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NMPA Approved the First New Drug Independently Discovered by GIBH


On November 25th, Olverembatinib  developed independently by Guangzhou Institutes of Biomedicine and Health, Chinese Academy of Sciences (referred to as GIBH hereinafter) was officially approved t by the National Medical Products Administration (NMPA) for the treatment of adult patients with tyrosine kinase inhibitor (TKI)-resistant chronic phase chronic myeloid leukemia (CML-CP) or accelerated-phase CML (CML-AP) harboring the T315I mutation. It marks the first class 1.1 new drug approved ever since the founding of the GIBH in 2003.  

CML is a malignant cancer related with leukocytes. The treatment of CML has been revolutionized with the TKI drug targeting BCR-ABL. However, acquired drug resistance has always been a major challenge to CML treatment. The kinase domain mutation of BCR-ABL is one of the major mechanisms of acquired drug resistance, with T315I as one of the most common resistant mutations with an occurrence rate of approximate 25% in resistant CML patients. CML patients with T315I mutation have developed resistance to all existing BCR-ALB inhibitors including the first generation drugs imatinib, the 2nd generation drugs nilotinib and dasatinib. There is no efficient drug available for the T315I mutated CML in China since the mutant was identified 15 years ago.  

In 2006, the GIBH recruited Dr. Ding Ke as a full-time Principal Investigator. Ding’s team initiated the new drug development program targeting the acquired resistance against imatinib under a support from the national “863” program by collaborating with Prof Jingxuan Pan in Sun Yat- Sen University. After 5-year extensive investigation, the team nominated GZD824 (Olverembatinib) as clinical candidate (PCC) and reached a license agreement with Guangzhou Shunjian Biomedicine Technology Company for further  development.  

In 2016, GZD824 (Olverembatinib) received the approval for clinical investigation from China NMPA (original CFDA). On 25th November, 2021, Olverembatinib was officially approved. The whole development process took approximate 13 years, exemplified as a typical success story of new drug translation from R & D by research institutions to industrialization by enterprises. 

Olverembatinib is a potential best-in-class new drug, supported by national major new drugs innovation and manufacturing initiative. The approval of Olverembatinib is mainly based on two sets of critical registered phase II clinical research data, respectively HQP1351CC201 research and HQP1351CC202 research. The clinical data show that Olverembatinib demonstrates solid effectiveness and great tolerance in CML-CP and CML-AP patients who have developed TKI resistance with T3151 mutation. What’s more, with the treatment continued, the alleviation rate and depth will be further increased. 

As China’s first 3rd generation drug for CML with BCR-ABL resistance, the approval of Olverembatinib will break the treatment bottleneck plaguing Chinese patients with drug resistance due to T315I mutation and thus end the plight of no treating drugs. Additionally, Olverembatinib also received “orphan drug destination” from both US FDA and European Committee (EC), indicating the potential global development opportunity of this drug.