Policy & Regulation
Shenzhen Chipscreen Biosciences' Epidaza approved for breast cancer marketing application
2 December 2019 -

Drug company Shenzhen Chipscreen Biosciences Co Ltd (Stock Symbol: 688321.SH) revealed on Friday that its lead innovative product Epidaza (Chidamide) has now received National Medical Products Administration (NMPA) approval for the breast cancer marketing application, reflecting its second indication.

The company said Epidaza (Chidamide) was previously approved for recurrent and refractory peripheral T cell lymphoma in China.

According to the company, Chidamide is combined with aromatase inhibitor in postmenopausal patients with hormone receptor (HR)-positive, HER2-negative advanced breast cancer (ABC) treated with endocrine therapies for recurrence or progression.

Chidamide is a selective HDAC inhibitor with unique epigenetic mechanisms against tumour cell growth, immune escape and drug resistance. In a pivotal phase 3 clinical trial, chidamide in combination with exemestane has demonstrated progression-free survival benefit and manageable adverse effects in postmenopausal patients with advanced, hormone receptor-positive breast cancer, added the company.

Breast cancer is the most common female malignancy in the world and China. In 2017, China's cancer registry annual report showed that the incidence of new breast cancer cases in China was 279,000, annually increased by 2%.



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