You have joined the meeting as an attendee and will be muted throughout the meeting. Thank you for joining InnoCare Pharma 2023 Annual Results Earnings Call. This is Ziyi Chen, China Healthcare Analyst at Goldman Sachs. Before we kick off the 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 or otherwise confidential information. Attendees are publicly and market participants who may not receive, initiate, or request non-public or otherwise confidential information about issuers or securities, or about the market securities. Today, for the call, we are honored to have the management team on the call to discuss the results and also providing 2024 forward-looking, for our investors, joined to this call, including Co-founder and CEO, Dr. Jasmine Cui, CFO, Mr. Xin Fu, and also our Director, Bonnie Ren. Management is gonna give us a introduction of the results, recapping some of the most updated business status, and then we're gonna open a live for question and answer sessions. If you wish to raise questions, you can raise your hand, we can connect you into the call, or you can put your question into the Q&A box in the Zoom app, then we can read out the question on behalf of you. Without further ado, I'm gonna turn the call to management team to get started. Okay. Thank you so much, Ziyi, and good morning, good evening. Thank you all for attending InnoCare 2023 Annual Earnings Call, and we are excited to share the results with you. InnoCare is a drug innovation company. Our mission is science-driven innovation for the benefit of the patients. Our vision is to become a global pharmaceutical leader that develops and delivers innovative therapies for patients worldwide. And our drug innovation focus on two therapeutic areas, oncology, autoimmune diseases. Those are two large therapeutic areas with a lot of unmet medical needs. Here is our key achievements in 2023, and classified into different aspects. In commercial, orelabrutinib revenue increased 18.5% compared to that of 2022. And we also, in 2023, get RR-MZL NDA approved. This is the first and the only PD-L1 inhibitor approved for the indication of MZL in China. We also very happy to say we get a successful renewal of RR-MCL, CLL/SLL indication, and additional RR-MZL to the NRDL coverage without price cutting, and keeping the same price. Also, early this year, we strengthened our commercial team by changing the leadership and the positioning for sustained long-term growth. In financial, our total revenue reached CNY 739 million, representing 18.1% year-over-year growth. Also, our gross profit increased by 26.6% to CNY 610.1 million. Therefore, our loss reduced, the total loss of the year decreased by 27.8% compared to 2022, and to CNY 645.5 million. And, we are very happy that we still have the cash balance of a total cash of CNY 8.2 billion, providing us a strong base for further development and flexibility. In operation, we got a removal of the 'B' in the Hong Kong Exchange, indicating we are transforming from a biotech to a biopharma company. And our Guangzhou manufacturing site commits the majority of our commercial products of orelabrutinib, resulting in a cost reduction of the gross margin increase. Also, we improved the ESG with environmental friendly operations, and we're rolling out company 2.0 objectives. In clinical trials, we made a significant progress. On the left bottom, showing NDA approval, registrational clinical trial progress. orelabrutinib, just mentioned, we got approval MZL indication in China, and we also get RR-MCL approval in Singapore. We finished our first-line CLL/SLL phase III patient enrollment in China, and the positioning for NDA submission in the second half of this year. We finished the MCL enrollment in the U.S., and we are positioning for NDA submission to FDA in the third quarter of this year. Our second graph, tafasitamab, and we got approval in Hong Kong, and the market approval in Hong Kong, and we got early access program in Hainan and the Greater Bay Area. Also, we finished the registrational trial in Mainland China and positioning the BLA submission in May of this year. We also made significant progress in the key clinical trials. orelabrutinib, we get FDA's endorsement and initiated first-line MCL global phase 3 trial. For ICP-248 in China, we are pushing through the phase 3 clinical trial, and we will finish patient enrollment this year, and hopefully finish full study next year and prepare it for the NDA submission by end of next year. For SLE, ICP-332, we are targeting patient enrollment completion. We're already more than 50% completion by mid-year, and hope to get interim analysis by end of the year. Also we get IND approval for the first-line treatment of CLL, SLL, the combo with the BCL-2 inhibitor ICP-248. Our ICP-248 is a novel compound of the BCL-2 inhibitor, and in China, we get excellent POC data in the treatment of lymphoma, and also we initiated a U.S. clinical trial last year. Our TYK2 inhibitor, the first one, ICP-332, and we finished phase 2 study and got excellent POC data in atopic dermatitis we'll share with you later. And our second TYK2 inhibitor, ICP-488, and we finished the phase 1, also got a POC data in the phase 1 of psoriasis cohort, and the phase 2 started, and the enrollment went really well, and we anticipate finish the 129 patient enrollment by middle of the year and get the phase 2 readouts, result by end of this year. And this is a 3-month study for psoriasis. Our solid tumor ICP-723 NTRK inhibitor registration trial is going very well, and we are almost finished patient enrollment. We are targeting NDA submission by end of this year. Our first-in-class asset, SHP2 inhibitor ICP-189, and we got approval for combo with the EGFR, third-generation EGFR inhibitor, and we already got the first patient enrollment. We targeted to get a POC by end of this year and to see whether we can provide novel treatment therapy for the lung cancer patients after resistant to the third generation of EGFR. In addition to above, we got 9 IND approvals in 2023, and in China, in U.S. and the other countries of the world. And now, we are presenting you where the hemato-oncology franchise we can strive to become a leader in that. So in that franchise, we have a comprehensive coverage from multiple myeloma, non-Hodgkin lymphoma, as well as leukemia. So in AML, we have two cornerstone products. As mentioned, orelabrutinib covers multiple indications and works really well. tafasitamab, first in class of DLBCL treatment, and it works really well. On top of that, we have just mentioned the BCL-2 inhibitor, 248, can use in combo for AML and also can