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Athenex and Its Partner, Guangzhou Xiangxue Pharmaceutical, Announced Chinese FDA IND Approval to Begin Clinical Trials of KX-02 Tablet for Glioblastoma

2017-05-25 00:56

BUFFALO, New York, May 25, 2017 /PRNewswire/ -- Athenex, Inc., Buffalo, NY, a global specialty oncology pharmaceutical company focusing on the development and commercialization of next generation therapies for cancers and supportive therapies, announced today that its partner, Guangzhou Xiangxue Pharmaceutical Co. Ltd., (Xiangxue) has received the Chinese FDA Investigational New Drug (IND) approval to begin clinical trials for KX-02 tablet for glioblastoma in May 2017 under the Class 1 New Drug Regulation in China. Athenex also received the US FDA allowance for KX-02 IND in 2014.

KX-02 is a new Src protein tyrosine kinase (PTK) inhibitor and tubulin polymerization inhibitor designed and developed by Athenex. It can disrupt cancer cell division, induce cell cycle arrest, apoptosis and cancer cell death. KX-02 can also cross the blood-brain-barrier and has induced durable complete remissions of glioblastoma in human xenograft animal models without sustained therapy.

Rudolf Kwan, Athenex's Chief Medical Officer stated, "Our partner Xiangxue submitted to the Chinese FDA an application for Class 1 clinical trial approval for the KX-02 tablet and obtained the approval earlier than the usual timeline of one year. This is a testament to both our companies' focus on developing cutting-edge oral treatments for cancer. Xiangxue has been a great partner throughout this process, and we remain focused on developing first and best-in-class innovative anti-cancer drugs to market globally by ourselves and with partners."

About Athenex, Inc.

Founded in 2003, Athenex is a global specialty oncology pharmaceutical company focused on the development and commercialization of next generation therapies for cancer diseases and supportive therapies. The company is dedicated to delivering innovative drugs that can have a life-changing impact on cancer patients. Our business includes innovative proprietary products under development, medical technology innovation centers, product development teams and a unique emerging manufacturing supply chain across both China and North America. Our employees include several hundred professionals dedicated to the mission of improving the lives of cancer patients throughout the world. With our connected innovation, development and manufacturing presence in China and the US, we can identify, develop, and deliver proprietary medical technology across continents and multiple regulatory environments. We have offices in: Buffalo and Clarence New York, Schaumburg Illinois, Cranford New Jersey, Hong Kong, Taipei Taiwan, and multiple locations in Chongqing, China. In addition to our offices, we have regional development partners in Dunedin New Zealand, Hong Kong, Guangzhou China, Seoul South Korea, Taipei Taiwan, Guatemala City, Guatemala, and Buenos Aires Argentina.

Source: Athenex, Inc.

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