Takara Bio has started a new three-year medium-term management plan concluding in FY2020 since May 2017. The plan aims to strengthen the three business segments and business base that supports these efforts, to enhance the standing as a global industrial company for regenerative medical products. In the first year of the plan, our overseas research reagents and CDMO businesses grew stably, and we engaged in collaboration with pharmaceutical companies in our two genetically engineered T cell therapy projects.

  Based on this progress in our businesses and on recent changes in the business environment, in May 2018, we upwardly revised our quantitative target for operating income, and revised our Medium-Term Management Plan to reflect changes that include an increase in R&D investments.

1. Plan Revision

Based on this progress in the business, we upwardly revised our quantitative target for operating income and increased in R&D investments.

2. Plans for Each Business Segment

(1) Bioindustry Business

Through the maximization of synergies with the two U.S. companies we acquired (WaferGen Bio-systems and Rubicon Genomics), we plan to accelerate our reagent and instrument business development overseas. In Japan, we increase our manufacturing capacity for regenerative medical products, and strengthen our CDMO business. We will further strengthen our technological base to continually generate gene therapy projects. Further, in order to expand our businesses, we are investing in new development and manufacturing facilities for regenerative medical products.

Takara Bio to Establish a New Facility for the research and Manufacturing of Regenerative Medical Products

⇒News released on February 19, 2018

Rendering of new facilities
拡大
Rendering of new facilities

Overview of measures in each field

  • Research reagents-
    Rapid commercialization of leading-edge technologies with open innovation
  • - Contracted services-
    Structural development based on GMP/GCTP*1, CAP-LAP*2, and other quality assurance and accuracy control systems, in order to expand contracted services for regenerative medical products and the clinical domains
  • - Scientific instruments-
    Development of PCR-related products and systemized single-cell analysis by combinations of devices and reagent

Main R&D in Bioindustry business

1. Basic technology and quality control technologies for regenerative medical products

2. Ultra-low input nucleic acid analysis methods

3. New technologies required for clinical sequencing

4. Industrial uses for PCR and expansion to the clinical domain

5. New genome editing-related technologies

Note 1
GMP (Good Manufacturing Practice) refers to the Standards for Manufacturing Control and Quality Control for Pharmaceuticals. GCTP (Good Gene, Cellular, and Tissue-based Products Manufacturing Practices) refers to the Standards for Manufacturing Control and Quality Control for Regenerative Medical Products.

 

Note 2
CAP (College of American Pathologists) is U.S.-based organization whose primary functions include providing quality management system tools, accrediting laboratories, and providing education. LAP (Laboratory Accreditation Program) is an international clinical laboratory testing outcome evaluation program conducted once a year by CAP, targeting both tangible assets (e.g., clinical testing labs' hardware) and the intangible assets for running such labs (e.g., software).

(2) Gene Therapy Business

In fiscal 2019, we plan to apply for approval of Canerpaturev (C-REV), which is Japan’s first gene therapy for cancer. Further attempt is to conduct joint development with partners in Japan and cooperate with partners in overseas.

Development Status of Gene Therapy Projects (as of April 2018)

Projects Indications Region Status Partnerships
Oncolytic
Virus
Canerpaturev
(C-REV)
Melanoma JP Phase II in progress
Approval application in FY2019*3
Otsuka
Pharma
U.S. Phase II completed
Investigator initiated Phase II in progress
Preparations
underway
Pancreas cancer JP Phase I in progress Otsuka
Pharma
Engineered
T-cell
Therapy
siTCRTM NY-ESO-1 Synovial sarcoma JP Phase I/II in progress Otsuka
Pharma
Solid cancer JP Investigator initiated Phase I in progress -
Solid cancer CA Investigator initiated Phase Ib in progress Preparations
underway
MAGE-A4 Esophageal, etc. JP Investigator initiated Phase I in progress -
CAR CD19 Adult ALL*4 JP Phase I/II in progress Otsuka
Pharma

Note 3
A new durg application for marketing approval in Japan has been submitted for C-REV as a regenerative medicine product for the treatment in patient with unresectable or metastic melanoma.

⇒Please refer to IR news released on March 29, 2019.

Note 4
ALL: Acute lymphoblastic leukemia

(3) AgriBio Business

The business aims at building a stable platform by continuing the profitable business for functional foods and mushrooms.

Overview of measures in each field

  • - Functional foods-
    Build a platform for the stable supply of products suited to the sales plan from Takara Healthcare Inc.
  • - Mushroom-
    1. Expand business efficiently through the unification of manufacture and sales systems (Integration into Mizuho Norin Co., Ltd. and KINOKO CENTER KIN Inc.)
    2. Build the brand strategy approaching to the market for each mushroom products

 

Note
With the aim of fulfilling "selection and concentration" in business operation and achieving the plan, functional food business and mushroom business have been transferred in January and March 2019, respectively.

⇒IR news released on September 28, 2018 for functional food business

⇒IR news released on December 17, 2018 for mushroom business