Ascentage Pharma Group International (6855) Earnings Call Transcript & Summary

Good day, and welcome to the Ascentage Pharma Year-end 2024 Conference Call. [Operator Instructions] As a reminder, this call will be recorded. I would now like to introduce your host for today's conference call, Hogan Wan, Head of Investor Relations and Strategy. You may begin.

Thank you, operator. Good morning, and welcome to today's call. As a reminder, the company's remarks today correspond with the earnings release that was issued before market opened today. In addition, a recording of today's call and the PowerPoint presentation will be made available on the Ascentage website within the Investor Relations section shortly following the conclusion of this call. As part of today's call, I will go over some of the safe harbor statements. We will be making certain forward-looking statements based on our current expectations. These statements are subject to numerous risks and uncertainties that may cause actual results to differ materially from what we expect due to a variety of factors, including those discussed in our SEC filings, including our earnings release furnished with the SEC on March 27, 2025. Should any of these risks materialize that assumptions may be proven to be incorrect and actual results may vary from what was mentioned in the forward-looking statements. On today's call, I'm joined by Dr. Dajun Yang, Chairman and Chief Executive Officer, who is going to provide an overview of recent developments and performance for the full year 2024, followed by a Q&A session. During the Q&A session, the team will be joined by Dr. Yifan Zhai, Chief Medical Officer; Dr. Xiaomen Wang, Co-Founder, Chief Scientific Adviser; Dr. Ji Chao Su, Head of Commercial; and Mr. Jing Chao, Head of Finance. With that, I will now turn the line over to Dr. Yang.

