YOFOTO (China) Health Announces Initiation of Facility
Build-Out, New Hires, and Preparation to Submit Applications to
China's Regulators
VANCOUVER, March 26, 2019 /CNW/ - RepliCel Life Sciences
Inc. (OTCQB: REPCF) (TSXV: RP) (FRA:P6P2) ("RepliCel" or the
"Company"), a company developing next-generation technologies in
aesthetics and orthopedics, is pleased to announce that its
Licensee, YOFOTO (China) Health
Co. ("YOFOTO"), headquartered in Ningbo,
China, is rapidly building momentum on its licensed programs
for Greater China, since closing
the transaction with RepliCel in October last year.
In a recent update to the RepliCel Board of Directors, the
YOFOTO team reported it had:
- completed the facility design and engineering plans for a
laboratory, clinic, and research manufacturing facility build-out
to be done in a building it already owns near its headquarters in
Ningbo as well as new construction
of an adjacent building for administration;
- obtained the necessary regulatory permits and approvals to
commence certain demolition and construction;
- retained the contractors;
- commenced construction of a 4,700 sq metre facility in its
existing building to hold clinical research manufacturing, material
handling, purified water processing, research and development labs,
QC/QA testing, cryopreservation storage, clinical biopsy/treatment
space, and an exhibition hall; and
- hired several team members for its new cell therapy division
and are engaged in recruiting several others for QC/QA, clinical,
operations and regulatory positions.
YOFOTO has announced that by mid-2019 it expects to have:
- hired over 20 people;
- completed primary facility construction and initiated
technology transfer, training, and validation testing; and
- submitted the initial regulatory documentation to the Chinese
regulatory authorities seeking approval to commence clinical trials
of the RCS-01 skin and RCT-01 tendon products.
RepliCel's Greater China Strategy: A Portfolio View
RCT-01 - Current plans suggest a clinical trial of RCT-01
treatment for chronic tendinopathy will be conducted in
China by YOFOTO overlapping with a
clinical trial of RCT-01 in Japan
leading to multiple clinical readouts. Applications for such trials
are now being prepared. The timing of such trials will depend on
regulatory approvals.
RCS-01 - Current plans suggest that a clinical trial of the
RCS-01 treatment for aging and sun-damaged skin will be conducted
in China by YOFOTO overlapping
with a clinical trial or RCS-01 in Japan leading to multiple clinical readouts.
Applications for such trials are now being prepared. The timing of
such trials will depend on regulatory approvals.
RCI-02 - RepliCel's next-generation, dermal injector, a medical
device designed to optimize the controlled injection of cell
therapies and other injectables, is expected to be launched in
Europe, Hong Kong and other market accepting CE mark
approval next year. It is anticipated that YOFOTO will be marketing
the device in Hong Kong at the
same time as using the device in a clinical study of RCS-01 in
China in anticipation of
regulatory approval to launch the product on the market in
the People's Republic of China.
Simultaneous to this activity in Greater
China, RepliCel will be submitting the necessary
applications to obtain market approval for the device in
Japan and to use it there for
clinical testing.
RCH-01 – RepliCel's RCH-01 treatment in development for hair
loss due to androgenic alopecia is licensed to Shiseido Company for
Asia including Greater China.
About YOFOTO
YOFOTO (China) Health Industry
Co., Ltd was established in 2004 as a company engaged in the health
and consumer products industry. With a wide range of successful
commercial products in the food, personal health care, and
household categories, YOFOTO is now diversifying into higher-value
health-related products and services such as genetic and blood
testing, regenerative medicine, and destination health-treatment
clinics. As part of its strategy, YOFOTO has made several
investments outside of China.
About RepliCel Life Sciences
RepliCel is a regenerative medicine company focused on
developing cell therapies for aesthetic and orthopedic conditions
affecting what the Company believes is approximately one in three
people in industrialized nations, including aging/sun-damaged skin,
pattern baldness, and chronic tendon degeneration. These
conditions, often associated with aging, are caused by a deficit of
healthy cells required for normal tissue healing and function.
These cell therapy product candidates are based on RepliCel's
innovative technology, utilizing cell populations isolated from a
patient's healthy hair follicles.
The Company's product pipeline is comprised of RCT-01 for tendon
repair, RCS-01 for skin rejuvenation, and RCH-01 for hair
restoration. RCH-01 is exclusively licensed in Asia to Shiseido Company. RepliCel and
Shiseido are currently co-developing the product in Japan. RepliCel maintains the rights to RCH-01
for the rest of the world. RCT-01 and RCS-01 are exclusively
licensed in Greater China to
YOFOTO (China) Health Company.
RepliCel and YOFOTO are currently co-developing these products in
China. RepliCel maintains the
rights to these products outside of Greater China.
