This is a phase Ib/II study that aims to investigate the safety, tolerability and explore the efficacy of BCL- XL inhibition in participants with high-risk AML.

Start Date22 May 2026

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

NCT07428486

/ WithdrawnPhase 1IIT

A Phase 1 Study Of FLAG Chemotherapy In Combination With Lisaftoclax And Pelcitoclax In Patients With Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia

To find safe and effective doses of lisaftoclax and pelcitoclax in combination with FLAG chemotherapy in patients with relapsed/refractory T-ALL.

Start Date27 Apr 2026

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

[+1]

ChiCTR2400094086

/ Not yet recruitingPhase 1IIT

A clinical study of olverembatinib in combination with APG-1252 for the treatment of relapsed/refractory Philadelphia chromosome-positive acute lymphoblastic leukemia or T-cell acute lymphoblastic lymphoma

Start Date01 Jan 2025

Sponsor / Collaborator

Shanghai Children's Medical Center

100 Clinical Results associated with Pelcitoclax

100 Translational Medicine associated with Pelcitoclax

100 Patents (Medical) associated with Pelcitoclax

Literatures (Medical) associated with Pelcitoclax

01 Nov 2025·BIOMATERIALS

Albumin nanocomplex of BCL-2/xL inhibitor reduced platelet toxicity and improved anticancer efficacy in myeloproliferative neoplasm and lymphoma

Article

Author: Wang, Shaomeng ; Xie, Jizhao ; Gao, Wei ; Song, Yudong ; Wen, Bo ; Hu, Hongxiang ; Li, Qiuxia ; Sun, Duxin ; Ke, Fang ; Li, Chengyi

The clinical application of BCL-2/xL inhibitors for cancer treatment is limited by the on-target thrombocytopenia. Although APG-1252 was designed to mitigate this issue, platelet toxicity at higher doses in clinical trials restricts dose escalation for greater efficacy. We have developed albumin nanocomplexes of APG-1252 (Nano-1252) to reduce platelet toxicity while improving drug efficacy through enhancing drug delivery to lymphoid organs. Nano-1252 forms stable nanoparticles due to the strong binding affinity between APG-1252 and albumin, reducing the platelet toxicity threshold by fourfold by limiting premature drug release and conversion to its active forms in circulation. Furthermore, Nano-1252 exhibited preferential accumulation in lymphoid organs, leading to enhanced anticancer efficacy in Mantle Cell Lymphoma (MCL) and Myeloproliferative Neoplasms (MPNs) mouse models. Our study not only develops a potential formulation to overcome the current translational barrier of APG-1252 but also reveals novel properties of the well-established albumin nanoformulation, thereby expanding its clinical applications.

01 Jun 2025·SLAS Discovery

Combinatorial screen with apoptosis pathway targeted agents alrizomadlin, pelcitoclax, and dasminapant in multi-cell type tumor spheroids

Article

Author: Coussens, Nathan P ; Doroshow, James H ; Silvers, Thomas ; Takebe, Naoko ; Dexheimer, Thomas S ; Sanchez, Phillip R ; Hollingshead, Melinda G ; Teicher, Beverly A ; Chen, Li

Apoptosis, or programmed cell death, plays a critical role in maintaining tissue homeostasis by eliminating damaged or abnormal cells. Dysregulation of apoptosis pathways is a hallmark of cancer, allowing malignant cells to evade cell death and proliferate uncontrollably. Targeting apoptosis pathways has emerged as a promising therapeutic strategy in cancer treatment, aiming to restore the balance between cell survival and death. The MDM2 inhibitor alrizomadlin, the Bcl-2/Bcl-xL inhibitor pelcitoclax, and the IAP family inhibitor dasminapant were evaluated both individually and in combinations with standard of care and investigational anticancer small molecules in a spheroid model of solid tumors. The multi-cell type tumor spheroids were grown from human endothelial cells and mesenchymal stem cells combined with human malignant cells that were either established or patient-derived cell lines from the NCI Patient-Derived Models Repository. The malignant cell lines were derived from a range of solid tumors including uterine carcinosarcoma, synovial sarcoma, rhabdomyosarcoma, soft tissue sarcoma, malignant fibrous histiocytoma, malignant peripheral nerve sheath tumor (MPNST), pancreas, ovary, colon, breast, and small cell lung cancer. Interactions were observed from combinations of the apoptosis pathway targeted agents. Additionally, interactions were observed from combinations of the apoptosis pathway targeted agents with other agents, including PARP inhibitors, the XPO1 inhibitor eltanexor, and the PI3K inhibitor copanlisib. Enhanced activity was also observed from combinations of the apoptosis pathway targeted agents with MAPK pathway targeted agents, including the MEK inhibitor cobimetinib as well as adagrasib and MRTX1133, which specifically target the KRAS G12C and G12D variants, respectively.

