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[Priority Issue 1]Fulfill Unmet Medical Needs


Note: The article on this page is taken from Sustainability Report 2018.

Target and Key points in FY2017 Activities

Target for 2030

The Fujifilm Group is striving forward in the development and dissemination of new therapies for unmet medical needs, where effective treatment is still to be found. Fujifilm possesses the highly functional material synthetic technologies and engineering skills that we have gained through our photographic film development and production, including advanced nano dispersion technology, analysis technology, and production engineering technologies. We are actively seeking synergetic collaborations with business partners who also possess superior technologies, in order to develop new solutions in regenerative medicine and cell therapy and improve accessibility to such advanced treatments.

Outline of Activities in FY2017


[Target] Develop new treatment solutions
((1) Regenerative medicine, (2) Anti-cancer measures, (3) Infectious disease treatment)

  1. Submitted application to the Ministry of Health, Labour and Welfare for
    approval on a partial usage change of Autologous Cultured Epidermis JACE® to expand applications for epidermolysis bullosa treatment.
  2. Started U.S. Phase I clinical trials of the anti-cancer agent FF-10832 for advanced solid tumors. (Development of a liposome drug that will be selectively delivered to the tumor, enhancing the pharmacological efficacy.
  3. Started Phase II clinical trials in Japan on therapeutic radiopharmaceutical F-1614 targeted at refractory melanocytoma.
  4. Started U.S. Phase I clinical trials of anti-cancer agent FF-10101 targeted at recurrent and/or refractory acute myeloid leukemia.
  5. Launched a PET radiopharmaceutical Fludeoxyglucose (18F) intravenous injection.
  6. Received the Prize for Science and Technology under a Commendation for Science and Technology by the Minister of Education, Culture, Sports, Science and Technology FY2018 for development of an influenza antiviral drug with a new mode of antiviral action for pandemic prevention.
  7. Started Phase III clinical trials of Favipiravir, a broad-spectrum antiviral agent targeted at severe fever with thrombocytopenia syndrome (SFTS).

[Target] Improve accessibility to new treatment solutions
((4) Contribution through contract development and manufacturing, (5) Contribution through development and dissemination of products that support advanced medicine)

  1. Further enhanced contract development and manufacturing business of biopharmaceuticals* and started operations at a new manufacturing building in the US Texas site.
  2. Built a new factory aiming at stable supplies of our high quality and reliability liposome drug utilizing our exclusive technologies.
  3. Acquired Irvine Scientific Sales Company and IS Japan, leading companies in the area of cell culture media

* Biopharmaceuticals: Pharmaceutical products utilizing biological particles, such as proteins, that provide effects unachievable by conventional chemically synthesized small-molecule drugs. Such biopharmaceuticals include insulin, vaccines, and antibody drugs. Antibody drugs utilize antibodies, proteins used by the immune system to protect our bodies from infectious or abnormal organisms, such as viruses and cancer cells, by recognizing them selectively.

Future Activities and Targets

  • Introduce our regenerative medicine products to the market, expand their application to treatment, and improve contract manufacturing for these products.
  • Accelerate development of our new drug pipeline.
  • Expand contract manufacturing for biopharmaceuticals.
  • Develop and disseminate cell culture or other production technologies that support advanced biomedical treatment (gene therapy, etc.).

Development and Dissemination of Cell Culture Media to Contribute to Regenerative Medicine and Cell Therapies

Cell culture media are critical technology and materials used in the research, development, and production of regenerative medicine products and biopharmaceuticals. It is said that the quality of the cell culture media determines the quality and medical efficacy of the cell culture. As social attention is increasingly drawn to biopharmaceuticals and cell therapies as new approaches to medical treatment, high quality cell culture media are also in demand.

The Fujifilm Group is accelerating its R&D in the field of regenerative medicine in various aspects, such as the acquisition of Japan Tissue Engineering Co., Ltd., the first company to develop and introduce products based on regenerative medicine to the Japanese market. In 2017, the Group acquired Wako Pure Chemical (current FUJIFILM Wako Chemical), a manufacturer and seller of laboratory chemicals, cell culture media, specialty chemicals and clinical diagnostic reagents, as a consolidated subsidiary. This acquisition enabled the Group to finally obtain the three key elements required in cell culture, as well as entering the cell culture media business. In June 2018, the Fujifilm Group also acquired Irvine Scientific Sales Company (ISUS) and IS Japan (ISJ), leading companies in cell culture media with a wide range of products including culture media for biopharmaceutical production, in vitro fertilization and cell therapy. Making the best use of their advanced R&D expertise, quality management skills, and production knowhow, we now can develop and produce customized culture media to suit various customer needs. We are now capable of developing a variety of medical solutions from biopharmaceuticals to in vitro fertilization and cell therapies, as well as offering optimized cell culture media to pharmaceutical companies, bioventure companies, and academic institutions across the world.

The Fujifilm Group will disseminate products based on regenerative medicine and cell therapies that have high potential as more accessible standard medical treatments by uniting all the Group's technologies toward wider industrialization.

Three key elements required in regenerative medicine
* Below is an explanation of these three elements using the analogy of “rice cultivation”

[image]Three key elements required in regenerative medicine

Development and Dissemination of Liposome Drug That Delivers Medicine Selectively to Cancer Cells for More Effective Performance

The Fujifilm Group is endeavoring to develop new medicines for cancer, central nervous system diseases, and infectious diseases, particularly focusing on drug delivery system (DDS) technology.* One example is our liposome drug that can deliver medicine selectively to cancer cells to increase the efficacy of the medicine. Our revolutionary drug could drastically change the standard of drug-based anti-cancer treatment such as application and expansion of technology to oligonucleotide therapeutics and gene therapy. We started clinical trials for the liposome drug FF-10832 for advanced solid tumors in the US in May 2017. We will construct a new manufacturing facility for liposome drugs at the production site of Toyama Chemical Co., Ltd. This new facility is expected to produce drugs for both research and commercial purposes, and will provide a stable supply of high quality liposome drugs. The new facility is scheduled to start operation in February 2020.

※ Drug delivery system (DDS): Systems to transport a pharmaceutical compound in the body in the required amount to the desired site in an appropriate timing. Liposome drug is expected to deliver a specific medicine solely to cancer cells, thereby reducing side effects and at the same time increasing medical efficacy.

Spreading Biopharmaceuticals as Effective Drugs


New manufacturing building of FUJIFILM Diosynth Biotechnologies where single use 2,000-litre mammalian cell culture tanks have been installed. This company possesses advanced biotechnology knowhow to efficiently produce proteins used for biopharmaceuticals utilizing animal cells and microorganisms, and process management expertise that covers from cultivation to extraction and purification.

Biopharmaceuticals are expected to be effective medicines for unmet medical needs as they have very few side effects and offer high efficacy. However, biopharmaceutical manufacturing requires advanced production technologies and facilities. Pharmaceutical companies across the world are thus increasingly contracting CDMOs* to develop manufacturing processes or actually manufacture their biopharmaceuticals. By utilizing the production and quality control technologies gained through our photographic film business, we have promoted a business for developing and manufacturing biopharmaceuticals to provide a stable supply of high quality products. In FY2017, we built new manufacturing facilities at our US Texas site and introduced additional equipment to produce antibodies to reinforce the development and manufacturing facilities of our CDMO site. We also added an antibody production process development site in the UK to reinforce our contract development and manufacturing business.

* CDMO (Contract Development Manufacturing Organization): A company or organization to develop production processes and provide manufacturing services.

Note: The article on this page is taken from Sustainability Report 2018.

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