Athenex Inc. (NASDAQ: ATNX) led biotech stocks higher on Wednesday after its Chinese subsidiary submitted an Investigational New Drug (IND) application to the China Food and Drug Administration (CFDA). Specifically this IND is in regards to Oraxol, an oral formulation of Paclitaxel, an anti-cancer chemotherapy drug.
Although this company has only come public recently, it has posted incredible gains in a short time. The stock first went public on June 14, entering the market around $12 a share. Since that time the stock has grown a whopping 62% to the current price level.
Accordingly, the CFDA has been accepted Oraxol for review and has assigned the application numbers JXHL1700121 (for the oral paclitaxel capsule) and JXHL1700122.
Athenex has also licensed the global rights (apart from Korea) for the Orascovery program, a novel approach that uses P-gp inhibitor HM30181A to enable favorable oral dosing administration of Oraxol and other clinical candidates, which was initially developed by Hanmi Pharmaceuticals. Athenex is currently conducting a Phase 3 clinical study for Oraxol in breast cancer patients.
Paclitaxel is used in the treatment of breast, ovarian, lung, bladder, prostate, melanoma, esophageal, as well as other types of solid tumor cancers. It has also been used in Kaposi’s sarcoma.
Most patients do not experience all the side effects of Paclitaxel, although chemotherapy drugs carry some serious adverse effects. In Paclitaxel the following side effects are common: low blood counts, hair loss, arthralgias and myalgias, peripheral neuropathy, nausea and vomiting, diarrhea, and mouth sores.
Dr. Rudolf Kwan, Athenex’s chief medical officer, commented:
Our application of Oraxol IND to the Chinese FDA reflects our commitment to developing Oraxol as a global anti-cancer drug as well as our plan to launch clinical studies in China for this product.
Jeffery Yordon, Athenex’s chief operating officer, also added:
This application underscores our global development plan for Oraxol, with the Chinese market being an important part of that strategy. Our innovative oncology, commercial, and supply chain platforms will allow us to efficiently develop Oraxol as a commercial product.
Shares of Athenex were last seen trading up 17% at $19.49, with a 52-week range of $11.21 to $20.43.