Good morning, everyone, welcome to the Global Jefferies Healthcare Conference in New York City. My name is Paul Yee, I'm with the Jefferies Investment Banking team. It is my great pleasure to introduce Dr. Dajun Yang, Chairman and CEO, and Dr. Veet Misra, the Chief Financial Officer at Ascentage Pharma Group. Thank you. Do I stand here? You can choose. This one. Maybe I use this for presentation. Okay. Good morning. Thank you, Paul and Jefferies for inviting us for making presentation today. It's my great pleasure to share with you all the progress, the update of Ascentage Pharma. We all just come back from the ASCO, very busy ASCO. This is one slide highlight our current overall company status. The key message here is that we now have two novel products commercialized in China, and actively putting seven molecules into global clinical trials. More importantly, we have over 500 issued patents globally, and we have over 800 staff, about 130 in U.S., and about 20 in Australia, and also more coming in Europe. This is a summary of our pipeline. I think that the key message is that first, these are all world-class innovation. As our mission from day one is to focus on unmet medical need globally and for the global market. As you can see, we have two products already commercialized in China and actively enrolling patients for the Phase III registration trial globally. We consider these a highly de-risked asset. We already market in China, treated thousands of patients since 2021. The lisaftoclax, which just got approved last year, about 10 months on the market in China. A lot of patients with heme malignancies benefit from our BCL-2 selective inhibitor. We are the first one in China. We also have about three novel molecules actively enroll patients in U.S. and globally. Those are MDM2-p53 inhibitors, triple kinase inhibitor, FAK, ALK, ROS1, and also dual BCL-2/BCL-XL inhibitor. All are actively enroll patients in the Phase II stage. If successfully carry out, this could be the first in class because those target, there's no approved product yet globally. We also have two very exciting novel compound in early phase clinical development in U.S., China. The EED inhibitor for the lymphoma and the prostate cancer, and also the BTK degrader. We got a clearance by FDA last year, just two days before Christmas, but we finished that from pre-IND to IND clearance in about eight months. U.S., China approved almost the same time. The CDE approved that IND in January. We actively enroll patients. Let's focus our two lead asset, the lisaftoclax, the BCL-2 selective inhibitor. You may notice that the BCL-2 is located on the mitochondrial. That's one of the most difficult target to develop a small molecule drug. Here's our global registration trial. We have the first one approved in China. That's the single agent after BTK failed CR/SR. I think for that label, we're actually the global first one. In terms of the target, we are the second one to the market after venetoclax. venetoclax was on the market globally for nine years until we made our lisaftoclax to the market. We actually are running four registration trials globally. Two of them are cleared by FDA. That is GLORA and GLORA-4. GLORA is add-on strategy, taking CLL and SLL patients after BTK inhibitor who did not achieve optimal response like a CR. This is actively enrolling. Also the GLORA-4, the high-risk MDS. That is a registration trial cleared by FDA, EMA, and many countries' regulatory agencies. GLORA-2 and GLORA-3 also worth to mention, but at least all I need to say, we are about to finish enrollment for those two. GLORA-2 is actually first-line CLL/SLL patients combo with Acalla fixed duration 18 months versus the chemo immunotherapy just for six months. Also the GLORA-3 is the AML same protocol as venetoclax combo with AZA versus AZA alone. I think you can see we are in very good shape. There are currently two other BCL-2 inhibitor on the market. I just want to highlight some key differentiations. We are the first one from the day one clinical trial design using this daily dosing up. You can see venetoclax was on since 2016, but because of tumor lysis syndrome risk, their approval label is weekly dosing up. Basically take a 20 mg every day for one week, then 50, 100, 200, 400. It takes five weeks for those CLL patients. sonrotoclax just got approved early this year in China. Takes them nine weeks. Okay? But they were able to shorten that. Still 9 dose cohort dosing up. Okay? We are the only one, only three dose strengths, five days to target dose since day one. That is very convenient, especially for the CLL/SLL patients. We do not need to combine with a BTK inhibitor. We offer the optimal response to those patients needed. This is just one slide summarize our registration trial in China. four or five years ago, actually, CDE gave us a high bar, require those RR CLL patients have to fail BTK. 100% of those patients who enter our trial actually failed BTK inhibitor. Was not that easy, it is also during the pandemic. We demonstrate in this really poor baseline patients very good response and also good safety and tolerance. More importantly, this