be used for the treatment leukemia, such as AML. And also we have our novel molecular glue molecule ICP-490, which we are in phase 1 trial. We get approval for the combo with that for the treatment of multiple myeloma. And so we also have two antibodies, a bispecific antibody, CD3/CD20, co-developed with Keymed, and an excellent potency, both by IV and subQ formulation. And also our novel CCR8 antibody, and we tested in the T-cell based lymphoma and demonstrate excellent efficacy by far. So this is orelabrutinib approved for the three indications. orelabrutinib demonstrates the best-in-class profile for the B-cell cancers, and it has excellent efficacy, such as the CLL/SLL. We observe excellent CR 31.3% is out, is much better than the competitors, less than, like, around 10%. For MCL, it has really nice PFS, and MCL showing excellent overall survival of 91% at 12 months. Importantly, it show you great safety profile. It avoid, completely avoid of grade 3 atrial fibrillation, which is the lethal, really serious cardiovascular liability for other BTK inhibitors. But we have been through over 1,000 patients in the clinical trials. We don't have anyone showing it above 3. And we also have a much reduced diarrhea and grade 3 infections. Here showing, in addition to the proof of the three indications, we have a series of first in line, of phase 3 trials ongoing, including the first-line CLL, SLL in China. We will be submitting NDA this year. First-line MCL global multiple country trial already endorsed by FDA. We are going to get the first patient in May, and also MCL confirmatory trial, and the first-line MCL, DLBCL, and also first-line CLL/SLL in combo with BCL-2 inhibitor. And this is our novel BCL-2 inhibitor, and we think with a lot of clinical advantage. As you know, by far the BCL-2 is a apoptosis inducer, and it's not easy to get a good drug from there. The only proof of the drug is venetoclax from AbbVie. In venetoclax, there's metabolic spots, soft spots that result in quite a bit disadvantage for the venetoclax pharmacological properties, such as it has a major metabolite, M27, representing 80% of AUC of the parent drug within 24 hours. And both M27 and the parent drug has significant inhibition of CYP2C8 and CYP2C9, as well as the transporter, PGP and BCRP. Therefore, it has concerns with drug-drug interaction. So our novel inhibitor, ICP-248, with our novel design, we eliminated the susceptible metabolic spot in the venetoclax. Therefore, we eliminated the major metabolite, reduced drug-drug interaction. The parent drug doesn't have a CYP inhibition or any inhibition on the transporter either. And of course, it has improved the PK and excellent efficacy, and also we observed a good safety profile by far. Here is our clinical studies of 248 in phase 1, phase 2, and so left-hand side shows dose escalation. I have finished the 50, 75, as well as a 100 mg, and we observed excellent efficacy in 100 mg, and we are doing dose expansion at this 100 mg with different you know indications and the combo with orelabrutinib, and also we are starting U.S. trials as well as we're exploring AML indication. Meanwhile, we are still continuing the dose escalation try to see whether we can get an even more efficacious dose than that. This page shows the expansion at a 600 mg, 6 out of 6 patients showing excellent efficacy, ORR 100%. Among that, three patients, 50%, they're showing complete remission, CR, and also, two patients, 33% showing, MRD undetectable. This comparing with the market, the drug, venetoclax, and also the BCL-2 inhibitors in the clinical trials, ICP-248 showing excellent efficacy, better efficacy. On the right-hand side, showing, ICP-248 has great synergy with orelabrutinib in, in the preclinical models in antitumor activity. Based on this result, we have get IND approval for the combo with orelabrutinib for the first dose, for the first line CLL/SLL, indication, and we are planning for the fixed dose durat- fixed duration therapy, as a global trial, and also we are exploring AML as a monodrug as well. So this is our second drug, tafasitamab, a CD19 antibody, and this is approved in U.S. and Europe, and we licensed it from Incyte, in the U.S. And so after we acquired the CD19, the tafasitamab, we have get approval, highlighted use in Hainan and the Greater Bay Area, get approved in Hong Kong for market use. And we have formed a collaboration with the TTY for the development of the drug in Taiwan. In mainland China, we do need a registrational trial to bring in the efficacy from, you know, global to China, Chinese patients. And in mainland, we already finished the clinical study, and we are going to submit BLA in May this year, and we anticipate the approval in next year. Also note, tafasitamab plus lenalidomide has excellent efficacy compared with the different mechanisms such as ADC, such as bispecific antibody. And it's not only in ORR and CR rate, but also the outstanding efficacy demonstrated by duration of response, especially in the overall response, OS, overall survival. So our next asset related to cancer is the CD3/CD20 antibody. And it is showing excellent efficacy both in IV and sub-Q formulation, and it is co-developed with Keymed. And so at 6 milligram, no matter by IV and by SC, we observe 100% efficacy, and among that, the CR rate is 78%. This is in the patient, the DLBCL and follicular lymphoma. On the right-hand side, showing that sub-Q formulation demonstrates excellent dose proportional PK, and also it has a great improvement of the CDC, especially in the tumor in the patient with large tumors. Next, so this is our another. So, there's a little bit of glitch, but the next. This slide show our another molecule, a new mechanism, molecular glue, that can be used for treatment for multiple myeloma and also for AML. For multiple myeloma, it has a superior potency and efficacy, and it can overcome the resistance caused by lenalidomide. And also, we got approval, clinical approval for combo with Dex to pursuing the first line treatment, multiple myeloma, and we have first patient in. And, in addition, as a direct target for multiple myeloma, it is also immunomodulator, and it actually increased IL-2 production. In there, we have a combo. We can use as a combo with our other assets for the treatment of AML, such as DLBCL, MCL, CLL, and et c. So that have potential of the potency of other, other compounds and also, and get, much better improved, PFS and OS and etc. So now let's switch to our well-positioned portfolio in autoimmune disease. And in there, our approach, we have assets in T-cell pathway and B-cell pathway. In T-cell pathway, as we mentioned to you before, we have two TYK2 inhibitor, 332, 488. And we are really glad to showing you, we just closed another, pathway, another MOA, another molecule, ICP-488. This is a small molecule of IL-17 inhibitor for multiple indications of T-cell based autoimmune diseases. And this, ICP-488 is, already, went to the IND-enabling study. We hope to submit it for, clinical IND next year. 332, we finished the phase 2 for atopic dermatitis. We'll show the result later. 