On April 17, the official website of the National Medical Products Administration (NMPA) showed that the 4th indication for the Class 1 new drug "Defu Combination" from CTTQ, a core enterprise of Sino Biopharmaceutical (1177.HK)—Benmelstobart (Andewei^®) combined with Anlotinib capsules (Fukewei^®)—has been approved for marketing for the treatment of advanced or unresectable alveolar soft tissue sarcoma (ASPS). This combination therapy was previously granted Breakthrough Therapy Designation by the Center for Drug Evaluation (CDE) of the NMPA and was included in the priority review and approval process. 

Benmelstobart is an innovative humanized anti-PD-L1 monoclonal antibody with a novel sequence. This is its 5th approved indication. Anlotinib is a novel oral small-molecule multi-target tyrosine kinase inhibitor (TKI). This is its 11th approved indication. Previously, the combination therapy of these two drugs has been approved in China for several indications, including endometrial cancer, extensive-stage small cell lung cancer (ES-SCLC), and first-line renal cell carcinoma. 

This approval is based on the excellent data from the TQB2450-Ib-02 clinical study. The results showed that the primary endpoint, objective response rate (ORR), reached 72.41%, with 10.34% of subjects achieving a complete response (CR) as their best efficacy. Prior chemotherapy history had no significant impact on the subjects' ORR, and no new safety risks were observed. After a median follow-up of 24.9 months, the median progression-free survival (PFS) has not been reached. 

ASPS is a rare soft tissue malignant tumor with a high rate of metastasis and poor prognosis, commonly occurring in adolescents, with an incidence of about 0.5%-1.0% of all soft tissue sarcomas^[1]. However, ASPS is not sensitive to radiochemotherapy, and radiotherapy is often ineffective in controlling tumor growth and metastasis. Treatment options are limited, with a recurrence rate as high as 70% and a 5-year overall survival rate of only 20%-46%^[2-3]. 

In recent years, anti-angiogenic tyrosine kinase inhibitors (TKIs) and immunotherapy have brought new hope to patients. In the "Chinese Society of Clinical Oncology (CSCO) Guidelines for the Diagnosis and Treatment of Bone and Soft Tissue Tumors (2024)," Anlotinib is listed as a Level I recommendation for the first-line treatment of advanced ASPS (Class 2A evidence). The approval of the "Defu Combination" therapy will bring a new treatment option for these patients. 

References:

[1] Yuan X, Zhou B, Zhong J. Prognostic factors of alveolar soft part sarcoma in children and adolescents: a populationbased study[J].J Stomatol Oral Maxillofac Surg, 2024,125(3S):101852.

[2] Chen AP, Sharon E, O'Sullivan-Coyne G, et al.Atezolizumab for Advanced Alveolar Soft Part Sarcoma.N Engl J Med. 2023, 389(10): 911-921.

[3] Qiao L, Liu JF, Wang B, et al. Progress in targeted therapy and immunotherapy for alveolar soft tissue sarcoma[J]. Journal of Shandong Medical College, 2025, 47(02):25-27. 

Declaration:

1. This press release is intended to facilitate the communication and exchange of medical information and is for reference by healthcare professionals only. It is not for advertising purposes. 

2. The company does not recommend any drugs and/or indications. 

3. The information contained in this press release is for reference only and cannot replace professional medical guidance in any way, nor should it be considered as a diagnosis or treatment recommendation. If you wish to understand specific disease diagnosis and treatment information, please follow the advice or guidance of a physician or other healthcare professional. 

Forward-Looking Statements:

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