Sotorasib

The treatment of advanced solid tumors with KRAS G12C mutation has long faced a clinical gap, which was not broken until the advent of small molecule targeted drugs. Sotorasib is a KRAS G12C inhibitor. It irreversibly binds to the mutated KRAS G12C protein, locks it in an inactive conformation, and blocks the conduction of downstream signaling pathways, thereby inhibiting the proliferation of tumor cells. At present, this drug is mainly used to treat adult patients with locally advanced or metastatic non-small cell lung cancer with KRAS G12C mutation, and has also shown positive efficacy in clinical studies on solid tumors such as colorectal cancer and pancreatic cancer, providing a brand-new treatment option for refractory patients who have received systemic therapy in the past.

The global sotorasib market size had exceeded USD 350 million in 2023, with a compound annual growth rate remaining above 45%, among which the non-small cell lung cancer indication contributed more than 80% of the market share. In terms of the competitive landscape, currently only the original research product has been approved for marketing worldwide. More than 20 pharmaceutical companies in multiple countries including China have initiated the generic drug R&D process. With the expiration of core patents one after another, it is expected that generic drugs will gradually enter the market after 2027, promoting a significant improvement in accessibility. In the domestic market, the drug was included in the National Medical Insurance Catalog in 2023, and the medical insurance payment standard has been reduced by more than 60% compared with the initial launch period, further reducing the medication burden of patients.

The original research enterprise of sotorasib is Amgen, and the original trade name is Lumakras. Its core compound patent in the United States will expire in 2030, and the expiration date of the compound patent in China is 2031. The main dosage form approved for the original research product is tablet, with the specification of 120mg, which has been included in the FDA Reference Listed Drug Catalog and the Chinese Catalog of Reference Preparations for Chemical Drugs. In terms of domestic API registration, up to now, 3 enterprises have obtained CDE registration numbers for sotorasib APIs, among which 2 are in A status. The original research enterprise and more than 10 domestic pharmaceutical companies have obtained marketing approval for sotorasib tablets 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 sotorasib impurity reference standards, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products comply with the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the use needs of different scenarios such as API R&D, quality research and consistency evaluation.