Japan headquartered GNI Group (TYO: 216), a clinical-stage bio-pharmaceutical company focusing on major diseases prevalent in Asia, especially China and Japan, has entered into an exclusive commercialization agreement for markets outside of China for Etuary (pirfenidone), its idiopathic pulmonary fibrosis (IPF) treatment drug, with AFT Pharmaceuticals.
Etuary, designated as drug F647 in China, was approved in 2011 by the China Food and Drug Administration (CFDA) under orphan drug status for the treatment of IPF in China. The license agreement with AFT is contingent on final manufacturing and commercialization approval for F647 being provided by the CFDA.
Under the terms of the deal, AFT will be granted the right to market F647 under the name Etuary, including production, registration, sales and distribution, in the defined territories of the agreement such as Australia, New Zealand, ASEAN countries, Hong Kong, Russia and the CIS countries.
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