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%.
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Astrazeneca Imfinzi perioperative regimen gains positive EU CHMP opinion in early gastric cancer
I Peace generates human iPS cells from NKT cells and offers them for research use
Frontage expands early phase clinical research capabilities across US and China
Summit Therapeutics' BLA for ivonescimab in EGFR-mutated NSCLC accepted by FDA
InSysBio agrees new collaborative project with BeOne Medicines
Physiomics secures new modelling contract with Numab Therapeutics
Mabwell reports first patient dosed with 7MW4911 in US trial
Atossa Therapeutics' founder and CEO named one of The Top 50 Healthcare Technology CEOs of 2025
Avacta secures FDA clearance for second pre|CISION oncology programme
Guardant Health and Merck enter multi-year oncology diagnostics collaboration
Akeso secures NMPA review acceptance for gumokimab in ankylosing spondylitis