Sino Biopharmaceutical wins approval for innovative breast cancer drug

Sino Biopharmaceutical Limited announced its culmerciclib capsule, a national Category 1 innovative drug, has been approved for marketing by the China National Medical Products Administration (NMPA). This First-in-Class triple inhibitor targets CDK2/4/6 and is indicated for use in combination with fulvestrant for patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer who have progressed following prior endocrine therapy.

The pivotal Phase III clinical trial demonstrated significant efficacy, with the culmerciclib plus fulvestrant group achieving a median progression-free survival (mPFS) of 16.62 months, a 9.16-month improvement over fulvestrant alone (7.46 months). This represents a 64% reduction in the risk of disease progression or death. The objective response rate (ORR) also significantly improved to 40.21% from 12.12%.

The company is further developing culmerciclib, having submitted a new drug application for first-line HR+/HER2-breast cancer in July 2025 and completed enrollment for a Phase III adjuvant use trial. These additional indications are expected to be approved within the next two years, enhancing Sino Biopharmaceutical's breast cancer treatment pipeline.