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Ascentage Pharma Outlined its Global Innovation Strategy During Presentation at 44th Annual J.P. Morgan Healthcare Conference

MWN-AI** Summary

Ascentage Pharma Group International presented a robust global innovation strategy during the 44th Annual J.P. Morgan Healthcare Conference, showcasing its significant achievements in 2025 and outlining plans for 2026. Chairman and CEO Dr. Dajun Yang highlighted the company's dual-engine growth strategy driven by two commercialized hematology products: Olverembatinib, a third-generation BCR-ABL inhibitor, and Lisaftoclax, a Bcl-2 inhibitor. Both products have established a strong market presence in China and are expected to be key drivers of growth moving forward.

In addition, Ascentage Pharma received Investigational New Drug (IND) clearance from the U.S. FDA for its next-generation BTK protein degrader, APG-3288, marking a significant milestone in the development of its global innovative pipeline. The company is advancing multiple registrational Phase III trials, including studies for Olverembatinib and Lisaftoclax, which aim to broaden patient accessibility while establishing their global competitiveness.

Dr. Yang emphasized the company's commitment to addressing unmet clinical needs with a promising portfolio that includes additional therapies targeting solid tumors, propelled by their proprietary proteolysis-targeting chimera (PROTAC) technology for protein degradation. The pipeline includes candidates like APG-5918 and APG-2449, which are demonstrating potential in treating severe hematologic malignancies and solid tumors.

Looking ahead to 2026, Ascentage Pharma aims to accelerate global clinical studies and expand its commercial reach, including advancing Phase III trials and broadening hospital coverage for its products. The company remains focused on leveraging its research capabilities and strategic global partnerships to drive further innovation in oncology and enhance patient outcomes worldwide.

MWN-AI** Analysis

Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855) showcased a promising outlook during the recent 44th Annual J.P. Morgan Healthcare Conference, emphasizing their dual-engine growth strategy powered by Olverembatinib and Lisaftoclax. This strategy is underpinned by remarkable advancements in their global innovative pipeline, particularly with their new BTK protein degrader, APG-3288, which has received IND clearance from the U.S. FDA.

Both Olverembatinib and Lisaftoclax cater to critical needs in the hematologic malignancy segment and have significantly positioned Ascentage within the Chinese market. Analysts should note that the upcoming Phase III trials and continued absorption into the National Reimbursement Drug List (NRDL) could further solidify market penetration and revenue growth. Importantly, Ascentage's strategic emphasis on global clinical development, including U.S. trials, indicates readiness to capture a vast international market.

The excitement surrounding APG-3288, accepted into clinical development, opens further avenues for growth as it complements existing therapies and enhances the company’s oncology profile. Given its innovative proteolysis-targeting chimera (PROTAC) technology, APG-3288 could disrupt traditional treatment landscapes, potentially improving efficacy and tolerability profiles.

Investors should monitor specific milestones slated for 2026, including advancements in registrational studies and commercialization efforts across multiple global sites. Given the expanding product portfolio and robust pipeline dynamics, Ascentage Pharma positions itself as a contender against competitors in the oncology space.

In conclusion, Ascentage’s dual-engine strategy, ongoing clinical advancements, and innovative drug development set a strong foundation for growth. Investors should keep a watchful eye on clinical trial results and market applications to gauge the company’s trajectory within the competitive biopharmaceutical arena. A strategically cautious approach, with attention to regulatory outcomes and market adoption rates, will be essential for pursuit of investment in AAPG shares.

**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.

Source: GlobeNewswire
  • Two commercialized hematology products, Olverembatinib and Lisaftoclax, drive dual-engine growth with strong China market presence
  • Next-generation BTK protein degrader APG-3288 receives IND clearance from the U.S. FDA, propelling expansion of global innovative pipeline
  • Multiple global registrational Phase III trials are progressing rapidly

ROCKVILLE, Md. and SUZHOU, China, Jan. 14, 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 Chairman and CEO, Dajun Yang, M.D., Ph.D., presented at the 44th Annual J.P. Morgan Healthcare Conference. In the corporate presentation, Dr. Yang provided an overview of milestone achievements in 2025 and outlined the Company’s global innovation strategy for 2026.

Dr. Yang said, “The annual J.P. Morgan Healthcare Conference provides an important platform for us to engage with peers from around the world and showcase our strategy and progress. For Ascentage Pharma, 2025 was a critical year in which we accelerated our global expansion, advancing product commercialization, global clinical development, and pipeline innovation. To date, we have built a powerful engine for innovation in hematologic malignancies and solid tumors, harnessing a diverse range of mechanisms and synergies between core components that include our commercialized products, late-stage programs in solid tumors, as well as our early-stage innovative therapies that utilize our cutting-edge protein degradation technology. This multi-faceted global portfolio of products and clinical programs has positioned Ascentage Pharma well for future challenges and laid a solid foundation for sustained growth. Entering 2026, Ascentage Pharma is opening a new chapter on its global innovation strategy. We remain steadfastly committed to our mission of addressing unmet clinical needs around the world and accelerating the development of our promising innovative therapeutics for the benefit of patients worldwide.”

