Ascentage Pharma's APG-3288 Receives FDA IND Clearance for Clinical Study

Written by Emily J. Thompson, Senior Investment Analyst

Source: Globenewswire

Updated: Jan 07 2026

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AAPG+1.36%

Should l Buy AAPG?

Source: Globenewswire

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.

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$24.52+Infinity%1D

Analyst Views on AAPG

Wall Street analysts forecast AAPG stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for AAPG is 48.80 USD with a low forecast of 45.00 USD and a high forecast of 51.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.

5 Analyst Rating

5 Buy

0 Hold

0 Sell

Strong Buy

Current: 24.190

Low

45.00

Averages

48.80

High

51.00

Current: 24.190

Low

45.00

Averages

48.80

High

51.00

Lucid Capital

NULL

Buy

initiated

$50

2025-12-15

Reason

Lucid Capital

Price Target

$50

AI Analysis

2025-12-15

initiated

NULL

Buy

Reason

Lucid Capital initiated coverage of Ascentage Pharma with a Buy rating and $50 price target. The firm says Ascentage is a commercial-stage biotechnology company focused on developing next generation tyrosine kinase inhibitors for oncology. The company has the potential to develop and commercialize "differentiated" assets with validated targets in multi-blockbuster opportunities, offering significant upside for somewhat mitigated risk, the analyst tells investors in a research note.

Oppenheimer

Matthew Biegler

Outperform

initiated

$45

2025-12-04

Reason

Oppenheimer

Matthew Biegler

Price Target

$45

2025-12-04

initiated

Outperform

Reason

Oppenheimer analyst Matthew Biegler initiated coverage of Ascentage Pharma with an Outperform rating and $45 price target. The firm believes Ascentage has the potential to become the next BeOne. To get there, they're taking a page from BeOne's playbook. Better drugs, focusing on chronic blood cancers with large TAMs, Oppenheimer argues, adding that olverembatinib looks like a best-in-class BCR-ABL inhibitor. Separately, Ascentage's BCL-2 inhibitor lisaftoclax is taking aim at BeOne's biggest market: Chronic Lymphocytic Leukemia. The firm believes lisaftoclax' tolerability could enable it to make inroads into an indication where other BCL-2 inhibitors have failed, namely Myelodysplastic syndrome.

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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.

Ascentage Pharma's APG-3288 IND Approved, Initiating Clinical Study

2 days agoNewsfilter

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.

Ascentage Pharma's Dual-Engine Growth: Global Innovation Strategy for 2026

Jan 15 2026Globenewswire

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.

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