488, we are doing phase 2. We are finishing this year, phase 2 for psoriasis. And also, we are initiating IND license for the 332, as a second indication, and we are also choosing indications of larger indications for development of these two assets. For B-cell pathway, orelabrutinib, we already just mentioned that we have SLE in phase 2b, ITP, registrational trial, MS, finished the global study, and MS phase 2, and also we are considering other indications as well. Actually, autoimmune disease is a really hot area that with enormous unmet medical needs. If you look at the indications, there are more than 150 indications in autoimmune disease and affect over 500 million people worldwide and over, like, 40 million in China. Autoimmune disease indications can be classified into 6 different categories, such as nephrology, gastroenterology, dermatology, hematology, neurology, and rheumatology. Among the 6, we already have 4 categories covered, and we are going to progressively cover other categories and other indications. orelabrutinib, just to mention, we are in phase 3 for ITP, and we are finishing patient enrollment, hoping to finish the clinical study by end of next year. SLE, we are finishing the phase 2B patient enrollment by middle of the year and hope to get interim result of this year. For the treatment of MS, we finished a global study and observed the best-in-class efficacy of 92.3%, the new lesion reduction at 80 mg QD, and MS, we are in phase 2 ongoing. So this page shows on the left, ITP phase 2, we get a positive result. We get efficacy from 40%-83% based on which, you know, the population and, and which subpopulation of a patient and which dose. So phase 3, we are using 50 mg QD, and, we, the registrational trial, 195 patients. We hope to finish patient enrollment and get the study done next year. And the BTK inhibitor involves multiple steps in remove the inhibitory effect for the platelet production. On the right-hand side is SLE phase 2B design and progress. Actually, in the 3-month phase 2A study, SLE, we observed very positive results, and based on that, we started a longer study, 48-week study, and each group is much more patient. We have three arms, each around 62 patients, placebo versus orelabrutinib 50 and 75 milligram QD. And, just imagine that we already enrolled more than half of the patients. We will finish patient enrollment by middle of the year, and we are targeting to see an interim result and may or may not be close to the capital market, but we are going to use the result communicated with the CDE for further registrational requirements. And this switch to our TYK2 inhibitors. We have two inhibitors based on the binding mode, and the JAK1 inhibitor, ICP-332, binding to the JAK1 so-called kinase domain, and also JAK2 inhibitor, ICP-488, binding to the allosteric pseudo-kinase domain. Both binding inhibitions inhibits the activity of TYK2. And so ICP-332 has great activity on TYK2 0.5 nanomolar. It has some JAK1 activity, 90 nanomolar, and it's weaker than TYK2 around 40-fold, and it has greater selectivity against JAK2 400-fold selectivity. Generally, JAK2 is the one people think cause, you know, the AEs for the JAK family drugs. And ICP-488, and it is a JAK2 inhibitor, 5 nanomolar, and without activity of any JAK JAK family. So ICP-332, just to mention, is a major TYK2 inhibitor with a minor JAK1 inhibitor. Our hypothesis is a potentially first-in-class TYK2 inhibitor. Why we choose atopic dermatitis AD? First of all, from mechanism wise, and the JAK1 is downstream of IL-4. So you know IL-4R is a well used drug for the treatment of AD, the antibody. And also the IL-13 downstream is the TYK2. And so both pathways are really important for AD. So we thought blockade of the two pathways will cause synergistic effect, therefore offer superior efficacy for the treatment of AD, as a small molecule especially. So also, and the second reason is that AD is a very serious disease, very heavy disease burden, and worldwide, over 200 million patients are suffering from AD, especially young people, and with, you know, the itching cause the low quality of life, loss of sleep, and also cause suicide and etc. So it has huge markets and globally. So ICP-332, we did a phase 2 study and 4 weeks, and each group, around 25 patients, placebo versus 80 and 100 milligram QOD of ICP-332. And the primary endpoint of the phase 2 is the% change from baseline in the EASI score. And we nicely to see that both groups treatment, 80 and 100 milligram QOD, result statistically highly statistically significant different from placebo. The placebo arm is 16.7% change, and the treatment arm is 78.2% and 72.5% for the two doses. Right-hand side shows you the time course of the change from baseline of EASI score. And we see the change already significant at the first week, and it is continuing on to the second week, and also showing very further decrease at the week four. And here showing we look at the different efficacy endpoint and such as EASI 50, 75 means the patient improvement reached 50 or 75. The higher percent the score, the better. So comparing placebo on the left-hand side, EASI 50, we see very significant change increase of 88, 72% versus the 20% placebo. EASI-75 generates the endpoint for the phase 3 study, and we see quite a significant change. Both those reached 64% versus 8% placebo. On the right-hand side, we compare the leading drug for AD treatment is the JAK1 inhibitor, upadacitinib, and they also did a phase 2 for 4-week study. We compared it at EASI-75, EASI-90, and IGA 0/1, as well as the itching score, so-called NRS. And at each of these endpoints, we see better response than the Upa in the phase 2 study. Now, we align our result, ICP-332, phase 2, 4-week results, and comparing to all different MOAs for the treatment of AD. And this number is subtract the placebo. From here, you can see our 4-week results, the percentage change in EASI-75 is better, you know, you know, than the large molecule IL-4, IL-13, and also better than the JAK1 inhibitor. So we're really happy to see that. For others, they have even a longer treatment. So our phase 3 will