World’s first CDK2/4/6 inhibitor approved in China

The world's first CDK2/4/6 inhibitor, developed by Chia Tai Tianqing Pharmaceutical Group, a subsidiary of Sino Biopharmaceutical, was officially approved for market launch on Thursday.

CDK2/4/6 inhibitors are targeted cancer drugs that stop certain proteins (CDK2, CDK4, and CDK6) that cancer cells need to grow and divide.

Breast cancer has become the most common cancer affecting women worldwide, including in China, where around 357,000 new cases were reported in 2022, according to data from the National Cancer Center of China.

Sino Biopharm said the HR+/HER2− subtype accounts for roughly 70 percent of diagnoses and represents the main source of clinical burden.

This domestically developed, next-generation CDK inhibitor is indicated for patients with HR+/HER2− locally advanced or metastatic breast cancer who have previously received endocrine therapy. Clinical studies indicate that the therapy offers a favorable balance of efficacy and safety and can significantly reduce the risk of disease progression.

The global market for breast cancer treatments has been expanding steadily in recent years, drawing intense competition in innovative drug development.

According to a recently released report by UBS Group, the drug was identified as having strong commercial potential, with peak sales in China alone expected to exceed 2 billion yuan ($280 million).