A Randomized Phase II Study of Lisaftoclax Combined with IA (2+5) Regimen versus Standard “3+7” Chemotherapy in Fit Patients with Treatment-Naïve Acute Myeloid Leukemia

Start Date01 Oct 2026

Sponsor / Collaborator

The First Affiliated Hospital of Wenzhou Medical College

NCT07813390

/ Enrolling by invitationPhase 2IIT

A Multi-Center, Prospective, Open-Label, Single-Arm Study of Homoharringtonine Combined With Lisaftoclax and Azacitidine in Patients With Acute Myeloid Leukemia After Failure of Venetoclax-Based Therapy

Venetoclax (Ven) resistance is common in the treatment of acute myeloid leukemia (AML). Patients with Ven resistance have poor response and survival, except those with specific targeted therapy. Whether we could use new BCL-2 inhibitors to replace Ven and combine with the agents which have been shown to enhance the antilekeumia effect of BCL-2 inhibitors, to overcome Ven resistance? This is unknown up until now. This multi-center, prospective, open-label, single-arm study will evaluate the efficacy and safety of homoharringtonine combined with lisaftoclax and azacitidine (HLA) as salvage therapy for adults with AML after failure of a Ven-containing regimen. Ven treatment failure is defined as no response after at least two consecutive cycles of a Ven-containing regimen or relapse during continued, protocol-compliant Ven-based therapy after a prior response. The study plans to enroll 73 participants. The primary endpoint is the overall response rate after two treatment cycles. Secondary endpoints include complete remission (CR), CR with incomplete blood count recovery (CRi), measurable residual disease (MRD) negativity, survival and relapse, and treatment-related adverse events.

Start Date01 Sep 2026

Sponsor / Collaborator

Guangdong General Hospital

[+4]

ChiCTR2600133952

/ SuspendedPhase 2IIT

A Multicenter Phase II Clinical Trial of Sequential, Pulsed Administration of Teriflunomide, Decitabine and Lisaftoclax for Myelodysplastic Neoplasms with TP53 Multi-hit

Start Date01 Sep 2026

Sponsor / Collaborator

Hematology Hospital of Chinese Academy of Medical Sciences

100 Clinical Results associated with Lisaftoclax

100 Translational Medicine associated with Lisaftoclax

100 Patents (Medical) associated with Lisaftoclax

Literatures (Medical) associated with Lisaftoclax

01 Sep 2026·Advanced Science

DHODH Drives Sunitinib Resistance Via a Non‐Enzymatic Mechanism by Inhibiting TRIM28 Ubiquitination and Consequent VEGFA Activation in RCC

Article

Author: Pu, Shihang ; Qian, Shijie ; Xu, Aiming ; Xu, Zhipeng ; Xing, Jiajun ; Jin, Ling ; Xi, Xiaohai ; Ding, Yiheng ; Li, Baochao ; Li, Qi ; Wang, Zengjun

ABSTRACT:

Sunitinib, a tyrosine kinase inhibitor, exerts its crucial therapeutic effect in renal cell carcinoma (RCC) primarily by inhibiting tumor angiogenesis and cellular proliferation. However, despite its initial efficacy, therapeutic resistance invariably develops in many RCC patients, underscoring the urgent need for novel strategies to overcome this limitation. We constructed patient‐derived xenograft (PDX) models using surgically resected RCC tissues and subsequently established stable sunitinib‐resistant and sunitinib‐sensitive PDX models. Proteomic profiling was performed to identify key regulators involved in sunitinib resistance. Mechanistic studies were conducted to investigate the molecular interactions among DHODH, TRIM28, and VEGFA. The therapeutic potential of lisaftoclax was evaluated in combination with sunitinib. Proteomic profiling identified DHODH as a key regulator in the development of sunitinib resistance in RCC. Mechanistically, DHODH competes with the E3 ligase TRIM37 for binding to TRIM28, thereby stabilizing TRIM28 by inhibiting its ubiquitination. TRIM28 subsequently activates VEGFA transcription, which promotes sunitinib resistance in RCC. Lisaftoclax, a small‐molecule inhibitor that disrupts the DHODH‐TRIM28 interaction, potentiates sunitinib efficacy and exerts a synergistic therapeutic effect. Collectively, our findings identify DHODH as a critical therapeutic target for overcoming sunitinib resistance in RCC and provide a novel strategy for the treatment of RCC.

