SINO BIOPHARM (01177) announced that its self-developed Class 1 innovative drug, Kumorixili Capsule (brand name: Saitanxin®), has received marketing approval from China's National Medical Products Administration (NMPA). The drug is indicated for use in combination with fulvestrant to treat hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer patients who have experienced disease progression after prior endocrine therapy.
Kumorixili is the world's first triple inhibitor targeting CDK2/4/6, demonstrating varying degrees of inhibitory effects on CDK2, CDK4, and CDK6 kinases, with particularly strong selective inhibition against CDK4. Due to its unique mechanism of action, Kumorixili not only helps delay resistance to CDK4/6 inhibitors in clinical settings but also reduces the risk of myelosuppression.
In the pivotal Phase III clinical trial (TQB3616-III-01), the Kumorixili-fulvestrant combination showed encouraging efficacy. Results revealed that the median progression-free survival (mPFS) in the Kumorixili-fulvestrant group reached 16.62 months, significantly extending by 9.16 months compared to the fulvestrant-only group (7.46 months), with a 64% reduction in the risk of disease progression or death (HR=0.36, p<0.0001). The objective response rate (ORR) also improved markedly (40.21% vs. 12.12%, p<0.0001).
In terms of safety, the most common treatment-related adverse events (TRAEs) were mostly Grade 1-2 and manageable. Hematologic toxicities such as ≥Grade 3 myelosuppression were minimal, and no TRAEs leading to treatment discontinuation or death were reported, indicating overall tolerability.
Beyond the approved second-line treatment indication, SINO BIOPHARM submitted a marketing application for the Kumorixili-fulvestrant combination as a first-line therapy for HR+/HER2- breast cancer to the NMPA in July 2025. Additionally, patient enrollment for its Phase III adjuvant therapy trial has been completed, with potential approvals expected within the next two years.
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