is actually data we first time presented two years ago, oral presentation at ASCO. This is all U.S. data, AML MDS patients. Okay? If you take a look at the AML, especially not just the naive patients, good response, but more importantly, we have a patient who failed venetoclax. That means venetoclax is actually a good drug for the AML patients, become SOC globally. Once the ven failed, there is no other options. We have a response about 31.8%, just Lisa combo with AZA. More importantly, in the MDS patients, naive patients, we have ORR about 80%, CR about 40%. Based on those data and others, FDA cleared us the global phase III registration trial for the high-risk MDS. Last year about this time, AbbVie announced the negative result for VERONA trial. That is important for us because before VERONA trial result release, everybody, all the investigators, investor, the first question always, what happened to VERONA trial? If it is positive, what are you going to do, right? I think we're very happy. We have Dr. Gaziano, the leading expert globally from the MD Anderson Cancer Center. He was the leading PI for VERONA trial, now he's the leading PI for us globally, and also Dr. Xiaojun Wang in China. This is a very interesting, highly unmet medical need globally. We are the only Phase III registrational trial for higher-risk MDS. Okay? You can imagine this is the first-line, not the second-line or third-line patient. First-line patient, unmet medical need, no competition. I think successfully carry out GLORA-4, we plan to file NDA next year. That will define Ascentage to be the global biotech leader, at least for heme malignancies. Also want to highlight the two key differentiation as well. We compare. This is not head-to-head comparison, okay? We try to compare same patient population in the registrational trial. You can see compare venetoclax or sonrotoclax, we have a better safety profile, much less infection, especially for those late-stage patients. The infection is very important. Also we have a much less drug-drug interaction risk. Okay? Sonrotoclax, they will publish the DDI data, but in the drug label released earlier this year, they actually show more DDI risk than ven. Okay? Both are substrate for PGP or BCRP. Even when they combine the BTK inhibitor, they have to reduce the dose. Okay? Most leukemia patients, myeloma, lymphoma, are elderly patients. They're taking lot of drugs, and in the late-stage infection, they all have to taking antifungal drugs. I think the DDI risk for the leukemia or lymphoma patients are really important. I also want to give you a few highlights of the key data of olverembatinib, the third-generation PI3K-ABL inhibitor. Here's the highlight of the overall registrational trial. You can see the first one we already marketed since 2021. We now market not just for mutation patients, also those CML patient without T315 mutation or compound mutations. Also both are under the NRDL coverage. Last year sales, we actually more than doubled the NRDL covered indication CML. Very significant. We also have the POLARIS-2 and POLARIS-1 FDA and EMA-cleared global phase III registrational trial. I want to highlight a few key data. First, this is actually also U.S. data. We have this data initially four years ago, led by Dr. Ali Jabu and Dr. Hagop Kantarjian at MD Anderson Cancer Center. Basically, you can see those are the CML patients in the U.S. Most of them are fourth or fifth-line who failed ponatinib, who failed asciminib, or some patients in the last column who failed both ponatinib and asciminib. Okay? We have one patient who failed seven different treatment for CML, and benefit single agent from olverembatinib. Okay, this is very important data, at least for the patient with CML. As you can see, some of the recent data from Takeda or 11 released at ASH last year. We have this data four years ago. Okay? Because of Project Optimus, FDA said no to the single-agent pivotal Phase II trial. This is also the update of our registrational trial single agent from China. This was released last year at the ASH. The key message is that four-year follow-up of registrational trial, good safety, overall response actually maintained. More importantly, look at the neutropenia or thrombocytopenia. This is bone marrow toxicity. Those are actually given for the CML patient. That's the cancer cells in bone marrow. Once you clear the cancer cells in bone marrow, actually those Grade III or IV thrombocytopenia, neutropenia significantly reduce. At the third year it's less than 10%. This is actually, you see the benefit for the patients, not just on the efficacy, but also reduce those Grade III or IV heme malignancies. We also conducted the second-line treat trials in China. If you look at the data just released last week, really fresh, this is updated data. Single agent for patient overall MMR is close to 50%. If you look at the sub-line analysis, patient in the first line who taken second gen TKI like dasatinib, ponatinib, actually MMR rate is higher. More importantly, if you look at the baseline patient who BCR-ABL less than 10%, our MMR rate is over 70%. I think that in the CML, you have to