Provexis Regulatory News (PXS)

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® 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 £4 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:

Notes for editors

About Provexis plc

AIM quoted Provexis is focused on the development, licensing and sales of its proprietary, scientifically-proven Fruitflow® 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.