Good day, and welcome to the Ascentage Pharma's Year-end 2024 Conference Call. At this time, all participants are in listen-only mode. Later, we will conduct a question-and-answer session, and instructions will follow at that time. 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 the 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'll go over some of the safe harbor statements. We'll 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 filing, 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 statement. 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. Shaomeng Wang, Co-founder, Chief Scientific Advisor, Dr. Zhichao Si, Head of Commercial, and Mr. Jun Cao, Head of Finance. With that, I'll now turn the line over to Dr. Yang.
Thank you, Hogan. 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 have further de-risked, going global and are capitalized. With our two 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 two products, we have completed or are conducting 11 registrational trials globally, including two that are FDA-cleared targeting six diseases. 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 GIST. Lisaftoclax has its NDA accepted by the CDE and a 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 a $100 million up in 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 in an option access fee and a certain milestone with a payment up to approximately $1.2 billion in the aggregate, as well as royalties in the range equal to 12%-19% of net sales. This partnership once again validates olverembatinib's therapeutic potential for global market.
We believe Takeda, with its global sales and marketing infrastructure and its expertise in CML and ALL, will be an ideal commercialization partner when they access the option. We have a significant strength on 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. Total revenue reached US$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 US$33 million.
Notably, in the second half of 2024, olverembatinib sales increased 149% year-over-year to US$18 million. We expect sales of olverembatinib in China will continue to grow 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 houses of 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 Asia countries.
We are encouraged by the fact that CDE also granted olverembatinib Breakthrough Therapy Designation, BTD, for Ph-positive ALL earlier this month. In 2024, we continued 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 our olverembatinib sales, selling and distribution costs remain stable, indicating our improved sales efficiency. As a result of higher revenue and effective expense control, our net loss narrowed significantly to US$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 the potential option access 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 seven 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 pre-treated patients with CML and a Ph-positive ALL. Olverembatinib was also included in the 2024 NCCN guideline for CML management. In addition to olverembatinib and the lisaftoclax, we have four other novel compounds in the pipeline.
APG-2449 is a novel orally active small molecule FAK, ALK, and ROS1 triple kinase inhibitor. We are conducting 2 phase III registration trials in ALK-positive non-small cell lung cancer patients. APG-115 is a novel orally bioavailable, highly selective small molecule MDM2-p53 inhibitor in multiple phase II development. FDA have granted 6 ODDs for APG-115, as well as 2 rare pediatric disease designation, RPDD. APG-1252 is a novel, highly potent dual BCL-2/BCL-xL inhibitor in multiple phase II development for various cancers. APG-5918 is a potent, orally active, highly selective EED inhibitor being investigated for anemia and oncology. An abstract recently accepted for this year's AACR demonstrate potent activity in the preclinical prostate cancer models. We are 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 CDE granted olverembatinib breakthrough designation for Ph-positive ALL early this month. This is the third BTD we receive for olverembatinib. POLARIS-2 is a monotherapy for SDH deficient GIST. Olverembatinib is differentiated from other BCR-ABL inhibitor with 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 pre-treated patients, particularly ponatinib or asciminib-failed patients, as well as those harboring T315I mutations. Long-term safety has also been demonstrated in a five-year follow-up. At the ASH 2024, we presented data for second-line therapy in CP-CML patients, majority of which receive second-generation TKI as first-line treatment. 74% and 41% patient achieve the CCYR and MMR, respectively.
No new safety signals emerge as compared with those previously reported, and no AE and the VTE were reported. The subgroup analysis show in patients who had been treated with second-generation TKI in the first-line setting, olverembatinib demonstrated CCYR rate of 78.9% and MMR rate of 43.5%, with efficacy improved over time. In patient who have BCR-ABL mutations, CCYR 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 CP-CML, 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. Jabbour from MD Anderson, olverembatinib was investigated in heavily pre-treated patients.