01 Apr 2025·ACTA PHARMACOLOGICA SINICA

The novel BCL-2/BCL-XL inhibitor APG-1252-mediated cleavage of GSDME enhances the antitumor efficacy of HER2-targeted therapy in HER2-positive gastric cancer

Article

Author: Qiu, Miao-Zhen ; Pan, Wen-Tao ; Sun, Jian ; Xia, Zeng-Fei ; Shi, Shan ; Yang, Jing ; Yang, Da-Jun ; Yang, Li-Qiong ; Zhang, Lin ; Luo, Qiu-Yun ; Di, Tian

HER2-positive gastric cancer has a poor prognosis, with a high incidence of drug resistance and a lack of effective treatments for drug-resistant patients. The exploration of the mechanism of resistance to HER2-targeted therapy in HER2-positive gastric cancer and the identification of effective strategies to reverse it are urgently needed. In this study, we found that HER2-targeted agents upregulated the expression of GSDME and that the overexpression of GSDME attenuated the sensitivity of HER2-targeted agents. Furthermore, we observed that the BCL-2/BCL-XL inhibitor APG-1252 plus lapatinib promoted GSDME-mediated pyroptosis and exhibited remarkable antitumor activity both in vitro and in vivo. Mechanistically, APG-1252 combined with lapatinib synergistically induced GSDME-mediated pyroptosis in HER2-positive gastric cancer by activating caspase-dependent pathways and blocking the phospho-AKT/GSK-3β/MCL-1 signaling pathway. Our data indicated that the combination of lapatinib and APG-1252 had a synergistic antitumor effect on HER2-positive gastric cancer through the induction of caspase-3/GSDME-mediated apoptosis and pyroptosis.

News (Medical) associated with Pelcitoclax

15 Jan 2026

·www.globenewswire.com

Ascentage Pharma Outlined its Global Innovation Strategy During Presentation at 44th Annual J.P. Morgan Healthcare Conference

