Ascentage Pharma's Lisaftoclax Shows 62.5% Response Rate in CLL/SLL Treatment
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 06 2025
0mins
Should l Buy AAPG?
Source: Globenewswire
- Significant Clinical Efficacy: Lisaftoclax achieved a 62.5% objective response rate in heavily pretreated BTK-refractory R/R CLL/SLL patients, underscoring its potential as a new treatment option, particularly among those with complex karyotypes.
- Extended Survival: The drug demonstrated a median progression-free survival of 23.89 months in patients, with no tumor lysis syndrome reported, indicating a favorable safety profile and the ability to provide new hope for high-risk patients.
- High-Risk Patient Response: Among 77 enrolled patients, 42.9% had complex karyotypes, and despite these high-risk factors, Lisaftoclax exhibited strong therapeutic potential, highlighting its importance in addressing unmet medical needs.
- Advancement of Global Registrational Studies: Ascentage Pharma is conducting four global registrational Phase III studies to evaluate Lisaftoclax across multiple indications, further solidifying its position in the global oncology treatment 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: 24.430
Low
45.00
Averages
48.67
High
51.00
Current: 24.430
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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- IND Approval: Ascentage Pharma's BTK-targeted protein degrader APG-3288 has received IND clearance from the China CDE, indicating its imminent entry into clinical studies for relapsed/refractory hematologic malignancies, which is expected to significantly enhance the company's competitive position in the hematologic oncology market.
- 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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- Market Dynamics: The overall market was mixed, with the Dow Jones index falling around 0.2%, yet several biotech stocks performed strongly, reflecting ongoing investor interest and confidence in the sector, which may signal future investment opportunities.
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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- Stock Surge: Following the approval news, Novo Nordisk's shares rose 8.6% to $52.26, reflecting strong investor confidence in the potential market demand for the new drug, which may enhance the company's market capitalization and investment appeal.
- 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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