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Yep it’s created a massive opportunity for FF to really stand out.
One thing I have been considering is that we have no idea how the financials will work for the BH agreement. We know that massively increased volumes will reduce the production costs probably substantially. We know that the volumes ordered will likely be substantial multiples of current production levels, we know that the value will be multiples of current total FF sales. We have no idea how much BH will pay per KG or what the costs per KG will be.
So if they order £10m in the fist 12 months. How much profit would we make on that? It could be less than we think. Perhaps the agreement starts with high profits, but changes with volume?
Either way, it will increase the profit margin on all the non-BH orders, which we understand to be significant.
November 2016: Strategic collaboration agreement announced for Fruitflow® between DSM and BYHEALTH
April 2017: MOU for a research and collaboration agreement announced for Fruitflow® between the Provexis and BY-HEALTH. BY-HEALTH plans to launch a number of Fruitflow® based products in the Chinese market, first launch envisaged in the second half (Dec) of 2017.
Sept 2018: Its announced that B-H are conducting 6 studies, at their sole expense, for Fruitflow and ‘blue cap’ health claim status, as required by the China Food and Drug Administration (CFDA), with BY-HEALTH intending to make the relevant submission to the CFDA by the end of 2018.
Sept 2021: its announced that:- By-Health is now working on an extensive regulatory submission to the SAMR for Fruitflow, seeking to establish a new permitted health function claim for food ingredients such as Fruitflow that can demonstrate an anti-platelet effect, addressing the aberrant blood clots which can lead to heart attacks and strokes .By-Health currently expects to be in a position to complete the last of its eight studies and file its regulatory submission to the SAMR for Fruitflow in the first half of 2022.
Sept 2022: By-Health continues to work on an extensive regulatory submission to the Chinese State Administration
for Market Regulation (SAMR) for Fruitflow, seeking to establish a new permitted health function claim for
foods such as Fruitflow that can demonstrate an anti-platelet effect, addressing the aberrant blood clots
which can lead to heart attacks and strokes.
July, 2016: China Food and Drug Administration (CFDA) published the formal “Administrative Measures on Health Food Registration and Filing”(Hereinafter called “new Administrative Measures”) which will replace the “Administrative Measure on Health Food Registration (Trial) (Order No.19)”, meanwhile, come into force on 1 July, 2016.
Once the new Administrative Measures implemented, there will be two kinds of policy (registration and filing) for health food produced or marketed in China.
April 2018: the State Administration for Market Regulation was formally established. On April 10, 2018
So..... not only has B-H gone from launching products to getting Blue Cap to getting a permitted health function claim there has also been a massive restructuring of the Chinese regulatory system not to mention probably major delays with trials because of the lock down measures in China.
Having a permitted health function claim will substantially increase the potential revenue that Fruitflow can achieve For B-H/PXS and if you go back to 2016 it was not possible, due to the regulations at the time, for B-H to submit such a claim.
Now to answer your question . "why it is taking so long?"
As the regulatory system has been changing in China so has B-Healths plans. The end result being greater revenue potential for Fruitflow.
DP54,
BH are not simply applying for. Health claim. The SAMR and BH are working together on this. They need to create the framework and criteria by which all foods/supplements applying against this claim in future can be effectively evaluated, whilst at the same time ensuring that they can clearly meet the criteria themselves and evidence it. They also need to agree and approve the 5 year monitoring period, what will be monitored, what are the red flags, what actions will be taken etc.
Then on top of that we had Covid restrictions, which in China were significant. The studies are carried out at medical centres, medical universities and hospitals and at multiple geographical locations. All of these places would have suffered terribly under lockdowns.
At the end of September they thought they would be wrapped up with the trial data evidence by new year. This tells us they are right at the end, but in January they still had not finished. I would assume it will be completed by the end of March at the latest now.
Then BH and SAMR reps need to finalise their submission and hit send. we have no idea how long this will take. I would hope the next part takes no more than a month or two. The board are obviously fully aware of what is going on and in agreement, so there should be no surprises, it should be a box ticking exercise. I am now thinking full approval in May/June this year??? But genuinely have no idea whether I am even in the right ball park. It could be tomorrow or it could be next year.
DR H,
Many thanks for your thoughtful and elaborate post. I still raise the same question why it is taking so long? I believe they started in 2016 now it is 2023.
The SAMR are embedded throughout the process. They would have been included in the initial scoping and testing. When trials are completed they write a recommendation to the board for its approval/ inclusion in the register. When the new claim is approved it will available for use exclusively by the applying company and monitored for a period of 5 years. After this it will be available on the register and other such supplements can submit their health claim evidence against it.