Two commercialized hematology products, Olverembatinib and Lisaftoclax, drive dual-engine growth with strong China market presenceNext-generation BTK protein degrader APG-3288 receives IND clearance from the U.S. FDA, propelling expansion of global innovative pipelineMultiple global registrational Phase III trials are progressing rapidly ROCKVILLE, Md. and SUZHOU, China, Jan. 14, 2026 (GLOBE NEWSWIRE) -- Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855), 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 that its Chairman and CEO, Dajun Yang, M.D., Ph.D., presented at the 44th Annual J.P. Morgan Healthcare Conference. In the corporate presentation, Dr. Yang provided an overview of milestone achievements in 2025 and outlined the Company’s global innovation strategy for 2026. Dr. Yang said, “The annual J.P. Morgan Healthcare Conference provides an important platform for us to engage with peers from around the world and showcase our strategy and progress. For Ascentage Pharma, 2025 was a critical year in which we accelerated our global expansion, advancing product commercialization, global clinical development, and pipeline innovation. To date, we have built a powerful engine for innovation in hematologic malignancies and solid tumors, harnessing a diverse range of mechanisms and synergies between core components that include our commercialized products, late-stage programs in solid tumors, as well as our early-stage innovative therapies that utilize our cutting-edge protein degradation technology. This multi-faceted global portfolio of products and clinical programs has positioned Ascentage Pharma well for future challenges and laid a solid foundation for sustained growth. Entering 2026, Ascentage Pharma is opening a new chapter on its global innovation strategy. We remain steadfastly committed to our mission of addressing unmet clinical needs around the world and accelerating the development of our promising innovative therapeutics for the benefit of patients worldwide.” Dual-Engine Driven by Two Core Products: Building a Global Hematologic Malignancy Treatment LandscapeThe Company’s two core products, the third-generation BCR-ABL inhibitor Olverembatinib and the Bcl-2 inhibitor Lisaftoclax, both achieved significant progress in 2025 and represent main growth drivers for 2026. Together, they generate powerful “dual-engine” effects that will drive the Company’s future growth and support the development of a global portfolio of innovative therapies covering a broad range of hematologic malignancies. Dr. Yang continued, “In the past year, Ascentage Pharma has made progress across multiple clinical studies underway for its key drug candidates globally, and presented data from these studies at prestigious international academic congresses. These data underscored the Company’s potential in delivering clinical breakthroughs for challenging hematologic malignancies and the global competitiveness of its products.” Developing the Next-Generation BTK Degrader: Propelling Strategic Expansion of Global Innovative PipelineAchieving breakthroughs in translational medicine and the development of a diverse pipeline, Ascentage Pharma has received an investigational new drug (IND) clearance from the U.S. FDA for APG-3288, the first novel, highly potent and selective BTK degrader developed utilizing Ascentage Pharma’s proprietary proteolysis-targeting chimera (PROTAC) technology platform. This clearance initiates Ascentage Pharma’s clinical development in the field of targeted degradation and lays a strong foundation for future exploration of the combinatory potential between APG-3288 and the Company’s existing proprietary small-molecule agents. Adding to the dual-engine effect generated by Olverembatinib and Lisaftoclax, other assets in the Company’s pipeline are also making rapid progress, forming a portfolio of advancing programs. The Company’s other key clinical programs include: APG-5918 (EED inhibitor): Preclinical data have shown therapeutic potential in hematologic malignancies (multiple myeloma and T-cell lymphoma) and solid tumors (prostate cancer). For non-hematologic indications, the Company is conducting a Phase I study in patients with anemia in China.APG-2449 (FAK/ALK/ROS1 inhibitor): Has entered global registrational Phase III studies in non-small cell lung cancer (NSCLC), representing a major breakthrough in the Company’s expansion into solid tumors.Alrizomadlin (APG-115; MDM2-p53 inhibitor): Currently being evaluated in a Phase II study and has shown clinical potential in solid tumors such as adenoid cystic carcinoma (ACC).Pelcitoclax (APG-1252; Bcl-2/Bcl-xL inhibitor): Currently being evaluated in a Phase II study, having shown clinical potential in a range of tumor types including EGFR-mutant NSCLC, relapsed/refractory non-Hodgkin lymphoma, ovarian cancer, and endometrial carcinoma. Outlook for 2026In the presentation, Dr. Yang touched on a number of potential milestones and catalysts expected in 2026 as follows: In global clinical development: Advance multiple registrational Phase III studies including GLORA, GLORA-4, POLARIS-1, and POLARIS-2.In commercialization: Continued growth in commercial sales, broader patient accessibility and coverage across 1,500 hospitals; inclusion in NRDL coverage of Lisaftoclax in China.In early-stage clinical programs: BTK Protein Degrader APG-3288 global Phase I PK, safety, tolerability, efficacy data, including U.S. and China; advancement of EED Inhibitor APG-5918 in oncology and anemia in the U.S. and China. *Olverembatinib, Lisaftoclax, Alrizomadlin, Pelcitoclax, APG-3288, APG-5918, and APG-2449 are currently under investigation and have not yet been approved by the U.S. FDA. 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 includes inhibitors targeting key proteins in the apoptotic pathway, such as Bcl-2 and MDM2-p53, as well as next-generation kinase inhibitors. The lead asset, 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. All indications are covered by the China National Reimbursement Drug List (NRDL). The Company is currently conducting an FDA-cleared, global registrational Phase III trial, or POLARIS-2, of Olverembatinib for CML, as well as global registrational Phase III trials for patients with newly diagnosed Ph+ ALL and SDH-deficient GIST patients. The Company’s second approved product, Lisaftoclax, is a novel Bcl-2 inhibitor for the treatment of various hematologic malignancies. Lisaftoclax is being commercialized in China following National Medical Products Administration (NMPA) approval 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 BTK inhibitors. The Company is currently conducting four global registrational Phase III trials: the FDA-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 acute myeloid leukemia (AML); and the GLORA-4 study in patients with newly diagnosed higher-risk myelodysplastic syndrome (HR MDS), a study that was simultaneously cleared by the U.S. FDA, the EMA of the EU, and China CDE. 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/ 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 “Special note regarding forward-looking statements and industry data” in its Registration Statement on Form F-1, as amended, filed with the SEC on January 21, 2025, and the Form 20-F filed with the SEC on April 16, 2025, 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 we made or make 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. Contacts Investor Relations:Stella YangAscentage PharmaStella.Yang@ascentage.com+1 (301) 792-6286 Stephanie CarringtonICR HealthcareAscentageIR@icrhealthcare.com+1 (646) 277-1282 Media Relations:Sean LeousICR HealthcareAscentagePR@icrhealthcare.com+1 (646) 866-4012

