Osimertinib

Targeted therapy for EGFR mutation-positive non-small cell lung cancer (NSCLC) is a major breakthrough in the field of lung cancer in recent years. The advent of third-generation EGFR-TKI drugs has solved the common T790M resistance problem of previous generations of drugs, and significantly prolonged the progression-free survival of patients. As a representative drug of this category, osimertinib selectively and irreversibly binds to EGFR sensitive mutations and T790M resistance mutation sites, while reducing the inhibitory effect on wild-type EGFR, which greatly reduces the occurrence of adverse reactions such as rash and diarrhea. At present, its indications cover the first-line treatment of adult patients with locally advanced or metastatic NSCLC harboring EGFR exon 19 deletion or exon 21 L858R substitution mutation, as well as NSCLC patients who progress after treatment with previous generations of EGFR-TKI and have T790M mutation. It is the preferred treatment recommended by global guidelines.

The global market size of osimertinib has continued to rise in recent years, exceeding US$6.5 billion in 2023, and the market size in China has exceeded RMB 12 billion, with a compound annual growth rate of more than 15%. After the arrival of the patent cliff, the domestic generic drug market has expanded rapidly. As of 2024, more than 10 enterprises have obtained approval for marketing of osimertinib generic drugs. The winning bid price in centralized procurement has decreased by more than 90% compared with the highest price of the original drug, and the accessibility of drugs for patients has been greatly improved. At present, the domestic API supply system is basically mature. Osimertinib API produced by local enterprises not only supplies domestic preparation manufacturers, but also is exported in large quantities to emerging markets such as Southeast Asia and Latin America.

The original developer of osimertinib is AstraZeneca, and the original brand name is Tagrisso®. Its compound patent in China will expire in 2032, and the crystal form patent will expire in 2033. The main dosage form approved for the original drug is tablet, with specifications of 40mg and 80mg, which has been included in the Chinese Catalogue of Reference Preparations of Chemical Drugs and the FDA Reference Preparation Catalogue. As of September 2024, there have been nearly 30 osimertinib API registration entries on the API Registration Platform of China Center for Drug Evaluation (CDE), among which more than 10 have been publicized with A status, and 15 domestic enterprises have obtained approval for marketing of osimertinib tablets. (Data as of September 2024, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for osimertinib API. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products fully comply with the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can provide stable reference standard support for pharmaceutical enterprises in API R&D, quality research and consistency evaluation.