be 6 weeks treatment as well. So another thing we look at is how quick the response was. Because, you know, for large molecule IL-4 and IL-13, they have a problem, they have an issue, that when patients receive the therapy injection, but there is no response for the first 2 weeks. It's a big issue for the patients because, you know, this is a very, the itching is very hard to tolerate. So we see whether our compound can have a quick response. We look at day 2, day 3, day 4, until day 14, and, and surprisingly, we see, and from day 2 already show you a significant decrease of the EASI, the itching score in NRS, and that continuously decrease on a daily basis, and until the 14th. Of course, by end of, week 4, we see further decrease of that. This is a significant change in NRS, and the quality of life got a significant change from week 1, week 2, and to week 4. So this is the safety and tolerability, of 332 at these 2 doses. We look at the total TRAE as, as well as TRAE related to infection, generally it's a problem for JAK1. So we don't know JAK1 inhibitors. And, we see overall, both doses in, are comparable to placebo. So you look at the details, actually, ICP-332 at 80 mg seems even slightly better than the placebo group. Of course, we didn't see any adverse effects and mentioned in the black box label of Upa. Now, we switch to ICP-488, and ICP-488 is a JAK2 inhibitor of TYK2, TYK2. And we finished the phase 1 in healthy volunteers, SAD from 1 mg to 36 mg, MAD 3 mg to 12 mg. And we observed excellent dose proportional PK in both SAD/MAD studies, and also we observed good safety profiles in the study. So in the phase 1 study, we also add a cohort of a psoriasis patient, and this is a 4-week study, and actually with a small number of placebo and the ICP-488 6 mg, so 7 versus 12 patients. This is a double-blind study, actually, and one month, and with one month of a specific observation. So we got the results in February, and also we are really glad to report that even it's a very small number, a short treatment of four weeks, we observed significant differences at a six milligram QD comparing to placebo, 38% versus 14% of percentage change in PASI score. And for psoriasis, it takes much longer. In general, it takes four to six months to see the maximal effect. And we also compare in the phase 1 study, actually, TAK-279, they licensed the compound from Nimbus, actually, by $1 billion. They also did a phase 1 cohort of 5 patients, and they also observed some change in the PASI 60, and we see comparable, similar efficacy or even, well, this is a small patient number and, better than TAK-279. So, this is a new mechanism, IL-17, a small molecule program. You all know IL-17 has a form of 17A, 17F, 17F, and etc, through the pathways and, of course, inflammatory signals in the body. It involves multiple mechanisms, multiple indications such as MS, asthma, COPD, psoriasis, Crohn's disease, and psoriasis as well. So now it's very hot that people are looking for small molecule, replacing the larger molecule for the easiness of, you know, avoid of injection. Injection time is always an issue in the clinic, and the market is big enough to, you know, to afford a small molecule. Actually, we're hoping to replace all the biologics of IL-17. So, this is an early program, and we have clinical data. We're doing IND-enabling study now. ICP-ICP-488 is a novel small molecule inhibitor of IL-17 and for the treatment of multiple autoimmune diseases. And, so in the clinical so far, only one company, Dice, has a small molecule of IL-17 in the clinic. They have a compound, they are leading compound as a reference, and we think our compound is three, has three advantage comparing to the, you know, Dice compound of this member. Dice compound is DC-853. So first of all, our potency is much better in inhibiting IL-17A and IL-17F. And also their compound seems, you know, has involvement in IL-17A, which is more potent than IL-17F. For ours, we have equal potency, almost inhibiting both the homodimer and heterodimer. We think this will be much better efficacy in that. And also, the third advantage is also avoidance of CYP inhibition. And the Dice compound has a CYP inhibition, CYP2C 0.3 micromolar, ours is above 50 micromolar. So in the pre-clinical models, we have several models, and we all observe good efficacy, and at 50 milligrams per kilo, we do see better efficacy in the model. So now let's switch to the solid tumor asset. For the solid tumor, our approach is either precision medicine, that is really good efficacy, and we have couple of assets, ICP-723, NTRK inhibitor, and also, Pan-FGFR inhibitor. Another is first-in-class compound that is immuno-oncology, immuno target, and, SHP2 inhibitor 189, and also CCR8 inhibitor, antibody, and that can be used for combo with multiple, with multiple, targeted therapy or immunotherapy. And so by this, we will have a broad indications. So this is our, precision medicine, ICP-723. It is the second generation of NTRK inhibitor. It can overcome the mutations caused by first generation of NTRK. And there are a few advantages for this inhibitor. It's very efficacious and, and, we have in a clinic, and we, we already observed... We are closing to finish patient enrollment. So far, it's open-label study. We observed ORR 80%-90% and also very long duration of response. And we've seen, you know, the patient already on the drugs for three years, and the effect is still very good. And also, this is a this TRK fusion of lung cancer for all the different types of cancers. And the fusion is very commonly seen in pediatric patients, you know, children 2-12, and also the young patient 12-18. So we are covering not only adults, but also the children. And we observed, we developed the formulation for the children, and we also developed we also see the good efficacy in both adult and children's patients. So we're striving to finish the patient enrollment as soon as possible, and we submit NDA by end of this year. And another is the SHP2 inhibitor, the first in class. We are in quite the frontline in the clinical trials, and we have done dose escalation, basically from 10 millimolar to now 160 millimolar, actually. And the drug is very safe. By now, we don't see any grade 3 and above TREs. And at 20 mg, we observe the PR in the ovary cancer. And also, we are doing combo with third generation EGFR inhibitor, furmonertinib, and at 80 mg, 80 mg. As you know, the EGFR third generation inhibitor EGFR is quite efficacious for the treatment of non-small cell cancer. But once developed resistance, by now there is no further therapy for the patient. There is a