01 Jun 2026·Clinical Lymphoma Myeloma & Leukemia

Phase 1 Trial of BCL-2 Inhibitor Lisaftoclax (APG-2575) in Chinese Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma and Other Non-Hodgkin Lymphomas

Article

Author: Chen, Zi ; Wang, Jianxiang ; Zhou, Keshu ; Yang, Dajun ; Qi, Junyuan ; Huang, Jianying ; Shen, Aizong ; Men, Lichuang ; Geng, Liangquan ; Liu, Huilan ; Sun, Mingyuan ; Cong, Danhua ; Zhang, Ke ; Zhai, Yifan ; Zhou, Fuling ; Lu, Fang

BACKGROUND:

Lisaftoclax is a novel BCL-2 inhibitor. This phase 1 trial (NCT03913949) evaluated the safety and preliminary efficacy of lisaftoclax in Chinese patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and other non-Hodgkin lymphomas (NHL).

PATIENTS AND METHODS:

Lisaftoclax was administered orally in 28-day cycles, targeting daily doses of 20-800 mg for up to 24 cycles, using a daily ramp-up to minimize tumor lysis syndrome (TLS) risk. Patients with previous resistance to a BCL-2 inhibitor or exposure to a BCL-2 inhibitor in the most recent treatment line were excluded. Among 51 enrolled patients, 14 had CLL/SLL, 13 mantle cell lymphoma (MCL), and 4 marginal zone lymphoma (MZL).

RESULTS:

The maximum tolerated dose of lisaftoclax was not reached; neither dose-limiting toxicity nor TLS was observed. Common adverse events included anemia, neutropenia, and thrombocytopenia. Significant antitumor activity was observed in CLL/SLL (overall response rate [ORR] 71.4%, complete response [CR] 28.6%); MCL (ORR 50.0%, CR 20.0%); and MZL (ORR 50.0%, CR 0). Median progression-free survival was 7.9 (95% CI, 4.9-14.1) months for all patients and 18.6 (95% CI, 8.4-not reached [NR]) and 7.9 (95% CI, 2.0-NR) months for those with CLL/SLL and MCL, respectively. The median overall survival was NR (95% CI, 26.2-NR) for all patients.

CONCLUSION:

Lisaftoclax has a manageable safety profile and induces durable responses in R/R CLL/SLL and NHL.

01 Jun 2026·EJHaem

Efficacy and Safety of Azacitidine Combined With Lisaftoclax in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia and Myelodysplastic Syndrome With Increased Blasts

Article

Author: Zhao, Wanhong ; Chen, Yinxia ; Lei, Bo ; Meng, Shan ; Zhang, Yilin ; Zhang, Wanggang ; Gu, Liufang ; Cao, Xingmei ; Wang, Jin ; Zhang, Hui

ABSTRACT:

Objective:

To retrospectively analyze the early efficacy and safety of azacitidine plus lisaftoclax in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome with increased blasts (MDS‐IB), providing a reliable clinical reference.

Methods:

A total of 17 patients admitted to the Department of Hematology between August 1 and December 31, 2025, were enrolled. The treatment was as follows: azacitidine 75 mg/m 2 (Days 1–7, subcutaneously) and lisaftoclax 200–600 mg (Days 1–10/14, orally), repeated in 28‐day cycles. Efficacy and safety were evaluated.

Results:

Among nine AML patients, 55.6% achieved complete remission (CR) after one cycle, with 60.0% of responders being MRD‐negative. Among eight MDS‐IB patients, 62.5% achieved CR and 25.0% achieved hematologic improvement, with 40.0% of CR patients being MRD‐negative. The median time to first CR was 1 month for both AML and MDS‐IB patients. In the entire cohort, common Grade 3–4 adverse events included thrombocytopenia/leukopenia (58.8%), lymphopenia (47.1%), and febrile neutropenia (35.3%, AML: 22.2%, MDS‐IB: 50.0%); no treatment‐related deaths occurred. Median follow‐up was 2.1 months; median OS was 1.9 months, and RFS was unevaluable.