Among those patients, about 30% had a T315I mutation, 32% had received more than 4 TKIs, 50% were ponatinib pre-treated, and 27% asciminib pre-treated. Olverembatinib was well-tolerated. The median treatment duration for the CP-CML was 48 weeks, and the longest treatment reached by more than 3 years. Olverembatinib shows strong anti-leukemia activity regardless of mutation status and prior treatment with the ponatinib or asciminib. All patient groups, including T315I mutants and ponatinib and asciminib-resistant patients, demonstrated more than 50% in CCYR and more than 30% in MMR as a single agent. Even CML patient who failed both ponatinib and asciminib can still benefit from single treatment of olverembatinib. Olverembatinib also demonstrate favorable activity and tolerability in Ph-positive ALL patients. At the 2024 ASH, olverembatinib combination with lisaftoclax statistically demonstrate promising clinical benefit as a chemo-free regimen for children with R/R Ph-positive ALL.
5 out of 6 patients achieve a CR rate at the end of a combination therapy. 4 patients achieve the MRD negativity rate. This is a fixed duration, 6 weeks only treatment. Olverembatinib in combination with low-intensity chemo or blinatumomab also demonstrate deep and strong response. Patients were able to achieve 100% ORR or CMR in as quickly as 2 weeks. With this real-world data, olverembatinib will potentially offer a chemo-free and transplant-free treatment option, will revolutionize the treatment paradigm of ALL patients. We expect to achieve the following near-term milestones for olverembatinib. We will continue enrollment for our 3 registration phase III trials, including POLARIS-2 for CML, POLARIS-1 for first-line Ph-positive ALL, and POLARIS-3 for SDH-deficient GIST. We will seek clearance from FDA to initiate registration trial for first-line Ph-positive ALL in 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 registrational trial, GLORA, lisaftoclax in combination with BTK inhibitors for patient with CLL or SLL previously treated with BTK inhibitors. We are also pursuing approval of lisaftoclax in combination with acalabrutinib as a front-line treatment for CLL, SLL in a phase III registrational trial or GLORA-2. We're also evaluating lisaftoclax in combination with azacitidine in 2 registration phase III trial, GLORA-3 and GLORA-4, as a front-line treatment of elderly or unfit 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 dose ramp-up design from the beginning.
Patient undergo daily dose ramp-up for up to only 5 days, 20 milligram on day 1, 50 milligram at day 2, and then up to 400 milligram on day 5. No BTK inhibitor lead-in is required for debulking. This dose ramp-up schedule has not resulted in TLS. The innovative dose ramp-up schedule differentiate from venetoclax, other BCL-2 inhibitor in the development or on the market, which all require weekly dose ramp-up for 5 to 7 weeks. The daily dose ramp-up is more convenient for healthcare professionals and friendly for patients because of therapeutic dose can achieve it earlier, especially combination setting as well. Through clinical validation, lisaftoclax shows clinical benefit and it well tolerated with a unique daily dose ramp-up schedule. Clinical activity was shown in patients who progress on venetoclax and the BTK-resistant patients.
Because of a shorter t1/2, it has a very good tolerability with no instance 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 R/R CLL patients, lisaftoclax demonstrated favorable clinical benefit and tolerability profile as single agent and in combination therapies. The combination of lisaftoclax and acalabrutinib was active in treatment-naive patients and R/R CLL patients with ORR of 98%. For the 14 patients with prior venetoclax exposure, the combination resulted in 86% ORR. In this updated analysis, it was longer follow-up, up to 22.3 months, no DDI, no safety findings were observed. In combination with Aza in AML, lisaftoclax demonstrate clinical meaningful ORR and tolerabilities in patients. In 33 evaluable patients with R/R AML, ORR and CRc rate were 72.7% and 45.5% respectively.
Among the 39 elderly unfit patients with newly diagnosed AML, ORR and the CRc rate were 64% and 51% respectively. Similarly, lisaftoclax show favorable safety profile with no TLS reported and no early mortalities. As reported in 2024 ASH, lisaftoclax combined with Aza has the potential to effective deeper and a 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 ORR 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 Tumor Lysis 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 Pom/dex show clinical benefit in R/R MM and amyloidosis patients, regardless they used the anti-CD38 antibody before. This was an oral presentation at ASH last year. The combination of lisaftoclax and Pom/dex resulted in ORR of more than 60% in all R/R MM patients and those pre-treated 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 venetoclax face in MM. We are exploring registration trial for MM. Lisaftoclax also has potential to combine with our other targeted products. In pre-clinical models, lisaftoclax combination with our MDM2-p53 inhibitor, APG-115, has demonstrated synergistic effect in AML, with potential to overcome venetoclax resistance.
