Inotuzumab Ozogamicin

ROCKVILLE, Md. and SUZHOU, China, June 09, 2025 (GLOBE NEWSWIRE) -- Ascentage Pharma (NASDAQ: AAPG; HKEX: 6855), a global biopharmaceutical company dedicated to addressing unmet medical needs in cancers, announced that 13 studies of its core assets - including the novel drug olverembatinib (HQP1351), the investigational Bcl-2 inhibitor lisaftoclax (APG-2575), and the investigational EED inhibitor APG-5918 – will be featured in an oral presentation, multiple poster presentations and multiple online publications at the 2025 European Hematology Association (EHA) Annual Congress taking place in Milan, Italy, from June 12-15, 2025. The EHA Annual Congress is the largest gathering of the hematology community in Europe. Attracting more than 10,000 attendees from more than 100 countries every year, the congress showcases cutting-edge research and ground-breaking clinical results in the field of hematology. Oral Presentation Integrating Genomic and Transcriptomic Insights for Predicting Responses and Outcomes in Patients with CML Receiving 3rd-Generation TKI Therapy Abstract#: S162 Session: Biology of CML treatment response and resistance Date and Time: Saturday, 14 June, 17:30-17:45 CEST / Saturday, 14 June, 23:30-23:45 Beijing Time Principal Authors: Prof. Qian Jiang, Peking University People’s Hospital; Dr. Xiaoshuai Zhang, Peking University People’s Hospital Poster Presentations Frontline Chemotherapy-Free Combination of Olverembatinib with Venetoclax and Azacitidine in Newly Diagnosed Ph+ Acute Lymphoblastic Leukemia: Preliminary Outcomes of a Prospective Study Abstract#: PF384 Session: Acute lymphoblastic leukemia – Clinical Date and Time: Friday, 13 June, 18:30-19:30 CEST / Saturday, 14 June, 00:30-01:30 Beijing Time Principal Author: Prof. Xiaowen Tang, The First Affiliated Hospital of Soochow University; Xin Zhang, The First Affiliated Hospital of Soochow University A Phase 2 Study of Olverembatinib for the Treatment of Myeloid/Lymphoid Neoplasms with FGFR1 Rearrangement Abstract#: PF390 Session: Acute lymphoblastic leukemia – Clinical Date and Time: Friday, 13 June, 18:30-19:30 CEST / Saturday, 14 June, 00:30-01:30 Beijing Time Principal Authors: Prof. Suning Chen, The First Affiliated Hospital of Soochow University; Wenzhi Cai, The First Affiliated Hospital of Soochow University Efficacy and Safety of Regimen with Olverembatinib and Blinatumomab for the Frontline Treatment of Ph-Positive or Ph-Like Acute Lymphoblastic Leukemia Abstract#: PS1367 Session: Acute lymphoblastic leukemia – Clinical Date and Time: Saturday, 14 June, 18:30-19:30 CEST / Sunday, 15 June, 00:30-01:30 Beijing Time Principal Authors: Prof. Hongsheng Zhou, Nanfang Hospital, Southern Medical University; Xiuli Xu, Nanfang Hospital, Southern Medical University Combination of Olverembatinib and VP Regimen as First-Line Therapy for Adult Patients with Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia: A Single-Arm, Multicentre, Phase 2 Trial Abstract#: PS1372 Session: Acute lymphoblastic leukemia – Clinical Date and Time: Saturday, 14 June, 18:30-19:30 CEST / Sunday, 15 June, 00:30-01:30 Beijing Time Principal Authors: Prof. Jie Jin, The First Affiliated Hospital, Zhejiang University School of Medicine; Dr. Gaixiang Xu, The First Affiliated Hospital, Zhejiang University School of Medicine Efficacy and Safety of The Third-Generation Tyrosine Kinase Inhibitor Olverembatinib in Combination with Inotuzumab Ozogamicin for the Treatment of Adult Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia Patients With Relapsed Disease or Persistent Minimal Residual Disease Bridging to Hematopoietic Stem Cell Transplantation: A Phase II Study Abstract#: PS1387 Session: Acute lymphoblastic leukemia – Clinical Date and Time: Saturday, 14 June, 18:30-19:30 CEST / Sunday, 15 June, 00:30-01:30 Beijing Time Principal Author: Erlie Jiang, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College; Xiaoyu Zhang, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College Embryonic Ectoderm Development (EED) Inhibitor APG-5918 Exhibits Potent Antitumor Activity and Synergizes with Histone Deacetylase Inhibitor Tucidinostat in Preclinical T-Cell Lymphoma (TCL) Models Abstract#: PS1993 Session: Lymphoma biology & translational research Date and Time: Saturday, 14 June, 18:30-19:30 CEST / Sunday, 15 June, 00:30-01:30 Principal Author: Dr. Eric Liang, Ascentage Pharma Group Inc. Online Publications Alternating Low-Dose Inotuzumab Ozogamicin and Blinatumomab in Maintenance Therapy for Ph+ ALL: A Single-Center Retrospective Analysis Abstract: PB2384 Principal Author: Prof. Zi-Yuan Nie, The Second Hospital of Hebei Medical University Efficacy and Safety of Blinatumomab in Newly-Diagnosed Patients with Ph-Positive/Negative B-Cell Acute Lymphoblastic Leukemia Abstract#: PB2363 Principal Author: Yinqiang Zhang, Institute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Efficacy and Safety of the Third-Generation TKI