Conclusion:

This regimen induces favorable responses with manageable toxicity, supporting its further investigation, while longer follow‐up and larger prospective studies are required to confirm the long‐term efficacy.Trial Registration: The authors have confirmed clinical trial registration is not needed for this submission

103

News (Medical) associated with Lisaftoclax

02 Sep 2026

·www.biospace.com

Ascentage Pharma to Participate in Four Upcoming Investor Conferences

ROCKVILLE, Md., Sept. 02, 2026 (GLOBE NEWSWIRE) -- Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855) (“Ascentage Pharma” or the “Company”), a global, commercial-stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel, differentiated therapies to address unmet medical needs in cancer, announced today that the Company’s management will participate in four upcoming investor conferences in New York, New York. Citi’s 2026 Biopharma Back to School Conference Format: Fireside chat and one-on-one investor meetings Date and Time: Wednesday, September 9, 2026, 4:20 p.m. to 4:55 p.m. ET Location: JW Marriott Essex House, 160 Central Park South, New York, NY H.C. Wainwright 28th Annual Global Investment Conference Format: Company presentation and one-on-one investor meetings Date and Time: Monday, September 14, 2026, 9:00 a.m. to 9:30 a.m. ET Location: Lotte New York Palace Hotel, 455 Madison Avenue, New York, NY Deutsche Bank 2026 Healthcare Summit Format: Company presentation and one-on-one investor meetings Date: Wednesday, September 16 - Thursday, September 17, 2026 Location: Deutsche Bank Center, One Columbus Circle, New York, NY ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); Bernstein Insights: Healthcare Leaders and Disruptors 3rd Annual Healthcare Forum Format: Company presentation and one-on-one investor meetings Date: Wednesday, September 23 - Thursday, September 24, 2026 Location: New York, NY Investors interested in scheduling a meeting with the Ascentage Pharma management team should contact their conference representative. About Ascentage Pharma Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855) (“Ascentage Pharma” or the “Company”) is a global, commercial stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel, differentiated therapies to address unmet medical needs in cancer. The Company has built a rich pipeline of innovative drug products and candidates that include inhibitors targeting key proteins in the apoptotic pathway, such as Bcl-2 and MDM2-p53, next-generation kinase inhibitors, and protein degraders. ezstandalone.cmd.push(function () { ezstandalone.showAds(132); }); The Company’s first approved product, Olverembatinib, is the first novel third-generation BCR-ABL1 inhibitor approved in China for the treatment of patients with CML in chronic phase (CML-CP) with T315I mutations, CML in accelerated phase (CML-AP) with T315I mutations, and CML-CP that is resistant or intolerant to first and second-generation TKIs. It is covered by the China National Reimbursement Drug List (NRDL). Ascentage Pharma is currently conducting an FDA- and EMA-cleared registrational Phase III trial, called POLARIS-2, of Olverembatinib for CML, as well as FDA- and EMA-cleared registrational Phase III trials for patients with newly diagnosed Ph+ ALL, called POLARIS-1, and SDH-deficient GIST patients, called POLARIS-3. The Company’s second approved product, Lisaftoclax, is a novel Bcl-2 inhibitor for the treatment of various hematologic malignancies. Lisaftoclax has been approved by China’s National Medical Products Administration (NMPA) for the treatment of adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have previously received at least one systemic therapy including Bruton’s tyrosine kinase (BTK) inhibitors. The Company is currently conducting four global registrational Phase III trials: the FDA- and EMA-cleared GLORA study of Lisaftoclax in combination with BTK inhibitors in patients with CLL/SLL previously treated with BTK inhibitors for more than 12 months with suboptimal response; the GLORA-2 study in patients with newly diagnosed CLL/SLL; the GLORA-3 study in newly diagnosed, elderly and unfit patients with AML; and the FDA- and EMA-cleared GLORA-4 study in patients with newly diagnosed higher risk MDS. Leveraging its robust R&D capabilities, Ascentage Pharma has built a portfolio of global intellectual property rights and entered into global partnerships and other relationships with numerous leading biotechnology and pharmaceutical companies, such as Takeda, AstraZeneca, Merck, Pfizer, and Innovent, in addition to research and development relationships with leading research institutions, such as Dana-Farber Cancer Institute, Mayo Clinic, National Cancer Institute and the University of Michigan. For more information, visit Cautionary Note Regarding Forward-Looking Statements ezstandalone.cmd.push(function () { ezstandalone.showAds(133); }); This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical facts, contained in this press release may be forward-looking statements, including statements that express Ascentage Pharma’s opinions, expectations, beliefs, plans, objectives, assumptions or projections regarding future events or future results of operations or financial condition. These forward-looking statements are subject to a number of risks and uncertainties as discussed in Ascentage Pharma’s filings with the SEC, including those set forth in the sections titled “Risk factors” and “Cautionary note regarding forward-looking statements” in its Annual Report on Form 20-F for the year ended December 31, 2025, filed with the SEC on April 29, 2026, the sections headed “Forward-looking Statements” and “Risk Factors” in the prospectus of the Company for its Hong Kong initial public offering dated October 16, 2019, and other filings with the SEC and/or The Stock Exchange of Hong Kong Limited where the Company’s ordinary shares are listed it has made or it makes from time to time that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. The forward-looking statements contained in this press release do not constitute profit forecast by the Company’s management. As a result of these factors, you should not rely on these forward-looking statements as predictions of future events. The forward-looking statements contained in this press release are based on Ascentage Pharma’s current expectations and beliefs concerning future developments and their potential effects and speak only as of the date of such statements. Ascentage Pharma does not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Contact Information Investor Relations: ezstandalone.cmd.push(function () { ezstandalone.showAds(134); }); Sumedh Sunkaraneni Ascentage Pharma IR@ascentage.com +1 (301) 792-6286 Brian Korb astr partners brian.korb@astrpartners.com +1 (917) 653-5122

