Zai Lab's Augtyro Included in China's National Reimbursement Drug List for ROS1+ NSCLC
核心洞察
Zai Lab's Augtyro (repotrectinib) has been added to China's National Reimbursement Drug List (NRDL) for treating adult patients with locally advanced or metastatic ROS1 (搜索)-positive non-small cell lung cancer (NSCLC (搜索)).
The NRDL update also includes the renewal of Nuzyra (omadacycline) for community-acquired bacterial pneumonia (CABP (搜索)) and acute bacterial skin and skin structure infections (ABSSSI (搜索)).
Qinlock (ripretinib) is also renewed for advanced gastrointestinal stromal tumor (GIST (搜索)) patients who have received prior treatment with three or more kinase inhibitors.
Zai Lab Limited announced that Augtyro (repotrectinib) has been included in the 2024 National Reimbursement Drug List (NRDL) in China for the treatment of adult patients with locally advanced or metastatic ROS1 (搜索)-positive non-small cell lung cancer (NSCLC (搜索)). This inclusion significantly expands access to a new treatment option with promising durability for patients in China.
Augtyro for ROS1-Positive NSCLC
Augtyro is a next-generation tyrosine kinase inhibitor (TKI) targeting ROS1 (搜索) and NTRK oncogenic drivers. It addresses resistance mutations that often limit the effectiveness of approved targeted therapies, leading to tumor progression in patients with solid tumors harboring ROS1 or NTRK gene fusions, including NSCLC (搜索). Augtyro is the first next-generation TKI designed to improve the durability of benefit, including in metastases to the brain.
In November 2023, the U.S. Food and Drug Administration (FDA) approved Augtyro for ROS1 (搜索)-positive NSCLC (搜索), followed by approval from China’s National Medical Products Administration (NMPA) in May 2024 for the same indication. Zai Lab anticipates launching Augtyro in mainland China by the end of 2024, under an exclusive license agreement with Turning Point Therapeutics, Inc. (a Bristol Myers Squibb company).
In China, lung cancer is the most commonly diagnosed cancer and the leading cause of cancer-related deaths. NSCLC (搜索) accounts for approximately 85% of lung cancer cases, with about 70% being locally advanced or metastatic at initial diagnosis. ROS1 (搜索) rearrangements occur in approximately 2% of patients with advanced NSCLC in China.
Nuzyra and Qinlock NRDL Renewal
The NRDL update also includes the renewal of Nuzyra (omadacycline) for its intravenous (IV) formulation in treating adults with community-acquired bacterial pneumonia (CABP (搜索)) and acute bacterial skin and skin structure infections (ABSSSI (搜索)). CABP is a common infectious disease with significant mortality and morbidity, while ABSSSI encompasses various bacterial infections of the skin and soft tissues. In 2020, there were approximately 10 million CABP patients and 2.8 million ABSSSI patients in mainland China. Nuzyra, a novel tetracycline-class antibacterial, has broad-spectrum activity against various bacterial infections.
Qinlock (ripretinib) is renewed for advanced gastrointestinal stromal tumor (GIST (搜索)) patients who have received prior treatment with three or more kinase inhibitors. It is estimated that approximately 30,000 GIST patients are newly diagnosed each year in China. Qinlock is an orally administered switch-control TKI that inhibits KIT and PDGFRA kinases, addressing tumor progression due to secondary mutations. The NMPA approved Qinlock in March 2021 for GIST patients who have received prior treatment with three or more kinase inhibitors.
Josh Smiley, president and chief operating officer of Zai Lab, stated, "A key part of Zai Lab’s mission is to bring innovative medicines to patients with significant unmet medical needs. We are pleased that we now have six products included in the NRDL, and we will continue our efforts to broaden patient access to our innovative treatments across China."