huge unmet medical need. We are doing a combo in the patient already developed resistance to third-generation EGFR inhibitor. We hope this year. We already get IND approval, as we already had the first patient in for the combo, and we hope to see POC this year for the combo therapy. So, by the way, our anticipated milestones in the coming year, and we separate into hematology, autoimmune disease, and solid tumor. So in hemato-oncology, we have, you know, the other five assets will have significant milestones. For orelabrutinib, we are going to submit NDA, the first-line CLL/SLL in China is important for our commercial. In the US, we are submitting RR-MCL NDA in the second half of the year, and this is important for our globalization. And also, we are doing a combo with this ICP-248, the BCL-2 inhibitor, in the first line CLL, and this year we will have data readouts to support our phase three initiation. tafasitamab, we are submitting the NDA, the BLA, this year, actually in May this year, and for the approval in mainland China, which is also very important, this is our second commercial drug and will be launched in the market. And our novel, the BCL-2, ICP-248, and we are finishing dose expansion, and we are doing multiple dose expansion, and we hope to read out in different indications of NHL, AML, and also we are starting the US trial. So ICP-B05 is for T-cell lymphoma, and we will get more patients in, and we will get solid POC data this year. This is global. We're the only one doing that, we're global first. For CD3, CD20 antibody, we are going to be defining our dose for SC, and therefore pursuing the registrational trial once this is done. Autoimmune disease, orelabrutinib brand name, we are just about completing the SLE patient enrollment and hope to get interim results this year for the phase 2b study. Also for ITP, we finish patient enrollment this year and hope to finish the clinical study next year. And ICP-332, we are initiating the phase 3 study for atopic dermatitis, and also we are initiating the second indication, vitiligo, in China, and also we are doing U.S. study. For ICP-488, we finished the phase 1 POC, and we are doing phase 2, and this is in psoriasis. It is a 129-patient study in three groups, placebo versus 6- and 9-milligram QD, ICP-488. And enrollment went really, really fast beyond our, you know, plan. And we should finish patient enrollment in May or July, and then should get the 3-month study result by end of this year. And as I just mentioned we are going to get a big POC result with the combo EGFR. And the ICP-723, we are try to, you know, finish the registrational trial, submit the NDA, and also submit the NDA this year. And I stop here, and Xin Fu will go through our financial update. Thank you, Jasmine. Hello, everyone. I'm Xin Fu, CFO of InnoCare. Now, I have the privilege to share with you the financial achievement of the company in 2023. Our relentless dedication to innovation and operational excellence has yielded solid performance. We have achieved 18.1% increase in total revenue, amounting to CNY 739 million. This revenue growth is anchored in the strength of our leading product, orelabrutinib, which has shown a robust sales performance and remains a cornerstone of our portfolio. We will continue to invest in building the commercial capability, expanding hospital coverage, adding new indications, pushing for more early line treatment. So with those drivers, we are confident to our revenue growth of orelabrutinib will continue to accelerate in the following years. Regarding the loss of the year, we have successfully reduced our net loss by 27.8% to CNY 645 million for the year 2023. This achievement reflects our focus on increasing sales revenue, improving gross margin, enhancing operation efficiency, and reducing total for the unrealized foreign exchange loss during the year. Our commitment to innovation is unwavering and evidenced by an increase in 17.5% in our R&D expenses. ... This investment is in alignment with what we have achieved in the clinical studies across multiple pipelines, and also strategically investment in the early stage candidates for the long-term value of the company. Besides the R&D expenses, we also see that decline for the spending of the sales sales expenses and also our G&A expenses, which demonstrates our effort to optimize the spending level. Last but not least, our cash balance stands robustly at around CNY 8.2 billion. This is showing the financial healthy and provides long-term the cash runway and enable us to accelerate clinical study and also strategic investment to expand in competing pipeline. So in summary, in 2023, we achieved rapid revenue growth, significantly narrowed down the net loss, and with improvement of operation efficiency. The strong liquidity position provides sufficient flexibility to ensure we stay at the forefront of the innovation. So, as we close for the year of the significant achievement, our unwavering focus on innovation and the strategy and execution position us to accelerate the growth and also continued success. We are deeply grateful for our shareholders' support as we strive to deliver breakthrough therapies and enhance value. So this is the last page of our today's presentation. Now, I hand over back to Ziyi for the Q&A section. Thank you. Sure. Thank you for a very comprehensive introduction, and, pretty much you already covered a lot of the detailed data of the assets. Just to remind investors, if you wish to raise questions, raise your hand in the Zoom app, we can connect you into the call, or you can type your questions into the Q&A box. And, I'm probably gonna start with two questions. One is really on the commercial and the other one is on the pipeline. On the commercial front, you know, last year, definitely the market has been seeing a lot of uncertainties, including the second half year. There was anti-corruption activities in China market. So getting to this year, how should we think about a more normalized, less disrupted commercial environment? And how should we think about the growth of the orelabrutinib, particularly, if we're looking at the BTK class in China? I would say, in 2022 and 2023, it was more getting into a relatively steady growth, but not at an early stage of introduction of the products. So, are we talking about, let's say, teens growth down the road, or we are expecting some of the new indications are gonna potentially drive the sales to another level? And of course, to back that, how should we think about your commercial team build up? Because I still remember last year Jasmine mentioned that you was planning to