https://lmspiq.fda.gov.tw/web/DRPIQ/DRPIQ1000Result?licBaseId=6A077D3C-3A25-4C28-89EE-C8AFA064C9E5

許可證字號：衛部藥輸字第027691號 有效日期：20250331

{"產品驗證": "https://lmspiq.fda.gov.tw/web/DRPIQ/DRPIQ1000Result?licBaseId=6A077D3C-3A25-4C28-89EE-C8AFA064C9E5"}

Solomon BJ, Liu G, Felip E, Mok TSK, Soo RA, Mazieres J, et al. Efficacy and safety of first-line lorlatinib versus crizotinib in patients with advanced, ALK-positive non-small-cell lung cancer: updated analysis of data from the phase 3, randomised, open-label CROWN study. Lancet Respir Med. 2023;11:354-66. doi:10.1016/S2213-2600(22)00437-4[1]. 2. Solomon BJ, Liu G, Felip E, Mok TSK, Soo RA, Mazieres J, et al. Lorlatinib Versus Crizotinib in Patients With Advanced ALK-Positive Non–Small Cell Lung Cancer: 5-Year Outcomes From the Phase III CROWN Study. J Clin Oncol. 2024;00:1-10. doi:10.1200/JCO.24.00581[2].

The active ingredient of our new drug Lorviqua is protected by Taiwan Invention Patent No. I 476199 and Invention Patent No. I616449. It is classified as an original developer's drug under the National Health Insurance Drug Payment Items and Payment Standards. This can be substantiated by the patent certificates issued by the Intellectual Property Office of the Ministry of Economic Affairs and the results of the patent system inquiry. According to the regulations of the National Health Insurance Drug Payment Items and Payment Standards, the patent holder of the new drug Lorviqua is Pfizer Inc., and the licensee, Wyeth LLC (Asia) Taiwan Branch, is a wholly-owned subsidiary of Pfizer Inc. This can be proven by a declaration issued by the Pfizer Group headquarters on July 24, 2019, and notarized by the government of New Jersey, USA. The above documents explain the patent certification and related authorization documents of the Lorviqua product.