13 Aug 2026

·www.globenewswire.com

Ascentage Pharma to Participate in the Evercore 2nd Annual China Biotech Summit

ROCKVILLE, Md., Aug. 13, 2026 (GLOBE NEWSWIRE) -- Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855) (“Ascentage Pharma” or the “Company”), a global, commercial-stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel, differentiated therapies to address unmet medical needs in cancer, announced today that the Company’s management will participate in the Evercore ISI 2nd Annual China Biotech Summit, being held August 17-19, 2026 at The Ritz-Carlton Shanghai, Pudong. Management will participate in a fireside chat moderated by the Evercore research team and one-on-one investor meetings during the conference. Fireside Chat Date: August 18, 2026Time: 7:45-8:00am Beijing TimeLocation: The Ritz-Carlton Shanghai, Pudong, Grand Ballroom 2 & 3 Investors interested in scheduling a meeting with the Ascentage Pharma management team should contact their Evercore representative. About Ascentage Pharma Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855) (“Ascentage Pharma” or the “Company”) is a global, commercial stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel, differentiated therapies to address unmet medical needs in cancer. The Company has built a rich pipeline of innovative drug products and candidates that include inhibitors targeting key proteins in the apoptotic pathway, such as Bcl-2 and MDM2-p53, next-generation kinase inhibitors, and protein degraders. The Company’s first approved product, Olverembatinib, is the first novel third-generation BCR-ABL1 inhibitor approved in China for the treatment of patients with CML in chronic phase (CML-CP) with T315I mutations, CML in accelerated phase (CML-AP) with T315I mutations, and CML-CP that is resistant or intolerant to first and second-generation TKIs. It is covered by the China National Reimbursement Drug List (NRDL). Ascentage Pharma is currently conducting an FDA- and EMA-cleared registrational Phase III trial, called POLARIS-2, of Olverembatinib for CML, as well as FDA- and EMA-cleared registrational Phase III trials for patients with newly diagnosed Ph+ ALL, called POLARIS-1, and SDH-deficient GIST patients, called POLARIS-3. The Company’s second approved product, Lisaftoclax, is a novel Bcl-2 inhibitor for the treatment of various hematologic malignancies. Lisaftoclax has been approved by China’s National Medical Products Administration (NMPA) for the treatment of adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have previously received at least one systemic therapy including Bruton’s tyrosine kinase (BTK) inhibitors. The Company is currently conducting four global registrational Phase III trials: the FDA- and EMA-cleared GLORA study of Lisaftoclax in combination with BTK inhibitors in patients with CLL/SLL previously treated with BTK inhibitors for more than 12 months with suboptimal response; the GLORA-2 study in patients with newly diagnosed CLL/SLL; the GLORA-3 study in newly diagnosed, elderly and unfit patients with AML; and the FDA- and EMA-cleared GLORA-4 study in patients with newly diagnosed higher risk MDS. Leveraging its robust R&D capabilities, Ascentage Pharma has built a portfolio of global intellectual property rights and entered into global partnerships and other relationships with numerous leading biotechnology and pharmaceutical companies, such as Takeda, AstraZeneca, Merck, Pfizer, and Innovent, in addition to research and development relationships with leading research institutions, such as Dana-Farber Cancer Institute, Mayo Clinic, National Cancer Institute and the University of Michigan. For more information, visit https://ascentage.com/ Cautionary Note Regarding Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical facts, contained in this press release may be forward-looking statements, including statements that express Ascentage Pharma’s opinions, expectations, beliefs, plans, objectives, assumptions or projections regarding future events or future results of operations or financial condition. These forward-looking statements are subject to a number of risks and uncertainties as discussed in Ascentage Pharma’s filings with the SEC, including those set forth in the sections titled “Risk factors” and “Cautionary note regarding forward-looking statements” in its Annual Report on Form 20-F for the year ended December 31, 2025, filed with the SEC on April 29, 2026, the sections headed “Forward-looking Statements” and “Risk Factors” in the prospectus of the Company for its Hong Kong initial public offering dated October 16, 2019, and other filings with the SEC and/or The Stock Exchange of Hong Kong Limited where the Company’s ordinary shares are listed it has made or it makes from time to time that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. The forward-looking statements contained in this press release do not constitute profit forecast by the Company’s management. As a result of these factors, you should not rely on these forward-looking statements as predictions of future events. The forward-looking statements contained in this press release are based on Ascentage Pharma’s current expectations and beliefs concerning future developments and their potential effects and speak only as of the date of such statements. Ascentage Pharma does not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Contact Information Investor Relations:Sumedh Sunkaraneni Ascentage PharmaIR@ascentage.com+1 (301) 792-6286 Brian Korbastr partnersbrian.korb@astrpartners.com+1 (917) 653-5122

