RE: ??28 Dec 2025 22:21
They are saying what we already know, that Fruitflow is essentially approved in China, leading the way as an industry first and proving the new framework and process works. The formal approval will likely be 2nd half of January and will garner much industry attention. By-Health will then begin rolling our their first 2 products nationally in .... March/April. What they will have is a state sanctioned monopoly on cardiovascular health. Since the start, BH said they want Fruitflow to address risks highlighted in the HC2030. Now they have done the work and created a regulatory moat, it's just the start. The interesting bit is what comes next. BH pushing out a few products does little to address the risk, so the Healthy China Nutrition Union / Alliance will be pushing for adoption of FF. It's what they do. The union involves BH, Nestle, Mengniu and Danone, along with professional bodies. Nestle, Mengniu and Danone will likely be leading the way. They may need to use CBEC path whilst they apply for their own products to have Blue Hat, but that's what they normally do. We already know from previous articles that 'a large number of multi-national food/drink and supplement companies have agreed to commercialise FF in China'.
What is very interesting and something of potentially immense value to FF BH/PXS is that in January 2026, there is a new Fastback process for approval of Botanical Drug Products in Hong Kong, where the aim is to get approval in 120 working days. Previously FF could not go for this because it has now been approved as a drug elsewhere (1+), but critically the process changes on Jan 01st. They will now take on Primary Evaluation too. This means that BH can submit their 8 studies, plus the 10 (was it?) that were for EFSA approval, so they can become a Botanical Drug in Hong Kong within 120 days. Indeed we have often wondered why 8 clinical trials, it's likely because BH are also part of the consultation group that create the rules for evaluating Botanical Drugs in Hong Kong, I kid you not. So if they do go down this route, it will be of huge ... huge value to BH/PXS. The drugs are sold at much higher premium over supplements. They would get access to 71 hospitals and medical hubs. HK doctors could prescribe FF. This would be of much interest to big Pharma.
So that's something to keep an eye on.