Business
BYHEALTH regulatory filing with Chinese SAMR
BYHEALTH regulatory filing with Chinese SAMR.
About this update from Provexis Plc
[{"type":"text","content":"\n\n30 August 2023\nProvexis plc\n('Provexis' or the 'Company')\n \nBYHEALTH regulatory filing with Chinese SAMR\n \nProvexis, 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.\n \nProvexis 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.\n \nThe 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.\n \nThe 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.\n \nSAMR 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.\n \nBYHEALTH 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.\n \nOn 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, wit...