Phase 3Drug ApprovalPhase 2

05 Aug 2026

·www.globenewswire.com

CORRECTION: Ascentage Pharma to Report 2026 Six Month Interim Results and Provide Corporate Update on August 19, 2026

In a release issued under the same headline earlier today by Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855),please note that in the first paragraph of the release, the time should be 7:00 am Eastern Daylight Time (EDT) on August 19, 2026 / 7:00 pm Hong Kong Time (HKT) and not 9 am EDT and 9 pm HKT as previously stated.The corrected release follows: ROCKVILLE, Md., Aug. 05, 2026 (GLOBE NEWSWIRE) -- Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855) (“Ascentage Pharma” or the “Company”), a global, commercial-stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel therapies to address unmet medical needs in cancer, announced today that it will release its six months 2026 unaudited interim results and provide business updates at 7:00 am Eastern Daylight Time (EDT) on August 19, 2026 / 7:00 pm Hong Kong Time (HKT) on August 19, 2026. Analysts and investors are invited to join the investor webcast with Q&A, conducted by the Company’s management team. Ascentage Pharma will host a Chinese (Mandarin) language investor webcast at 9:00 pm EDT on August 19, 2026 / 9:00 am HKT on August 20, 2026. To access the Chinese language investor event or conference call, please register in advance here. The English language investor conference call and webcast will be held at 8:00 am EDT / 8:00 pm HKT on August 20, 2026. To access the English language webcast, please register in advance here. The webcast replay for the English language conference call and presentation will also be available on the News & Events page of the Ascentage Pharma website. About Ascentage PharmaAscentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855) (“Ascentage Pharma” or the “Company”) is a global, commercial stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel, differentiated therapies to address unmet medical needs in cancer. The Company has built a rich pipeline of innovative drug products and candidates that include inhibitors targeting key proteins in the apoptotic pathway, such as Bcl-2 and MDM2-p53, next-generation kinase inhibitors, and protein degraders. The Company’s first approved product, Olverembatinib, is the first novel third-generation BCR-ABL1 inhibitor approved in China for the treatment of patients with CML in chronic phase (CML-CP) with T315I mutations, CML in accelerated phase (CML-AP) with T315I mutations, and CML-CP that is resistant or intolerant to first and second-generation TKIs. It is covered by the China National Reimbursement Drug List (NRDL). Ascentage Pharma is currently conducting an FDA- and EMA-cleared registrational Phase III trial, called POLARIS-2, of Olverembatinib for CML, as well as an FDA- and EMA-cleared registrational Phase III trials for patients with newly diagnosed Ph+ ALL, called POLARIS-1, and SDH-deficient GIST patients, called POLARIS-3. The Company’s second approved product, Lisaftoclax, is a novel Bcl-2 inhibitor for the treatment of various hematologic malignancies. Lisaftoclax has been approved by China’s National Medical Products Administration (NMPA) for the treatment of adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have previously received at least one systemic therapy including Bruton’s tyrosine kinase (BTK) inhibitors. The Company is currently conducting four global registrational Phase III trials: the FDA- and EMA- cleared GLORA study of Lisaftoclax in combination with BTK inhibitors in patients with CLL/SLL previously treated with BTK inhibitors for more than 12 months with suboptimal response; the GLORA-2 study in patients with newly diagnosed CLL/SLL; the GLORA-3 study in newly diagnosed, elderly and unfit patients with AML; and the FDA- and EMA-cleared GLORA-4 study in patients with newly diagnosed higher risk MDS. Leveraging its robust R&D capabilities, Ascentage Pharma has built a portfolio of global intellectual property rights and entered into global partnerships and other relationships with numerous leading biotechnology and pharmaceutical companies, such as Takeda, AstraZeneca, Merck, Pfizer, and Innovent, in addition to research and development relationships with leading research institutions, such as Dana-Farber Cancer Institute, Mayo Clinic, National Cancer Institute and the University of Michigan. For more information, visit https://ascentage.com/. Cautionary Note Regarding Forward-Looking StatementsThis press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical facts, contained in this press release may be forward-looking statements, including statements that express Ascentage Pharma’s opinions, expectations, beliefs, plans, objectives, assumptions or projections regarding future events or future results of operations or financial condition. These forward-looking statements are subject to a number of risks and uncertainties as discussed in Ascentage Pharma’s filings with the SEC, including those set forth in the sections titled “Risk factors” and “Cautionary note regarding forward-looking statements” in its Annual Report on Form 20-F for the year ended December 31, 2025, filed with the SEC on April 29, 2026, the sections headed “Forward-looking Statements” and “Risks Factors” in the prospectus of the Company for its Hong Kong initial public offering dated October 16, 2019, and other filings with the SEC and/or The Stock Exchange of Hong Kong Limited where the Company’s ordinary shares are listed it has made or it makes from time to time that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. The forward-looking statements contained in this presentation do not constitute profit forecast by the Company’s management. As a result of these factors, you should not rely on these forward-looking statements as predictions of future events. The forward-looking statements contained in this press release are based on Ascentage Pharma’s current expectations and beliefs concerning future developments and their potential effects and speak only as of the date of such statements. Ascentage Pharma does not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Contact Information:Stella YangAscentage PharmaIR@ascentage.com+1 (301) 792-6286

