Zai Lab (ZLAB) Announces Breakthrough Therapeutic Designations Granted for Repotrectinib in China


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Breakthrough Therapy Designations Granted to ROS1-Positive Non-Small Cell Lung Cancer (NSCLC) Patients Pretreated with a Prior Line of ROS1 Tyrosine Kinase Inhibitor (TKI) With or Without Prior Chemotherapy

— Potentially best-in-class therapy for ROS1-positive metastatic NSCLC and NTRK-positive advanced solid tumors

Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), an innovative, patient-focused global biopharmaceutical company, today announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has granted two Breakthrough Therapy Designations for investigational repotrectinib for the treatment of patients with metastatic ROS1-positive NSCLC who have received prior line ROS1 TKI and prior line platinum-based chemotherapy (EXP-2) and for those with ROS1-positive metastatic NSCLC who have received a prior line of ROS1 TKI and no chemotherapy or immunotherapy (EXP-4). Breakthrough therapy designations for repotrectinib were supported by data from TKI-pretreated ROS1 positive NSCLC patients globally and in China enrolled in the Phase 1/2 TRIDENT-1 study.

“Since repotrectinib received Breakthrough Therapy designation from the CDE earlier this year for TKI-naïve ROS1-positive patients, today’s recognition further supports repotrectinib as a potential first-line treatment for ROS1-positive NSCLC in TKI-naïve and treatment-experienced patients in China,” said Alan Sandler, MD, president and global development manager, oncology at Zai Lab. “There remain significant unmet needs for patients with ROS1-positive NSCLC, and we look forward to our continued partnership with regulatory authorities in China to bring this important medicine to the patients who need it as soon as possible.”

The Breakthrough Therapy Designation review policy is designed to facilitate the rapid development and review of new drugs intended for the prevention or treatment of serious, life-threatening illnesses or conditions that seriously affect the quality of life for which there is no treatment, or when there is sufficient evidence to indicate the benefits of the new medicine over currently available treatment options. Drugs with breakthrough therapy designation receive priority CDE communications and guidance to promote and expedite the drug development process.

Lung cancer is both the most commonly diagnosed type of cancer and the leading cause of cancer death in China. The incidence of lung cancer in China in 2020 was 815,563 cases, with 714,699 deaths1. NSCLC accounts for approximately 85% of lung cancers and approximately 70% of NSCLCs are locally advanced or metastatic at the time of initial diagnosis. In China, ROS1 rearrangements occur in 2-3% of patients with advanced NSCLC.

1Globocan 2020.

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