Ascentage Pharma's Lisaftoclax Shows 62.5% ORR in BTK-Refractory CLL/SLL Patients
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 06 2025
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Should l Buy AAPG?
Source: Newsfilter
- Significant Clinical Efficacy: Lisaftoclax achieved a 62.5% objective response rate (ORR) in 77 heavily pretreated BTK-refractory R/R CLL/SLL patients, underscoring its potential as a new treatment option, particularly among those with complex karyotypes.
- No Tumor Lysis Syndrome: The median progression-free survival (PFS) was reported at 23.89 months, with no cases of tumor lysis syndrome observed, indicating a favorable safety profile suitable for heavily pretreated patients.
- Addressing High-Risk Patients: Among the participants, 42.9% had complex karyotypes and 39% had del(17p)/TP53 mutations, yet Lisaftoclax demonstrated strong efficacy in these high-risk patients, fulfilling an urgent clinical need for breakthrough therapies.
- Advancing Global Registrational Studies: Ascentage is conducting four global registrational Phase III studies to evaluate Lisaftoclax across multiple indications, further solidifying its position in the global hematologic oncology landscape.
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Analyst Views on AAPG
Wall Street analysts forecast AAPG stock price to rise
6 Analyst Rating
6 Buy
0 Hold
0 Sell
Strong Buy
Current: 23.200
Low
45.00
Averages
48.67
High
51.00
Current: 23.200
Low
45.00
Averages
48.67
High
51.00
About AAPG
Ascentage Pharma Group International is an investment holding company primarily engaged in the discovery, development, and commercialization of therapies for hematologic malignancies. The Company's main products include Olverembatinib (HQP1351), Lisaftoclax (APG-2575), Alrizomadlin (APG-115), Pelcitoclax (APG-1252), APG-5918, and APG-2449. The Company's products are primarily used to treat chronic myeloid leukemia (CML), acute myeloid leukemia (AML), chronic lymphocytic leukemia (CLL), acute lymphoblastic leukemia (ALL), myelodysplastic syndrome (MDS) and multiple myeloma (MM). The Company primarily conducts its businesses in domestic market.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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- Global Development Capability: The IND approval for APG-3288, following its clearance by the U.S. FDA, showcases Ascentage Pharma's robust global development capabilities in the field of targeted protein degradation, further solidifying its leadership in innovative drug development.
- Urgent Clinical Need: Given BTK's critical role in the B-cell signaling pathway, the development of APG-3288 is particularly significant for patients resistant to BTK inhibitors, addressing the urgent clinical need for new drugs with novel mechanisms of action and potentially offering new treatment options.
- Strategic Investment Outlook: The Chief Medical Officer of Ascentage Pharma noted that the IND approval for APG-3288 marks a significant milestone in the company's global innovation strategy, with expectations to expedite its clinical development and explore combinatory potential with other key assets to meet market demands for new therapies.
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- FDA Approval for New Drug: The company received IND clearance from the U.S. FDA for APG-3288, marking the initiation of clinical development in targeted degradation and laying a strong foundation for future combinatory potential with existing small-molecule agents.
- Global Clinical Advancements: Ascentage Pharma is rapidly advancing multiple global registrational Phase III trials, including APG-2449 for non-small cell lung cancer, showcasing its competitiveness in the oncology treatment landscape.
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- Global Clinical Study Launch: The drug will enter a global multicenter Phase I clinical study to evaluate its safety and preliminary efficacy in patients with relapsed/refractory hematologic malignancies, further advancing the company's clinical development in targeted degradation.
- Significant Technical Advantages: Developed using Ascentage's PROTAC technology platform, APG-3288 is designed to induce rapid and effective degradation of the BTK target rather than inhibition, overcoming resistance associated with existing BTK inhibitors, showcasing substantial clinical application potential.
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- Global Development Capability: The IND approval for APG-3288, following its clearance by the U.S. FDA, showcases Ascentage Pharma's robust global development capabilities in the field of targeted protein degradation, further solidifying its leadership in innovative drug development.
- Urgent Clinical Need: Given BTK's critical role in the B-cell signaling pathway, the development of APG-3288 is particularly significant for patients resistant to BTK inhibitors, addressing the urgent clinical need for new drugs with novel mechanisms of action and potentially offering new treatment options.
- Strategic Investment Outlook: The Chief Medical Officer of Ascentage Pharma noted that the IND approval for APG-3288 marks a significant milestone in the company's global innovation strategy, with expectations to expedite its clinical development and explore combinatory potential with other key assets to meet market demands for new therapies.
See More
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- Dual-Engine Growth: Ascentage Pharma's two core products, the third-generation BCR-ABL inhibitor Olverembatinib and the Bcl-2 inhibitor Lisaftoclax, made significant progress in 2025 and are expected to drive growth in the global innovative therapy portfolio for 2026.
- FDA Approval for New Drug: The company received IND clearance from the U.S. FDA for APG-3288, marking the initiation of clinical development in targeted degradation and laying a strong foundation for future combinatory potential with existing small-molecule agents.
- Global Clinical Advancements: Ascentage Pharma is rapidly advancing multiple global registrational Phase III trials, including APG-2449 for non-small cell lung cancer, showcasing its competitiveness in the oncology treatment landscape.
- Market Coverage Expansion: In 2026, the company plans to continue expanding commercial sales across 1,500 hospitals and include Lisaftoclax in China's National Reimbursement Drug List, enhancing patient accessibility and coverage.
See More
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See More
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- Innovative Drug Approval: Ascentage Pharma's BTK-targeted protein degrader APG-3288 has received IND clearance from the U.S. FDA, marking a significant expansion of the company's global innovative pipeline and is expected to provide new treatment options for patients with relapsed/refractory B-cell malignancies.
- Global Clinical Study Launch: The drug will enter a global multicenter Phase I clinical study to evaluate its safety and preliminary efficacy in patients with relapsed/refractory hematologic malignancies, further advancing the company's clinical development in targeted degradation.
- Significant Technical Advantages: Developed using Ascentage's PROTAC technology platform, APG-3288 is designed to induce rapid and effective degradation of the BTK target rather than inhibition, overcoming resistance associated with existing BTK inhibitors, showcasing substantial clinical application potential.
- Strategic Development Outlook: This FDA clearance lays a solid foundation for Ascentage Pharma's ongoing innovation in hematologic malignancies, with plans to accelerate global clinical development of APG-3288 and explore its combinatory potential with existing small-molecule agents.
See More
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- Market Reaction: Other related companies like WW International and Lifezone Metals also saw gains due to positive market sentiment, with WW International's stock jumping 14.4%, indicating increased investor interest in health and weight loss-related products, potentially boosting overall industry growth.
- Industry Impact: Novo Nordisk's successful approval may prompt other pharmaceutical companies to accelerate the development of similar products, thereby driving competition in the GLP-1 market and fostering innovation and market expansion.
See More
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Cementos Pacasmayo Surge: Shares of Cementos Pacasmayo SAA rose 47.4% to $10.30 after Holcim agreed to purchase a majority stake in its parent company.
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