Thank you, Horgan. Hello, everyone. I'm Dr. Dajun Yang, CEO and Chairman of Ascentage Pharma. Thank you for joining us today for Ascentage Pharma's 2024 Full Year Results and business update. 2024 was a transformational year for Ascentage Pharma. We are further derisked going global and capitalized. With our 2 lead molecules, olverembatinib and Lisaftoclax in commercial stage and late-stage clinical development, we have established ourselves as a global leading player in hematological oncology. For these 2 products, we have completed or are conducting 11 registrational trials globally, including 2 that are FDA cleared targeting 6 disease. Olverembatinib has been approved in China for commercialization since 2021. We are conducting an FDA-cleared registration trial for CML as well as global registration trials for PH-positive ALL and GST. This has its NDA accepted by the CD and the priority review in 2024. We are conducting an FDA-cleared registrational Phase III trial for CLL as well as the global registrational trials for AML and MDS. On the business front, in June 2024, we entered into an option agreement with Takeda for Olverembatinib ex-China global rights with $100 million option payment. At the same time, Takeda also made an equity investment of $75 million, become our second largest shareholder after founders. In addition to the option agreement we already received, we are eligible to be paid an option excise fee and a certain milestone with payment up to approximately $1.2 billion in the aggregate as well as royalties in the range equal to 12% to 19% of net sales. This partnership once again validate Olverembatinib's therapeutic potential for global market. We believe Takeda with its global sales and marketing infrastructure and expertise in CML and AL will be an ideal commercialization partner when they exercise the option. We have significant strength of our balance sheet. In January 2025, we were successfully listed on NASDAQ, raising net $132.5 million. Our cash balance supported by future sales and other expected payments is sufficient to support us through 2027. In 2024, we achieved impressive growth in both total revenue and Olverembatinib sales, and total revenue reached USD 134 million, representing a remarkable 342% increase compared to 2023. This outstanding growth was primarily driven by the option payment from Takeda and also substantial sales growth of Olverembatinib. The sales of Olverembatinib primarily in China increased 52% year-over-year to USD 33 million. Notably, in the second half of 2024, Olverembatinib sales increased 149% year-over-year to USD 18 million. We expect sales of Olverembatinib in China will continue growth significantly by multiple tailwinds. Since the beginning of 2025, all approved indications are covered by China NRDL, further improving affordability, accessibility for patients. In 2024, the number of hospitals Olverembatinib on formulary increased by 86%, expanding dramatically to patient access. Since the launch in 2021, we have a growing potential patient base using the drug. The expanded patient population on treatment and the long treatment duration will further drive the sales. As we continue to execute the first-line POLARIS-1 trial for PH-positive ALL, we also expect Olverembatinib to become important treatment option for PH-positive ALL in China and Asian countries. We are encouraged by the fact that CD also granted Olverembatinib breakthrough therapy designation, BTD, for PH-positive ALL earlier this month. In 2024, we continue to exercise prudent expense management to ensure long-term sustainable growth. Our R&D expenses totaled about $130 million. We managed to keep the increase in the R&D spending under control even as we have launched multiple global registration trials. Despite the 52% increase in Olverembatinib sales, selling and distribution costs remained stable, indicating our improved sales efficiency. As a result of higher revenue and effective expense control, our net loss narrowed significantly to USD 56 million. We are really well capitalized with visibility into additional near-term cash flow. As of December 31, 2024, we had more than $170 million in the bank cash. And also, we raised another $132.5 million in net proceeds through our successful NASDAQ IPO. As mentioned, our cash balance is further supported by cash flow from revenue, sales, milestone payments and potential option exercise fee from Takeda. As in the past, we have been presenting at major international conferences such as ASH, AACR, ASCO, EHA and ESMO. In 2024, we have more than 30 publications Olverembatinib was featured in an oral report at ASH for 7 years in a row this year presenting data on second-line CML. We also made an oral report on Lisaftoclax for multiple myeloma at ASH. Notably, the findings of Olverembatinib have been published on JAMA Oncology, recognize Olverembatinib's unique potential in heavily pretreated patients with CML and PH-pos AL. Olverembatinib was also included in the 2024 NCCN guideline for CML management. In addition to Olverembatinib and Lisaftoclax, we have 4 other novel compounds in the pipeline. APG2449 is a novel orally active small molecule FAK ALK and ROS1 triple kinase inhibitor. We are conducting 2 Phase III registrational trials in ALK-positive non-small cell lung cancer patients. APG115 is a novel orally bioavailable, highly selective small molecule MDM2 inhibitor in multiple Phase II development. FDA have granted 6 ODDs for APG115 as well as 2 rare pediatric disease designation, RPDD. APG-1252 is a novel, highly potent dual BCL-2XL inhibitor in multiple Phase II development for various cancers. ABG-5918 is a potent already active, highly selective ED inhibitor being investigated for anemia and oncology. An abstract recently accepted for this year's AACR demonstrated potent activity in the preclinical prostate cancer models, while also conducting Phase I trial in anemia patients. We are currently conducting 3 registration trials on Olverembatinib, including POLARIS-2, an FDA-cleared Phase III registration trial as a monotherapy for CML. POLARIS-1 is for the first-line treatment PH-positive ALL, if approved, expected to become the first TKI for first-line PH-positive ALL. We're also encouraged by the news that CD granted Olverembatinib breakthrough designation for PH-positive ALL early this month. This is the third BTD we received for Olverembatinib. POLARIS-2 is a monotherapy for SDH deficient GIST. Olverembatinib is differentiated from other BCI inhibitor with a favorable safety profile efficacy. In the preclinical study, we have demonstrated potent activities against broad mutations, including compound mutations. Olverembatinib has also demonstrated favorable clinical benefit in heavily pretreated patients, particularly ponatinib Olverembatinib failed patients as well as those harboring T315I mutations. Long-term safety has also been demonstrated in a 5-year follow-up. At ASH 2024, we presented data for second-line therapy in CML CP patients, majority of which received second-generation TKI as first-line treatment. 