Athenex Announces Chinese FDA Allowance of Investigational New Drug Application of Oraxol to Begin Clinical Trials

BUFFALO, N.Y., Jan. 08, 2018 -- Athenex, Inc. (Nasdaq:ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, today announced that the Chinese FDA has allowed the Investigational New Drug (IND) application for Oraxol, an oral formulation of paclitaxel. As previously announced, the IND application was submitted to the Chinese FDA in June 2017. In May 2017, Athenex, together with its partner Xiangxue Pharmaceuticals, also obtained Chinese FDA IND allowance of KX-02 in order to begin Phase I clinical trials for Glioblastoma Multiforme (GBM) in China.

Acceptance of the Oraxol IND by the Chinese FDA allows Athenex to commence a clinical trial program for Oraxol in China in 2018, further demonstrating the Company’s commitment to developing Oraxol as a global anti-cancer drug. Oraxol is a combination of HM30181A, a highly potent and selective non-absorbed P-glycoprotein inhibitor, with oral paclitaxel. This combination significantly enhances the gastrointestinal absorption of oral paclitaxel, with a pharmacokinetic profile designed to provide excellent and potentially better clinical efficacy and lower rates of neuropathy than current forms of paclitaxel.  Athenex has licensed the rights to HM30181A, which was initially developed by Hanmi Pharmaceuticals, in all key markets (apart from Korea) and works together with Hanmi as a strategic partner in the programs derived from this technology.

Dr. Rudolf Kwan, Athenex’s Chief Medical Officer, commented, “Athenex is delighted to obtain a second Chinese FDA IND approval for our proprietary drug candidates.  This important IND approval reflects the collective efforts and hard work of our pre-clinical, clinical and regulatory teams in both the U.S. and in China, and demonstrates our strong commitment to the Chinese market. The Oraxol clinical studies in China will complement our ongoing global clinical trials in breast cancer patients.  Our Phase III trial recently received the unanimous recommendation to continue by an independent Drug Safety Monitoring Board. The second interim analysis is expected in the middle of 2018. We are excited to continue to advance towards our goal of improving the lives of cancer patients worldwide.”

About Athenex, Inc.
Founded in 2003, Athenex, Inc. is a global clinical stage biopharmaceutical company dedicated to becoming a leader in the discovery and development of next generation drugs for the treatment of cancer. Athenex is organized around three platforms, including an Oncology Innovation Platform, a Commercial Platform and a Global Supply Chain Platform. Athenex’s Oncology Innovation Platform generates clinical candidates through an extensive understanding of kinases, including novel binding sites and human absorption biology, as well as through the application of Athenex’s proprietary research and selection processes in the lab. The Company’s current clinical pipeline is derived from two different platform technologies Athenex calls Orascovery and Src Kinase Inhibition. The Orascovery platform is based on the novel oral P-glycoprotein pump inhibitor molecule HM30181A, through which Athenex is able to facilitate oral absorption of traditional cytotoxics, which Athenex believes may offer improved patient tolerability and efficacy as compared to IV administration of the same cytotoxics. The Orascovery platform was developed by Hanmi Pharmaceuticals and licensed exclusively to Athenex for all major worldwide territories except Korea, which is retained by Hanmi. The Src Kinase Inhibition platform refers to novel small molecule compounds that have multiple mechanisms of action, including the inhibition of the activity of Src Kinase and the inhibition of tubulin polymerization during cell division. Athenex believes the combination of these mechanisms of action provides a broader range of anti-cancer activity as compared to either mechanism of action alone. Athenex’s employees worldwide are dedicated to improving the lives of cancer patients by creating more active and tolerable treatments. Athenex has offices in Buffalo and Clarence, New York; Cranford, New Jersey; Houston, Texas; Chicago, Illinois; Hong Kong; Taipei, Taiwan and multiple locations in Chongqing, China.

Forward-Looking Statement Disclaimer/Safe Harbor Statement

Except for historical information, all of the statements, expectations, and assumptions contained in this press release are forward-looking statements. Actual results might differ materially from those explicit or implicit in the forward-looking statements. Important factors that could cause actual results to differ materially include: the development stage of our primary clinical candidates and related risks involved in drug development, clinical trials, regulation, manufacturing and commercialization; risks relating to doing business in China; need to raise additional capital; competition; intellectual property risks; and the other risk factors set forth from time to time in our SEC filings, copies of which are available for free in the Investor Relations section of our website at http://ir.athenex.com/phoenix.zhtml?c=254495&p=irol-sec or upon request from our Investor Relations Department. We assume no obligation and do not intend to update these forward-looking statements, except as required by law.

CONTACT:
Jim Polson
Tel: +1-716-427-2952
Athenex, Inc.