On March 31st, the new drug Qingle ® (Repatinib) has been approved by the National Drug Administration for marketing and is used to treat adult patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with three or more kinase inhibitors, including imatinib. The drug became the first GIST four line therapeutic drug approved for marketing in Chinese Mainland, filling the gap in the field of disease treatment in China. This drug is also the first clinically urgently needed medication to be applied under the policy of "taking medicine away from the park" in the Lecheng pilot area.
According to the latest version of the "Clinical Practice Guidelines for Soft Tissue Sarcoma" released by the National Comprehensive Cancer Network (NCCN) in the United States and the first version of the "Chinese Society of Clinical Oncology (CSCO) GIST Guidelines" in China, repatinib is recommended as the only GIST fourth line treatment drug after the failure of imatinib, sunitinib, and regofinib third line treatments.
It is reported that with in-depth research on GIST, the widespread application of targeted drugs has brought better survival benefits to patients. However, some patients may still develop new gene mutations after receiving first, second, and third line targeted drug treatment, leading to resistance to the original drug. Therefore, repatinib has been approved for marketing, providing a new treatment plan for domestic GIST patients, which will further assist patients in improving prognosis and quality of life.
It is worth mentioning that in July 2020, just two months after the global first approval, Ruipaitinib was applied in the Hainan Free Trade Port Boao Lecheng International Medical Tourism Pilot Zone, benefiting domestic patients and being the first new drug to be used simultaneously by Chinese and global patients. At the same time, this drug is also the first clinically urgently needed medication specifically approved for use outside the Hainan Free Trade Port after the release of the overall construction plan, and the first offshore patient management project to be implemented in Hainan.
So far, dozens of patients have benefited from the "take medicine away from the park" policy in the Lecheng pilot area of Hainan, and have taken the lead in using this innovative drug. With the approval of repatinib, more Chinese patients with gastrointestinal stromal tumors will be able to use this innovative drug, leading to new innovative therapies.