FUJIFILM ANNOUNCES THE RECEIPT OF IMPORTED DRUG LICENSE FOR ITS ORAL SYNTHETIC QUINOLONE ANTIBACTERIAL AGENT IN CHINA
July 25, 2019
Tokyo, July 25, 2019 ― FUJIFILM Corporation (President: Kenji Sukeno) announces the receipt *1 of an imported drug license for the oral synthetic quinolone antibacterial agent “T-3811” (generic name: garenoxacin mesilate hydrate) from the National Medical Products Administration (NMPA) of China with respiratory infections such as pneumonia.
“T-3811” is a synthetic quinolone antibacterial agent developed by FUJIFILM Toyama Chemical Co., Ltd. and demonstrates antibacterial activity against drug-resistant bacteria such as multidrug-resistant Streptococcus pneumoniae. The oral agent has a high level of absorption and tissue penetration performance, demonstrating efficacy with once-daily administration. The agent has been available*2 in Japan since October 2007 as “Geninax® Tablet 200mg”.
Fujifilm will export the “T-3811” manufactured in FUJIFILM Toyama Chemical’s plant in Japan to China, and market the drug through its marketing partner Shenzhen Main Luck Pharmaceuticals Inc., a prominent pharmaceutical company in China. The start of sales is planned in the fiscal year ending March 2021.
The pharmaceutical market in China has grown to become the world’s second largest market after the U.S., and it is expected to continue to grow at an annual rate of 3 to 6%*3. The market is moving forward rapidly with internationalization, joining the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), and it is accelerating efforts to introduce new drugs from overseas. Currently, in light of the globally increasing problem of drug-resistant bacteria, there is a growing need in China for new drugs that are anticipated to deliver a high level of efficacy.
Fujifilm utilizes its advanced technologies including chemical synthesis, compound design and nanodispersion to develop new drugs in the areas of “cancer”, “central nervous system diseases”, and “infectious diseases”, where there are high unmet medical needs, and is engaged in the development of drug delivery system technologies that deliver the required drug to the specific area of the body in timely manner. Fujifilm will continue to contribute to the resolution of social issues through the development and provision of innovative, high value-added pharmaceutical products.
*1Fujifilm Toyama Chemical Co., Ltd., a 100% subsidiary of Fujifilm received the imported drug license.
*2FUJIFILM Toyama Chemical and Astellas Pharma Inc. (President & CEO: Kenji Yasukawa, Ph.D.; hereinafter “Asellas Pharma”) signed a basic licensing agreement in March 2006 for the drug’s marketing and joint development within Japan. FUJIFILM Toyama Chemical manufactures the drug while Astellas Pharma takes in charge of sales and distribution as well as working in partnership with Taisho Pharmaceutical Co., Ltd.(President: Shigeru Uehara) for sales promotion.