Phase 2Phase 1Phase 3INDDrug Approval

23 Oct 2023

·www.prnewswire.com

Live from ESMO 2023 | Oral Report Featuring Latest Data of Pelcitoclax (APG-1252) Combined with Osimertinib Demonstrates Potential as a New Treatment Option for TP53-and EGFR-Mutant NSCLC

SUZHOU, China and ROCKVILLE, Md., Oct. 23, 2023 /PRNewswire/ -- Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancer, chronic hepatitis B (CHB), and age-related diseases, announced today that it has released the latest clinical data of its dual Bcl-2/Bcl-xL inhibitor, APG-1252 (pelcitoclax), combined with osimertinib for the treatment of patients with EGFR-mutant non-small cell lung cancer (NSCLC) in a Mini Oral at the 2023 European Society of Medical Oncology (ESMO) Congress. Developed by Ascentage Pharma, pelcitoclax is a potential best-in-class novel dual Bcl-2/Bcl-xL inhibitor that can restore the apoptosis of cancer cells by selectively inhibiting Bcl-2 and Bcl-xL proteins, thus delivering its therapeutic effects on a range of solid tumors and hematologic malignancies. The clinical data presented at the ESMO Congress this year demonstrated promising therapeutic utility of pelcitoclax combined with osimertinib in patients with EGFR-mutant NSCLC. Those results show that among the 26 EGFR-tyrosine kinase inhibitor (TKI)-naïve patients, 21 partial responses (PRs) were observed, resulting in an objective response rate (ORR) of 80.8%; while among the 16 EGFR-TKI naïve patients with TP53 and EGFR-mutations, 14 PRs were observed, resulting in an ORR of 87.5%. Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma, said, "Currently, there are many challenges in the treatment of NSCLC. Among them, TP53 and EGFR mutations can significantly affect the prognosis of patients with NSCLC, and there is no standard of care treatment for this subtype of NSCLC. At the ESMO 2023, we presented the latest clinical data that continued to suggest encouraging therapeutic potential of pelcitoclax combined with osimertinib in EGFR-TKI-naïve patients with TP53- and EGFR-mutant NSCLC. In earlier studies, pelcitoclax combined with osimertinib demonstrated clinical potential for the treatment of patients with EGFR-mutant advanced NSCLC resistant to EGFR-TKIs. Adding to the body of evidence, updated data presented this year revealed clinical potential of the combination regimen in patients resistant to third-generation EGFR-TKIs. Moving forward, we will continue to fulfill our mission of addressing unmet clinical needs in China and around the world and expedite our clinical programs for the benefit of more patients." Highlights of the data on pelcitoclax presented at the 2023 ESMO Congress are as follows: Updated study results of pelcitoclax (APG-1252) combined with osimertinib in patients (pts) with EGFR-mutant non-small-cell lung cancer (NSCLC) Format: Mini Oral Abstract#: 5586 Date and Time: October 22, 2023 (Sunday), 02:30 PM – 02:35 PM (Madrid Time) / October 22, 2023 (Sunday), 08:30 PM – 08:35 PM (Beijing Time) Category: NSCLC, metastatic Highlights This open-label, multi-center, Phase Ib study being conducted in China was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of pelcitoclax in combination with osimertinib in patients with EGFR-mutant NSCLC. As of April 21, 2023, 64 patients were enrolled with a median age of 56 years. To the 13 patients enrolled in the dose escalation phase, pelcitoclax was administered intravenously once weekly (QW) at 160 mg (n=6) and 240 mg (n=7); while osimertinib was orally administered once daily (QD) at 80 mg, in 21-day cycles. After establishing 160 mg as the recommended Phase II dose (RP2D) of pelcitoclax, the study enrolled another 51 patients into the dose-expansion phase that divided the 64 patients into 3 cohorts: Cohort 1 included patients with disease resistant to first-generation EGFR-TKIs (n=8), Cohort 2 included patients with disease resistant to third-generation EGFR-TKIs (n=29), Cohort 3 included patients whose disease was previously untreated with EGFR-TKIs (n=27). Efficacy results: In the 26 efficacy-evaluable EGFR-TKI-naïve patients, 21 partial responses (PRs) were observed, resulting in an ORR of 80.8%. In the 16 EGFR-TKI- naïve patients with TP53 and EGFR mutations, 14 PRs were observed, resulting in an ORR of 87.5% and a median progress-free survival (mPFS) of 16.39 months (95%Cl, 8.11-NR). Furthermore, preliminary biomarker data from