Chidamide, an original anti-tumor chemical new drug authorized by Shenzhen CHIPSCREEN BIOSCIENCES to Taiwan's Watson Hospital, has recently been approved by Taiwan's TFDA to enter the third phase of breast cancer clinical trials, which is also the second indication developed by Chidamide in Taiwan.

Chidamide is a new generation of epigenetic regulator, the new drug being carrying out by the China, the United States, Japan, south Korea and Taiwan and other regional countries at the same time. In December 2014, Chidamide was approved by CFDA and marketed in mainland China. The first indication was rare disease of peripheral T-cell lymphoma (PTCL), which is refractory to recurrence. Watson Hospital co-developed Chidamide in Taiwan in 2013, taking PTCL as the first indication, carrying out relevant tests and producing preparations in Taiwan according to the requirements of Taiwan's new drug inspection and registration regulations, and moving towards obtaining drug certificates. Dr. Chen Jianan, the general manager of Watson Hospital, said that the application of Chidamide combined with aromasin? for the third phase of clinical trials of advanced breast cancer with hormone receptor positive and HER-2 negative was approved by Taiwan TFDA on April 07, 2017, which is the second indication developed by Chidamide in Taiwan.

The clinical treatment of patients with hormone receptor positive and HER-2 negative advanced breast cancer has not been satisfied. More new mechanisms and more effective new drugs are still needed to meet the needs of the patients. According to clinical and epidemiological research statistics, there are more than 10,000 newly diagnosed breast cancer cases in Taiwan each year, of which 65-70% of breast cancer patients are hormone receptor positive and HER-2 negative. This kind of patients need careful evaluation of the treatment plan by doctors, and often use first-line endocrine therapy drugs to carry out adjuvant therapy or rescue treatment of hormone production inhibition or receptor binding blockade of patients. In the course of endocrine therapy for several years, a very high proportion of patients will develop drug resistance and relapse, and second-line endocrine therapy is necessary. The combination of Chidamide and exemestane is a second-line treatment. Watson Hospital hopes that through Chidamide's epigenetic control mechanism, it can reverse the difficult treatment problem of resistance to endocrine therapy and recurrence, delay the recurrence of the disease and prolong the survival time of the patient. According to research data, the 5-year survival rate of patients with advanced breast cancer (stage IV) is only 24%. There is an urgent need for a new mechanism of action and a new drug with definite curative effect to treat patients with advanced breast cancer.

CHIPSCREEN BIOSCIENCES hopes to accelerate the clinical development of Chidamide's first and second indications in Taiwan through cooperation with Watson Hospital. In addition, the high-quality Chidamide manufactured in Taiwan's PIC/S GMP pharmaceutical factory will benefit Taiwan's patients.