Ascentage Pharma Announces IND Clearance by the China CDE for BTK Degrader APG-3288
Rhea-AI Summary
Ascentage Pharma (NASDAQ: AAPG) announced that its next‑generation BTK degrader APG-3288 received IND clearance from the China Center for Drug Evaluation on Feb 5, 2026, following earlier U.S. FDA IND clearance.
The company will start a multicenter, open‑label Phase I study in relapsed/refractory hematologic malignancies to evaluate safety, tolerability, PK, and preliminary efficacy.
Positive
- Received China CDE IND clearance for APG-3288
- Previously cleared by the U.S. FDA for IND
- Planned multicenter, open‑label Phase I study evaluating safety, PK, and preliminary efficacy
- APG-3288 degrades both wild‑type BTK and multiple resistance-associated BTK mutants
- Company has approved hematologic products Olverembatinib and Lisaftoclax in China
Negative
- APG-3288 is investigational and not approved by regulatory authorities
- Clinical evidence currently limited to preclinical data; no human efficacy results reported yet
- Phase I focus on safety and PK means near‑term commercial impact is uncertain
Key Figures
Market Reality Check
Peers on Argus
AAPG was modestly positive at +0.17% pre-news, while biotech peers MIRM (-5.66%), ZLAB (-2.08%), ACAD (-4.24%), ACLX (-4.53%), and ARWR (-3.52%) were broadly negative, pointing to stock-specific dynamics.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Jan 14 | Strategy & pipeline update | Positive | -3.6% | Outlined 2026 innovation strategy and FDA IND for APG-3288 with advancing Phase III trials. |
| Jan 06 | IND clearance | Positive | -3.5% | Announced U.S. FDA IND clearance for BTK degrader APG-3288 enabling global Phase I trial. |
| Dec 17 | Conference participation | Neutral | -3.1% | Disclosed upcoming presentation at the 44th J.P. Morgan Healthcare Conference for investor outreach. |
| Dec 08 | Clinical data update | Positive | -4.0% | Reported four-year Phase II olverembatinib data showing superior event-free survival vs BAT in CML-CP. |
| Dec 08 | Clinical data update | Positive | -4.0% | Presented ASH 2025 olverembatinib data with high CCyR and MMR rates in second-line CML-CP. |
Recent AAPG news, including multiple positive clinical and strategic updates, was followed by consistent single-day share declines, suggesting a pattern of negative reactions to favorable headlines.
Over the last few months, Ascentage Pharma reported several milestones, including U.S. FDA IND clearance for APG-3288, progress of multiple global Phase III trials, and strong olverembatinib efficacy data at ASH 2025 (e.g., event-free survival 21.2 vs 2.9 months). It also emphasized a dual-engine growth model led by olverembatinib and lisaftoclax and outlined its 2026 innovation strategy. Despite these largely positive updates, AAPG’s shares fell between 3.15% and 3.99% after each event, contrasting with the constructive news flow ahead of today’s China IND clearance.
Market Pulse Summary
This announcement adds China CDE IND clearance for BTK degrader APG-3288, complementing the earlier U.S. FDA IND and enabling a global multicenter Phase I program in relapsed/refractory hematologic malignancies. It reinforces Ascentage’s focus on targeted protein degradation alongside its existing hematology portfolio. In context of prior updates on APG-3288 and olverembatinib, investors may track trial initiation timing, early safety and PK readouts, and how this candidate integrates with the broader hematology pipeline.
Key Terms
investigational new drug (ind) regulatory
center for drug evaluation (cde) regulatory
bruton's tyrosine kinase medical
b-cell receptor (bcr) signaling pathway medical
proteolysis-targeting chimera (protac) medical
cereblon e3 ubiquitin ligase medical
waldenström’s macroglobulinemia medical
xenografts medical
AI-generated analysis. Not financial advice.