patients resistant to third-generation EGFR-TKIs suggest that the combination regimen can potentially prolong the PFS of patients with high Bcl-xL expressions. Safety results: A total of 59 patients (92.2%) experienced treatment-emergent adverse events (TEAEs), of whom only 13 (20.3%) experienced grade≥3 AEs. The most common TEAEs included increased aspartate aminotransferase (68.8%) and alanine aminotransferase (64.1%), reduced platelet counts (43.8%), increased serum amylase (29.7%), and increased blood creatinine (28.1%). Conclusions: According to the preliminary results, pelcitoclax in combination with osimertinib showed favorable tolerability in patients with EGFR-mutant NSCLC, and the potential for improving the prognosis of EGFR-TKI-naïve patients with TP53- and EGFR-mutant NSCLC. In patients resistant to third-generation EGFR-TKIs, those with higher Bcl-xL expressions achieved better responses. These encouraging findings warrant further clinical investigations. (Pelcitoclax is an investigational drug that has not been approved for any indication anywhere in the world.) About Ascentage Pharma Ascentage Pharma (6855.HK) is a globally focused biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B, and age-related diseases. On October 28, 2019, Ascentage Pharma was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code 6855.HK. Ascentage Pharma focuses on developing therapeutics that inhibit protein-protein interactions to restore apoptosis, or programmed cell death. The company has built a pipeline of 9 clinical drug candidates, including novel, highly potent Bcl-2, and dual Bcl-2/Bcl-xL inhibitors, as well as candidates aimed at IAP and MDM2-p53 pathways, and next-generation tyrosine kinase inhibitors (TKIs). Ascentage Pharma is also the only company in the world with active clinical programs targeting all three known classes of key apoptosis regulators. The company is conducting more than 40 Phase I/II clinical trials in the US, Australia, Europe, and China. Ascentage Pharma has been designated for multiple Major National R&D Projects, including five Major New Drug Projects, one New Drug Incubator status, four Innovative Drug Programs, and one Major Project for the Prevention and Treatment of Infectious Diseases. Olverembatinib, the company's core drug candidate developed for the treatment of drug-resistant chronic myeloid leukemia (CML) and the company's first approved product, has been granted Priority Review Designations and Breakthrough Therapy Designations by the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA). To date, the drug had been included into the China 2022 National Reimbursement Drug List (NRDL). Furthermore, olverembatinib has been granted an Orphan Drug Designation (ODD) and a Fast Track Designation (FTD) by the US FDA, and an Orphan Designation by the EMA of the EU. To date, Ascentage Pharma has obtained a total of 16 ODDs, 2 FTDs, and 2 Rare Pediatric Disease (RPD) Designations from the US FDA and 1 Orphan Designation from the EMA of the EU for 4 of the company's investigational drug candidates. Leveraging its robust R&D capabilities, Ascentage Pharma has built a portfolio of global intellectual property rights and entered into global partnerships with numerous renowned biotechnology and pharmaceutical companies and research institutes such as UNITY Biotechnology, MD Anderson Cancer Center, Mayo Clinic, Dana-Farber Cancer Institute, MSD, and AstraZeneca. The company has built a talented team with global experience in the discovery and development of innovative drugs and is setting up its world-class commercial manufacturing and Sales & Marketing teams. One pivotal aim of Ascentage Pharma is to continuously strengthen its R&D capabilities and accelerate its clinical development programs, in order to fulfil its mission of addressing unmet clinical needs in China and around the world for the benefit of more patients. Forward-Looking Statements The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, Ascentage Pharma undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events, or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development. SOURCE Ascentage Pharma

Clinical ResultOrphan DrugFast TrackBreakthrough TherapyPhase 1

03 Aug 2023

·www.prnewswire.com

ESMO 2023 | Ascentage Pharma to Present Results from Two Clinical Studies, including One Oral Presentation, at 2023 ESMO Congress

