Anlotinib

The third-line treatment of advanced non-small cell lung cancer has long faced the clinical dilemma of limited optional regimens and insufficient survival benefit. Anlotinib, a multi-target tyrosine kinase inhibitor independently developed in China, can not only block tumor angiogenesis but also directly inhibit tumor cell proliferation by simultaneously inhibiting multiple signaling pathways such as VEGFR, PDGFR and FGFR. At present, it has been approved for multiple indications including non-small cell lung cancer, small cell lung cancer, soft tissue sarcoma and medullary thyroid carcinoma, covering the post-line treatment needs of adult patients with advanced solid tumors, and is an important domestic innovative achievement in the field of targeted therapy for solid tumors in China.

The domestic market size of anlotinib has grown steadily in recent years, and the overall market size has exceeded 4.5 billion yuan in 2023. With the continuous expansion of indications, it is expected that the compound annual growth rate will remain at around 8% from 2025 to 2029. The current market competition pattern is dominated by original research products, and no generic drug has been approved for marketing yet. As a Class B variety in the National Medical Insurance Catalog, its accessibility in primary medical institutions is gradually improving, and the layout of generic drug enterprises after the subsequent patent expiration will become the core variable affecting the market pattern.

The original research enterprise of anlotinib is Chia Tai Tianqing Pharmaceutical Group Co., Ltd., and the original research trade name is "Fuketavir". Its core compound patent will expire in China in 2028. The main currently approved dosage form is capsule, with three specifications including 12mg, 10mg and 8mg, which has been included in the China Listed Drug Catalogue as the reference preparation. In terms of domestic API registration, only the API under Chia Tai Tianqing has been approved for registration (A status) at present, and no valid API registration information of other enterprises has been published. All anlotinib preparations approved for marketing in China are currently from the original research enterprise. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for anlotinib API, most of which are in stock. Orders placed before 16:00 can be shipped on the same day. The products meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can fully meet the reference substance use needs in drug R&D, quality research and production links.