▎Edited by the WuXi AppTec content team

Today (May 11), the latest announcement on the official website of China's National Medical Products Administration (NMPA) revealed that applications submitted by Bristol-Myers Squibb Company and Zai Lab have been disclosed.Ripretinib CapsulesThe marketing application has been approved in China for adult patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).RipretinibIs aNew Generation Tyrosine Kinase Inhibitor (TKI），Zai Lab has the exclusive rights to develop and commercialize this product in Greater China.。

Screenshot source:NMPA Official Website

Ripretinib was initially developed by Turning Point (now acquired by Bristol-Myers Squibb) and is aROS1 and NTRK Targeted Inhibitors。It has a unique structure, binding to the target protein's site within the "ATP pocket," and remains unaffected by various resistance mutations.Therefore,It can overcome various genetic mutations that confer resistance to other TKIs., killing the carriersROS1OrNTRKMultiple tumor cells with gene fusion have the potential to treat ROS1-positive NSCLC, as well as solid tumors positive for ROS1, NTRK, and ALK.

In July 2020, Zai Lab entered into a collaboration with Turning Point worth over $170 million, obtaining exclusive development and commercialization rights for Ripretinib in Greater China (including mainland China, Hong Kong, Macao, and Taiwan regions). In June 2022, Bristol-Myers Squibb Company announced a collaboration with Turning Point.CompanyReach an agreement, investing over 4 billion US dollarsAcquisitionThe latter, thereby incorporating Ripretinib into its R&D pipeline.

Ripretinib TreatmentEfficacy in adult patients with locally advanced or metastatic ROS1-positive NSCLC has beenPhase 1/2 TrialValidated in TRIDENT-1.Based on the TRIDENT-1 study,RipretinibAs of November 2023In the United StatesApproved for Marketing，For the treatment of adult patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer.

According to the previously published TRIDENT-1 study by Zai LabChina SubgroupMain data of the population,Ripretinib TreatmentAdult patients with locally advanced or metastatic ROS1-positive NSCLC show good efficacy and safety.

• In the ROS1 TKI-naive cohort, 11 patients were from China, as assessed by blinded independent central review (BICR).The confirmed objective response rate (cORR) was 91%.The confirmed duration of response (DOR) ranged from 3.6+ months to 7.5+ months, with a median follow-up time of 3.7 months.

• In the previously treated cohort who received one frontline ROS1 TKI and one frontline chemotherapy, 3 patients were from China.cORR was 67%The range of DOR was 3.6+ months to 3.7+ months, with a median follow-up time of 3.7 months.

• In the pretreated cohort who had previously received two frontline ROS1 TKIs, there were 4 patients from China.cORR is 50%The range of DOR was 1.9+ months to 3.4+ months, with a median follow-up time of 2.6 months.

• In the pretreated cohort who had previously received one frontline ROS1 TKI and had not received chemotherapy or immunotherapy,Patients from China totaled 11 cases,cORR was 36%, The range of DOR is 2.0+ months to 3.7+ months., with a median follow-up time of 3.1 months.
  
  

[4] World Conference on Lung Cancer (WCLC) Abstract Released: Ripretinib Median Progression-Free Survival Reaches 35.7 Months. Retrieved Aug 17, 2023 from https://mp.weixin.qq.com/s/UEC8k6xghFNdQ4nhVd3TgA

[5] Zai Lab announces the first patient enrolled in the Greater China region for the TRIDENT-3 study of Repotrectinib in ROS1-positive non-small cell lung cancer. Retrieved Jan 3, 2024, from https://mp.weixin.qq.com/s/Kr28GKG23Uqg66TgxaJM4g