Drug development company Chipscreen Biosciences’ oral subtype-selective histone deacetylase (HDAC) inhibitor, Epidaza (Chidamide), has secured approval in China for its second indication.
The approval from China’s National Medical Products Administration (NMPA) is indicated for breast cancer.
The indication includes Chidamide integrated 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, which targets the subtype 1, 2, 3 of Class I and subtype 10 of Class IIb HDAC, has earlier been approved for recurrent and refractory peripheral T-cell lymphoma in China.
In December 2014, the China Food and Drug Administration approved Chidamide for recurrent and refractory peripheral T-cell lymphoma.
Chidamide is being studied in several clinical trials in the US, Japan, Korea, China and Taiwan as a single agent or in combination with chemotherapeutic / targeted agents to treat various haematological tumours, solid cancers and HIV.
In a pivotal Phase III randomised, double-blind clinical trial, chidamide in combination with exemestane, showed progression-free survival benefit and manageable adverse effects in postmenopausal patients with advanced, hormone receptor-positive breast cancer.
The Phase III study is said to be the first to demonstrate the clinical benefit of HDAC inhibitor with existing treatment for solid tumours and to achieve a breakthrough in clinical development of epigenetic modulators.
Chidamide is claimed to be the only epigenetic modulator approved to date globally for solid tumour treatment that will provide a therapeutic choice for ABC patients.
Established in Shenzhen in 2001, Chipscreen focuses on the research and development of original small molecule drugs.
The company has developed several original drug product lines for oncology, metabolic diseases and autoimmune diseases.