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Bijan Nejadnik, M.D., Appointed as Chief Medical Officer of SanBio

MOUNTAIN VIEW, Calif.–(BUSINESS WIRE)–The SanBio Group (SanBio Co., Ltd. and SanBio, Inc.)(TOKYO:4592), a
scientific leader in regenerative medicine for neurological disorders,
today announced the appointment of Bijan Nejadnik, M.D., as its new
Chief Medical Officer in charge of development and regulatory affairs.

Dr. Nejadnik has held many important positions, including key roles at
Johnson & Johnson Services, Inc., a major pharmaceutical company, as
well as pioneering clinical programs in the pharmaceutical and biotech
industry, such as Jazz Pharmaceuticals, Inc., Galena Biopharma, Inc.,
and Eureka Therapeutics, Inc. At Johnson & Johnson, he was involved in
the development of immunological and oncology therapeutics, including
the development of infliximab (trade name: Remicade) used for the
treatment of rheumatic and other autoimmune disorders. At Jazz
Pharmaceuticals, he submitted Biologics License Applications (BLA) for
multiple oncology therapeutics and obtained approval from the U.S. Food
and Drug Administration (FDA) and the European Medicines Agency (EMA).
As Chief Medical Officer at Galena Biopharma, he led the research of
immunotherapy for multiple cancers and research in adoptive T-cell
therapy in combination with checkpoint inhibitor drugs. As Chief Medical
Officer at Eureka Therapeutics, he was involved in the development of
genetically modified T-cells and obtained FDA approval for several IND
and launched the clinical trials. Dr. Nejadnik thus is a leading figure
in clinical development, with diverse experience.

In Japan, using the conditional and term-limited authorization system
for regenerative medicine products under the Revised Pharmaceutical
Affairs Act, the SanBio Group is currently working toward applying for
manufacturing and marketing approval of SB623 for the treatment of
chronic motor deficit resulting from traumatic brain injury (TBI) during
the fiscal year ending January 31, 2020 (February 1, 2019–January 31,
2020). Further, it plans to initiate a Phase 3 clinical trial of SB623
for the same indication by the end of the fiscal year ending January 31,
2020. Dr. Nejadnik will work on leading these clinical developments for
obtaining approval, and in the long term, will work to promote global
expansion of the Group.

Damien Bates, M.D., PhD, FRACS, MBA, who until today has served as the
Group’s Chief Medical Officer and Head of Research, will continue to
contribute to the global development of the regenerative cell medicine
SB623 as the Group’s senior advisor.

Accepting the position of Chief Medical Officer, Dr. Nejadnik commented,
“I have been involved in the development of many new pharmaceutical
drugs with a view to meeting unmet medical needs that lack effective
treatment. SanBio is a pioneer in drug development for patients
suffering central nervous system disorders. I understand that the
development of SB623 has already come close to the stage of product
launch in Japan; taking advantage of my past experiences, I will do my
best to bring SB623 to patients worldwide as soon as possible.”

“I am very pleased to welcome Dr. Bijan Nejadnik as SanBio’s new Chief
Medical Officer,” said Keita Mori, CEO of SanBio, Co., Ltd. “In Japan,
the development program for SB623 as a treatment for chronic motor
deficit resulting from TBI has already advanced to a stage that we are
preparing for obtaining the approval for launch under the conditional
and term-limited authorization system for regenerative medicine
products. Going forward, we aim to bring the product to the global
market. We expect that Dr. Nejadnik will receive the baton from Dr.
Damien Bates and, by drawing on his extensive experience, will make
further contributions to the clinical development and submission process
towards the approval of SB623.”

About SanBio, Inc. (SanBio)

SanBio is a regenerative medicine company headquartered in Tokyo and
Mountain View, California, with cell-based products in various stages of
research, development and clinical trials. Its proprietary cell-based
investigational product, SB623, is currently in a Phase 2b clinical
trial for treatment of chronic motor deficit resulting from ischemic
stroke, and in a Phase 2 clinical trial for treatment of chronic motor
deficit resulting from traumatic brain injury. More information about
SanBio, Inc. is available at http://sanbio.com.

Contacts

For more information, contact:
SanBio Co., Ltd.
Yoshihiro
Kakutani, Corporate Officer of Management Administration
[email protected]

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