Dual-Engine Driven by Two Core Products: Building a Global Hematologic Malignancy Treatment Landscape
The Company’s two core products, the third-generation BCR-ABL inhibitor Olverembatinib and the Bcl-2 inhibitor Lisaftoclax, both achieved significant progress in 2025 and represent main growth drivers for 2026. Together, they generate powerful “dual-engine” effects that will drive the Company’s future growth and support the development of a global portfolio of innovative therapies covering a broad range of hematologic malignancies.

Dr. Yang continued, “In the past year, Ascentage Pharma has made progress across multiple clinical studies underway for its key drug candidates globally, and presented data from these studies at prestigious international academic congresses. These data underscored the Company’s potential in delivering clinical breakthroughs for challenging hematologic malignancies and the global competitiveness of its products.”

Developing the Next-Generation BTK Degrader: Propelling Strategic Expansion of Global Innovative Pipeline
Achieving breakthroughs in translational medicine and the development of a diverse pipeline, Ascentage Pharma has received an investigational new drug (IND) clearance from the U.S. FDA for APG-3288, the first novel, highly potent and selective BTK degrader developed utilizing Ascentage Pharma’s proprietary proteolysis-targeting chimera (PROTAC) technology platform. This clearance initiates Ascentage Pharma’s clinical development in the field of targeted degradation and lays a strong foundation for future exploration of the combinatory potential between APG-3288 and the Company’s existing proprietary small-molecule agents.

Adding to the dual-engine effect generated by Olverembatinib and Lisaftoclax, other assets in the Company’s pipeline are also making rapid progress, forming a portfolio of advancing programs. The Company’s other key clinical programs include:

  • APG-5918 (EED inhibitor): Preclinical data have shown therapeutic potential in hematologic malignancies (multiple myeloma and T-cell lymphoma) and solid tumors (prostate cancer). For non-hematologic indications, the Company is conducting a Phase I study in patients with anemia in China.

  • APG-2449 (FAK/ALK/ROS1 inhibitor): Has entered global registrational Phase III studies in non-small cell lung cancer (NSCLC), representing a major breakthrough in the Company’s expansion into solid tumors.

  • Alrizomadlin (APG-115; MDM2-p53 inhibitor): Currently being evaluated in a Phase II study and has shown clinical potential in solid tumors such as adenoid cystic carcinoma (ACC).

  • Pelcitoclax (APG-1252; Bcl-2/Bcl-xL inhibitor): Currently being evaluated in a Phase II study, having shown clinical potential in a range of tumor types including EGFR-mutant NSCLC, relapsed/refractory non-Hodgkin lymphoma, ovarian cancer, and endometrial carcinoma.

Outlook for 2026
In the presentation, Dr. Yang touched on a number of potential milestones and catalysts expected in 2026 as follows:

  • In global clinical development: Advance multiple registrational Phase III studies including GLORA, GLORA-4, POLARIS-1, and POLARIS-2.

  • In commercialization: Continued growth in commercial sales, broader patient accessibility and coverage across 1,500 hospitals; inclusion in NRDL coverage of Lisaftoclax in China.

  • In early-stage clinical programs: BTK Protein Degrader APG-3288 global Phase I PK, safety, tolerability, efficacy data, including U.S. and China; advancement of EED Inhibitor APG-5918 in oncology and anemia in the U.S. and China.

*Olverembatinib, Lisaftoclax, Alrizomadlin, Pelcitoclax, APG-3288, APG-5918, and APG-2449 are currently under investigation and have not yet been approved by the U.S. FDA.

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, as well as next-generation kinase inhibitors.

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:
Stella Yang
Ascentage Pharma
Stella.Yang@ascentage.com
+1 (301) 792-6286

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**

How does Ascentage Pharma Group International AAPG plan to leverage the dual-engine growth generated by Olverembatinib and Lisaftoclax to enhance its overall market share in the competitive landscape of hematologic malignancies?

Ascentage Pharma Group International plans to leverage the dual-engine growth from Olverembatinib and Lisaftoclax by expanding their clinical applications, enhancing synergistic combinations, and increasing market presence through strategic partnerships and targeted marketing efforts in hematologic malignancies.

What specific milestones does Ascentage Pharma Group International AAPG anticipate for 20regarding the global commercial sales and patient accessibility of Olverembatinib and Lisaftoclax?

Ascentage Pharma Group International (AAPG) anticipates achieving global commercial sales and enhanced patient accessibility for Olverembatinib and Lisaftoclax by securing regulatory approvals in major markets and expanding distribution networks by 2026.

How does Ascentage Pharma Group International AAPG’s recent IND clearance for APG-3288 position the company in the burgeoning protein degradation market, and what synergies are expected with existing products?

Ascentage Pharma's recent IND clearance for APG-3288 enhances its position in the expanding protein degradation market by potentially leveraging synergies with its existing portfolio, particularly in targeting critical pathways for cancer treatment and broadening therapeutic applications.

What are the implications of Ascentage Pharma Group International AAPG’s partnerships with major pharmaceutical companies on the commercialization and clinical development of its novel therapies, including Olverembatinib and Lisaftoclax?

Ascentage Pharma's partnerships with major pharmaceutical companies enhance its commercialization and clinical development capabilities for novel therapies like Olverembatinib and Lisaftoclax, enabling access to broader resources, expertise, and market reach, potentially accelerating their success.

**MWN-AI FAQ is based on asking OpenAI questions about Ascentage Pharma Group (OTC: ASPHF).

Ascentage Pharma Group

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