On November 29, 2019, Chidamide (trade name: Epidaza), a first-in-class molecular entity independently developed by Shenzhen Chipscreen Biosciences Co., Ltd., the world’s first oral subtype-selective histone deacetylase (HDAC) inhibitor and a national Class 1.1 innovative drug, was officially approved by the National Medical Products Administration (NMPA) for a new indication — in combination with aromatase inhibitors for the treatment of postmenopausal patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HER2-negative), locally advanced or metastatic breast cancer who have experienced disease recurrence or progression following endocrine therapy. This marks the second indication of Chidamide approved in China, following relapsed or refractory peripheral T-cell lymphoma (PTCL).
Breast Cancer Overview
Breast cancer is the most common malignant tumor in women both globally and in China. According to the 2017 China Cancer Registry Annual Report, there were 279,000 new cases and 69,500 deaths from breast cancer in China that year, with an annual increase of 2%. Among females under 45 years of age, breast cancer ranks first in cancer-related mortality and is showing a trend of younger onset. Estrogen receptor-positive breast cancer accounts for approximately 70% of all breast cancer cases, and endocrine therapy is the main treatment modality for such patients. However, endocrine resistance that develops in patients with disease recurrence or progression after endocrine therapy severely impacts their subsequent treatment. Overcoming tumor resistance and developing new therapeutic approaches with favorable efficacy-safety profiles have become key priorities in current new drug research and development as well as clinical studies.
Epigenetic abnormalities constitute a critical biological basis for the development of acquired resistance, recurrence and metastasis in tumor patients. As a selective epigenetic modulator, Chidamide has been shown in preclinical studies on breast cancer resistance mechanisms to reverse drug resistance and enhance the sensitivity of existing therapeutic agents. In April 2018, Chipscreen Biosciences completed a multicenter, randomized, double-blind pivotal Phase III clinical trial of Chidamide in combination with exemestane for the treatment of hormone receptor (HR)-positive advanced breast cancer.
About Chidamide
Chidamide (trade name: Epidaza) is a first-in-class molecular entity with global patent protection independently developed by Chipscreen Biosciences, and the world’s first oral subtype-selective HDAC inhibitor, belonging to the class of selective epigenetic modulators. It was approved for marketing by the China Food and Drug Administration (CFDA) in December 2014 for its first indication: relapsed or refractory peripheral T-cell lymphoma. Meanwhile, clinical studies of Chidamide as a monotherapy or in combination with other antineoplastic agents for the treatment of other hematologic malignancies, solid tumors and HIV are underway simultaneously in the United States, Japan, China, Chinese Taiwan and other countries and regions.
About Chipscreen Biosciences
Founded in 2001 by a senior team of returnees from the United States, Shenzhen Chipscreen Biosciences Co., Ltd. is a leading enterprise in the research and development of original innovative drugs in China’s biopharmaceutical sector. The company possesses a complete capability covering target discovery, clinical candidate drug development, industrialization and commercialization, and has a professional team of technical, management and intellectual property experts specializing in original innovative drug R&D. With its independently established integrated drug discovery and early evaluation platform based on chemical genomics as its core competitiveness and the tenet of Originality, Safety and Superior Efficacy, Chipscreen Biosciences is committed to providing patients with affordable innovative mechanism-based therapeutic drugs. The company has achieved a number of breakthroughs in the development of innovative small-molecule drugs targeting major diseases, with global patent protection and unique clinical efficacy.