74% and 41% patients achieved CCYR and MMR, respectively. No new safety signals emerged as compared with those previously reported and no AOE and VTE were reported. The subgroup analysis showed in patients who had been treated with second-generation TKI in the first-line setting, Olverembatinib demonstrated CCR rate of 78.9% and MMR rate of 43.5% with efficacy improved over time. In patients who have BCRA mutations, CCR was even higher, 85.7% and the MMR rate was 55.6%. This data added to our confidence that Olverembatinib may be a viable second-line treatment option for patients with CPCML, especially for those failing on the first-line second-gen TKIs. Olverembatinib clinical benefit, particularly in overcoming ponatinib and asciminib resistance was published on JAMA Oncology last November. In a trial lead by Dr. Jabu from MD Anderson, Olverembatinib was investigated in heavily pretreated patients. Among those patients, about 30% had a T315 mutation, 52% had received more than 4 TKIs. 50% were ponatinib pretreated and 27% Asciminib pretreated. Olverembatinib was well tolerated. The median treatment duration for the CMLCP was 48 weeks and the longest treatment reached more than 3 years. Olverembatinib shows strong antid-ukemia activity regardless of mutation status and prior treatment with ponatinib or Asciminib. All patient groups, including T305 mutants and ponatinib and Asciminib patients demonstrated more than 50% in CCYR and more than 30% in MMR as a single agent. Even CML patients who failed both ponatinib and Asciminib still benefit from single treatment of Olverembatinib. Olverembatinib also demonstrated favorable activity and tolerability in PH-positive AL patients. At 2024 ASH, Olverembatinib combination with Lisaftoclax synergistically demonstrated promising clinical benefit as a chemo-free regimen for children with RR PH-positive ALL. 5 out of 6 patients achieved a CR rate at the end of combination therapy and 4 patients achieved MRD activity rate. This is a fixed duration 6 weeks only treatment. Olverembatinib in combination with low-intensity chemo or [indiscernible] also demonstrated deep and strong response. Patients were able to achieve 100% ORR or CMR in as quickly as 2 weeks. With those real-world data, Olverembatinib will potentially offer a chemo-free and transplant-free treatment option, revolutionize the treatment paradigm of ALL patients. We expect to achieve the following near-term milestones for Olverembatinib. We'll continue enrollment for our 3 registration Phase III trials, including POLARIS-2 for CML, POLRIS-1 for first-line PH-positive ALL and POLARS-3 for SDH-deficient GIST. We will seek clearance from FDA to initiate registration trial for first-line PH-positive ALL in the U.S. We anticipate exercise of option agreement with Takeda. Moving to our second lead asset, Lisaftoclax, APG-2575. In addition to the pivotal Phase II trial for which we have submitted NDA, we are currently conducting an FDA-regulated registration trial, GLORA, the Lisaftoclax in combination with BTK inhibitors for patients with CLL or SLL previously treated with BTK inhibitors. In addition, we are also pursuing approval of Lisaftoclax in combination with acalabrutinib as a frontline treatment for CSL in a Phase III registration trial or GLORA-2. We're also evaluating Lisaftoclax in combination with aza in 2 registration Phase III trial, GLORA-3 and GLORA-4 as a frontline treatment of elderly or unfit it AML and high-risk MDS. Other clinical trial Lisaftoclax are ongoing for multiple myeloma and other hematological malignancies. As a key differentiation versus other BCL-2 inhibitors, Lisaftoclax has a patient-friendly daily dosing up design from the beginning. Patients undergo daily dosing up for up to only 5 days, 20 milligram on day 1, 50 milligram on day 2 and then up to 400 milligram on day 5. No BTK inhibitor leader in is required for debulking. This dosing up schedule has not resulted in PLS. The innovative dosing up schedule differentiated from Lisaftoclax other BCL-2 inhibitor in the development or on the market, which all require weekly dosing up for 5 to 7 weeks. The daily dose run-up is more convenient for health care professionals and friendly for patients because our therapeutic dose can achieve earlier, especially combination setting as well. Through clinical validation, Lisaftoclax shows clinical benefit and well tolerated with a uniquely dose schedule. Clinical activity was shown in patients who progress on [indiscernible] and BTK-resistant patients. Because of a shorter TAB, it has really good tolerability with low incidence of neutropenia, thrombocytopenia and infections. More importantly, there's no drug-drug interaction observed with any BTK inhibitor and other therapeutic agents such as antifungal or antibiotic drugs. In RRCL patients, Lisaftoclax demonstrated favorable clinical benefit and tolerability profile as a single agent and in combination therapies. The combination of Lisaftoclax and acalabrutinib was active in treatment-naive patients and RRCL patients with ORR of 98%. For the 14 patients with prior Lisaftoclax exposure, the combination resulted in 86% ORR. And in this updated analysis with longer follow-up up to 22.3 months, no DDI and no safety findings were observed. In combination with aza in AML, Lisaftoclax demonstrated clinical meaningful ORR and tolerabilities in patients. In 33 evaluable patients with RR/AML, ORR and CRC rate were 72.7% and 45.5%, respectively. Among the 39 elderly unfit patients with newly diagnosed AML, ORR and CRC rate were 64% and 51%, respectively. Similarly, the first class showed favorable safety profile with no TRS reported and no early mortalities. As reported in 2024 ASH, Lisaftoclax combined with aza has a potential to effective deeper and more durable response in MDS patients. Meaningful ORR and a favorable tolerability profile were also observed in treatment-naive MDS. In 23 patients with treatment-naive MDS treated with Lisaftoclax and aza, the OR rate was 73.9% and the CR rate was 30%. There's no 30-day mortality, very few dose reductions and a comparatively low infection rate, no tumorliized syndrome were reported. With this result, we are confident about the clinical benefit that Lisaftoclax could bring to the MDS patients who do not currently have targeted