Phase 3Drug ApprovalFinancial Statement

100 Deals associated with Lisaftoclax

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Chronic Lymphocytic Leukemia	China	Suzhou Yasheng Pharmaceutical Co., Ltd.	08 Jul 2025
Small Lymphocytic Lymphoma	China	Suzhou Yasheng Pharmaceutical Co., Ltd.	08 Jul 2025

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
High Risk Myelodysplastic Syndrome	Phase 3	United States	Ascentage Pharma Group, Inc.	22 Jan 2025
High Risk Myelodysplastic Syndrome	Phase 3	China	Ascentage Pharma Group, Inc.	22 Jan 2025
High Risk Myelodysplastic Syndrome	Phase 3	Australia	Ascentage Pharma Group, Inc.	22 Jan 2025
High Risk Myelodysplastic Syndrome	Phase 3	Belgium	Ascentage Pharma Group, Inc.	22 Jan 2025
High Risk Myelodysplastic Syndrome	Phase 3	Bulgaria	Ascentage Pharma Group, Inc.	22 Jan 2025
High Risk Myelodysplastic Syndrome	Phase 3	Canada	Ascentage Pharma Group, Inc.	22 Jan 2025
High Risk Myelodysplastic Syndrome	Phase 3	Czechia	Ascentage Pharma Group, Inc.	22 Jan 2025
High Risk Myelodysplastic Syndrome	Phase 3	Finland	Ascentage Pharma Group, Inc.	22 Jan 2025
High Risk Myelodysplastic Syndrome	Phase 3	France	Ascentage Pharma Group, Inc.	22 Jan 2025
High Risk Myelodysplastic Syndrome	Phase 3	Germany	Ascentage Pharma Group, Inc.	22 Jan 2025

