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The Stock Exchange of Hong Kong Limited take no responsibility for the contents of this announcement, make no representation as to its

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Ascentage Pharma Announces Its Novel Bcl-2 Inhibitor

Lisaftoclax Approved by China NMPA, Ushering in a New Era for the Treatment of CLL/SLL

ROCKVILLE, Md. and SUZHOU, China, July 10,

2025 - Ascentage Pharma (NASDAQ: AAPG; HKEX: 6855), a global biopharmaceutical company dedicated to addressing unmet medical

needs in cancers, announced that its proprietary novel Bcl-2 selective inhibitor lisaftoclax (APG-2575) has been approved by China's

National Medical Products Administration (NMPA) 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 Bruton's tyrosine kinase (BTK) inhibitors,

which makes lisaftoclax the first Bcl-2 inhibitor receiving conditional approval and marketing authorization for the treatment of patients

with CLL/SLL in China, and the second Bcl-2 inhibitor approved globally.

Lisaftoclax is a proprietary, novel orally administered

small-molecule Bcl-2 selective inhibitor developed by Ascentage Pharma to treat patients with malignancies by selectively blocking the

antiapoptotic protein Bcl-2 and hence restoring the normal apoptosis process in cancer cells. In the clinical trials, lisaftoclax has

shown broad therapeutic potentials in multiple hematologic malignancies and solid tumors, particularly in CLL/SLL, both as a monotherapy

and in combinations. Furthermore, lisaftoclax is Ascentage Pharma's second commercialized novel drug following olverembatinib. This

approval for lisaftoclax underscores Ascentage Pharma's outstanding capabilities in global clinical development and innovation,

marking another major milestone in the Company's successful development of its deep pipeline.

This approval is based on the results from a pivotal

registrational Phase II study (APG2575CC201) that was designed to evaluate the efficacy and safety of lisaftoclax monotherapy in patients

with relapsed or refractory CLL/SLL, with the overall response rate (ORR) as the primary endpoint. Lisaftoclax demonstrated compelling

efficacy and an ORR that met the prespecified endpoint in patients who previously treated with BTK inhibitors and/or immunochemotherapy.

Moreover, lisaftoclax showed a favorable safety profile with no tumor-lysis syndrome (TLS) occurring during the study, a low incidence

of hematologic toxicities which were manageable, and a low incidence of non-hematologic toxicities which were mostly grade 1-2.

CLL/SLL is a hematologic malignancy caused by

mature B-cell neoplasms. It primarily affects older populations with over 100,000 new diagnoses reported globally each year1.

In China, where the incidence rate of CLL/SLL is lower than that of the western countries, the disease is occurring at a rapidly rising

rate, with a younger age of onset and higher aggressiveness2. As the current primary option for the first-line treatment of

CLL/SLL, BTK inhibitors have significantly improved treatment outcome for patients. However, BTK inhibitors still face a range of issues

such as limited ability to induce deep responses, high risk of relapse in mid-and long-term treatment, toxicities and intolerability associated

with prolonged treatment; thus, the need for safer and more effective treatment options for the patients with CLL/SLL.

The introduction of Bcl-2 inhibitors has further

revolutionized the treatment of CLL/SLL. The apoptosis suppressor factor Bcl-2, commonly overexpressed in a variety of hematologic malignancies,

particularly CLL/SLL, is a key mechanism by which tumor cells evade apoptosis. However, the discovery of Bcl-2 inhibitor as a therapeutic

target is highly challenging mainly because its mechanism of action is based on the protein-protein interaction (PPI). The binding interface

of Bcl-2 is relatively large, making it difficult for small-molecule inhibitors to exert blocking effects. Additionally, the Bcl-2 protein

is located on mitochondria, with double-membrane structure, is among the most complex and challenging cellular components as it requires

drugs to first penetrate the cell membrane before they can further act on the mitochondrial membrane. Prior to this, no Bcl-2 inhibitor

had been approved for the treatment of CLL/SLL in China. This approval for lisaftoclax fills a treatment gap in CLL/SLL, bringing renewed

hope to many patients in the country.

Prof. Jianyong Li, Principal Investigator of

the study from the Lymphoma Center at Jiangsu Province Hospital, noted, "CLL/SLL is a common hematologic malignancy in aging

societies, and its prevalence has been steadily rising in China. Despite advancements in treatment, patients with CLL/SLL still face a

range of challenges such as drug resistance, long-term medical treatment that is difficult to manage, and disappointing response rates.