SUZHOU, China, and ROCKVILLE, Md., Aug. 2, 2023 /PRNewswire/ -- Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancer, chronic hepatitis B (CHB), and age-related diseases, announced today that it is going to release results from two clinical studies at the 2023 European Society of Medical Oncology (ESMO) Congress. These presentations include a Mini Oral featuring the latest data from a study of pelcitoclax (APG-1252), a Bcl-2/BcL-xL dual-targeted inhibitor, combined with osimertinib in patients with EGFR-mutant non-small cell lung cancer (NSCLC); and a Poster on a study evaluating olverembatinib (HQP1351), the first and only China-approved third-generation BCR-ABL inhibitor, in patients with tyrosine kinase inhibitor (TKI)-resistant succinate dehydrogenase- (SDH-) deficient gastrointestinal stromal tumor (GIST). As one of the most authoritative and influential congresses in oncology globally, the ESMO Congress showcases the latest results from some of the most cutting-edge research from around the world. This year, the ESMO Congress will take place on October 20 to October 24, local time, in Madrid, Spain. "We are pleased that results from the study of pelcitoclax combined with osimertinib in patients with NSCLC and that from the study evaluating olverembatinib in patients with succinate dehydrogenase- (SDH-) deficient gastrointestinal stromal tumor (GIST) have been selected for presentations at the 2023 ESMO Congress," said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. "These presentations highlight Ascentage Pharma's robust capabilities in clinical development and global innovation, as well as our strong potential in solid tumors. Remaining steadfastly committed to our global innovation roadmap, we will expeditiously advance the global clinical development of our lead drug candidates with the hope to bring benefit to patients in China and around the world as soon as possible." These two clinical studies to be presented at the ESMO Congress this year are as follows: Pelcitoclax Updated study results of pelcitoclax (APG-1252) combined with osimertinib in patients (pts) with EGFR-mutant non-small cell lung cancer (NSCLC) Format: Mini Oral Abstract#: 5586 Category: NSCLC, Locally Advanced First Author: Yuxiang Ma, MD, Sun Yat-sen University Cancer Center Olverembatinib Antitumor activity of olverembatinib (HQP1351) in patients (pts) with TKI-resistant succinate dehydrogenase- (SDH-) deficient gastrointestinal stromal tumor (GIST) Format: Poster Abstract#: 5746 Category: Sarcoma First Author: Haibo Qiu, MD, PhD, Sun Yat-sen University Cancer Center *Pelcitoclax is an investigational drug that has not been approved in any country and region. *Olverembatinib is an investigational drug that has not been approved for any indication outside the Chinese mainland. This drug is jointly commercialized in China by Ascentage Pharma and Innovent Biologics. About Ascentage Pharma Ascentage Pharma (6855.HK) is a globally focused biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B, and age-related diseases. On October 28, 2019, Ascentage Pharma was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code 6855.HK. Ascentage Pharma focuses on developing therapeutics that inhibit protein-protein interactions to restore apoptosis, or programmed cell death. The company has built a pipeline of 9 clinical drug candidates, including novel, highly potent Bcl-2, and dual Bcl-2/Bcl-xL inhibitors, as well as candidates aimed at IAP and MDM2-p53 pathways, and next-generation tyrosine kinase inhibitors (TKIs). Ascentage Pharma is also the only company in the world with active clinical programs targeting all three known classes of key apoptosis regulators. The company is conducting more than 40 Phase I/II clinical trials in the US, Australia, Europe, and China. Ascentage Pharma has been designated for multiple Major National R&D Projects, including five Major New Drug Projects, one New Drug Incubator status, four Innovative Drug Programs, and one Major Project for the Prevention and Treatment of Infectious Diseases. Olverembatinib, the company's core drug candidate developed for the treatment of drug-resistant chronic myeloid leukemia (CML) and the company's first approved product, has been granted Priority Review Designations and Breakthrough Therapy Designations by the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA). To date, the drug had been included into the China 2022 National Reimbursement Drug List (NRDL). Furthermore, olverembatinib has been granted an Orphan Drug Designation (ODD) and a Fast Track Designation (FTD) by the US FDA, and an Orphan Designation by the EMA of the EU. To date, Ascentage Pharma has obtained a total of 16 ODDs from the US FDA and 1 Orphan Designation from the EMA of the EU for 4 of the company's investigational drug candidates. Leveraging its robust R&D capabilities, Ascentage Pharma has built a portfolio of global intellectual property rights and entered into global partnerships with numerous renowned biotechnology and pharmaceutical companies and research institutes such as UNITY Biotechnology, MD Anderson Cancer Center, Mayo Clinic, Dana-Farber Cancer Institute, MSD, and AstraZeneca. The company has built a talented team with global experience in the discovery and development of innovative drugs and is setting up its world-class commercial manufacturing and Sales & Marketing teams. One pivotal aim of Ascentage Pharma is to continuously strengthen its R&D capabilities and accelerate its clinical development programs, in order to fulfil its mission of addressing unmet clinical needs in China and around the world for the benefit of more patients. Forward-Looking Statements The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, Ascentage Pharma undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events, or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development. SOURCE Ascentage Pharma

