Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) announced that China’s National Healthcare Security Administration (NHSA) has updated its 2024 National Reimbursement Drug List (NRDL) to include several of the company’s medicines. These updates expand patient access to innovative treatments across the country and highlight Zai Lab’s commitment to addressing significant medical needs.
Key NRDL Updates
- AUGTYRO® (repotrectinib): Now included for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).
- NUZYRA® (omadacycline): Renewed for its intravenous (IV) formulation to treat community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI) in adults.
- QINLOCK® (ripretinib): Renewed for advanced gastrointestinal stromal tumor (GIST) in patients who have received prior treatment with three or more kinase inhibitors.
Andrew Zhu, Chief Commercial Officer of Zai Lab, emphasized the significance of AUGTYRO’s inclusion: “The NRDL listing greatly expands access for ROS1+ NSCLC patients in China, offering a new treatment option with promising durability. We are preparing for AUGTYRO’s commercial launch by the end of 2024.”
Josh Smiley, President and Chief Operating Officer of Zai Lab, added, “With six products now included in the NRDL, Zai Lab remains focused on improving affordability and access to innovative treatments. We are committed to working with the NHSA to address unmet medical needs and enhance patient lives.”
Lung Cancer and ROS1+ NSCLC in China
Lung cancer is the most prevalent cancer and the leading cause of cancer deaths in China, accounting for approximately 1,060,600 new cases and 733,300 deaths in 2022. Non-small cell lung cancer (NSCLC) represents about 85% of all lung cancer cases, with around 70% diagnosed at an advanced or metastatic stage. Among NSCLC patients in China, approximately 2% exhibit ROS1 rearrangements, a critical target for therapies like AUGTYRO.
About AUGTYRO
AUGTYRO (repotrectinib) is a next-generation tyrosine kinase inhibitor (TKI) designed to target ROS1 and NTRK oncogenic drivers. This therapy addresses resistance mutations that often develop with earlier targeted treatments, offering improved durability and efficacy, particularly in brain metastases.
In November 2023, AUGTYRO received approval from the U.S. Food and Drug Administration (FDA) for treating locally advanced or metastatic ROS1-positive NSCLC. This was followed by its approval in May 2024 by China’s National Medical Products Administration (NMPA) for the same indications. Additionally, AUGTYRO was granted Breakthrough Therapy Designation in August 2023 by the NMPA for patients with advanced solid tumors harboring NTRK gene fusions.
Zai Lab holds an exclusive license from Turning Point Therapeutics, Inc. (a Bristol Myers Squibb company) to develop and commercialize AUGTYRO across Greater China. The company plans to launch AUGTYRO in mainland China by late 2024.
Broader Implications
The inclusion of AUGTYRO in the NRDL underscores Zai Lab’s leadership in bringing cutting-edge therapies to China. Alongside the renewals of NUZYRA and QINLOCK, the company continues to expand its portfolio and enhance patient outcomes through increased access to advanced and affordable medical solutions. These developments represent a significant milestone in Zai Lab’s mission to address critical healthcare challenges in the region.