RepliCel has also developed a proprietary injection device,
RCI-02, and related consumables, which is expected to improve the
administration of its cell therapy products and certain other
injectables. YOFOTO has exclusively licensed the commercial rights
for the RCI-02 device and consumables in Greater China for dermatology applications and
is expected to first launch the product in Hong Kong upon it being CE marked. Please
visit www.replicel.com for additional information.
Neither TSX Venture Exchange nor its Regulation Services
Provider (as that term is defined in policies of the TSX Venture
Exchange) accepts responsibility for the adequacy or accuracy of
this release.
This press release contains forward-looking statements and
information that involve various risks and uncertainties regarding
future events, including, but not limited to, statements regarding:
that YOFOTO is rapidly building momentum on its licensed programs
for Greater China; the
laboratory, clinic, and research manufacturing facility build-out
to be done by YOFOTO in a building it already
owns near its headquarters in Ningbo as well as new construction of an
adjacent building for administration; that YOFOTO will
commence certain demolition and construction; that YOFOTO is
engaged in recruiting several other team members for QC/QA,
clinical, operations and regulatory positions; that
by mid-2019 YOFOTO expects to have: hired over 20 people, completed
primary facility construction and initiated technology transfer,
training, and validation testing, and submitted the initial
regulatory documentation to the Chinese regulatory authorities
seeking approval to commence clinical trials of the RCS-01 skin and
RCT-01 tendon products; that a clinical trial of RCT-01
treatment for chronic tendinopathy will be conducted in
China by YOFOTO overlapping with a
clinical trial of RCT-01 in Japan
leading to multiple clinical readouts; that a clinical trial
of the RCS-01 treatment for aging and sub-damaged skin will be
conducted in China by YOFOTO
overlapping with a clinical trial or RCS-01 in Japan leading to multiple clinical
readouts; that RepliCel's next-generation,
dermal injector, a medical device designed to optimize the
controlled injection of cell therapies and other injectables, is
expected to be launched in Europe,
Hong Kong and other market
accepting CE mark approval next year; that
YOFOTO will be marketing the device in Hong Kong at the same time as using the device
in a clinical study of RCS-01 in China in anticipation of regulatory approval
to launch the product on the market in the People's Republic of
China; that simultaneous to the activity
in Greater China, RepliCel will be
submitting the necessary applications to obtain market approval for
the device in Japan and to use it
there for clinical testing; that YOFOTO is now
diversifying into higher-value health-related products and services
such as genetic and blood testing, regenerative medicine, and
destination health-treatment clinics; that
RepliCel's proprietary injection device, RCI-02, is expected to
improve the administration of its cell therapy products and certain
other injectables; and that YOFOTO is expected
to first launch the RCI-02 device and consumables in Greater China for dermatology applications in
Hong Kong upon it being CE
marked.
These statements are only predictions and involve known and
unknown risks which may cause actual results and the Company's
plans and objectives to differ materially from those expressed in
the forward-looking statements, including: risks related
YOFOTO spending the required amounts on RepliCel's
programs and related infrastructure over the next 5 years in
Greater China; risks related
YOFOTO not completing its stated goals; risk related to
YOFOTO paying $4.5M CDN in milestone
payments and sales royalties; risks that the
Company's products may not perform as, or have the
benefits, expected; risks that the
Company's products may not be
accepted and adopted by the public; the risk that the
Company will not obtain CE mark clearance for its
injector device as anticipated or at all; the risk that
there will be delays enrolling clinical trial participants or
commencing any clinical or research programs as anticipated or at
all; the risk that the Company will receive negative results from
the Company's clinical trials; the effects of government regulation
on the Company's business; risk that the Company may not obtain any
further data from Shiseido; risks associated with the Company
obtaining all necessary regulatory approvals for its various
programs; risks associated with the Company's ability to obtain and
protect rights to its intellectual property; risks and
uncertainties associated with the Company's ability to raise
additional capital; and other factors beyond the Company's control.
Although the Company believes that the expectations reflected in
the forward-looking statements are reasonable, it cannot guarantee
future results, levels of activity or performance. Further, any
forward-looking statement speaks only as of the date on which such
statement is made and, except as required by applicable law, the
Company undertakes no obligation to update any forward-looking
statement to reflect events or circumstances after the date on
which such statement is made or to reflect the occurrence of
unanticipated events. New factors emerge from time to time, and it
is not possible for management to predict all of such factors and
to assess in advance the impact of such factors on the Company's
business or the extent to which any factor, or combination of
factors, may cause actual results to differ materially from those
contained in any forward-looking statement. Readers should consult
all of the information set forth herein and should also refer to
the risk factor disclosure outlined in the Company's annual report
on Form 20-F for the fiscal year ended December 31, 2017 and other periodic reports
filed from time-to-time with the Securities and Exchange Commission
on Edgar at www.sec.gov and with the British Columbia
Securities Commission on SEDAR at www.sedar.com.
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SOURCE RepliCel Life Sciences Inc.