Pfizer's Leukemia Innovative Drug Besponsa® (Inotuzumab Ozogamicin) Officially Launched in China with First Prescriptions Issued Nationwide

ShanghaiJune 27, 2022PR Newswire -- Recently, Pfizer's innovative leukemia drug Besponsa^®(Inotuzumab Ozogamicin for Injection) has been prescribed in the first batch of prescriptions in multiple cities across China.Multi-city Linkage, officially implemented. This marksThe World's FirstAntibody-drug conjugates (ADC) for relapsed or refractory precursor B-cell ALL (R/R B-ALL) are beginning to benefit patients with acute lymphoblastic leukemia in China.

To Accelerate Besponsa^®This innovative therapy has been used in clinical treatment. Pfizer and its partners have worked together with "Lightning Speed Action" to promote the import and distribution of the drug, rapidly covering major hematology treatment centers across China. Currently, the institutions that have first prescribed the drug for patients include: the Peking University Institute of Hematology, the First Affiliated Hospital of Soochow University, the Harbin Institute of Hematology and Oncology, the Blood Disease Hospital of the Chinese Academy of Medical Sciences, Nanfang Hospital of Southern Medical University, and the First Affiliated Hospital of Zhejiang University School of Medicine, etc.

Besponsa^®Approved by the China National Medical Products Administration in December 2021 for adult patients with relapsed or refractory precursor B-cell acute lymphoblastic leukemia (R/R B-ALL). As a hot drug in current tumor immunotherapy, Besponsa^®Is the world's first ADC targeting CD22 to receive FDA approval. The unique mechanism of ADC drugs can improve the complete remission (CR) rate for R/R B-ALL treatment (achieving CR is a prerequisite for hematopoietic stem cell transplantation), marking an epoch-making significance in the treatment of acute lymphoblastic leukemia.

Professor Huang Xiaojun, Director of the Hematology Research Institute of Peking University, stated: "The arrival of Ogiyituzumab brings hope for patients to have more treatment options. More leukemia patients will have the opportunity to undergo hematopoietic stem cell transplantation, thereby achieving long-term survival. The current treatment dilemma is expected to be broken, and a new treatment standard may be further established. The R/R B-ALL treatment field has reached a milestone."

Innovative Therapies forR/R B-ALL Patients Break Clinical Dilemma

Acute Lymphoblastic Leukemia (ALL) is one of the four main types of leukemia, a malignant tumor disease originating from the abnormal proliferation of B- or T-lymphocyte cell lines in the bone marrow. The abnormally proliferating blast cells can accumulate in the bone marrow, suppressing normal hematopoietic function, and may also infiltrate extramedullary tissues.

Wu Depei, Director of the Hematology Department at the First Affiliated Hospital of Soochow University, introduced: "Currently, the treatment for ALL patients in China is mainly chemotherapy. Under traditional standard chemotherapy regimens, it is difficult for R/R ALL patients to achieve complete remission (CR) and obtain long-term survival. After years of exploration and modification, there are still many unmet clinical needs for adult R/R B-ALL."

Acute Lymphoblastic Leukemia (ALL) is an extremely aggressive leukemia with a very poor prognosis in adult patients. According to statistical data, 40%-50% of adult patients eventually experience relapse. For relapsed or refractory patients, current treatment options have even lower complete remission (CR) rates and poor survival outcomes. After disease recurrence in adult ALL patients, the overall CR rate of previous treatment regimens is approximately 40%, with a 3-year survival rate of about 11% [1], and the 5-year overall survival rate is less than 10% [2].

Professor Jun Ma, Director of the Harbin Hematology and Oncology Research Institute, stated: "Traditional treatment regimens have not significantly improved long-term survival for relapsed patients. Additionally, conventional cytotoxic drugs can lead to severe adverse events and long-term sequelae, affecting quality of life. The advent of antibody-drug conjugates brings new hope to anti-tumor therapy, breaking the current clinical treatment status for adult R/R ALL patients, increasing their chances of receiving hematopoietic stem cell transplantation (HSCT), and providing more opportunities for a cure."

Professor Wang Jianxiang, Director of the National Clinical Research Center for Hematologic Diseases, emphasized: "As one of the hotspot drugs in current tumor immunotherapy, antibody-drug conjugates, with their unique tumor specificity and potency, represent a breakthrough new drug. It is hoped that its therapeutic advantages can be further confirmed during clinical use, improving patients' OS rates, bringing greater therapeutic benefits to our patients, and helping more patients enhance their quality of life."

Besponsa^®Composed of two parts: a monoclonal antibody targeting CD22 and the cytotoxic drug calicheamicin. The CD22 antigen is commonly found on the surface of B cells. Besponsa^®Capable of targeting cancer cells and binding to the CD22 antigen on their surface [3]. Subsequently, it rapidly degrades by leveraging the environmental differences between the blood system and tumor cells, releasing toxic molecules intracellularly, which can more easily penetrate the cell membrane and kill surrounding cells [4]. Compared with standard chemotherapy, Besponsa^®More than doubled the CR/CRi rate, with a higher MRD negativity rate [5] and a higher bridging-to-transplant rate [8].

Driving Innovation for Drug Accessibility, Empowering Patients with Treatments

As one of the hotspot drugs in current tumor immunotherapy, Oportuzumab can target cancer cells, more easily penetrate the cell membrane, and kill surrounding cells [6]; compared with standard chemotherapy, it can help more patients subsequently have the opportunity for hematopoietic stem cell transplantation, thereby achieving long-term survival. However, while innovative drugs enter clinical application, treatment costs are also a key factor affecting treatment, thus improving drug accessibility has become a focus of clinical attention.

Professor Qifa Liu, Director of the Hematology Research Institute of Southern Medical University, stated: "Congratulations on the rapid clinical implementation of this innovative therapy. I hope that in the future, it can achieve medical insurance reimbursement as soon as possible, benefiting patients and their families in China with higher accessibility and pharmacoeconomic effects, thereby truly realizing the value of innovative outcomes for patients and the healthcare system."

Professor Jie Jin, Director of the Hematology Department at the First Affiliated Hospital of Zhejiang University School of Medicine, stated: "Efficacy and cost are the two most important concerns for cancer patients. We look forward to more innovative drugs being applied clinically in the future to benefit more patients. We also hope that innovative treatment drugs like Inotuzumab Ozogamicin, which are recommended by international guidelines, will be included in China's medical insurance catalog as soon as possible to alleviate the financial burden on more patients."

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