News

TOKYO – FUJIFILM Corporation (President: Kenji Sukeno) is expanding its gene therapy offering, with the addition of viral vector process development and GMP1  manufacturing services at FUJIFILM Diosynth Biotechnologies’ in the North East of the United Kingdom (UK).  FUJIFILM Diosynth Biotechnologies’ viral vector process development laboratories in the UK will be online from spring 2021. The laboratories will be outfitted with state-of-the-art equipment to support upstream (suspension and adherent) processes, downstream processing and analytical development. The GMP manufacturing capabilities are expected to be available from autumn 2021 and will support bulk drug substance production of investigational drugs used in early-stage clinical trials.  “FUJIFILM Corporation is committed to supporting the creation of new therapies for our customers through the stable supply of high-quality viral vectors that have the potential to have a profound impact for patients around the world,” said Takatoshi Ishikawa, senior executive vice president, general manager of Bio CDMO Division,

-Process development and manufacture of formulations using lipid nanoparticles Drug Delivery System technology- TOKYO—FUJIFILM Corporation (President: Kenji Sukeno) announces the conclusion of a manufacturing contract agreement with biotechnology company, VLP Therapeutics Japan LLC (Representative Executor: Wataru Akahata, hereinafter “VLP Therapeutics”) regarding COVID-19 vaccine formulation developed by VLP Therapeutics. VLP Therapeutics’ COVID-19 vaccine is self-amplifying (replicon) RNA*1 vaccine and uses a formulation (lipid nanoparticle)*2, which is a type of Drug Delivery System (DDS) technology*3. Fujifilm will utilize its manufacturing facilities and infrastructure for lipid nanoparticle to handle operations relating to VLP Therapeutics’ COVID-19 vaccine formulations, from process development to manufacturing for the clinical trials. VLP Therapeutics is the Japanese subsidiary of VLP Therapeutics, LLC (Chief Executive Officer: Wataru Akahata), a U.S. biotechnology company engaged in the development of next-generation COVID-19 vaccine, aiming to prevent infections for which no effective treatment methods exist. Research is currently under way at VLP Therapeutics LLC

LONDON and TOKYO ― Centus Biotherapeutics Ltd., a joint venture between Fujifilm Kyowa Kirin Biologics Co., Ltd. and AstraZeneca, today announced that the European Commission (EC) has granted the marketing authorization for Equidacent® (Product Code: FKB238), the company’s biosimilar to Avastin® (bevacizumab). The authorization follows the adoption of a positive opinion by the Committee for Medicinal Products for Human Use (CHMP), which concluded that the development program including analytical, functional, clinical, and immunogenicity data demonstrated biosimilarity with the reference product, Avastin. The EC approval of Equidacent applies to 27 European Union (EU) member states, the United Kingdom (UK) and the European Economic Area (EEA) member states of Norway, Iceland, and Liechtenstein. Equidacent is indicated for the following indications: metastatic carcinoma of the colon or rectum metastatic breast cancer unresectable advanced, metastatic, or recurrent non-small cell lung cancer advanced and/or metastatic renal cell cancer epithelial ovarian, fallopian tube, or primary peritoneal

TOKYO — FUJIFILM Toyama Chemical Co., Ltd. (President: Junji Okada; hereinafter “FUJIFILM Toyama Chemical”) has announced today that primary endpoint has been met in phase III clinical trial of “Avigan Tablet” (generic name: favipiravir, “Avigan”) conducted in Japan for patients with novel coronavirus infections (hereinafter “COVID-19”). The efficacy primary endpoint is time to negative conversion of detectable SARS-CoV 2 viral RNA in the RT-PCR assays, and to alleviation of symptoms (body temperature, oxygen saturation and chest images). FUJIFILM Toyama Chemical began a phase III clinical trial of Avigan in Japan in March 2020, for COVID-19 patients with non-severe pneumonia. The company conducted randomized, placebo-controlled, single-blind comparative study*1 to evaluate the efficacy and safety of Avigan. The median value of primary endpoints, using 156 individuals as analysis targets, were 11.9 days for the Avigan group and 14.7 days for the placebo group. FUJIFILM Toyama Chemical confirmed, with a statistically significant difference