expand the team more aggressively, but because of third quarter disruption, you start to revisit the strategy and rethink about how we should be injecting the resources and building the team. So what about now? What is your updated view on how you're gonna build the commercial team for that? And in terms of pipeline, I think TYK2 inhibitor has been very interesting. You got two, and this is gonna be targeting a broader indication in immunology. So, because given InnoCare it has been have a very strong cash runway. Are you actively looking for any partnerships for earlier global development, or you're gonna run it by your own before, you know, it get into pivotal stage, pivotal study stages? So, two questions from me. Sure. Thank you, Ziyi. Let me give a try to answer your series of questions, and just remind me if I miss anyone. So for commercial, you are absolutely right. Last year, you know, there are quite a bit of a challenge and in every aspect. And then, you know, we changed our plan in the middle of it and seeing the market. I think last year, although the total, you would say, the total revenue is not as we hope, you know, bigger number, but our profit actually was very nice last year. And that shrink our really significantly, you know, our loss, and provided quite a bit of actually commercial profit to the company, to R&D research. So last year, we did, you know, although the revenue is not as high, but the, you know, the profit actually roughly meet what we wanted at the beginning. And the commercial team now is about 300, total 350 people. You know, and then, why we changed the leadership this year? We're positioning ourselves, you know, for the new indication, MZL, actually is a pretty, you know, sizable indication. And so we're the only BTK inhibitor approved for that indication and it works really well. And also we get an NRDL coverage this year, actually keeping the same price. We are pretty happy about that. So with MZL getting into the, you know, getting into under NRDL and with our, you know, year-after-year effort on the, you know, CLL and MCL, and this year, you know, we've been much more confident and moving forward. And also with tafasitamab going to launch in about 1 year, and with all the new disease indications will be launched perhaps about 2 years. And with them, we need a team more, you know, for the more specifically for autoimmune disease, for the, you know, different cancers, our solid tumor also will be approved, you know, will be launched in about 1 year or 2 years. So we do anticipate really bright future in the next 2-3 years with multiple drug launch. For this year, 2024, we are still largely relying on orelabrutinib, and we are confident with the team switch and with our more focused MZL and also, you know, the NRDL cover the indication and with all the approval of first line CLL, and we are confident to move forward. And this first quarter, you know, we just had a team switch, and we need a little bit of more time to say how much we are going to accomplish for this year. But we do feel confident we'll have greater growth in 2024 from 2023 than, you know, we observed the 18.5% growth from 2022 to 2023. So that's the commitment for now. Give a little bit more time with the new management team, we will have a better sense on that. And we also will see whether we need to increase more resources on that. And we still give a couple of months observation before we make that decision. If there is a need, we will have no hesitation to increase resource on the commercial. And so that's the first question. And what's the second question on the commercial, Ziyi Chen? No, it's more on the takeout license. Are you actually looking for partnerships? Right, right, right, right. The TYK2, actually, we got, you know, we are very happy got the dermatitis data. And it is the most important, we are all scientists, it really fit our hypothesis. And besides, you know, the big commercial potential. So, we are moving to the phase three and quickly, as you know, for small molecule, you do have some certain GLP animal study to support the human study, so we should have that done in the third quarter. And we are, you know, putting together the protocol for the phase three, and we will do that. And we anticipate fast enrollment. We already have a calculation, how many people are needed, how many patients are needed for phase three. Also we do have a timeline on that, but we want to disclose, you know, when are we going to submit an IND. Maybe by once we started the phase three, we will have a better idea. Also we're starting the second indication in China with orelabrutinib, and it's also with a large big market with unmet medical needs. And from our hypothesis, it should work for that indication as well, but we do need a phase two study to confirm that. So in global, we submitted IND, and we're getting approval anytime. So our plan is we will first do a phase, you know, the healthy volunteer, make sure the PK is the same in China versus Caucasian patients, people, and then after that. We still want to do AD for the global, and we might also, we are considering another novel indications for the global study. So, in terms of whether development ourselves or by partner, we think of autoimmune disease in the global market, it will be good to have a partner. You know, we're open to out-license, license, and also we are open to co-development and etc. So it depend on, purely depend on how good the deal is. So, yeah, we are planning, we are in the middle of activity of doing all of those, and hope we will get some news to disclose in, you know, sometime this year. Got it. Thank you. We saw some questions coming from online. Next question coming from Jack Lin from Morgan Stanley. Jack, you can ask your questions. Hello, can you hear me? Yes. Yes. Hi, hi, thank you, Dr. Cui, and, thank you, Xin, for taking my question. I have a few questions regarding the autoimmune pipelines, specifically the ICP-332 and the new IL-17. So for the ICP-332, I'm glad to see the very robust efficacy data and also fairly clean safety profile. I'm curious to hear kind of what your thoughts are in terms of you know we're seeing strong response as well as potentially earlier response time. So wondering what your thoughts are as far as how much contributed from the JAK1 portion, how much contributed from the TYK2? And also, as far as the safety data, I'm curious about how long is the follow-up on that, and are you, you know, concerned at all as far as, you know, any infection-related adverse events related to JAK1? So that's the 332. And just on the IL-17, just really