SBP GROUP (01177) announced that its subsidiary, Chia Tai Tianqing Pharmaceutical Group Co., Ltd., has received marketing approval from the National Medical Products Administration (NMPA) for its independently developed Class 1 innovative drug, bemostobart monoclonal antibody (brand name: Andewei®), in combination with anlotinib (brand name: Focovix®). The approval is for the treatment of advanced or unresectable alveolar soft part sarcoma (ASPS). This marks the fourth approved indication for this combination therapy, following previous approvals in China for first-line small cell lung cancer, second-line or later endometrial cancer, and first-line renal cell carcinoma. The bemostobart monoclonal antibody is a novel-sequence, innovative humanized anti-PD-L1 monoclonal antibody, and this approval represents its fifth indication. Anlotinib is an oral novel small-molecule multi-target tyrosine kinase inhibitor (TKI), and this is its eleventh approved indication. The approval is based on excellent data from the TQB2450-Ib-02 clinical study. Results showed an objective response rate (ORR) of 72.41% for the primary endpoint, with 10.34% of subjects achieving a best response of complete remission (CR). Prior chemotherapy history did not significantly affect the ORR of subjects, and no new safety risks were identified. After a median follow-up of 24.9 months, the median progression-free survival (PFS) had not yet been reached. ASPS is a rare, highly metastatic, and poor-prognosis malignant soft tissue tumor, predominantly affecting adolescents, with an incidence accounting for approximately 0.5%-1.0% of soft tissue sarcomas. However, ASPS is insensitive to radiotherapy and chemotherapy, and radiotherapy is often ineffective at controlling tumor growth and metastasis. Treatment options are limited, with a recurrence rate as high as 70% and a five-year overall survival rate of only 20%-46%. Anlotinib has already received a Level I recommendation (Class 2A evidence) in the "Chinese Society of Clinical Oncology (CSCO) Guidelines for the Diagnosis and Treatment of Bone and Soft Tissue Sarcomas (2024 Edition)" for the first-line treatment of advanced ASPS. The successful approval of the bemostobart monoclonal antibody combined with anlotinib therapy will provide a new treatment option for such patients.
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