According to a report from Zhengda Tianqing, the company has recently submitted a marketing application to the Center for Drug Evaluation (CDE) of the National Medical Products Administration for its self-developed Class I innovative drug, anlotinib hydrochloride capsules, in combination with chemotherapy for treating advanced unresectable or metastatic soft tissue sarcoma. This application has been accepted.

Zhengda Tianqing noted that there are currently no officially approved combination therapies for first-line treatment of advanced soft tissue sarcoma globally. The Phase III clinical study (ALTN-III-04) evaluating the use of anlotinib hydrochloride capsules in combination with chemotherapy for first-line treatment of advanced unresectable or metastatic soft tissue sarcoma has achieved its pre-specified primary efficacy endpoint, as assessed by an Independent Data Monitoring Committee (IDMC). This study is the first key Phase III research globally to utilize an anti-angiogenic drug in combination with chemotherapy.

At present, anlotinib hydrochloride capsules have received approval for six indications in China. In addition, applications for the use of anlotinib hydrochloride capsules in combination with bemarituzumab for the treatment of recurrent or metastatic endometrial cancer, as well as for the first-line treatment of advanced unresectable or metastatic renal cell carcinoma, were submitted in February and August 2024, respectively, and have also been formally accepted by the CDE. The application for first-line treatment of advanced soft tissue sarcoma marks the ninth indication for which anlotinib hydrochloride capsules have been submitted for marketing approval.

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