On May 6, 2022, Olverembatinib Tablets, a Class 1 novel drug independently developed by the Guangzhou Institutes of Biomedicine and Health (GIBH), Chinese Academy of Sciences (CAS), garnered another prestigious recognition. Having been successively included in the 2022 Edition of CSCO Guidelines for the Diagnosis and Treatment of Hematological Malignancies and selected as one of China’s 2021 Major Medical Advances, the drug has fully demonstrated the recognition of its originality and clinical value by the industry and clinical community.
Recently, the CSCO Guidelines Conference was held online, where a number of updated CSCO guidelines were released. Olverembatinib (GZD824), a third-generation BCR-ABL inhibitor independently developed by GIBH, was successfully incorporated into the 2022 Edition of CSCO Guidelines for the Diagnosis and Treatment of Hematological Malignancies. It is explicitly recommended for the treatment of patients with tyrosine kinase inhibitor (TKI)-resistant chronic myeloid leukemia (CML) harboring the T315I mutation and those with Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL).
China’s 2021 Major Medical Advances compiled over 276,000 pieces of basic data including papers, patents, and approved drugs from Chinese researchers in 2021. Through quantitative analysis, expert evaluation, and comprehensive assessment, 77 candidate entries were shortlisted. After recommendation by academic division members, review by the Audit Committee, and approval by the Executive Committee, 31 major advances of the year were finally identified, among which 8 belonged to the pharmaceutical field. Olverembatinib was honored to be listed as a key advance in the pharmaceutical sector.
Olverembatinib Tablets were developed by the research team led by Professor Ding Ke at GIBH. In 2013, preliminary laboratory validation confirmed GZD824 as a drug candidate, and the related patents were transferred to Guangzhou Shunjian Biomedical Technology Co., Ltd. for industrialization and development. In 2016, Olverembatinib obtained clinical approval as a Class 1.1 novel drug, and its clinical trials were subsequently advanced by Jiangsu Yasheng Pharmaceutical Co., Ltd., the parent company of Guangzhou Shunjian. On November 25, 2021, Olverembatinib was approved for marketing by the National Medical Products Administration (NMPA), marking the culmination of a 13-year development journey. On December 31, 2021, the first batch of Olverembatinib prescriptions were issued simultaneously in multiple regions across China, officially launching its clinical application.
As the first Class 1 novel drug approved for marketing since GIBH’s establishment, Olverembatinib is also China’s first and only approved third-generation BCR-ABL inhibitor. It has filled the domestic clinical gap and holds potential best-in-class advantages on a global scale. The official launch of this drug has broken the survival predicament of T315I-mutated resistant CML patients who previously had no access to effective treatment, demonstrating significant social and clinical value.
