TIDMPXS
RNS Number : 7831K
Provexis PLC
30 August 2023
30 August 2023
Provexis plc
('Provexis' or the 'Company')
BYHEALTH regulatory filing with Chinese SAMR
Provexis, the business that develops, licenses and sells the
proprietary, scientifically-proven Fruitflow(R) heart-health
functional food ingredient, announced in November 2021 that it had
entered into a long term strategic co-operation framework agreement
for Fruitflow with BYHEALTH Co., Ltd. ('BYHEALTH'). BYHEALTH is a
listed Chinese dietary supplement business with a current market
capitalisation of approximately GBP4 billion.
Provexis has been working with BYHEALTH for more than six years
to support the planned launch of a number of Fruitflow based
products in the Chinese market. Clinical studies conducted in China
are typically required to obtain the necessary regulatory
clearances in China, and a significant investment in eight separate
Fruitflow studies has been undertaken at BYHEALTH's expense.
Completed studies have shown excellent results in use for
Fruitflow, and they provide strong evidence for the efficacy of
Fruitflow on platelet function.
The Chinese regulatory system for functional health food
ingredients, such as Fruitflow, is governed by the State
Administration for Market Regulation (the 'SAMR') and it is based
on a defined list of permitted health function claims which brand
owners are permitted to use on product labels.
The SAMR provides the possibility of adding new health function
claims to the list, with claims needing to demonstrate a
relationship between a food or nutrient and a consequent health
improvement, subject to evaluation and verification by the
SAMR.
SAMR certified functional health foods are required to use a
blue cap / blue hat logo on their product packaging, which
identifies products as approved functional health foods in
China.
BYHEALTH has been working on an extensive regulatory submission
to the SAMR seeking to establish a new permitted health function
claim for foods such as Fruitflow that can demonstrate an
anti-platelet effect, inhibiting platelet function and conferring
beneficial health effects.
On 28 August 2023 the SAMR announced in China that the
'Implementation Rules for Health Food New Functions and Product
Technology Evaluation' (the 'Implementation Rules') had been agreed
by the SAMR in June 2023, with these new rules to take effect from
28 August 2023.
On 29 August 2023 it was announced in China that BYHEALTH had
submitted: i) the first application under the Implementation Rules,
seeking to obtain a new permitted health function claim for foods
such as Fruitflow which help to 'maintain normal platelet
aggregation function and benefit blood flow health'; and ii) some
related product registration applications.
BYHEALTH has noted that it has been working on the project since
2015, with 'tens of millions of funds' invested by BYHEALTH in the
research and development work.
The Company has previously stated that if BYHEALTH is successful
in obtaining a new permitted health function claim in China for
functional health foods, such as Fruitflow, that can demonstrate an
anti-platelet effect, it is expected that this would result in some
significant orders for Fruitflow, potentially at a multiple of
current total sales values.
A further announcement will be made by the Company at the
appropriate time.
For further information please contact:
Provexis plc Tel: 07490 391888
Dawson Buck, Chairman enquiries@provexis.com
Ian Ford, CEO
Allenby Capital Limited Tel: 020 3328 5656
Nick Naylor
Notes for editors
About Provexis plc
AIM quoted Provexis is focused on the development, licensing and
sales of its proprietary, scientifically-proven Fruitflow(R)
heart-health functional food ingredient.
Fruitflow is a natural, breakthrough ingredient that helps with
platelet aggregation. This helps promote normal blood flow and
circulation, which in turn benefits cardiovascular health.
Fruitflow helps the platelets to circulate freely and smoothly
throughout your blood, without sticking to one another or to the
blood vessels themselves. Freely flowing blood helps reduce stress
on your cardiovascular system.
Fruitflow is a highly concentrated form of bioactives which is
lycopene-free and contains over 30 known anti-platelet compounds.
Published clinical studies have shown that Fruitflow works to
maintain healthy blood flow in a similar way to 75mg aspirin but
with a milder and reversible action; Fruitflow has a similar
antiplatelet effect to a single dose of aspirin - but when taken
daily, it has none of aspirin's side effects.
The science behind Fruitflow has been validated by leading peer
review publications and regulatory authorities. Fruitflow is the
only natural antiplatelet to have a health claim approved by the
European Food Safety Authority, stating that 150mg of Fruitflow
'helps maintain normal platelet aggregation, which contributes to
healthy blood flow'.
Fruitflow has a number of specific health benefits which have
been reflected in separate patent filings for the use of Fruitflow
in:
-- mitigating exercise-induced inflammation;
-- managing blood pressure;
-- protecting against the adverse effects of air pollution on
the body's cardiovascular system. Laboratory work has shown that
Fruitflow can reduce the platelet activation caused by airborne
particulate matter, such as that from diesel emissions, by
approximately one third; and
-- conferring health benefits in modulating the gut microbiome
of humans, to include a reduction in TMAO, following the completion
of a successful human study which is further detailed here
www.dsm.com/human-nutrition/en/talking-nutrition/press-releases/2023-01-20-new-study-reveals-dsms-fruitflow-activates-gut-heart.html.
Provexis sells a high quality dietary supplement product
containing Fruitflow and Omega-3 from its website
www.fruitflowplus.com on a mail order basis. The product is also
available to purchase from Amazon.co.uk and from Holland &
Barrett.
Provexis was founded in 1999 and is headquartered in Reading,
Berkshire. Provexis' shares are traded on the AIM market of the
London Stock Exchange under the ticker symbol PXS.
For further information, please visit www.provexis.com and
www.fruitflowplus.com.
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