Orphan DrugFast TrackDrug ApprovalBreakthrough TherapyClinical Result

100 Deals associated with Pelcitoclax

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KEGG	Wiki	ATC	Drug Bank
-	-	-	DB16285

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute Erythroleukemia	Phase 2	United States	The University of Texas MD Anderson Cancer Center	22 May 2026
Acute Megakaryoblastic Leukemia	Phase 2	United States	The University of Texas MD Anderson Cancer Center	22 May 2026
Refractory acute myeloid leukemia	Phase 2	United States	The University of Texas MD Anderson Cancer Center	22 May 2026
Non-Small Cell Lung Cancer	Phase 2	China	Ascentage Pharma Group International Co., Ltd.	12 Jul 2022
ALK-positive anaplastic large cell lymphoma	Phase 2	China	Suzhou Yasheng Pharmaceutical Co., Ltd.	14 Jun 2022
Immunoblastic Lymphadenopathy	Phase 2	China	Suzhou Yasheng Pharmaceutical Co., Ltd.	14 Jun 2022
Mycosis Fungoides	Phase 2	China	Suzhou Yasheng Pharmaceutical Co., Ltd.	14 Jun 2022
Non-Hodgkin's lymphoma refractory	Phase 2	China	Ascentage Pharma Group, Inc.	14 Jun 2022
Peripheral T-Cell Lymphoma	Phase 2	China	Suzhou Yasheng Pharmaceutical Co., Ltd.	14 Jun 2022
Recurrent Non-Hodgkin Lymphoma	Phase 2	China	Ascentage Pharma Group, Inc.	14 Jun 2022

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04001777 (APG1252NC101, ESMO2023) Manual	Phase 1	EGFR-mutated non-small Cell Lung Cancer TP53 Mutation \| EGFR Mutation	64	Pelcitoclax 160 mg + Osimertinib 80 mg	beuivsdopz(xnsphxybel) = rdealvqvix vrbcgfqpju (wndfxevvlx ) View more	Positive	22 Oct 2023
NCT04001777 (APG1252NC101, ESMO2023) Manual	Phase 1		64	Pelcitoclax 160 mg + Osimertinib 80 mg (previously untreated with EGFR-TKIs.)	beuivsdopz(xnsphxybel) = qsfbnvssgy vrbcgfqpju (wndfxevvlx )	Positive	22 Oct 2023
NCT04001777 (ASCO2022) Manual	Phase 1	EGFR-mutated non-small Cell Lung Cancer EGFR Mutation	20	Pelcitoclax (EC-2)	uynochlkby(scxatgpcup) = kmwibokjph mnkreyfsio (wuntgxjddv, 25.8 - 92.0) View more	Positive	02 Jun 2022
NCT04210037 (ASCO2022) Manual	Phase 1/2	Recurrent Lung Small Cell Carcinoma	28	Paclitaxel+Pelcitoclax	vmljoygbcv(blrtvxhhgt) = ambpfffwjl npupfvbpbm (hoxdgxuzls ) View more	Positive	02 Jun 2022
NCT03080311 (AACR2018)	Phase 1	Small Cell Lung Cancer	50	APG-1252	chxxqgdgix(zpohhzcmel) = hgqflxnone uvyqmlqnpl (kwruznfkgd )	-	01 Jul 2018
NCT03080311 (AACR2018)	Phase 1	Small Cell Lung Cancer	50	ABT-263	chxxqgdgix(zpohhzcmel) = vsfeqsiqlb uvyqmlqnpl (kwruznfkgd )	-	01 Jul 2018

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