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Ascentage Pharma Wins FDA IND Clearance for BTK Degrader APG-3288 to Enter Global Phase I Trial

Story Highlights
  • Ascentage Pharma secured FDA IND clearance for APG-3288 on January 6, 2026, enabling a global Phase I trial in relapsed or refractory B-cell and other hematologic malignancies.
  • The novel BTK degrader APG-3288 broadens Ascentage’s hematology pipeline by targeting wild-type and resistant BTK mutants, potentially overcoming inhibitor resistance and supporting future combination strategies.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
Ascentage Pharma Wins FDA IND Clearance for BTK Degrader APG-3288 to Enter Global Phase I Trial

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The latest announcement is out from Ascentage Pharma Group International Unsponsored ADR ( (AAPG) ).

On January 6, 2026, Ascentage Pharma Group International announced that the U.S. Food and Drug Administration had granted investigational new drug clearance for APG-3288, a novel next-generation Bruton tyrosine kinase (BTK)-targeted protein degrader developed using the company’s proprietary PROTAC platform, enabling the launch of a global, multicenter Phase I trial in patients with relapsed or refractory B‑cell and other hematologic malignancies. The move significantly broadens Ascentage’s innovative hematology pipeline and positions the company at the forefront of BTK-targeted protein degradation, as APG-3288 is designed to selectively degrade both wild-type and BTK mutant forms associated with resistance to existing BTK inhibitors, potentially overcoming a key mechanism of treatment failure and creating opportunities for future combination regimens with the company’s own small‑molecule agents, including its commercialized oncology drugs.

The most recent analyst rating on (AAPG) stock is a Buy with a $50.00 price target. To see the full list of analyst forecasts on Ascentage Pharma Group International Unsponsored ADR stock, see the AAPG Stock Forecast page.

Spark’s Take on AAPG Stock

According to Spark, TipRanks’ AI Analyst, AAPG is a Underperform.

The overall stock score reflects significant financial challenges, including high debt levels and negative profitability, which are the most impactful factors. The technical analysis indicates weak momentum, and the valuation is unattractive due to negative earnings and lack of dividends. These factors collectively result in a low overall score.

To see Spark’s full report on AAPG stock, click here.

More about Ascentage Pharma Group International Unsponsored ADR

Ascentage Pharma Group International is a global, commercial-stage, integrated biopharmaceutical company focused on discovering, developing and commercializing novel, differentiated therapies to address unmet medical needs in cancer. Its pipeline includes inhibitors targeting key proteins in the apoptotic pathway, such as Bcl-2 and MDM2-p53, as well as next-generation kinase inhibitors. The company’s lead asset, Olverembatinib, is a third-generation BCR-ABL1 inhibitor approved in China for multiple chronic myeloid leukemia indications and included in the national reimbursement list, while its second approved product, the Bcl-2 inhibitor Lisaftoclax, is being commercialized in China for previously treated CLL/SLL alongside several ongoing global registrational Phase III trials. Ascentage also leverages extensive global R&D partnerships with major pharmaceutical companies and leading academic institutions to support its innovation-led growth strategy.

Average Trading Volume: 5,966

Technical Sentiment Signal: Strong Sell

Current Market Cap: $2.48B

Learn more about AAPG stock on TipRanks’ Stock Analysis page.

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