Independent research and development of new anti-cancer drugs in the United States was approved for market

recently, zaubrutinib, the first cancer drug developed entirely by China and based on clinical research in Chinese patients, was officially approved for listing by the U.S. Food and Drug Administration (FDA). The drug is a new generation of BTK inhibitors introduced by Baiji Shenzhou to treat adult patients with set cell lymphoma who have been treated at least once before. Based on the positive results demonstrated by Zebutini in clinical trials of heterocytic lymphoma, the FDA has identified it as a "breakthrough therapy", which has enabled China's innovative drugs to achieve a breakthrough from 0 to 1 in the process of going global.
As the lead of Zebtini Clinical Research Project, Professor Zhu Jun of Peking University Oncology Hospital, Beijing University Oncology Hospital officially opened Zebtini Clinical Research Project in February 2017. This is a single-arm multi-center key phase 2 study, including a total of 86 patients with relapsed or difficult-to-treat set of cell lymphoma nationwide. For a medium follow-up period of 18.4 months, the researchers assessed the best ORR (total efficiency) at 84% and CR (full mitigation rate) at 78%. Compared with the first generation of BTK inhibitors, Zebutini not only improved the efficacy, but also the occurrence of atrial fibrillation, second tumor, tumor dissolution syndrome is 0, once again proved that it has better safety as a new generation of BTK inhibitors.
Zhu Jun pointed out that during the International Lymphoma Conference in June 2019, Professor Song Yuqin of Peking University Cancer Hospital gave his first oral report on Zebutini's use in the treatment of patients with relapsed/resuscable sleeve lymphoma. From October 21 to 24, 2019, Professor Zhu Jun's research team, together with the Drug Clinical Trials Agency, the Ethics Committee and other auxiliary departments, accepted the FDA's on-site verification of the clinical trial. FDA inspectors are fully positive about the quality of clinical trials and quickly approve the drug for market approval in a relatively short period of time.
"This indicates that the research of innovative new drugs in our country has entered a fast track or a new platform, or even a new period of development." Zhu Jun said that most of the once-effective anti-cancer drugs were developed by foreign pharmaceutical companies and marketed abroad for many years before entering China, causing many patients to lose the best treatment time while waiting. The FDA's approval of any new drug is based primarily on clinical data from patients in The U.S. and Europe, and even global clinical trials involving Chinese patients account for only a small share, requiring our own clinical studies to give Chinese patients tangible results.
Experts predict that Zebtini will be able to approve the listing in China by the first half of 2020 at the latest. Dr. Wu Xiaobin, General Manager and President of Baiji Shenzhou China, said, "We are proud that Zebutini has been approved by the FDA, which represents an international recognition of the level of research and development of new drugs in China. More importantly, it proves that China's innovative pharmaceutical companies can not only benefit their own patients, but also have the strength to serve patients around the world. " (Health News)