ROCKVILLE, Md. and SUZHOU, China, Feb. 05, 2026 (GLOBE NEWSWIRE) -- Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855), a global, commercial stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel, differentiated therapies to address unmet medical needs in cancer, announced that its novel next-generation Bruton's tyrosine kinase (BTK)-targeted protein degrader, APG-3288, has received investigational new drug (IND) application clearance from the China Center for Drug Evaluation (CDE) and is poised to enter a clinical study in patients with relapsed/refractory hematologic malignancies. This IND clearance from the China CDE, which came shortly after the IND was cleared by the U.S. Food and Drug Administration (FDA), ushers in a new phase in the multicenter clinical development of APG-3288 and highlights Ascentage Pharma’s robust global development capabilities in the field of targeted protein degradation.
Ascentage Pharma will be conducting a multicenter, open-label Phase I study designed to evaluate the safety, tolerability, pharmacokinetic (PK) profile, and preliminary efficacy of APG-3288 in patients with relapsed/refractory hematologic malignancies.
BTK is a key kinase in the B-cell receptor (BCR) signaling pathway and plays a central role in the activation, proliferation, and survival of B-cells. Aberrant BTK activation is closely associated with the initiation and progression of multiple B-cell malignancies such as B-cell lymphoma (including diffuse large B-cell lymphoma, mantle cell lymphoma, and follicular lymphoma), chronic lymphocytic leukemia (CLL), and Waldenström’s macroglobulinemia (WM)1. BTK inhibitors have drastically improved treatment outcomes for patients with B-cell malignancies. However, BTK mutations and remodeling of signaling pathways often lead to acquired resistance during prolonged treatment. There remains an urgent clinical need for new drugs promising novel mechanisms of action2.
APG-3288 is a highly potent and selective BTK degrader developed utilizing Ascentage Pharma’s proprietary proteolysis-targeting chimera (PROTAC) technology platform. This candidate induces the formation of a ternary complex consisting of the BTK target, the PROTAC, and the Cereblon E3 ubiquitin ligase, leading to proteasome-mediated degradation of the BTK target. Unlike conventional BTK inhibitors, APG-3288 is designed to act through degradation rather than inhibition, inducing rapid, potent, highly selective, and sustained degradation of both wild-type BTK and multiple BTK mutants associated with resistance to existing BTK inhibitors. Critically, this approach blocks the BCR-BTK signaling axis at its source, thereby overcoming resistance to BTK inhibitors and potentially providing a novel and differentiated therapeutic strategy for BTK-targeted treatment3.
As a company focused on developing innovative drugs for cancer treatment, Ascentage Pharma has dedicated many years building a strong presence in the field of hematologic malignancies with a portfolio that includes Olverembatinib and Lisaftoclax, two products that have already been approved in China. This IND clearance for APG-3288 in China will further strengthen the Company’s pipeline in hematologic malignancies and lay a strong foundation for potential combinations with other key assets within the pipeline.
Yifan Zhai, M.D., Ph.D., Chief Medical Officer of Ascentage Pharma, said, “After receiving IND clearances for APG-3288 from the U.S. FDA and then the China CDE, we have reached a significant milestone in the field of targeted protein degradation, taking another major step forward with our global innovation strategy. There is considerable unmet clinical need in patients with hematologic malignancies, particularly those drug-resistant patients who desperately lack treatment options. We will expeditiously advance this global clinical development program for APG-3288 and actively explore its combinatory potential in efforts to bring this innovative therapeutic to patients in China and around the world as soon as possible.”
*APG-3288 is currently under investigation and has not been approved by the U.S. FDA
References:
[1]. Pal Singh, S., F. Dammeijer, and R.W. Hendriks, Role of Bruton’s tyrosine kinase in B cells and malignancies. Molecular Cancer, 2018. 17(1).
[2]. Wang, E., et al., Mechanisms of Resistance to Noncovalent Bruton’s Tyrosine Kinase Inhibitors. New England Journal of Medicine, 2022. 386(8): p. 735-743.
[3]. Zhang, D., et al., NRX-0492 degrades wild-type and C481 mutant BTK and demonstrates in vivo activity in CLL patient-derived xenografts. Blood, 2023. 141(13): p. 1584-1596.
About Ascentage Pharma
Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855) (“Ascentage Pharma” or the “Company”) is a global, commercial stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel, differentiated therapies to address unmet medical needs in cancer. The Company has built a rich pipeline of innovative drug products and candidates that includes inhibitors targeting key proteins in the apoptotic pathway, such as Bcl-2 and MDM2-p53, next-generation kinase inhibitors, as well as protein degraders.
