Nandu News Reporter Sun Xiaopeng On December 18, Nandu reporter learned from the team of Professor Dink of Jinan University that the new drug orebatinib (Nelik) developed by the team was officially announced, which is used to treat chronic granular leukemia (CML) resistance, which will greatly alleviate the plight of Chinese CML resistant patients without drugs, and is also expected to bring new choices to CML patients around the world. It is reported that orebatinib is a compound entity independently designed by Chinese, a "Chinese intelligent drug" independently completed by Chinese scientific research institutions to evaluate drugability, and Chinese enterprises independently completed clinical research and development.
According to the team leader, chronic myeloid leukemia (CML) is a malignant tumor formed by clonal proliferation of bone marrow hematopoietic stem cells, accounting for 15% of adult leukemia, and the global annual incidence rate is 1.6/100,000 to 2/100,000. Most CML patients can survive with tumors by taking Gleevec for a long time. However, a significant proportion of patients develop resistance after taking the drug for several years.
Dink is currently the dean and professor of the School of Pharmacy at Jinan University. In 2006, he paid attention to the problems of poor drug accessibility and high treatment cost for Chinese oncology patients, and decided to closely follow the clinical needs and develop Chinese his own original innovative drugs. In 2008, he cooperated with Professor Pan Jingxuan of Sun Yat-sen University to launch a new generation of anti-tumor drugs for Gleevec resistance, and was supported by the national "863 Program" in that year.
Through a rational drug design strategy based on structure, Dink instructed doctoral students such as Wang Depingbo to design and synthesize hundreds of new molecules in three years. He carefully evaluated the in vivo and in vitro pharmacodynamics, toxicity, pharmacokinetics and other data of each molecule, comprehensively analyzed the structure-activity relationship and druggability, repeatedly carried out multiple rounds of molecular structure modification, and preliminarily determined that orebatinib (formerly numbered GZD824) was a safe and effective drug candidate. It has been 3 years since the project was launched.
In 2012, after a systematic safety assessment, Professor Dink led the team to complete the key data of the preclinical druggability study of GZD824, which fully proved its effectiveness and safety. After that, Guangzhou Shunjian Biomedical Technology Co., Ltd. signed an intellectual property transfer agreement with the team and obtained its global development rights; the Dink team spent more than 2 years to complete the preclinical research on the pharmacy, pharmacology and toxicology of the drug, and formally submitted a clinical trial application to the State Food and Drug Administration in April 2015, and successfully passed the on-site verification.
On November 25, 2021, China's State Food and Drug Administration (NMPA) conditionally approved the listing of orrebutinib for the treatment of any tyrosine kinase inhibitor resistance. According to reports, orebatinib is the first and only third-generation BCR-ABL inhibitor approved for marketing in China.
"Solving clinical needs is our starting point and will always be the focus of our new drug research." On this road, we will not forget our original intention, forge ahead, and strive to make more innovative drugs that are clinically useful. Dink said.
Image: Courtesy of the team