therapies. Lisaftoclax could be the first BCL-2 inhibitor for patients with MDS. In an oral presentation at ASH 2024, Lisaftoclax together with [indiscernible] show clinical benefit in RRMM and amyloidosis patients regardless they used anti-38 antibody before. This was an oral presentation at ASH last year. The combination of Lisaftoclax and [indiscernible] resulted in an ORR of more than 60% in all RRMM patients and those pretreated with anti-CD38 antibody. The median PFS were very impressive, about 9.7 months for those patients. There were no observed DDI and limited hematological side effects. Lisaftoclax may be able to overcome the challenges [indiscernible] faced in MM. We are exploring registration trial for MM. Lisaftoclax also has the potential to combine with our other targeted products. In preclinical models, Lisaftoclax combination with our MDM2 P53 inhibitor, 115 has demonstrated synergistic effect in AML with potential to overcome Class resistance. Mechanistically, MDM2 inhibitor could also prime cancer cells to BCL-2 induced cellular apoptosis by downregulating other anti-apoptotic proteins such as BCL-XL and MCL1. Another preclinical study suggests Olverembatinib and Lisaftoclax may have a synergistic effect. Olverembatinib downregulate MCL1 and potently induce apoptosis and inhibit FLT3 in this model. demonstrated again, really synergistic effect in the AML models. We expect to achieve the following near-term milestone for Lisaftoclax. We plan to launch in China for RR-CLL in 2025. We will continue enrollment for 4 registrational trials, namely GLORA trial for BTK treated CLLSL patients, GLORA-2 for first-line CLL, GLORA-3 for first-line AML and GLORA-4 for first-line MDS. And we will seek clearance from FDA to initiate registration trial in U.S. for first-line MDS. Moving to our other pipeline product. APG-2449 tri-kinase inhibitor, including targeting ALK, FAK and ROS1 is being evalued in 2 Phase III registration trial for the first-line ALK-positive non-small cell lung cancer patients and also ALK-positive non-small cell lung cancer patients who are resistant and/or intolerant of a second-generation ALK inhibitor. Our APG-1252, a dual BL-2XL inhibitor is being investigated for various solid tumors and lymphoma. For APG-115, we are conducting clinical studies in various solid tumors, showing preliminary clinical benefit in ACC and rare pediatric tumor MPNST. And we have previously mentioned it may have potential synergistic effect with [indiscernible] on AML patients. Our EED inhibitor, APG-5918 show potent antitumor activity and also have potential for treating various kinds of anemia. APG-2449 is potentially the first ALK FAKROS1 triple kinase inhibitor globally. There are 2 Phase III registration trial of 2449, first-line ALK-positive non-small cell lung cancer patients and also ALK-positive non-small cell lung cancer patients who are resistant or intolerant of a second-generation ALK inhibitor. We are also conducting clinical trials for ovarian cancer, Phase II and AML. At ASCO 2024, updated data demonstrated that APG2449 efficacy in patients with non-small cell lung cancer, both treatment-naive and resistant to second-generation ALK inhibitor, especially in brain metastases, 68% and 78% ORR in patients with ROS1 positive and ALK treatment-naive non-small cell lung cancer, respectively. 45% of non-small cell lung cancer resistant to second-generation ALK inhibitor achieved a PR. In patients who had brain metastases, 75% achieved intracranial ORR -- at the same time, no significant CNS toxicity was noted, which may set APG-2449 apart from other third-generation ALK inhibitor such as [indiscernible]. APG-115 is a novel orally active, highly selective small molecule inhibitor of MDM2PV3. We believe this may have potential to treat a number of rare and orphan disease and address unmet medical needs globally. Compared with adult tumors, pediatric solid tumors are characterized by low PV3 mutations and high MDM2 amplification. Today, FDA has granted 6 ODDs and 2 rare pediatric disease designation or RPDD for APG-115. We have plan to discuss with regulatory authorities and explore global registration trial for malignant peripheral nerve cell tumors or MPNST and also ACC adenoid cystic carcinoma for which there's no current effective treatment, and we have demonstrated preliminary Phase II results in clinical studies. [indiscernible] or APG-1252 is a novel highly potent dual BCL-2 XL inhibitor. As of today, we have treated more than 200 patients across many clinical trials. We are currently evaluating 1252 in 2 Phase Ib trials and 1 Phase Ib/II trials in patients with non-small cell lung cancer, neuroendocrine tumor and lymphoma. ABG5918 is an orally bioavailable small molecule allosteric EED inhibitor. It has demonstrated potent in vitro and in vivo activity in many cancer cell line models. At ASH 2024, data from a preclinical study demonstrated that APG-5918 has robust antitumor activity in T-cell lymphoma. And in AACR 2025, the abstract have accepted to demonstrate in combination with AR antagonist show very potent antitumor activity and synergistic effect in prostate cancer models. APG-5918 has also demonstrated potential for treating patients with anemia, including beta thalassemia, sickle cell anemia and CKD anemia, the renal anemia and/or chemo-induced anemia. We are conducting Phase I trial and moving into the patients with anemia. We also continue to discover, develop our next-generation pipeline products, in particularly continued collaboration with our co-Founder, Dr. Shimon Weng Lab at the University of Michigan. We have several targeted protein degraders in preclinical evaluation. Compared with the traditional small molecule inhibitor, the degrader may have potential advantage targeting those undruggable proteins and can also overcome certain drug resistance of existing small molecule inhibitors. Today, we have identified and tested very potent degrader for PV3MDM2 pathway and also targeting the BCL-XL protein. We anticipate to move those preclinical assets into clinical studies soon. We have accomplished a lot today. We have 3 molecules in commercial stage or Phase III registration trial, 2 of which were FDA cleared, targeting a wide range of disease and truly address unmet medical needs globally. We have built corporate infrastructure from manufacturing and commercial organization to bring those drugs to patients globally. Our global ambition is supported by our agreement with Takeda as well as a well-funded balance sheet. We are very excited about the future of Ascentage Pharma and the opportunities ahead with multiple near-term milestones to come. Thank you all, and now open for questions.

