China SFDA Approves F647/pirfenidone for the Treatment of Idiopathic Pulmonary Fibrosis

Source Press Release
Company GNI 
Tags Investments in Infrastructure, Full Approval, Respiratory
Date September 22, 2011

GNI Group Ltd. an international biopharmaceutical company, announced today that the China State Food and Drug Administration has issued New Drug Certificate for  F647 (pirfenidone) to Shanghai Genomics, the wholly owned subsidiary of GNI Group.  F647 is indicated for the treatment of idiopathic pulmonary fibrosis (IPF) in adults, a progressive and fatal lung disease. This approval finally gives the estimated 182,000~550,000 IPF patients in China an effective treatment.

“GNI is very proud to bring the first IPF medicine to Chinese patients,” said Dr. Ying Luo, CEO and President of GNI Group. “IPF is a deadly disease with estimated survival of only 20% after 5 years. Patients in China are told by their physician that it is more lethal than lung cancer. In the last 10 years,  F647 had been our lead product under development. Even at the most difficult time, we never gave up our hope to bring  F647 to these patients some day. Today’s milestone can not be achieved without dedication by many executives, scientists, and staffs in the past.

GNI has separately announced that it has received government approval to acquire 51% of Beijing Continent as the future manufacture site for  F647 in Beijing. Beijing Continent has almost completed renovating works for its GMP-compliant factory to meet requirements for the application for manufacture permit. The sales and marketing team within Beijing Continent is also working diligently to make this product accessible to Chinese patients as soon as it becomes available.

Mr. Takashi Kataoka, COO of GNI Group, said, “I am very pleased as this approval opens a new chapter in  GNI Group’s history and marks a transition point for our company from a R&D organization to become a real pharmaceutical company.”

About F647 (pirfenidone)

F647 is an orally active, small molecule drug that inhibits the synthesis of  TGF-?, which plays a key role in fibrosis. The approved formulation is capsule. In laboratory studies, F647 also inhibits the synthesis of TNF-alpha, a cytokine that is known to have an active role in inflammation. In late 2008,  pirfenidone has been approved in Japan as  Pirespa(R) by Shionogi. In March, 2011, pirfenidone is also approved in Europe as  Esbriet(R) by Intermune. In USA, pirfenidone is still under clinical trial for the treatment of IPF.

Source: Evaluate™
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