The lead asset, Olverembatinib, is the first novel third-generation BCR-ABL1 inhibitor approved in China for the treatment of patients with CML in chronic phase (CML-CP) with T315I mutations, CML in accelerated phase (CML-AP) with T315I mutations, and CML-CP that is resistant or intolerant to first and second-generation TKIs. All indications are covered by the China National Reimbursement Drug List (NRDL). The Company is currently conducting an FDA-cleared, global registrational Phase III trial, or POLARIS-2, of Olverembatinib for CML, as well as global registrational Phase III trials for patients with newly diagnosed Ph+ ALL and SDH-deficient GIST patients.
The Company’s second approved product, Lisaftoclax, is a novel Bcl-2 inhibitor for the treatment of various hematologic malignancies. Lisaftoclax is being commercialized in China following National Medical Products Administration (NMPA) approval for the treatment of adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have previously received at least one systemic therapy including BTK inhibitors. The Company is currently conducting four global registrational Phase III trials: the FDA-cleared GLORA study of Lisaftoclax in combination with BTK inhibitors in patients with CLL/SLL previously treated with BTK inhibitors for more than 12 months with suboptimal response; the GLORA-2 study in patients with newly diagnosed CLL/SLL; the GLORA-3 study in newly diagnosed, elderly and unfit patients with acute myeloid leukemia (AML); and the GLORA-4 study in patients with newly diagnosed higher-risk myelodysplastic syndrome (HR MDS), a study that was simultaneously cleared by the U.S. FDA, the EMA of the EU, and China CDE.
Leveraging its robust R&D capabilities, Ascentage Pharma has built a portfolio of global intellectual property rights and entered into global partnerships and other relationships with numerous leading biotechnology and pharmaceutical companies, such as Takeda, AstraZeneca, Merck, Pfizer, and Innovent, in addition to research and development relationships with leading research institutions, such as Dana-Farber Cancer Institute, Mayo Clinic, National Cancer Institute and the University of Michigan. For more information, visit https://ascentage.com/
Forward-Looking Statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical facts, contained in this press release may be forward-looking statements, including statements that express Ascentage Pharma’s opinions, expectations, beliefs, plans, objectives, assumptions or projections regarding future events or future results of operations or financial condition.
These forward-looking statements are subject to a number of risks and uncertainties as discussed in Ascentage Pharma’s filings with the SEC, including those set forth in the sections titled “Risk factors” and “Special note regarding forward-looking statements and industry data” in its Registration Statement on Form F-1, as amended, filed with the SEC on January 21, 2025, and the Form 20-F filed with the SEC on April 16, 2025, the sections headed “Forward-looking Statements” and “Risk Factors” in the prospectus of the Company for its Hong Kong initial public offering dated October 16, 2019, and other filings with the SEC and/or The Stock Exchange of Hong Kong Limited we made or make from time to time that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. The forward-looking statements contained in this presentation do not constitute profit forecast by the Company’s management.
As a result of these factors, you should not rely on these forward-looking statements as predictions of future events. The forward-looking statements contained in this press release are based on Ascentage Pharma’s current expectations and beliefs concerning future developments and their potential effects and speak only as of the date of such statements. Ascentage Pharma does not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Contacts
Investor Relations:
Yuly Chen, Senior Investor Relations Director
Ascentage Pharma
IR@ascentage.com
+86 512 85557777
+1 (301) 792-5658
Stephanie Carrington
ICR Healthcare
AscentageIR@icrhealthcare.com
+1 (646) 277-1282
Media Relations:
Sean Leous
ICR Healthcare
AscentagePR@icrhealthcare.com
+1 (646) 866-4012
FAQ
What does the China CDE IND clearance for APG-3288 mean for Ascentage Pharma (AAPG)?
What is the design and objective of the APG-3288 Phase I study for AAPG?
How does APG-3288 differ from existing BTK inhibitors for AAPG shareholders?
Does APG-3288 have regulatory approval for treatment under AAPG?
How does this IND clearance affect Ascentage Pharma’s hematologic pipeline (AAPG)?