[Operator Instructions] Now we're going to take our first question. And it comes from the line of Brian Chen from JPMorgan.

Dr. Yang, maybe just first, could you discuss how you think about the outlook Olverembatinib sales in 2025? What are some of the key dynamics in sales that investors should look for? And also just any color on how much NRDL inclusion late last year added to the bottom line?

Thank you, Brian, for a very good question. So as you know, the -- our Olverembatinib in China received the full clinical approval in the end of 2021 -- or 2023. And that patient population are those who fail and/or intolerant to TKI. This is really different than the mutation-only patient we received conditional approval from 2021. So I think the estimate of patient number with these -- with this new improved expanded label are more than at least 4 to 5x higher than the T315 mutation only patient population. So that's very, very important because those are 2 TKI resistant and/or intolerant patient population. Second, we also received with a simplified procedure of NRDL coverage in December last year. So the -- all the 3 labels for the CML patients in China are now covered by the NRDL. So I think this will dramatically increase our patient accessibility and persistent use of this new and effective drug for CML patients in China. So we are really excited to see actually our first quarter, almost to the end right now in March, the patient, especially the new patients of CML dramatically increased over the previous because for those CML patients in China, especially those chronic patients, the price are very sensitive to them, right? So the NRDL coverage average overall in China will reimburse 2/3 of their monthly cost. And for certain regions, the cities, the reimbursement can up to 80% or 90%. So that's a really important help for the CML patients in China. So we are very confident this year's sales of Olverembatinib in China will dramatically increase over the previous years based on the patient population and also really good coverage of NRDL.

