Athenex announced that, through its subsidiary, it has entered into a licensing and partnership agreement with Chongqing Jingdong Junzhuo Pharmaceutical to exclusively develop and commercialize KX2-391 for the treatment of actinic keratosis and oncology indications in humans in China. KX2-391, also known as KX-01, is a first-in-class dual Src kinase and tubulin polymerization inhibitor. KX2-391 ointment is a topical medicinal product for the treatment of actinic keratosis that is in late stage Phase III development. Actinic keratosis is a common skin condition that is induced through ultra-violet light damage, resulting in patches of thick, scaly, or crusty skin. Left untreated, the lesions have risk of progression to squamous cell carcinoma and, consequently, treatment by a dermatologist is recommended. Other drug candidates with KX2-391 as the active ingredient are also being developed for oncology indications. Pursuant to the terms and conditions of the arrangement, Athenex will grant to Chongqing Jingdong Pharmaceutical an exclusive license under Athenex's intellectual property to commercialize topical and oral products containing KX2-391 in mainland China, excluding Hong Kong, Macau and Taiwan. Athenex is expected to receive an upfront payment of an aggregate amount of $14.5M. Athenex will also be eligible to receive other development milestone payments of up to $15M. In addition, the agreement provides for tiered royalties based on annual net sales starting at 15% and with incremental increases of royalties with increases in sales. Athenex will be responsible for conducting all preclinical and clinical studies, as well as regulatory submissions, required for approval in China. Chongqing Jingdong Pharmaceutical will employ its expertise to plan and prepare for the commercialization of the products in China. Athenex announced on July 26, 2018 that statistical significance was achieved in two Phase III studies conducted in the United States to support the registration of KX2-391 ointment for the treatment of actinic keratosis. Athenex has submitted an abstract to the American Academy of Dermatology for potential presentation of top-line data from Phase III studies at the AAD meeting in March.