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EHA2026	Not Applicable	Myelodysplastic Syndromes	10	Lisaftoclax plus AZA (LA)	iyjqutrjez(legslhjwrc) = symaqbaqnd srtorbsxbu (pfsagxxsri ) View more	Positive	12 May 2026
				Lisaftoclax plus AZA (LA) (first-line)	iyjqutrjez(legslhjwrc) = eggpzgpyte srtorbsxbu (pfsagxxsri ) View more
EHA2026	Not Applicable	Myeloid Tumor NPM1 \| IDH2 \| DNMT3A ... View more	30	Lisaftoclax	psnylacjuc(ukufoqztos) = tetqisntve dwdqtchpmw (brbrwjrmqb ) View more	Positive	12 May 2026
NCT05147467 (EHA2026)	Phase 2	Chronic Lymphocytic Leukemia \| Small Lymphocytic Lymphoma TP53 \| SF3B1 \| KIT ... View more	72	Lisaftoclax 600 mg QD (refractory to BTKis)	qkkaapdpfu(hcyywbpxdr) = oaygcnperr pgychziown (taayejgyww ) View more	Positive	12 May 2026
NCT05147467 (PRNewswire) Manual	Phase 2	Chronic Lymphocytic Leukemia \| Small Lymphocytic Lymphoma	72	Lisaftoclax	thardzpobj(wdgxtiuoku) = mgkwslccvy vbsuewdfvs (sjbpodgvne ) View more	Positive	07 Dec 2025
NCT05147467 (APG2575CC201, ASH2025)	Phase 2	Chronic Lymphocytic Leukemia \| Small Lymphocytic Lymphoma	77	Lisaftoclax	aqbumtphth(esttjtbzzv) = sjuujzswmt bsbgjbuhvw (laiidfjqzi ) View more	Positive	06 Dec 2025
NCT04215809 (Pubmed \| Med)	Phase 1/2	Chronic Lymphocytic Leukemia	176	Lisaftoclax monotherapy	bvzgpbnklp(zbtgzzegsl) = xoonggwvcz lvvacydlrm (ysjyrmpsau ) View more	Positive	01 Dec 2025
				Lisaftoclax+rituximab	bvzgpbnklp(zbtgzzegsl) = vnmgjwyvvz lvvacydlrm (ysjyrmpsau )
NCT04964518 (APG2575AU101, ASCO2025 \| NEWS) Manual	Phase 1/2	Acute Myeloid Leukemia \| Chronic Myelomonocytic Leukemia \| Mixed phenotype acute leukemia ... View more	97	Lisaftoclax+azacitidine	euvulmepru(tjmfrsyfqd) = zuogllsqzd ahprqazlel (iaolyihzws ) View more	Positive	30 May 2025
NCT04942067 (APG2575MU101, ASH2024) Manual	Phase 1/2	Multiple Myeloma \| Refractory Multiple Myeloma \| Immunoglobulin Light-Chain Amyloidosis	49	Lisaftoclax + pomalidomide + dexamethasone (Arm A)	ijictfvbrg(bxlkyhmkxa) = ienjwouqqd owwgmvuyeq (qiqgxiykor ) View more	Positive	09 Dec 2024
				lisaftoclax and daratumumab, lenalidomide, and dexamethasone (R/R MM + Arm B)	ijictfvbrg(bxlkyhmkxa) = wwmvlirbyg owwgmvuyeq (qiqgxiykor ) View more
NCT04215809 (ASH2024) Manual	Phase 1	Chronic Lymphocytic Leukemia \| Small Lymphocytic Lymphoma	176	APG-2575	aqpyzbjevw(hwtaxxfbbw) = Incidence and severity of TEAEs were similar across cohorts. Common (>10%) any-grade TEAEs in all cohorts combined were neutropenia (59 [33.5%]), diarrhea (38 [21.6%]), anemia (27 [15.3%]), and thrombocytopenia (26 [14.8%]). eigaksgnxa (vspawwshox ) View more	Positive	09 Dec 2024
				APG-2575+Acalabrutinib
NCT04501120 (APG2575AC101, ASH2024) Manual	Phase 1/2	Myelodysplastic Syndromes	49	Lisaftoclax Azacitidineazacitidine (R/R MDS)	ymtuqwtbrw(haqsoscttn) = ydqewjpnby scooaqxhqa (vqrkrnftdp ) View more	Positive	08 Dec 2024
				Lisaftoclax Azacitidineazacitidine (TN MDS)	dyromuddbd \| ymtuqwtbrw(xfsrnkgvrx) = orahmzxzqu wpkfsmjlsu (dctqgekyfw, 61.5 - 89.2) View more

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