Okay. And then maybe just a quick follow-up. Just looking at the upcoming AACR abstract, I think you have a couple of abstracts there. Can you give us a highlight on what we should look for there?

Yes. We are very excited that we have 5 abstracts accepted this year's AACR meeting. I think the -- of course, the AACR is mostly focused on the preclinical. And so we have the very excitement in terms of how our clinical program is in the Olverembatinib combination with our BCL-2 selective inhibitor, LSC, APG-2575 to overcome the venetoclax resistance in the preclinical model of AML. As we all know that venetoclax has been used widely in AML become kind of SC now. But at the same time, patients also emerged who failed or become resistant to venetoclax. So I think clinically, this is very important, meaningful to have a strategy to overcome then failed patients, especially in the AML. So I think we're very excited to see the further demonstration, especially we have the 2 targeted orally active agent, Olverembatinib and Lisaftoclax. This is also further supported by our last year ASH meeting reported in the pediatric patient population, ALL, we already have clinical combination data Olverembatinib with Lisaftoclax. I think that this is even though it's preclinical, but really consistent with the notion of these 2 orally active agent, especially in the setting to overcome the resistance. We also have multiple other novel compounds, including the EED inhibitor, APG-5918 demonstrate activity in the preclinical, but a very exciting area, the prostate cancer model. I think that's also exciting -- expanding the potential use of ED inhibitor in addition to the lymphoma or heme indications. I think this is something we're looking forward to move into the clinical setting later. Of course, we also have the preclinical new compounds emerge like the orally active IAP inhibitor, potentially moving into the clinical later. I think basically, we are very excited that we have 5 abstracts accepted at AACR. We're looking forward to have more interactions, collaborations and hopefully moving those preclinical studies into more clinical stage. Thank you. There are no further questions.

[Operator Instructions] I would now like to hand the conference over to your speaker, Jun Yang for any closing remarks.

Thank you all for joining our annual report. We have made a tremendous progress in all fronts, commercialization of Olverembatinib in China with expanded indications and a good coverage of NRDL and also very excited about all the clinical development program, especially the Phase III registration trial in Olverembatinib. Last year, particularly about a year ago this time, cleared by FDA for the POLARIS-2, the registration trial for the CML with a single-agent Olverembatinib. And also, we made a very exciting the NDA application acceptance by CDE, also priority review. And of course, we also have solid tumor program with ABG-2449 registration trial cleared by CDE. I think you can see last year; we are really excited with all these late-stage important registration trial moving forward in multiple countries in the global setting. But at the same time, very, very important, excited as we call the transformational year for us is the entered agreement, the global partnership agreement with Takeda with Olverembatinib -- at the same time, we decided to proceed and successfully filed with the SEC for NASDAQ IPO and complete the very successful IPO in January this year. I think overall, we call this is really exciting and also transformational year, allow us to move in -- really moving this globally leading late-stage asset into the global development and commercialization stage. And we're looking forward to have more interactions, collaborations, both in U.S. and Europe and China and looking forward to bring the best and potentially effective and safe drug to the patients with unmet medical need globally. at the same time, create value for our shareholders and have a good return for all the investors. And we're looking forward to working with you all. And thank you again for joining us today, and thank you for all those online participating in our today's call.

Thank you so much for your remarks. So just wanted to let you know we have just a last question came through. And if you don't mind, we will just take it. No problem.

And the question comes from the line of Bin Zhou from...

So congratulation on the good results. And I have 2 small questions. So first one is about the Lisaftoclax. So very glad to see the encouraging progress. I think we can get approval in China later this year. So my question is about the commercialization. So we will do it by ourselves or some partners for the commercialization in China for this product.

Should I answer now or wait for the second question also?

Yes. Maybe I will ask later for the second question.

