On June 30, 2025, the official website of the National Medical Products Administration (NMPA) announced that Anlotinib, a Class 1 innovative drug developed by Chia Tai Tianqing Pharmaceutical Group, has secured approval for a new indication. Specifically, it is approved for the first-line treatment of patients with unresectable locally advanced or metastatic soft tissue sarcoma (STS) who have not received prior systemic therapy.
This represents the 9th approved indication of Anlotinib in China, and also marks the global approval of the first chemotherapy-combined regimen for the first-line treatment of advanced or metastatic STS. Previously, Anlotinib monotherapy had been recommended by the guidelines of the Chinese Society of Clinical Oncology (CSCO) for the second-line treatment of advanced or metastatic STS.
Soft tissue sarcoma is a group of malignant tumors originating from non-epithelial extraosseous tissues. In China, the annual incidence rate is approximately 2.91 per 100,000 population and has been on a steady rise. Characterized by high heterogeneity, STS encompasses 19 tissue types and over 50 pathological subtypes. For unresectable locally advanced or metastatic STS, although the sensitivity of different sarcoma subtypes to chemotherapeutic drugs varies, the current first-line treatment still mainly relies on anthracycline-based palliative chemotherapy regimens.
At the 2025 Annual Meeting of the American Society of Clinical Oncology (ASCO), Chia Tai Tianqing released groundbreaking results from a phase III clinical trial evaluating Anlotinib Hydrochloride Capsules in combination with chemotherapy for the first-line treatment of unresectable advanced or metastatic STS. Data showed that compared with the control group, the median progression-free survival (mPFS) in the Anlotinib group was significantly prolonged by 5.6 months; the objective response rate (ORR) increased nearly sixfold (17.8% vs. 2.9%); and the disease control rate (DCR) was substantially improved (79.3% vs. 54.7%). These findings demonstrate that Anlotinib Hydrochloride Capsules combined with chemotherapy exerts definite antitumor efficacy in the first-line treatment of STS.
As a small-molecule tyrosine kinase inhibitor (TKI) with anti-angiogenic activity, Anlotinib boasts broad clinical application potential. Its approved indications cover multiple major therapeutic areas, including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), medullary thyroid carcinoma (MTC), differentiated thyroid carcinoma (DTC), endometrial carcinoma, and soft tissue sarcoma.
In addition, three marketing applications for Anlotinib-based combination therapies have been officially accepted by the Center for Drug Evaluation (CDE) under the NMPA, including combinations with Penpulimab for advanced hepatocellular carcinoma treatment, and with Bempegaldesleukin for the first-line treatment of advanced squamous NSCLC as well as the consolidation treatment of stage III NSCLC. Going forward, the company will continue to explore the therapeutic potential of Anlotinib and accelerate the development of innovative products, bringing benefits to patients worldwide.