quick, I'm curious in terms of how you see the this pipeline positioning, as you've seen domestically, there's a lot of other players playing either 17 or other biologic targets in the autoimmune space. So I know we've shown some kind of MOA difference, differentiations on the our own IL-17, but if in the broader picture, like, how do we see us positioned against others? So just at least two questions. Thank you. Yeah, Jack, thank you for the question. For ICP-332, so your question is about the safety. So we have a one-month study. We also had a one-month safety observation, of course, that's for phase 2. For the phase 3, we will have 400-500 people, and also the study will be longer than 16 weeks, and also we will have a year of safety observation. And meanwhile, we are opening a second indication that will provide another around 500-700 people. So by registration, we should have over 1,000, you know, patient number for the long term. So we should have a better assessment by then. But in terms of mechanism, as I mentioned, if you go back to the slide of the mechanism, so this is why we are doing AD for TYK2 inhibitor. You know, TYK2 is much more potent than JAK1. And then, so in there, you see both JAK1 and TYK2 play a role in the AD, in the disease progression of AD. And if we block both pathways, we should get better response. In terms of how much from JAK1, how much from TYK2, we know the compound is 40-fold more potent on TYK2 than JAK1. So we think we are hitting TYK2 much stronger. We also calculated the hitting on the JAK1 versus Rinvoq, and based on there, you make a fully, fully binding and such, we feel our hitting is much lighter on JAK1 than Rinvoq. Our team does have the detailed calculation of all the detailed numbers, that we believe both contribute to the AD efficacy and perhaps TYK2, and contribute more. That's our current understanding. So for IL-17, currently, it is really hard, you are right, there are people pursuing the, you know, the cytokine treatment, and with the small molecule biologic-like function. But IL-17, so far, there's only one compound, actually two compounds. The first one may not work, it's very weak. And the second compound is from, I think, Dice, both compounds from Dice, and they licensed to Eli Lilly, and so that's reference compound, and we feel, you know, we do have a advantage in that. And like, you know, all our compounds from InnoCare, we're carefully looking into all the different pharmacological parameters, efficacy, safety parameters. We generally choose the best from it, it's from internal innovation. And so we do feel ICP-488, at least comparing to the front runner in the clinic, it has all the advantages in terms of potency, in terms of taking both homodimer, heterodimer, as well as the safety, the avoidance of drug-drug interaction. So, you know, maybe the target multiple people to do that, but still the best compound winning the market. Understood. Thank you so much for your explanation. Okay, thank you. Great. Well, I think there's another follow-up, which is also on the pipeline coming from email: could you update us on the BTK and multiple sclerosis? What is the status now? 'Cause recently, Merck KGaA pretty much gave up the assets. They didn't move forward with the asset, which just didn't show very strong efficacy. I think for Sanofi, they are still waiting for the phase three data to come out in mid of the year or third quarter of the year. So, what is the status for our orelabrutinib? Any recent feedback from FDA? Yeah. So that's a good question. Actually, there are some landscape changes, since, you know, last time we updated the market. Interestingly, BTK inhibitor, there are 5 total, in the global study, you know, in the U.S. for pursuing RMS. And except for Novartis, so all the 4 has partial clinical hold, and including our orelabrutinib for, RMS. And then, Merck Serono, they finished the phase three, from, you know, the study, the patient enrollment outside of U.S. and in the RMS, and they did not see the efficacy. They failed the phase three. So I have to say from phase two data, and there is quite weak. If you look at, you know, all the phase two data and, and, Merck Serono's, and probably, you know, this like 70% or, or 60-70% of the new lesion reduction, while we're getting 90-some%, and Serono, Sanofi got 89, 87, whatever the%. So, so there is a weak in the phase two. So it's not surprising it didn't work for the phase three in RMS. And now for, Roche has a, also has a BTK inhibitor. Their reversible BTK inhibitor also has a partial clinical hold on RMS. And so, the current thinking is actually Merck Serono get some progress, and although the RMS, they finished patient enrollment outside of U.S., you know, the hold is just only in the U.S. And they are getting the RMS data sometime this year, like you said, Ziyi. And their PPMS, they have primary progressive MS, actually got partial relief from partial clinical hold, and they lifted the hold, and now they are resuming the global enrollment of the patients. The reason is actually for RMS, the FDA raised the standard because the approval of the CD20 antibody, they approved the three, and they worked also pretty well for the RMS. However, for the progressive MS, PMS, also, you know, RMS eventually become PMS, secondary PMS, and no treatment or therapy so far. So people think the brain penetratable like a BTK inhibitor of orelabrutinib and other BTK inhibitors, because the role in microglia in the brain. So you do need not only systemic B cell reduction of the inflammation, also you need local, local inflammation, reduction of inflammation from microglia. So that's the reason they get lifted. And we are for orelabrutinib, because, as I say, we finished the phase two, we observed the excellent results for RMS. And since we haven't performed any study and we have no further data to lift the clinical hold yet. And we are also looking into the possibility for PPMS due to that, you know, really unmet medical need. Also outside of U.S. and, such as in China, there's we get approval for third, for phase three trials on RMS. We are evaluating the, you know, whether it's worth it to do the trials if without including U.S., and so that we get more data with the, hold and then include the U.S. for the phase three study and for RMS. So that's the current status. And, and then we are also doing some effort, and we'd like to update you when we get the results. Otherwise, you guys will be really anxious to ask on the weekly basis, what's the progress and how is that? And, and so we would like to know if we get a progress one way or another. Got it. Great. And also I think, this year, well, last year, you have moving a lot of new assets into clinical studies, and now InnoCare is really managing a pretty large pipeline under clinical development. So how should we think about, number one, in your early stages discovery, what you're being focusing on? Number two, among all those very meaningful progresses in the clinical pipelines, how you're gonna pick and choose prioritizing the projects? 