Mechanistically, MDM2 inhibitor could also prime cancer cells to BCL-2 induce the cellular apoptosis by down-regulating other anti-apoptotic protein such as BCL-xL and MCL-1. Another pre-clinical study suggests olverembatinib and lisaftoclax may have a synergistic effect. Olverembatinib down-regulate MCL-1 when the protein induce apoptosis and inhibits for the three in this model. Demonstrate again very synergistic effect in the AML models. We expect to achieve the following near-term milestone for lisaftoclax. We plan to launch in China for R/R CLL in 2025. We will continue enrollment for full registrational trials, namely GLORA trial for BTK-treated CLL/SLL patient, GLORA-2 for first-line CLL, GLORA-3 for first-line AML, and GLORA-4 for first-line MDS. 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, a tri-kinase inhibitor, including targeting ALK, FAK, and ROS1, is being evaluated in two phase III registration trial for the first-line ALK-positive with non-small cell lung cancer patients. 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 BCL-2/BCL-xL 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 the rare pediatric tumor MPNST. We have previously mentioned it may have potential synergistic effect with the resembling class on AML patients. Our EED inhibitor, APG-5918, show potent anti-tumor activity and also have potential for treating various kinds of anemia. APG-2449 is potentially the first ALK, FAK, ROS1 triple kinase inhibitor globally. There are two phase III registration trial of 2449.
First-line ALK-positive non-small cell lung cancer patient and also ALK-positive non-small cell lung cancer patient 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 the ASCO 2024, our positive data demonstrate that APG-2449 efficacy in patient with non-small cell lung cancer, both treatment-naive and resistant to second-generation ALK inhibitor, especially in brain metastasis. 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 achieve the PR. In patients who had brain metastasis, 75% achieve intracranial ORR. At the same time, no significant CNS toxicity was noted, which may set APG-2449 apart from other third-generation ALK inhibitors such as lorlatinib.
APG-115 is a novel, orally active, highly selective small molecule inhibitor of MDM2-p53. We believe this may have potential for 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 TP53 mutations and high MDM2 amplification. Today, FDA has granted six ODDs and two rare pediatric disease designation or RPDD for APG-115. We have a plan to discuss with regulatory authorities and explore global registration trial for malignant peripheral nerve sheath 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. Pelcitoclax, or APG-1252, is a novel, highly potent dual BCL-2 and BCL-xL inhibitor. As of today, we have treated more than 200 patients across many clinical trials.
We are currently evaluating 1252 in two phase I-B trials and one phase I-B/II trials in patient with non-small cell lung cancer, neuroendocrine tumor, and lymphoma. APG-5918 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 the ASH 2024, data from preclinical studies demonstrate that APG-5918 has robust anti-tumor activity in T-cell lymphoma. In AACR 2025, the abstract have accepted to demonstrate in combination with AR antagonists, show very potent anti-tumor 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 all chemo-induced anemia. We are conducting phase I trial and moving into the patients with anemia. We are also continue to discover, develop our next generation pipeline products.
In particular, continue collaboration with our co-founder, Dr. Shaomeng Wang's lab at the University of Michigan. We have several targeted protein degraders in pre-clinical 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 p53/MDM2 pathway and also targeting the BCL-XL protein. We anticipate to move those pre-clinical assets into clinical studies soon. We have accomplished a lot today. We have three molecules in commercial stage or phase III registration trial, two 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 the 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 really excited about the future of Ascentage Pharma and the opportunities ahead with multiple near-term milestones to come. Thank you all. Now open for questions.
Thank you. Dear participants, as a reminder, if you wish to ask a question, please press star one one on your telephone keypad and wait for a name to be announced. To withdraw a question, please press star one one again. Please stand by, we'll compile the Q&A roster. This will take a few moments. Now we're going to take our first question. It comes to the line of Brian Chen from JP Morgan. Your line is open. Please ask your question.
