Alectinib

In response to the increasing demand for long-term survival of patients with ALK-positive non-small cell lung cancer (NSCLC), the clinical application of second-generation ALK inhibitors has brought breakthrough therapeutic benefits to this population. Alectinib is a highly selective ALK tyrosine kinase inhibitor, which can precisely inhibit ALK kinase phosphorylation and the conduction of downstream signaling pathways, and block the proliferation of tumor cells. Compared with first-generation inhibitors, it exhibits stronger intracranial lesion control ability. Clinically, it is mainly used for the first-line treatment of patients with ALK-positive locally advanced or metastatic NSCLC, as well as patients who have progressed or are intolerant after prior crizotinib treatment. It can significantly prolong the progression-free survival of patients and greatly reduce the risk of brain metastasis progression.

At present, the global market size of ALK inhibitors continues to expand. Among them, alectinib, with its excellent clinical efficacy, achieved global sales of more than 1.5 billion US dollars in 2023. There are about 35,000 new annual cases of ALK-positive NSCLC in China. With the inclusion of targeted drugs in medical insurance and the improvement of clinical accessibility, the domestic market size of alectinib exceeded 3 billion yuan in 2023, with an annual growth rate remaining above 20%. At present, the original research products still dominate the domestic market, and generic drugs from 3 domestic enterprises have been approved for marketing. The implementation of the centralized procurement policy has further promoted the improvement of drug affordability, and the market penetration rate of generic drugs is expected to gradually expand in the future.

The original research enterprise of alectinib is Roche, and the original research trade name is Alecensa®. Its compound patent in China will expire in 2027, and the crystal form patent will expire in 2031. The main dosage form approved for the original research product is hard capsule, with a specification of 150 mg, which has been included in the Chinese Catalogue of Chemical Drugs and the FDA Reference Preparations List. As of now, the alectinib APIs of 6 Chinese enterprises have completed registration at CDE (status A), and nearly 10 other enterprises have obtained approval for marketing of their generic preparations. (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 alectinib API. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. They fully comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can meet the reference standard requirements of enterprises in the whole process of R&D, quality research and registration declaration.