Tucidinostat/Chidamide (Trade name in Mandarin :剋必達®, Trade name in English : Kepida®)

Tucidinostat/Chidamide (Trade name in Mandarin :剋必達®,  Trade name in English : Kepida®)

Tucidinostat is a subtype-selective histone deacetylase inhibitor (HDACi), which is a new generation of epigenetic modulator by selectively inhibiting HDACs 1, 2, 3, and 10 isoforms, and is a well-known new targeted anti-cancer drug. Tucidinostat has been licensed the patent right and market right of Taiwan to GNTbm by originator Chipscreen Biosciences in September 2013, and GNTbm has led the development of a number of clinical trials and domestic manufacture of API and drug product in Taiwan.

Tucidinostat is a new drug for the treatment of a variety of cancers, possessing epigenetic activity, which is a very potential mechanism of action for a variety of cancers resulting from uncontrolled epigenetic expression. After obtaining the license right, GNTbm R&D team independently studied the mechanisms of regulation of tumor microenvironment by Tucidinostat, and therefore developed several potential TMRs (tumor microenvironment regulators), including CC-01, CC-02 and CT-01. CC-01 has entered the POC of phase Ib clinical trial of advanced colorectal cancer and CT-01 has entered phase Ib/II clinical trial of intermediate and advanced HCC,  both of which are currently recruiting patients.

Tucidinostat is a new drug under development worldwide, in addition to being developed in Taiwan, there are 3 well-known pharmaceutical companies  around the world actively developing Tucidinostat for new indications. First of all, Tucidinostat has obtained two indications, relapsed or refractory peripheral T-cell lymphoma (R/R PTCL) and HR+/Her-2- advanced breast cancer in China. Tucidinostat has also obtained two new indications, relapsed or refractory adult T-cell lymphoma (R/R ATL) and R/R PTCL in Japan. Tucidinostat in combination with the immune checkpoint inhibitor Opdivo®,in a pivotal phase III trial for first-line treatment of advanced melanoma, is recruiting patients worldwide in US and other countries. And in Taiwan, Tucidinostat has obtained its first approval of indication for the treatment of HR+/Her-2- advanced breast cancer. The expansion of new indications, including R/R PTCL, intermediate and advanced HCC and advanced colorectal cancer, is underway in Taiwan.



Basic Information of Tucidinostat/Kepida®

Tucidinostat Patent Licensing and Development

After the originator Chipscreen Biosciences completed the global multinational patent layout of Tucidinostat, it  successively licensed the patents to many international new drug development companies and well-known big pharmaceutical companies, and the international licensing and development status is as follows:

In 2006, Chipscreen Biosciences granted patents outside China, Hong Kong and Taiwan to HUYABIO International, LLC.
In 2013, Chipscreen Biosciences authorized Taiwan right to GNTbm.
In 2020, HUYABIO International reauthorizes a total of eight countries, including Japan, Korea and Southeast Asia to Meiji Seika Pharma of Japan.
Tucidinostat is currently developed globally and owned by four pharmaceutical companies, cooperating with each other.



Table 1. The current status of Tucidinostat clinical development.

*GNTbm follows the same clinical trial protocol from Chipscreen Biosciences.
**Historical retrospective studies were based on TFDA/CDE recommendations.
#Clinical investigators initiate trials, sponsored by GNTbm.
## Clinical trials sponsored by GNTbm
###Clinical trials sponsored by GNTbm

Taiwan: GNTbm
China: Chipscreen Biosciences 
US: HUYA Bioscience International
Japan/Korea: HUYA/Meiji Seika Pharma