Great. Thanks for taking our questions this morning. Dr. Yang, maybe just first, could you discuss how you think about the outlook of olverembatinib sales in 2025? What are some of the key dynamics in sales that investors should look for? Also, just any color on how much NRDL's inclusion late last year added to the bottom line. Thank you.
Thank you, Brian, for a very good question. As you know, our olverembatinib in China, received the full clinical approval in the end of 2021 or 2023. That patient population are those who fail and/or intolerant to TKI. This is really different than the mutation-only patient will receive a conditional approval from 2021. I think that the estimate of a patient number with this new, improved, expanded label are more than at least four to five times higher than the T315 mutation-only patient population. That's very, very important because those are two TKI-resistant and/or intolerant patient population. Second, we also received with a simplified procedure of NRDL coverage in December last year. All the three labels for the CML patient in China are now covered by the NRDL.
I think that this will dramatically increase our patient accessibility and a persistent use of this new and effective drug for CML patients in China. We are really excited to see actually our first quarter, almost to the end right now is March. The patient, especially new patient 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? The NRDL coverage averages all in China will reimburse two-thirds of their monthly cost. For certain regions or the cities, the reimbursement can up to 80% or 90%. That's a really important help for the CML patients in China. 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.
Thank you.
Okay. Maybe just a quick follow-up. Just looking at the upcoming AACR abstracts. I think you have a couple abstracts there. Can you give us a highlight on what we should look for there?
Yeah. We are very excited that we have five abstracts accepted this year's AACR meeting. Of course, the AACR is mostly focused on the preclinical. We have the very excitement in terms of how our clinical program is in the olverembatinib combination with our BCL-2 selective inhibitor, the lisaftoclax, 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 SOC now. At the same time, patient also emerged who failed or become resistant to venetoclax. As clinically, this is very important, meaningful to have a strategy to overcome then failed patients, especially in the AML. I think we're very excited to see the further demonstration, especially we have the two targeted orally active agent, olverembatinib and the lisaftoclax.
This is also further support by our last year ASH meeting report in the pediatric patient population, ALL, we already have clinical combination data olverembatinib with lisaftoclax. I think that even though this is preclinical, it's really consistent with the notion of these two orally active agents, especially in the setting to overcome the venetoclax resistance. We also have multiple other novel compounds, including the EED inhibitor, APG-5918, demonstrate activity in the preclinical, a very exciting area, the prostate cancer model. I think that's also exciting, expanding the potential use of EED inhibitor in addition to the lymphoma or HEM 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. We're potentially moving into the clinical later.
I think that basically we are very excited that we have five abstracts accepted at the AACR. We're looking forward to have more interactions, collaborations, and hopefully moving those preclinical studies into more clinical stage. Thank you.
Great. Thank you.
Thank you. Dear participants, as a reminder, if you wish to ask a question, please press star one one on your telephone keypad and wait for your name to be announced. Dear speakers, we'll just give a moment to our participants to press star one one if they wish to ask a question. There are no further questions. I would now like to hand the conference over to speaker, Dajun 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. 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 was a single agent olverembatinib. Also, we made a very exciting, the NDA application acceptance by CDE, also priority review. Of course, we also have solid tumor program, with the APG-2449 registration trial cleared by CDE. I think that you can see last year we are really excited with all this late stage important registration trial moving forward in multiple countries in the global setting.
At the same time, really important, excited as we call the transformational year for us is the enter the 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 a very successful IPO in January this year. I think overall, we call this a really exciting and also transformational year, allow us to really moving this globally leading late-stage asset into the global development and commercialization stage. We're looking forward to have more interactions, collaborations, both in the 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, we will create a value for our shareholders and have a good return for all the investors.
We're looking forward to working with you all, and thank you again for joining us today, and thank you for all those online participate our today's call.
Dajun, thank you so much for your remarks. Just wanted to let you know we have just a last question come through, and if you don't mind, we will just take it.
No problem. Yeah.
The question comes from Wangbin Zhou from Citi. Line is open. Please ask your question.
Yeah. Thanks management for taking my question. Congratulate on the good results. I have two small questions. First one is about the use of the products. Very glad to see the encouraging progress. I think we can get approval in China later this year. My question is about the commercialization. We will do it by ourselves or seek some partners for the commercialization in China for this product?