look at first the base characteristics. The prior treatment and the stage, and also how long they are treated. I think that you cannot just look, oh, someone has a 60% MMR, is better than those 50%. You have to look at the baseline, the mutation status, and because our drug is probably the most potent one against the T315I mutation and the compound mutations among all the TKIs or allosteric inhibitors for the CML. I think another important highlight is in the Ph-positive ALL. This is a part A of our registration trial, POLARIS-1. You can see the best compound for the Ph-positive ALL is actually ponatinib. Based on the PhALLCON trial, they achieve about 34% MRD negative CR rate, double the imatinib, 17%. In the real world, dasatinib is actually widely off-label use, but the MRD CR rate is only about 20+%. We actually achieve 64% in this part A of a registration trial. More importantly, just to highlight one data from the last week, ASCO presentation by Dr. Elias Jabbour. In U.S., we try combo with BLINCYTO for the Ph-positive ALL in this chemo-free regimen. This is the early data, but you can see the CR rate is over 90%, overall inactive rate over 60%. Remember, this is a chemo-free regimen. I think we'll continue enroll more patients, especially the new version sub-Q of BLINCYTO from Amgen. I think I just want to highlight the exciting update in the data we have because this is truly the best in disease for the Ph-positive ALL patient data. A few highlight the pipeline, in the interest of time, maybe just go relatively quick. We have this BTK degrader, actively enroll patients in U.S., China. I think that the first thing is we are not too late in terms of a BTK degrader. Second, we have a best BCL2 inhibitor. We're going to combine once we finish the Phase I component of PK/PD and the safety efficacy on some of the CLL or DLBCL lymphoma. Thirdly, all the BTK inhibitor or degrader, especially degrader now, have also long oncology indications. We're going to actively pursue those. We also have this MDM2-p53 inhibitor. The reason I put that here is this is a slide I really like. You look at the BCL-2 as a cornerstone. A couple of years ago, if you attend the ASH or ASCO, the saying is BCL-2 is a small molecule of a PD-1 because of multiple indications and multiple combinations. We can combine with our olverembatinib and also combine the MDM2-p53 inhibitor being the mechanism of synthetic lethality, and of course, a combo with the BTK degrader. We have many preclinical studies, combo with the MDM2-p53 inhibitor is the synthetic lethality. We have clinical data now demonstrate just last Saturday, the first oral presentation at ASCO. This is actually in the pediatric soft tissue sarcoma patient. You know most of those kids do not have optimal treatment. Sarcoma patients or rhabdomyosarcoma, neuroblastoma, and the Ewing sarcoma are all really poor prognosis. The first time we demonstrate we can combo our MDM2-p53 inhibitor with our BCL-2 inhibitor, lisaftoclax, for the patients with soft tissue sarcoma. In the one case, Ewing sarcoma, we even achieve the CR. This is a chemo-free target agent. That's a really huge benefit for kids with soft tissue sarcoma. We also just the next week will highlight update another indication combo with the olverembatinib and the lisaftoclax for Ph-positive ALL patient in the pediatric setting. This is also like a fixed duration of these two oral active target agent. You can see the response is over 90%. We demonstrate a clinical benefit for pediatric sarcoma, like a PI3K-δ, and the pediatric Ph-positive ALL of olverembatinib and the lisaftoclax. Looking forward this year, we always say Ascentage is probably one of very few. If you look in the China-based one, maybe just another one is BeiGene, that we conduct global Phase III registrational trial. We have two novel compounds, similar to BeiGene, two novel compounds in global Phase III. We're going to achieve all the enrollment early this year or early next year. There are a lot of progress made in our clinical enrollment, and some of them about to finish. Our goal is to finish most of them this year or early next year. Looking for the MMR rate or MMR inactive rate for olverembatinib or CR rate for high-risk MDS. We are looking for filing the NDA sometime next year. I think that's a key year for us this year and the next year. Of course, we're going to advance our pipeline, the EED inhibitor for prostate cancer and the BTK degrader for oncology and the non-oncology. This is probably the last slide. Maybe Veet and I can answer the question using this slide. If you look at our assets here, we highlight the five of them. The first two already commercialized in China, running actively FDA, European Medicines Agency cleared Phase III registrational trial. We're competing with Novartis, AbbVie or BeiGene, and also some of the newcomer, like 11. We demonstrate clinical data in U.S. and the global of the benefit of the differentiation in terms of safety and efficacy. We also have this MDM2-p53 inhibitor, the PI3K-δ inhibitor, the EED inhibitor, and also BTK degrader. I think each one of those, as some of the investor said, could