National Medical Products Administration (NMPA) Approves Chipscreen Bioscience's Chidamide (Epidaza) for Breast Cancer Indication

SHENZHEN, China, Nov. 29, 2019 /PRNewswire/ -- On November 29, 2019, Shenzhen Chipscreen Biosciences Co., Ltd. (Chipscreen Biosciences, Stock Symbol: 688321.SH) announced that the company's lead innovative product Epidaza® (Chidamide), an oral subtype-selective histone deacetylase (HDAC) inhibitor, previously approved for recurrent and refractory peripheral T cell lymphoma in China, has received approval for marketing application in its second indication from NMPA. The indication includes Chidamide 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.

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%. Breast cancer deaths account for 69,500 cases per year and act as the leading cause of cancer deaths among women aged below 45 years old. Estrogen receptor positive breast cancer accounts for about 70% of all breast cancers, and endocrine therapy is the cornerstone treatment for this type of disease. However, the emerging of treatment resistance in patients with recurrent or progressive disease after endocrine therapy is an important factor affecting the follow-up treatment selection in this type of patients. How to overcome drug resistance and develop a new therapeutic regime with good efficacy and safety profile is an important direction for new drug research and clinical development.

Epigenetic abnormality is a common biological basis for drug resistance, tumor recurrence and metastasis in cancer patients. Chidamide is a selective HDAC inhibitor with unique epigenetic mechanisms against tumor cell growth, immune escape and drug resistance. In a pivotal phase 3 clinical trial (ACE study), 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. This is the first randomized, double blind phase 3 clinical study to prove clinical benefit of adding HDAC inhibitor into existing treatment for solid tumors, and to achieve a breakthrough in clinical development of epigenetic modulators. Chidamide is so far the only epigenetic modulator approved globally for solid tumor treatment that will provide a new therapeutic choice for ABC patients.

About Chidamide (Epidaza®)

Chidamide (CS055/HBI-8000/Tucidinostat) is an orally bioavailable, low-nanomolar inhibitor of cancer-associated histone deacetylase (HDAC) enzymes with favorable pharmacology and tolerability profiles relative to existing benzamide and non-benzamide HDAC inhibitors. It targets specifically the subtype 1, 2, 3 of Class I and subtype 10 of Class IIb HDAC and is being studied in multiple clinical trials as a single agent or in combination with chemotherapeutic/targeted agents for the treatment of various hematological tumors, solid cancers, and HIV in the United States, Japan, Korea, China and Taiwan. In clinically administrated concentrations, it demonstrated a unique epigenetic mechanism of actions against tumor cell development, involving preferential induction of growth arrest and apoptosis in blood and lymphoid-derived tumor cells, activation of NK-mediated and CD8-mediated antigen-specific cellular anti-tumor immunity, differentiation of tumor stem cells, reversal of drug-resisting tumor cells and epithelia to mesenchymal transition, which are hallmarks of treatment resistance, tumor cell metastasis and recurrence. Chidamide was approved on December 23(rd) of 2014 by China Food and Drug Administration (CFDA) for recurrent and refractory peripheral T-cell lymphoma in China.

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About Chipscreen

Chipscreen Biosciences was founded in Shenzhen on 2001, specializing in the research and development of original small molecule drugs. With the self-created "integrated drug discovery and early evaluation platform based on chemical genomics" as its core competitiveness, Chipscreen Biosciences has now become one of China's leading innovative drug enterprises, forming a modern biopharmaceutical group company in Shenzhen, as its headquarter, research and development center, and GMP production base, Chengdu, as a regional headquarter for research and development center and a large scale GMP production base for both drug substances and products, Beijing clinical research center and Shanghai commercial center. At present, the company has developed a number of original new drug product lines for oncology, metabolic diseases, and autoimmune diseases. Shenzhen Chipscreen Biosciences Co., Ltd. has been listed on Shanghai Stock Exchange STAR Market on August 12, 2019 (Stock Symbol: 688321.SH).

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SOURCE Shenzhen Chipscreen Biosciences, Ltd.