YOFOTO (China) Health Now Commissioning its
Manufacturing Facility in Preparation for Technology Transfer of
Skin and Tendon Product Manufacturing and Applications for Clinical
Trials
VANCOUVER, Sept. 10, 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, has now completed the construction of its cell
therapy manufacturing facility.
In a recent update to the RepliCel Board of Directors, the
YOFOTO team reported that construction of its 4,700 sq metre
facility dedicated to cell therapy manufacturing is now complete
being commissioned for active production with capacity for 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.
YOFOTO also reported that it now has over 20 people employed in
the facility and is actively engaged in:
- the pursuit of the facility's certification;
- initiation of technology transfer training by RepliCel at its
contract laboratory at the University of
British Columbia laboratory (Vancouver, Canada); its contract manufacturing
facility in Europe (Innsbruck,
Austria), and at clinical trial
sites in China; and
- preparing the initial applications to the Chinese regulatory
authorities seeking approval to commence clinical trials of the
RCS-01 skin and RCT-01 tendon products in China.
"The speed at which YOFOTO has designed and built this facility
is impressive," stated RepliCel President and CEO, R. Lee Buckler, "and certainly is indicative of
their commitment to the portfolio of products they licensed from
and are co-developing with RepliCel."
"YOFOTO is very committed to rapidly moving forward the
development and commercialization of RCT-01, RCS-01 and RCI-02 in
Greater China," stated YOFOTO
(China) Health Vice-President,
Larissa Huang. "We now look forward
to working with some of China's
leading clinical hospitals and clinicians as well as China's regulatory authorities to prepare for
clinical studies in tendon regeneration and skin rejuvenation in
China."
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 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.
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; that YOFOTO
will obtain certification of its facility; that YOFOTO has
hired over 20 people, that YOFOTO will submit 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.