In recent years, drugs targeting pro-apoptotic proteins have received widespread interest in the oncology field while Bcl-2 inhibitors

have emerged as a new treatment strategy for patients with CLL/SLL. Globally, Bcl-2 inhibitors have already become a key part of the treatment

of CLL/SLL, but no Bcl-2 inhibitor has been approved in China up till now. This approval for the next-generation Bcl-2 inhibitor lisaftoclax

represents a timely response to the urgent unmet medical need of this patient population, effectively fulfilling the void for Bcl-2 inhibitors

in CLL/SLL in China. As the first China-developed Bcl-2 inhibitor, lisaftoclax has demonstrated favorable efficacy and a unique safety

profile, thus providing clinicians a new treatment option that can meaningfully improve the survival of patients with CLL/SLL. In April

2025, supported by its groundbreaking efficacy and safety data in Chinese patients with CLL/SLL, lisaftoclax was included in the 2025

Chinese Society of Clinical Oncology (CSCO) Guidelines for the Diagnosis and Treatment of Lymphoid Malignancies. The approval and guideline

recommendations for lisaftoclax, the only Bcl-2 inhibitor approved in China for the treatment of CLL/SLL, validated the drug as a safe

and efficacious new treatment option, underscoring a major advancement in precision therapy for hematologic malignancies in China."

Dr. Yifan Zhai, Chief Medical Officer of Ascentage

Pharma, commented, "We are encouraged by the Chinese drug regulators' recognition of lisaftoclax's efficacy and

safety, and would like to thank our investigators and their team, and the patients for participating in the clinical study, for their

efforts and trust. This approval for lisaftoclax is a milestone achieved through over a decade of committed research and clinical development

by Ascentage Pharma. Lisaftoclax addresses an urgent unmet clinical need and brings a safe and effective new treatment option to patients

with CLL/SLL. This represents another big step forward in our patient-centric global innovation. Lisaftoclax has broad therapeutic potentials

in multiple hematologic malignancies and solid tumors. We will accelerate the global development of this drug in various indications and

bring it to more patients as soon as possible."

Dr. Dajun Yang, Chairman & CEO of Ascentage

Pharma, said, "Our founding team has over 20 years of research experience in the field of apoptosis and accumulated deep expertise

on the Bcl-2 target. This approval for lisaftoclax is a culmination of their dedicated research and a major milestone in our never-ending

journey of innovation, further solidifying our leadership in the hematology field. As a proprietary novel drug developed through global

innovation, lisaftoclax is a testament to our strength in drug development, bringing much needed change to the global landscape for Bcl-2

inhibitors. Moving forward, Ascentage Pharma will remain steadfastly committed to its mission of addressing unmet clinical needs in China

and around the world and aspire to bring more innovative therapeutics to more patients globally."

Ascentage Pharma is currently conducting 4 global

registrational Phase III trials of lisaftoclax: GLORA, an FDA-cleared study of lisaftoclax in combination with BTK inhibitors for patients

with CLL/SLL previously treated with BTK inhibitors for more than 12 months with suboptimal response, as well as for the patients with

newly diagnosed CLL/SLL GLORA-2 study, with newly diagnosed, elderly and unfit acute myeloid leukemia (AML) GLORA-3 study, and newly diagnosed

higher risk myelodysplastic syndrome (MDS) GLORA-4 study.

*In the United States, lisaftoclax (APG-2575)

is an investigational compound and has not been approved by the US FDA.

About Ascentage Pharma

Ascentage Pharma (NASDAQ: AAPG; HKEX: 6855) is

a global biopharmaceutical company dedicated to addressing unmet medical needs in cancers. The company has built a rich pipeline of innovative

drug candidates that includes inhibitors targeting key proteins in the apoptotic pathway, such as Bcl-2 and MDM2-p53 and next-generation

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.

It is 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 second lead asset, lisaftoclax, is a novel

Bcl-2 inhibitor for the treatment of various hematologic malignancies. The NDA for the treatment of relapsed and/or refractory CLL and

SLL just received approval by China's National Medical Products Administration (NMPA). The Company is currently conducting 4 global

registrational Phase III trials: the 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 AML; and the GLORA-4 study in patients with newly diagnosed higher

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/

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