Ascentage Pharma's APG-3288 Receives FDA Clearance for Clinical Study
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 07 2026
0mins
Should l Buy AAPG?
Ascentage Pharma announced that its novel next-generation BTK-targeted protein degrader, APG-3288, has received the IND clearance from the U.S. Food and Drug Administration and is poised to enter a clinical study in patients with relapsed/refractory B-cell malignancies. This clearance officially opens the chapter on Ascentage Pharma's clinical development in the field of targeted degradation and marks another major expansion to the company's global innovative pipeline, the company said. This is a global, multicenter, open-label Phase I study designed to evaluate the safety, tolerability, pharmacokinetic profile, and preliminary efficacy of APG-3288 in patients with relapsed/refractory hematologic malignancies.
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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
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
- 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
Ascentage Pharma's Dual-Engine Growth: Global Innovation Strategy for 2026
- 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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Ascentage Pharma's APG-3288 Receives FDA IND Clearance for Clinical Study
- 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.
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Ascentage Pharma's APG-3288 IND Approved, Initiating Clinical Study
- 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
Ascentage Pharma's Dual-Engine Growth: Global Innovation Strategy for 2026
- 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
Monte Rosa Therapeutics Shares Surge 45.2% After Phase 1 Data Release
- Stock Surge: Monte Rosa Therapeutics Inc (NASDAQ:GLUE) shares soared 45.2% to $23.25 after announcing interim data from its Phase 1 clinical study evaluating MRT-8102, indicating strong market confidence in its research progress and potentially attracting more investor interest.
- Acquisition Rumors: Ventyx Biosciences Inc (NASDAQ:VTYX) saw a 37.5% increase to $13.82 following reports that Eli Lilly & Co (NYSE:LLY) is in advanced talks to acquire the company for over $1 billion, which may further drive market interest in biotech stocks.
- Analyst Rating: Erasca Inc (NASDAQ:ERAS) rose 17.1% to $4.25 after Piper Sandler analyst Kelsey Goodwin initiated coverage with an Overweight rating and a price target of $5, reflecting optimism about its future growth potential.
- 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
Ascentage Pharma's APG-3288 Receives FDA IND Clearance for Clinical Study
- 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
Novo Nordisk Receives FDA Approval for Wegovy, Shares Surge 8.6%
- FDA Approval: Novo Nordisk's GLP-1 drug Wegovy received FDA approval, marking the first of its kind globally, which signifies a major breakthrough for the company in the weight loss medication market and is expected to drive sales growth and enhance competitive positioning.
- 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
Cementos Pacasmayo, Rezolve AI, Emerald Holding, and Other Major Stocks Rising on Monday
U.S. Stock Market Performance: U.S. stocks declined, with the Dow Jones index dropping over 100 points on Tuesday.
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.
Notable Stock Gains: Several companies saw significant stock increases, including Rezolve AI PLC (23.7%), Emerald Holding Inc (17%), and Tilray Brands Inc (15%).
Strategic Moves and Buybacks: Sezzle Inc announced a $100 million stock buyback, while Emerald Holding is reviewing strategic options following acquisition inquiries.
See More