Okay. Yes. I think this is a very important question. As Ascentage, we -- at least in China, we positioned ourselves to be the integrated biopharma company from discovery to the clinical development to manufacturing and commercialization. So about 3, 4 years ago, we established our commercial team in China for Olverembatinib, our first marketed product in China. At the same time, as we were the first time to have a commercial stage product in China, so we also entered the partnership with Inman for the co-development, co-promotion deal structure. So in the last 3 years, we have established our own commercial team for sales and marketing of Olverembatinib in China. I would very happy and proud to say our commercialization team have done a great job, demonstrate very successful commercialization and sales, especially continued growth of Olverembatinib sales in China. So I think the decision for ourselves in China is we plan to commercialize Lisaftoclax in China by ourselves. I think we are confident we have the team. And also in China, the hematological oncology is highly concentrated, focused on the probably top 300 hospitals. And also most of the KOLs, the clinical PIs for those CLL and AML are really concentrated in the larger cities or the AAA hospitals. The estimate of including our own experience, the top 300 hospitals probably can cover up to 80% of market potential for patients in China. So our plan, at least in China, is we're going to commercialize ourselves. We already started actively recruiting the sales experts. We're actually very excited joining me today on our call is the Head of Commercial team for both Olverembatinib and Lisaftoclax, Mr. Dr. Jin Cao , he actually have very vast experience in both CML,CLL as he worked at Novartis, J&J and also participate actively responsible for the -- another BTK inhibitor from the InnoCare a couple of years ago. So now we have a very exciting team and the leadership for commercialization in China for Lisaftoclax. Outside China, we're actively working both clinical development and business development, looking for the potential -- the best partners to work together for commercialization outside China. I hope I answered your question.

Yes. Understood. Very clear. And my second question is about -- could you please tell us how about the patient enrollment progress for the POLRASE-1,2 global trials and when you have the data readout for these studies?

Again, very good question. Maybe I can answer the -- about the POLARIS-2 first. So POLARIS-2 is FDA-cleared global Phase III registration trial with the Olverembatinib monotherapy in the RCT design against bosutinib in a 2:1 ratio. And FDA also gave us a second -- the Part B, the single-arm single agent for those with T3155 mutation only patients, which is about 48. So the Part A, the 2:1 randomized ratio is about 285 patients, 190 in the investigation arm, 95 in the bosutinib control arm. We have actively enrolled patients since last year. And with this global registration trial, of course, you first have to go through the individual countries, regulatory agency. And we already cleared multiple countries in addition to initial FDA clearance. And we have multiple sites through those countries enroll patients. And we're looking forward to have the patients enrolled in the near term. And also the primary endpoint for this particular trial design is the 6 months MMR rate. And hopefully, we can complete the trial soon and then be able to file NDA with FDA after completion of the enrollment and the 6 months of the last patient's MMR analysis. And for POLARIS-1, it was initially cleared by CD in China for the first-line treatment naive PH-positive ALL. I think this is really significant for 2 reasons. First, as you know, in the AL globally, there's no very effective targeted agent. Early days, most patients are treated by imatinib, but that efficacy is not that great. And if you look in the FALCON trial published by Takeda team last year, the control arm, the imatinib in that patient population, the CMR, the 3 months complete molecular response rate is only like 16%, 17%, very low. And ponatinib be able to double that about 33%, 34%. So the FDA gave conditional -- the accelerated approval for ponatinib. So our POLARSO-1 are very excited. In the same patient population, we have a lot of IIT study, many real-world study data report a much higher efficacy rate, and the patient can achieve CMR rate as short as only 2 weeks. And we also have many data in the real world that patients use this as a maintenance therapy even after the transplantation. So I think the POLARIS-1 has also been discussed with the FDA. We're looking forward to have clearance from FDA. At the same time, we are also entering the trials outside China with several countries, regulatory agency clearance. So basically, I think POLARIS-1 will be very significant. This is a first-line PH-positive ALL patient, and we have excellent data in terms of safety, efficacy and the real-world studies in multiple patient population, including those outside China. So I think the -- of course, the last part is POLARIS-3, which is in the real form of the SDH deficient GIST patient population. I think they already actively enroll patients in China. The patient number is small, but at the same time, it may take a little bit while to enroll -- fully enroll those patients because the patient number is small. But again, this is also a very excited trial because those patients with SDH deficient GIST has no effective treatment globally. So I think we are very excited all the POLARIS 1, I and II registration trial, looking forward, especially with FDA cleared POLARIS-2 for the global unmet medical need.

Dear speakers, there are no further questions for today. This concludes today's conference call. Thank you for participating. You may now disconnect. Have a nice day.

Thank you. Thank you all.