Olverembatinib in Relapsed and Persistent MRD Positive Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia Patients Abstract#: PB2360 Principal Author: Xinwen Jiang, The Second Hospital of Hebei Medical University Clinical Features and Genetic Abnormalities Predict Outcomes in Patients with Chronic Myeloid Leukemia in the Accelerated-Phase Receiving Olverembatinib Therapy: A Retrospective Multicenter Study Abstract#: PB2701 Principal Author: Mengyao Yuan, Peking University People's Hospital A Real-World Study of Olverembatinib in the Treatment of Chronic Myeloid Leukemia from China: A Single-Center Retrospective Study Abstract#: PB2714 Principal Author: Tian Dong, West China Hospital of Sichuan University Synergistic Effects of Olverembatinib (HQP1351) Combined with Bcl-2 Inhibitor Lisaftoclax (APG-2575) and Bcl-2/Bcl-xL Inhibitor Pelcitoclax (APG-1252) in T-Cell Acute Lymphoblastic Leukemia (T-ALL) Abstract#: PB2341 Principal Author: Bo Peng, Ascentage Pharma (Suzhou) Co., Ltd. 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 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. 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 newly diagnosed Ph + ALL patients 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 was accepted with Priority Review designation by China’s National Medical Products Administration. The Company is currently conducting an FDA-cleared, global registrational Phase III trial, or GLORA, 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 global registrational Phase III trials for newly diagnosed CLL/SLL, AML, and MDS patients. 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: Hogan Wan, Head of IR and Strategy Ascentage Pharma Hogan.Wan@ascentage.com +86 512 85557777 Stephanie Carrington ICR Healthcare Stephanie.Carrington@icrhealthcare.com +1 (646) 277-1282 Media Relations: Sean Leous ICR Healthcare Sean.Leous@icrhealthcare.com +1 (646) 866-4012 Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

New Delhi: With more than 1.5 million active cases across the country, the prevalence of cancer in India has certainly outpaced the available treatment interventions. However, what makes the situation even worse is the sky-high cost of treatment, which makes these therapies inaccessible to many patients, leaving them in a desperate struggle to secure financial aid and loans for life-saving medicines. A walk around Mumbai’s Tata Memorial Hospital, India’s premium cancer care institution, shows the appalling situation. T he entrance is always overflowing with patients from across the country, while many managing to live in makeshift shelters in extreme financial distress to cope with costs of treatment. A study showed a small fraction of Indians, roughly 3 per cent can afford expensive immunotherapies in India, making it a big challenge for public health establishments to reach modern medicines to the low income strata. To confront this growing crisis, the government has opted for a strategy of waiving customs duties on life-saving medications, thereby reducing import costs and hoping to translate these savings into more affordable treatment options for patients. The Finance Minister said in her Budget 2025 speech, “To provide relief to patients, particularly those suffering from cancer, rare diseases, and other severe chronic conditions, I propose to add 36 life-saving drugs and medicines to the list of medicines fully exempted from Basic Customs Duty .” She also proposed to add “six life-saving medicines to the list attracting a concessional customs duty of 5 percent.” The government order states, “In exercise of the powers conferred by sub-section (1) of section 25 of the Customs Act, 1962 (52 of 1962), the Central Government, on being satisfied that it is necessary in the public interest to do so,” has exempted Basic Customs Duty on 36 life-saving medications. A rough analysis of the list shows that out of the 36 medications, 25 are indicated for the treatment of various types of cancer. Feb 4, World Cancer Day , is the perfect time to assess whether exempting customs duties could make a significant difference to patient expenses. The majority of these drugs are protected by patents, granting them global exclusivity, and are marketed by major pharmaceutical giants such as Merck, Roche, GSK, and AstraZeneca. Strikingly, in the previous Budget 2024, the government announced the exemption of customs duty on three cancer drugs—Osimertinib, Durvalumab, and Trastuzumab Deruxtecan. The first two medications are indicated for lung cancer, while the latter is used in the treatment of breast cancer. All three are marketed by UK pharma giant AstraZeneca. According to the government, “Drugs/medicines generally attract a basic customs duty of 10 percent, while some categories of life-saving drugs/vaccines attract a concessional rate of 5 percent or nil.” The Basic Customs Duty (BCD) is calculated over the customs value, which is the accumulation of the