Rociletinib

For the rare mutation subtype of epidermal growth factor receptor (EGFR) exon 20 insertion mutation, which is associated with poor prognosis in non-small cell lung cancer (NSCLC), traditional EGFR-TKIs generally have limited efficacy, and the advent of rociletinib has filled this clinical gap. As a domestically independently developed third-generation, highly selective EGFR tyrosine kinase inhibitor, it can irreversibly bind to the EGFR exon 20 insertion mutation site, and simultaneously inhibit the EGFR T790M drug-resistant mutation. Moreover, it has low affinity for wild-type EGFR, which significantly reduces off-target side effects. At present, its clinical indications are mainly for patients with locally advanced or metastatic non-small cell lung cancer carrying EGFR exon 20 insertion mutation, and clinical expansion studies for other EGFR rare mutation subtypes are also ongoing, providing a new option for this type of lung cancer population who lacked effective treatment regimens in the past.

Rociletinib is currently in the late stage of clinical research and development, and has not been officially commercialized and launched, so publicly verifiable market size data is temporarily unavailable. From the perspective of the global treatment track for EGFR exon 20 insertion mutation NSCLC, only two drugs of the same class have been approved for marketing so far, and the market is in a state of insufficient supply. In China, patients with this mutation subtype account for about 2% of all NSCLC patients, with approximately 28,000 new cases annually, and the clinical demand has not been fully met. If it is successfully approved for marketing subsequently, the market growth space is considerable. A number of domestic pharmaceutical companies have already laid out pipelines for this target with the same indication, and future competition will focus on clinical efficacy, safety and pricing strategies.

Rociletinib was originally developed by Jiangsu Allist Biopharmaceutical Co., Ltd., and there is no public trade name information at present. The core compound patent will expire in 2038. It is currently in the Phase Ⅲ clinical trial stage and has not been approved for marketing. There is no public information on the marketed dosage form and specification, and it is not included in the *Catalogue of Chemical Drugs* and the FDA Reference Listed Drug Catalogue. The Center for Drug Evaluation (CDE) of the National Medical Products Administration has no API registration information for this product for the time being, and no corresponding preparation has been approved for marketing in China. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for rociletinib, covering starting material impurities, intermediate impurities and degradation impurities that may be generated during the synthesis process. All products meet the requirements of the Chinese Pharmacopoeia and relevant FDA regulations. Most categories are in regular stock, and orders submitted before 16:00 can be shipped on the same day, which can effectively meet the reference standard needs of pharmaceutical companies in the stages of process research and development, quality research and declaration.