in the first round, when we look for partnership, we exclusively look at the big partners, and we did not even look at, you know, anyone, the small partners. And actually, from Biogen, the partnership, we learned a lot, and also we learned the lessons as well. We do want, you know, our goal at this stage, you know, we have cash, we have other very good pipeline. We want to have a drug launch as quickly as possible. So we are looking for somebody who is really on the same page with us and take this, you know, back and agree with, you know, our interpretation of the data, have confidence with the compound, and will move forward, together with us.
So now we are open-minded, and, and we do feel important to other partners who are, you know, put this asset on the top of their list, rather than, you know, after the upfront payment and then you, you don't know, you know, the timeline for the compound to being developed.
Got it. Well, on the BD front, investors are also interested in two TYK2 inhibitors, 'cause we're gonna have some of the data read out towards the end of the year. So after that, looking for partner is already getting initiated for those two assets.
So we are for TYK2, we are sort of in the early stage, looking for partners, but we do want to have the data read out before we have serious, you know, partnership. The POC data, the phase II data, we think is really important to de-risk the compound. And so, we still prefer to have a partner after, you know, like, ICP-332. We should have the readout in a few months, by end of the year.
Great. There's an online investor would like to ask questions. David, you can unmute yourself and ask questions.
Hi. Thanks so much, Ziyi, and thanks for the opportunity for the question. I'm David from UBS, and I would like just, like to ask one question about any colors about this new NRDL negotiations process. So all the Minjuvi has passed the formality for the contract renewal, and since we have new indications, do we have any colors for the potential, maybe the simple pathway of negotiation or any colors about the price copies? Thank you very much.
Yeah, this is for the question, and surprisingly, the whole day today, nobody mentioned about the NRDL. We think this is a much better policy now. So indeed, we do have the, you know, Minjuvi new indication. This year also, the, you know, the second year of, you know, under NRDL. We are doing, we are, we are in the path to do a simple negotiation, and we still hope, you know, keep the price well and, and doing the simple, simple negotiation. We should know that, actually by middle of October and about it. Now still in the application stage, we passed the first round.
Okay, got it. Very clear. Thank you very much.
Thank you. I think the reason not a lot of people asking about NRDL, probably no one's expecting that there are gonna be huge price cuts anymore. So, the people are taking it more positively.
Yes.
We are running out of time. It's already one hour. So, before we closing the call, I'm gonna turn back to Jasmine for any closing remarks.
Sure. Ziyi, thank you for host the meeting. We really appreciate, you know, early morning or late evening for this meeting. So, you know, InnoCare, I mean, we do have, we're really confident actually with our pipeline and with our excellent assets and differentiated assets, and with our internal discovery innovation platform, and with our strong team, we have 1,100 employees, and covering all aspects of drug innovation from, you know, our own disease research, target identification, our own clinical team carry on all those critical and speed high speed of clinical trials, and our own manufacturing, Guangzhou, producing all the materials, and established two big manufacturing, one in Guangzhou and one in Beijing.
Our commercialization team is highly effective. So, and also, you know, InnoCare always be very cautious with spending. In the first stage, the company value increased dramatically, 100-fold. We only use 100 million CNY to, you know, carry the company's use-- investors' money. We are confident with the version 2.0, you know, version two, and we will achieve our objective. I need your continued-- We need your continuous help and support, and hopefully, you know, you all have confidence on us. Thank you so much for your attention, good night, and have a good day. Bye then.
Thank you, Jasmine. We're closing the call for now, and any questions, please reach out to us or to the IR team of InnoCare. Have a good day. Thank you.
Great. Bye.