CIF cost where C represents the cost of goods, I stands for insurance, and F accounts for freight or logistics costs. Besides BCD, the government levies a social welfare surcharge of 10 per cent, calculated over the BCD value, and a 5 per cent Integrated Goods and Services Tax (IGST), calculated over the accumulated figure of CIF value and BCD of the imported goods. Speaking to ET Pharma, Leena Menghaney, a lawyer and public health activist, stressed, “The customs duty waiver on some of the exorbitantly priced cancer and rare disease drugs is a welcome move, but it is like a band-aid and does not address the underlying problem of high prices due to patent monopolies that block local production.” “India is a country where half the population lives on less than $1 per day and bears a large public health burden for cancers. How can patients pay for patented medicines like Keytruda ?” she added. While industry stakeholders are still analysing the net impact of the announcement, Dr.B. S. Ajaikumar, Executive Chairman of Healthcare Global Enterprises Limited, said, “The exemption of customs duty will have an impact of 5-10 percent on the price of drugs, and this development will primarily benefit cash-paying patients, with some benefit extending to those utilizing insurance.” Bhanu Prakash Kalmath, a consultant at Grant Thornton Bharat LLP, underlined, “The final reduction will depend on manufacturers, hospitals, and supply chains. This move directly reduces import costs and supports broader access to essential treatments. It also benefits insurance providers, government health schemes like Ayushman Bharat , and Patient Assistance Programs (PAPs).” Under the Patient Assistance Programs (PAP) offered by pharmaceutical companies, medicines are provided in 1+1 or 2+1 packages, where the patient pays for one or two drugs and receives an additional one free of cost. However, under the condition of anonymity, an expert shared that very few patients in the country are currently covered under PAP programs. Additionally, at times, the last-stage providers (mostly hospitals) that stock these drugs apply a profit margin over the products. Furthermore, it is crucial to note that while the Finance Minister’s announcement has exempted customs duties, patients still have to contend with the Maximum Retail Price (MRP) of drugs. The MRP is compiled based on several other costs, as post-import, the product often requires special storage, handling, and packaging before distribution to retail outlets. The distribution costs include transportation to wholesalers and retail outlets, along with the distributor’s margin. To make novel treatments truly affordable for the Indian demographic, Menghaney emphasised, “The country needs to boost local production and competition by granting a compulsory license clause. This would cut the cost of the drug by allowing another company to manufacture the therapy, even though it is still under patent.” “In the past, such measures have slashed prices by introducing local generic versions of cancer drugs—by an astounding 97 percent,” she added. The high price of cancer drugs has long been a contentious issue across low- and middle-income countries (LMICs), including India. However, given the scale and severity of the problem, it categorically requires a more holistic solution—one that ensures benefits are truly materialized for patients. As philanthropist Bill Gates once said, “The good news is that we have the tools to prevent most diseases. But the bad news is that not enough people are getting them.” List of Cancer Drugs to exempted from BCD under Budget 2025-26 S. No. Drug Company Brand Name MRP (INR) 1. Pembrolizumab MSD (Merck, Sharp & Dohme) Keytruda 2,16,500 2. Lorlatinib Pfizer Lorbrena 10,400 3. Dacomitinib Pfizer Vizimpro 2,135 4. Inotuzumab Ozogamicin Pfizer Besponsa 3,30,000 5. Ribociclib Novartis Kisqali 1,125 6. Dabrafenib Novartis Tafinlar 1,516 7. Selumetinib AstraZeneca Koselugo - 8. Fulvestrant AstraZeneca Faslodex 21,100 9. Acalabrutinib AstraZeneca Calquence 15,147 10. Olaparib AstraZeneca Lynparza 5,416 11. Amivantamab J&J Rybrevant 98,500 12. Teclistamab J&J Tecvayli 76,218 13. Daratumumab and hyaluronidase-fih J&J Darzalex Faspro 2,64,600 14. Ibrutinib J&J Imbruvica 3,644 15. Bortezomib J&J Velcade 18,060 16. Daratumumab J&J Darzalex 18,900 17. Cetuximab Merck Specialties (Merck KGaA) Erbitux 21,250 18. Avelumab Merck Specialties Bavencio - 19. Tepotinib Merck Specialties Tepmetko 5,094 20. Brentuximab Vedotin Takeda Adcetris 2,22,709 21. Vedolizumab Takeda Entyvio - 22. Atezolizumab Roche Tecentriq 2,77,708 23. Pertuzumab+trastuzumab Roche Phesgo 2,80,000 24. Polatuzumab vedotin Roche Polivy 2,22,225 25. Alectinib Roche Alecensa 2,215 Note* the above price is without any deduction and of lowest dosage strength as some of the drugs are available in multiple strengths and their prices also very depending upon that particular strength. By Abhijeet Singh ,