On February 5, 2021, Chia Tai Tianqing announced that the New Drug Application (NDA) for its antitumor agent Anlotinib Hydrochloride Capsules (trade name: Fukewei) has been approved by the National Medical Products Administration (NMPA). The approved indication is: for the treatment of patients with unresectable locally advanced or metastatic medullary thyroid carcinoma (MTC) who present with clinical symptoms or definite disease progression. This marks the fourth approved indication for anlotinib, following its approvals for advanced or metastatic non-small cell lung cancer (NSCLC), soft tissue sarcoma (STS), and small cell lung cancer (SCLC). The approval of this new indication makes anlotinib the first targeted therapy for MTC available in China.
Anlotinib Hydrochloride Capsules is an innovative anti-tumor drug independently developed by Chia Tai Tianqing. As a multi-targeted small-molecule tyrosine kinase inhibitor (TKI), it primarily targets vascular endothelial growth factor receptor (VEGFR), platelet-derived growth factor receptor (PDGFR), fibroblast growth factor receptor (FGFR), c-Kit, among others.
In April 2013, Chia Tai Tianqing initiated the Phase II clinical study of anlotinib for MTC. The results were first presented at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting and subsequently published in THYROID—the only SCI-indexed peer-reviewed journal dedicated to thyroid research. Findings from the Phase IIB study, launched in June 2015, were first unveiled at the 2019 ASCO Annual Meeting, which once again received unanimous recognition from experts both at home and abroad. Notably, the longest-surviving patient in the Phase II study has been receiving anlotinib treatment for over 7 years.
Clinical trial data demonstrated that, compared with the placebo group, patients with MTC treated with Anlotinib Hydrochloride Capsules achieved a 9.6-month prolongation in progression-free survival (PFS) and a 47% reduction in tumor recurrence risk. The drug is characterized by a low incidence of adverse reactions, which are mostly mild and manageable in the vast majority of cases.
Medullary Thyroid Carcinoma (MTC) is an aggressive malignancy associated with poor prognosis. Currently, there remains a significant unmet medical need in the treatment of MTC. The approval of anlotinib for MTC breaks the deadlock of having no effective treatment options for this disease, providing clinicians with a novel therapeutic choice and bringing new hope to patients. This milestone holds profound positive social significance and promising application prospects.
In addition, Chia Tai Tianqing has extensively advanced combination therapy strategies involving anlotinib, including combinations with chemotherapy, PD-1 inhibitors, and PD-L1 inhibitors. To date, more than 20 such combination regimens are under Phase II or III clinical trials. Furthermore, single-agent anlotinib is being evaluated in Phase II or III studies for over 10 different cancer types. As its indications continue to expand, anlotinib is poised to benefit a broader patient population across multiple oncology fields.