'Cause, although we believe InnoCare still have a very strong cash flow with CNY 8+ billion, and with a loss of CNY 650 million last year, so it should be supporting your operation for a very, very long time. But still, we are being cautious about, you know, in this type of environment, when we're spending all those resources, we're gonna be focusing on returns. So how should we think about which project is gonna be your prioritization, prioritize projects and which are potentially gonna be those good to have assets? Yeah, that's a good question. Let me answer your second question, it's easier. So for our assets in the clinic, we do have a, you know, very differentiated priority. And orelabrutinib is our, you know, cornerstone commercial product. We are putting quite a bit of resource in China, in global for the studies. And also tafasitamab, yeah, we are launching, we are launching pretty soon. In addition to that, we are really think, you know, the asset of bringing really big return, we are thinking is for hematology, is BCL-2 inhibitor, since that's excellent safety profile and it's a potential for broad indication, either alone or by combo, like AML globally, there's huge unmet medical needs. If our asset is better than venetoclax, and we do get, you know, the AML potentially global presence. So we work, that will be one of our top priority. In addition, the autoimmune disease, orelabrutinib, we put a lot of effort, ITP, and that will be our first indication going through the autoimmune disease. If we build a commercial team, that will be based on that approval time. Also SLE, this is a, you know, huge indication. Globally, we are the first and only BTK inhibitor showing excellent efficacy in multiple parameters of SLE. So we're really excited about it. So that's where we are going to put a higher priority. That will be big indication to pursue in our autoimmune disease and also, you know, help a lot of people for SLE, the small molecule to provide advantage of using it, perhaps safer. And in addition, our two TYK2 inhibitors, 332, already demonstrated excellent efficacy and the primary safety in the large indication like AD, and we are pursuing, you know, multiple large indications. So, so that will be our... In terms of importance for our commercial, the orelabrutinib will be 248, will be 332, and 488. And we do have great confidence, and those are, you know, those are maybe best in class compound on a target with a number of first in class of indications and the large indications. For China, definitely we are going to, you know, develop all those indications. Like for global, like you say, autoimmune disease is very expensive. We do a lot of phase 3s. It does cost a lot of money. So for autoimmune disease, we have a strategy that we like to, you know, either out-license in the compound or some of the compound, or, or actually prefer, uh, prefer with from co-development partner, so to give us potential for the global income revenue. So this where for autoimmune disease. For oncology, you know, we're tied together, orelabrutinib and 248. And, you know, these two together can cover really well for, for the, liquid cancer, for, hematology oncology, field. And, and then, we will see, either, you know, we can co-develop them, or, or maybe, if we do a BD deal, we really need a really good deal to out-license them. And that's our current thought. We are developing them ourselves meanwhile. If we get better data, more data, and definitely, you know, we can get better return even by, out-licensing. So, Ziyi, do I answer your question? And, for the near term, of, our asset priority? Yeah, that's clear. Thank you. So for the preclinical, you know, we have a very powerful, you know, discovery side, internal discovery. We focus a lot on autoimmune disease. Like you see, IL-17 is just, just, you know, the ice just showing above the water. We still have a lot of other mechanisms in pursuit, this small molecule with cytokines and etc. And also, we have antibody approaches for autoimmune diseases. So that will still continuously, systematically covering different MOAs, covering different large indications. Our inspiration is next few years, we can have 15 large indications covered by our autoimmune disease, so we're developing more assets. And for the solid tumor, we think, you know, we have opportunities, really, a few opportunities, such as our first in class, SHP2. And it's excellent molecule with very safety profile. It's unbelievably safe and narrow band. You may wonder whether it's a SHP2 inhibitor, so it's very good. And then the combo with EGFR, third generation EGFR, furmonertinib, so, and then we are going to get open a huge field that will put a lot of resource. Meanwhile, we are waiting for the POC. Once we reach POC, and if it works, that will be huge for solid tumor, and not just for non-small cell lung cancer and also for others, and on other combos. And meanwhile, we are developing platform in our hand. We like to get assets that can get, can be really useful, what I said useful, so as a tumor, you really prolong the PFS, the OS by, you know, by years, not by a couple of months. So we think that that's worth our effort. So we try to get different MOA combo with targeted therapy, immunotherapy in the, in the same, again, in the same drug or with the combo, and to get prolonged effect for the solid tumor. That's our... actually, we're doing a lot of research on that. Got it. That's really good to know. You have explained it very clearly about your early stage discovery efforts. I think we don't see any more questions. I guess you pretty much cover all the major stuff, including very detailed data in the presentation already, and also your answers to our questions. So I think to close the call, any wrap-up comments from you, Jasmine? Yeah, it is late. It's already beyond one hour. Thank you so much, Ziyi, for moderate this session. Thank you all for attending our presentation today, and also thank you for your support. Look forward to see you all face face to face. Thank you, Ziyi. Thank you. Thank you everyone for joining today's call. We're gonna wrap up call here. Have a good day. Thank you.