--- title: "Ascentage Pharma Announces IND Clearance by the China CDE for BTK Degrader APG-3288 | AAPG Stock News" description: "Ascentage Pharma has received IND clearance from the China CDE for its BTK-targeted protein degrader, APG-3288, following prior approval from the U.S. FDA. This marks a significant milestone in the cl" type: "news" locale: "en" url: "https://longbridge.com/en/news/275046102.md" published_at: "2026-02-05T15:30:00.000Z" --- # Ascentage Pharma Announces IND Clearance by the China CDE for BTK Degrader APG-3288 | AAPG Stock News > Ascentage Pharma has received IND clearance from the China CDE for its BTK-targeted protein degrader, APG-3288, following prior approval from the U.S. FDA. This marks a significant milestone in the clinical development of APG-3288, which aims to treat relapsed/refractory hematologic malignancies. The multicenter Phase I study will assess the drug's safety, tolerability, and efficacy. APG-3288 utilizes a novel mechanism to degrade BTK, potentially overcoming resistance seen with traditional BTK inhibitors. Ascentage Pharma continues to strengthen its pipeline in hematologic cancers with this innovative therapy. 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 ### Related Stocks - [AAPG.US - Ascentage Pharma](https://longbridge.com/en/quote/AAPG.US.md) ## Related News & Research | Title | Description | URL | |-------|-------------|-----| | Ascentage Pharma 在第 44 届摩根大通医疗健康大会上展示了其全球创新战略 \| AAPG 股票新闻 | Ascentage Pharma 在第 44 届摩根大通医疗健康大会上展示了其全球创新战略，强调了 2025 年的成就和 2026 年的计划。该公司专注于由其血液学产品 Olverembatinib 和 Lisaftoclax 驱动的双引擎 | [Link](https://longbridge.com/en/news/272624438.md) | | Rodman & Renshaw 开始对 Ascentage Pharma Group International（纳斯达克代码：AAPG）进行研究覆盖 | Rodman & Renshaw 已经开始对 Ascentage Pharma Group International (NASDAQ:AAPG) 进行覆盖，给予 “买入” 评级，并设定目标价为 48.00 美元，表示潜在上涨幅度为 75. | [Link](https://longbridge.com/en/news/272436579.md) | | APi 集团（APG）第四季度财报预期 | APi (APG) 将于本周三公布其第四季度财报。上个季度，它的收入为 20.9 亿美元，同比增长 14.2%，超出分析师的预期。本季度，预计收入将增长 12.2%。分析师们重申了他们的预期，显示出对公司表现的信心。APi 在过去曾面临收入 | [Link](https://longbridge.com/en/news/276676870.md) | | 巴克莱银行维持对 APi Group (APG) 的买入评级 | 巴克莱分析师朱利安·米切尔对 APi Group (APG) 维持了买入评级，目标价为 44.00 美元。这位专注于工业领域的分析师，其推荐的平均回报率为 17.8%，成功率为 69.73%。目前对 APi Group 的共识评级为强烈买入 | [Link](https://longbridge.com/en/news/276217453.md) | | Evogene 与昆士兰科技大学合作开发基于人工智能的癌症治疗方法 | Evogene 与昆士兰科技大学（QUT）合作开发基于人工智能的小分子癌症治疗药物，重点关注耐药性非小细胞肺癌（NSCLC）。此次合作将利用 Evogene 的 ChemPass AI 平台生成和优先筛选具有强抑制特性的化学先导物。该合作旨 | [Link](https://longbridge.com/en/news/276226631.md) | --- > **Disclaimer**: This article is for reference only and does not constitute any investment advice.