Larotrectinib

In response to the clinical pain point that patients with TRK fusion-positive solid tumors generally lack precise treatment regimens, larotrectinib, as the first tumor-agnostic small-molecule tyrosine kinase inhibitor, exerts an anti-tumor effect by highly specifically binding to the TRK protein encoded by NTRK gene fusion and blocking the abnormal activation of downstream signaling pathways. Its indications cover adult and pediatric solid tumor patients carrying NTRK gene fusion, including 17 tumor types such as lung cancer, thyroid cancer, soft tissue sarcoma, and infantile fibrosarcoma. It breaks the treatment logic of traditional anti-tumor drugs classified by the primary site of the tumor, and provides cross-tumor treatment options for patients with rare target mutations.

The global market size of larotrectinib had exceeded 400 million US dollars in 2022, with a compound annual growth rate maintained at over 25%. The growth momentum mainly comes from the increase in the global screening penetration rate of NTRK fusion-positive solid tumors and the expansion of pediatric indications. The domestic market is still in the early stage of development. At present, generic drugs from 3 local enterprises have been approved for marketing. After the 2023 National Medical Insurance Negotiation, its annual treatment cost has dropped to the level of ten thousand yuan, which has significantly improved patient accessibility, driven the rapid expansion of the domestic market size, with a year-on-year increase of more than 180% in 2023.

The original research enterprise of larotrectinib is Bayer AG, and the original research trade name is Vitrakvi®. The expiration date of its core compound patent in China is 2033. The approved dosage forms of the original research product include capsules (25mg, 100mg) and oral solution (20mg/mL), which have been included in the China Listed Drug Catalog as reference preparations, and are also included in the FDA Reference Preparation Catalog. Up to now, China NMPA has approved the marketing of the original research preparation. There are no approved API registration numbers in A status on the CDE API Registration Platform, and there are only 3 registration records under review. (Data as of October 2024, please refer to the official CDE website for the latest information)

For the impurity research needs involved in the R&D and quality control process of larotrectinib, CATO can provide a full set of impurity reference standards for this API. Most products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. They fully meet the requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and provide stable reference standard support for pharmaceutical enterprises in the stages of R&D declaration and mass production.