compete with one of the listed company here. This is our global expansion strategy. One key message I want to share is we are in the midst of to be ready for commercialization in the U.S. We are actively looking for chief commercial officer. Of course, at the same time, we're also open flexible for partnership, such as co-development, co-promotion in U.S. I think that if you look forward the Ascentage, by the time hopefully next year will be really different company with the clinical data in the registration trial. Here's our leadership team. We have our CFO here, and we're really happy also have our board member, Debbie here. Our nine board members are really global, and most of them have doctorate degrees or even the four of them have M.D. degrees. We have also a global leadership in our clinical advisory board, which is Dr. Allen Lichter serving as our first Chairman, and also now currently Dr. Kantarjian. Basically, we're very excited. We made a lot of progress in the global clinical development and aiming for the global market for all the patients around the world with unmet medical need. Basically, we have seven product. At least five of them cover most of the heme malignancies. I think we are very excited and happy to answer the questions you may have. Thank you again. So me and maybe Yifan sit here to answer your question. You may have mentioned this, but where are you in terms of sort of building out a sort of a commercial infrastructure in the U.S. and other ex-China? Good question. We are in the middle of hiring chief commercial officer. I think that's the key because you need about 18-24 months to be ready for launching, and he or she will build a team, develop a strategy. I think our goal is to be able, ready, hopefully by the time early 2028 for the commercialization in U.S. The first compound, the first drug would be? I think in terms of our current development timeline, both were about the same time to file NDA, second half of next year. Depend on the regulatory review process. One could slip one quarter or the other. Yeah. Looks like they're about the same timeframe. Right. Okay. Yeah. I forgot to mention our first product, olverembatinib, entered the option agreement with Takeda two years ago. The global commercialization of olverembatinib will be led by Takeda team. Yeah, we essentially have a good idea about the centers we need to essentially, in terms of our launch, where to concentrate on. We started to forecast our U.S. footprint build-out at this point. Yeah. We have currently about 300 commercial team in China. Our goal is to expand that to about 400. That will cover 90% of marketing potential in China. Dajun, it would be helpful if you could elaborate on some of the highlights from this past weekend at ASCO. Okay. Good question. We had a total of six presentations from the company. Three oral presentation cover three novel compounds. As I highlight the slide here, the first one, very exciting to see, is actually the first time we demonstrate combination of MDM2-p53 inhibitor with our BCL-2 selective inhibitor, lisa, especially for those hard-to-treat kids with sarcoma. We achieve even CR in one of Ewing sarcoma patients. Those are chemo-free regimen. It's important for the children. With that data, we're looking for more trials, especially registration trial. The 115, the MDM2-p53 inhibitor, actually received the SPARK Program from CDE in China. That's some kind of accelerated priority review for any pediatric drug development. Second, I think we had two oral presentations with our olverembatinib. The second-line data is very exciting. The consensus from the CML community, the KOL around the world, is that once you have any mutations resistant from the first-line treatment, doesn't matter which generation of TKI or allosteric inhibitor, you want to give this patient the most potent TKI, the drug, to achieve a deeper response, and then achieve a TFR. For the CML patient, it's great we have a very good safety drug the patient can take a long time. The long DOT is one of the important in the drug development for those with leukemia. At the same time, many young CML patients, they may not want to take a drug a lifetime, right? You give them the best possible drug, safe and efficacious early, that's moving to the second line. You can see with those second generation in the first-line treatment, we actually achieve a better, higher MMR rate, and also this with lower BCR-ABL baseline to begin with, we achieve more than 70% MMR rate. I think that's very remarkable. Another one obviously is a combo with BLINCYTO from Dr. Elias Jabbour. He actually is the leading PI for Turns compound 10 to 711. He knows all the BCR-ABL inhibitors or allosteric inhibitors. He really truly believe our drug probably the best one in terms of potency and the safety, and the combo with BLINCYTO offer the chemo-free regimen for the pediatric or the Ph-positive ALL patients. We are very excited. Another one worth to mention in the SDH deficient GIST, this time we actually treated a patient with paraganglioma. Also the SDH deficient patient as well. A lot of clinical progress made. Thank you.