Zai Lab Limited, a pioneering biopharmaceutical enterprise engaged in research and commercialization, has disclosed an update pertaining to the inclusion of specific pharmaceuticals and their indications in the 2024 National Reimbursement Drug List (NRDL), as unveiled by the National Healthcare Security Administration (NHSA) of China.
Among the drugs approved, Augtyro (repotrectinib) now features in the NRDL for adults battling locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). Nuzyra (omadacycline) retains its spot, covering its intravenous formula for adults suffering from community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). Likewise, Qinlock (ripretinib) maintains its listing for those with advanced gastrointestinal stromal tumors (GIST) who have undergone treatment with three or more kinase inhibitors in the general setting.
Andrew Zhu, Zai Lab’s chief commercial officer, emphasized, “Including Augtyro in the NRDL profoundly enhances patient access in China to a viable treatment alternative with durable outcomes for ROS1+ NSCLC. We anticipate launching Augtyro fully by the close of 2024.” Zhu further highlighted that the augmentation of Augtyro, coupled with Nuzyra and Qinlock renewals, enhances the availability of crucial medications across China, making treatments more economically feasible for patients and their kin.
Josh Smiley, president and COO of Zai Lab, stated, “Our core mission at Zai Lab revolves around introducing groundbreaking medicines to those with urgent medical needs. We are excited to have six products now in the NRDL and committed to expanding patient access to our innovative solutions throughout China. We eagerly await working alongside the NHSA to enhance affordability and reach for unique treatment options in China, ultimately aiming to improve the quality of life for patients.”
China faces a significant challenge with lung cancer, being the most prevalent diagnosed cancer type and leading in cancer-related fatalities. In 2022, there were approximately 1,060,600 new lung cancer cases and 733,300 resultant deaths. NSCLC is responsible for around 85% of lung cancers, with about 70% being advanced or metastasized when initially diagnosed. ROS1 genetic rearrangements are noted in nearly 2% of patients with advanced NSCLC in China.
Augtyro (repotrectinib) stands as a cutting-edge tyrosine kinase inhibitor (TKI) that aims at ROS1 and NTRK oncogenic catalysts. Patients with solid tumors, including NSCLC, possessing ROS1 or NTRK gene fusions, often develop resistance mutations to approved targeted therapies, curtailing drug efficacy. Augtyro emerges as the inaugural next-gen TKI tackling ROS1 oncogenic fusions in NSCLC, promising enhanced response duration, including cerebral metastasis treatment.
In the USA, November 2023 saw the FDA approve Augtyro for adult usage with locally advanced or metastatic ROS1-positive NSCLC. China’s NMPA followed suit in May 2024 for identical clinical scenarios. Additionally, August 2023 marked the NMPA awarding Augtyro with a Breakthrough Therapy Designation for solid tumors with NTRK gene fusions.
Zai Lab’s alliance with Turning Point Therapeutics, Inc. (partnered with Bristol Myers Squibb), authorizes them to develop and commercialize Augtyro in Greater China, comprising mainland China, Hong Kong, Taiwan, and Macau. The strategic commercial launch of Augtyro in mainland China is targeted by year’s end in 2024.
CABP, the predominant pneumonia type contracted outside hospital settings, is widespread and a notable mortality and morbidity cause globally. ABSSSI encompasses bacterial skin infections involving subdermal layers and mucosal surfaces, presenting in varying severity forms. Mainland China recorded an estimated 10 million CABP cases in 2020, with ABSSSI affecting 2.8 million individuals by 2015. The demand persists for broad-spectrum antibiotics combating multi-drug resistance with an exceptional safety profile.
Omadacycline, branded Nuzyra, a novel tetracycline-class antibacterial available in oral and IV formats, combats a broad range of bacterial infections, targeting Gram-positive, Gram-negative, atypical, and other pathogens.
Recognized as a Category 1 innovative drug for CABP and ABSSSI in adults, the NMPA approved Nuzyra in both formats with Zai Lab initiating its mainland China launch in December 2021. NRDL listed Nuzyra for CABP and ABSSSI treatment in IV form from January 2023 and oral form from January 2024.
Zai Lab holds an exclusive license from Paratek Pharmaceuticals, Inc. (acquired by Novo Holdings A/S), for developing, producing, and marketing Nuzyra in Greater China.
An estimated 30,000 GIST cases arise annually in China, highlighting a paramount clinical need. GIST patients initially responsive to traditional TKIs often face disease progression due to secondary mutations.
Qinlock (ripretinib) is an orally delivered switch-control TKI that inhibits KIT and PDGFRA kinases, including varied mutation forms, by regulating kinase switch pocket and activation loop synergy.
Authorized by the NMPA in March 2021 for adults with advanced GIST returning for treatment post three or more kinase inhibitors, Zai Lab launched Qinlock in mainland China for this indication the same year. NRDL encompassed Qinlock as of January 2023 for GIST patients treated with three or more kinase regimens in any inclusion setting.
Zai Lab’s exclusive agreement with Deciphera Pharmaceuticals, Inc. (affiliated with ONO Pharmaceutical), facilitates Qinlock’s development and marketing in Greater China.
Zai Lab Limited, headquartered in China and the United States, represents ingenuity as a biopharmaceutical company at a commercial stage driven by research.