Company Overview of Athenex, Inc.
Athenex, Inc., a specialty oncology pharmaceutical company, focuses on the development and commercialization of next generation therapies for cancer diseases and supportive therapies. It offers Oraxol, an oral formulation of paclitaxel that allows for the oral delivery of paclitaxel when combined with Hanmi Pharmaceutical’s absorption enhancer HM30181, a potent and selective P-glycoprotein (PGP) pump inhibitor. The company also provides Oratecan, an oral formulation of Irinotecan for oncology indications, such as colorectal cancers; KX01 (KX2-391), an orally active and highly selective inhibitor of Src tyrosine kinase signaling and tubulin polymerization; and KX02 (KX2-361), a dual Src/pre-t...
1001 Main Street
Buffalo, NY 14203
Founded in 2003
Key Executives for Athenex, Inc.
Chairman and Chief Executive Officer
Co-Founder and Chief Scientific Officer
Chief Financial Officer, Chief Operating Officer and Director
President of Pharmaceutical Division
Compensation as of Fiscal Year 2016.
Athenex, Inc. Key Developments
Athenex Announces Completion of the Investigational New Drug (IND) Application for KX-02 Active Pharmaceutical Ingredient and KX-02 Tablet
Oct 18 16
Athenex announced that its development partner for KX-02, Xiangxue Pharmaceuticals Company Limited, has publicized that the Guangdong Province Food and Drug Administration (FDA) declared completion of the Investigational New Drug (IND) application for KX-02 active pharmaceutical ingredient and KX-02 Tablet and referred the IND to the Center of Drug Evaluation (CDE) of China FDA for review. The IND application to the Chinese FDA was submitted jointly by Xiangxue New Drug Development Company Limited, Xiangxue Pharmaceuticals Limited, and Hangzhou Converd Co. Ltd. The Guangdong Province FDA has determined, after their inspection of the factory and initial review of the IND submission, that it is complete and was referred to the Center of Drug Evaluation (CDE) of China FDA for review. This IND application has been assigned the application number CXHL1600187. In 2012, Athenex and Xiangxue Pharmaceuticals announced the execution of a license agreement granting Xiangxue Pharmaceuticals exclusive rights to KX-02, for all oncology indications, in the greater China territory (China, Hong Kong, Taiwan) and Singapore. KX-02, a novel lipophilic dual Src/pretubulin inhibitor, was discovered and developed by Athenex through their internal research and development efforts. It is a small molecule that has shown potent inhibitory activity against a broad panel of brain tumor cell lines, including cells (T98G) that are resistant to Temodar, the most widely used chemotherapy for the treatment of malignant glioma. In a well-established brain tumor animal model, KX-02 has been shown to consistently clear brain tumors after 4 weeks of therapy in 30-60% of treated animals. Pharmacokinetic studies showed that KX-02 is absorbed orally and has 76% penetration to brain tissue from plasma. KX-02 is already in Phase 1 study in the US and has been assigned "Orphan Drug" status by the US FDA. Preclinical studies have shown that KX-02 showed excellent brain penetration and promising anti-tumor activities in mouse brain tumor models. A proportion of rodents cleared the tumor after 6 weeks of oral KX-02 treatment.
Athenex Pharmaceutical Division and SunGen Pharma Enter into Joint Venture Agreement to Launch and Market 7 Pharmaceutical Products in the United States
Oct 6 16
Athenex Pharmaceutical Division and SunGen Pharma reported a joint venture agreement to launch and market 7 pharmaceutical products, both injectable and solid oral dosage, in the United States. many of these products are therapeutically relevant to the Athenex proprietary pipeline of products under development. In addition, all of these products are approved by the U.S. FDA and will be launched in the near future by Athenex Pharmaceutical Division.
Athenex Pharmaceutical Division and SunGen Pharma LLC Enter into Joint Venture Agreement for Portfolio of 7 Approved Pharmaceutical Products
Sep 26 16
Athenex Pharmaceutical Division and SunGen Pharma LLC announced a joint venture agreement to launch and market 7 pharmaceutical products, both injectable and solid oral dosage, in the United States. Many of these products are therapeutically relevant to the Athenex proprietary pipeline of products under development. In addition, all of these products are approved by the U.S. FDA and will be launched in the near future by Athenex Pharmaceutical Division. The specialty products being launched in the near term are expected to create a revenue and margin contribution to help subsidize the ongoing clinical trials and research and development projects for the Athenex proprietary pipeline. To further the synergies, Athenex will be working closely with its Active Pharmaceutical Ingredient (API) division, Polymed, to back-integrate into its pipeline of products. The company fully expects to consummate several more of these types of transactions in the near future.
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September 23, 2016