Thank you. Very good question.
Yeah.
Should I answer it now or wait for the second question also?
Yeah. Thank you, Doctor. Maybe I will ask later for the second question.
Okay. Yeah. I think that this is a very important question. As Ascentage, at least in China, we position ourself to be the integrated biopharma company from discovery to the clinical development to manufacturing and commercialization. About three, four 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 of product in China, we also entered the partnership with InnoVent for the co-development, co-promotion deal structure. In the last three years, we have established our own commercial team for sales and the marketing of olverembatinib in China. I would be very happy to, 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.
I think that the decision for ourself in China is we plan to commercialize lisaftoclax in China by ourself. I think that we are confident, we have the team, and also in China, the hematological oncology is highly concentrated, focused on the probably top 300 hospitals. Most of the KOLs, the clinical PIs for those CLL and AML are really concentrated in the larger cities or the triple A 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. Our plan, at least in China, is we're going to commercialize ourself. We already started actively recruiting the sales experts. We actually very exciting, joining me today on our call is the head of the commercial team for both olverembatinib and lisaftoclax, Dr. Zhichao Si.
He actually have a very vast experience in both CML, CLL, as he worked at Novartis, J&J, and also participate actively responsible for another BTK inhibitor from the InnoCare a couple years ago. Now we have a very exciting team and leadership for commercialization in China of lisaftoclax. Outside China, we're actively working both the clinical development and the business development, looking for the potential, the best partners, to work together for commercialization outside China. I hope I answer your question.
Yeah. Understood. Very clear. My second question is about, could you please tell us how about the patient enrollment progress for the POLARIS-1, 2, 3 global trials, and when to have the data readouts for these studies? Thank you.
Again, very good question. Maybe I can answer about the POLARIS-2 first. POLARIS-2 is an FDA-cleared global phase III registration trial with the olverembatinib monotherapy in the RCT design against bosutinib in a 2-to-1 ratio. FDA also give us a second, the part B, the single arm, single agent, for those with the T315I mutation-only patient, which is about 48. The part A, the 2-to-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 country's regulatory agency, and we already cleared multiple countries in addition to initial FDA clearance.
We have multiple sites through those countries enroll patients, and we're looking forward to have the patients enrolled in the near term. Also, the primary endpoint for this particular trial design is the 6-month MMR rate. Hopefully, we can complete the trial soon and then be able to file NDA with the FDA after completion of the enrollment and the 6 months of last patient's MMR analysis. For POLARIS-1, is initially cleared by CDE in China for the first-line treatment-naive Ph-positive ALL. I think this is very significant for 2 reasons. First, as you know, in the ALL globally, there's no very effective targeted agent. In early days, most patients are treated by imatinib, but that efficacy is not that great.
If you look in the PhALLCON 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 16%-17%, very low, and ponatinib will be able to double that, about 33%-34%. The FDA gave a conditional accelerated approval for ponatinib. Our POLARIS-1, very excited. In the same patient population, we have a lot of IT study, many real-world study data, report a much higher efficacy rate, and the patient can achieve a CMR rate as short as only 2 weeks. We also have many data in the real world that patients use this as a maintenance therapy even after the transplantation. I think that 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. Basically, I think that POLARIS-1 will be very significant as this is the first-line Ph-positive ALL patient, and we have excellent data in terms of safety, efficacy, and the real-world studies in multiple patient populations, including those outside China. Of course, the last part is the POLARIS-3, which is in the rare form of the GIST, the SDH-deficient GIST patient population. I think we already actively enroll patients in China. The patient number is small, but at the same time, it may take a little bit while to fully enroll those patients because the patient number is small. Again, this is also a very exciting trial because those patients with SDH-deficient GIST has no effective treatment globally.
I think we are very excited of all these POLARIS-1, POLARIS-2, and POLARIS-3, all registration trials, looking forward, especially with FDA-cleared POLARIS-2 for the global unmet medical need.
Okay. Thank you.
Thank you. The speakers have run out of the questions for today. This concludes today's conference call. Thank you for participating. You may now disconnect. Have a nice day.