As Gix says, this is the first company to add an additional health claim that we are aware of, which is why it will gain significant attention. As it stands there are no such products in China that inhibit platelet aggregation and there cannot be for at least 5 years following the approval. Each of the other health claims on the register has hundreds or thousands or products using those claims. This is why a large number of multi-national food and drink companies have expressed strong interest in commercialising FF. as it stands, companies are restricted in their heart health range. When FF is available it gives them a cheap, approved, no risk option.
On top of all that, By-Health are targeting a specific health risk that has been highlighted in the Healthy China 2030 initiative. This is likely why some of the funding for the research has come from grants. BH will also get government help with getting their product out there. They will help break down barriers.
It is an enormous opportunity for PXS, BH and other companies. We already know Nestle have FF in their labs, so I would not be surprised if they are lining a product or two up. JuneYao Dairy were releasing at product in 2016 (Werdery Qin Drink) with massive volumes, but the regulatory framework changed in 2016 and stopped them in their tracks.
The China Cross Border E-Commerce distribution parter agreement is separate, but complimentary to the BH agreement. I assume that to mean that BH will supply FF+ Omega 3 in China with Blue Hat approval/logo exclusively to the CBEC distributor when Blue Hat is approved. This means they can hit the ground running, order it from BH and can immediately sell it in shops and pharmacies, for which they will have had a year to get those sales channel agreements in place.
Some interesting points and protection from ip theft for 5 years ,very positive for pxs .
Just to add.
Once By-Health have the new health claim approved it has a a five-year monitoring period. During these five years, the new claim is proprietary to the company (By-Health), and others may not use it. After the end of the monitoring period, if no issues are observed, SAMR will add the new claim to the approved list of claims for health foods. Through such listing, anyone can then use the new claim on their health foods.
sphinx, Yes that's how I read the article. Blue Cap in as little as 3 to 4 months. This is much reduced from the initial 2 to 3 years (from memory) that it was taking not so long ago. But, as you rightly point out, By-Health is "seeking to establish a new permitted health function claim for foods such as Fruitflow that can demonstrate an anti-platelet effect" and as far as I can tell this has never been done before by any organization or individual and therefore impossible for us to judge timescales for the new health function claim.
DP64, No.
So based on that analysis it seems so many of the company are getting the SAMR approval. What on earth our friend BH still could not get the much waited SAMR approval!! Are they reinventing fruitflow so that they can by pass PXS???
Gixer you’re posting on Advfn tells us that the Registration process can take as little as 3 months , because BH are trying to claim a new category I expect this to be a bit longer but Looking promising once we get these trials finished . Imo https://www.foodnavigator-asia.com/Article/2022/07/20/most-blue-hat-health-foods-approved-this-year-made-immune-antioxidant-claims
Healthspan just emailed me saying a price increase from March , will be £15.45 for 30
In medicine terms the difference between hypercholesterolemia and dyslipidemia is that hypercholesterolemia is an excess of cholesterol in the blood while dyslipidemia is an inbalance of lipids (especially cholesterol) in the blood.
It's potentially a long way off, as it needs to go through drug approval process. Not suggesting a huge amount of time as they already have a lot of quality trial evidence, but could be a couple of years or so. But WTFDIK.
So it seems BH launch of Xinluosu will be massive. If we get 20% of Dyslipidemia market that will be $400m. Hope IF could give us some hints how far they are from lunching Xinluosu.
https://www.databridgemarketresearch.com/reports/global-dyslipidemia-market
Agree Dr-H and this is probably the patent to go with it
https://patents.google.com/patent/CN114504617A/en?q=(%22water+soluble+tomato+concentrate%22)&oq=%22water+soluble+tomato+concentrate%22&sort=new
Related to FF as a drug, as it is specifically targeting dyslipidemia in the 2nd one. Then the timing of when its raised and approved by ethics committee would also support that.
Human Trial Effect Evaluation of Xinluosu Tablets in Helping to Maintain Normal Platelet Aggregation and Beneficial to Blood Flow Health Function
https://www.chictr.org.cn/showprojen.aspx?proj=184552
Study on the effect of water-soluble tomato concentrate combined with red yeast rice on blood lipid levels in subjects with dyslipidemia
https://www.chictr.org.cn/showprojen.aspx?proj=184849
52 sold in last 48 hrs
lol
W$
Nice find. SP very quiet this week.zeems everyone is holding and watching come on Ian give us some good news
It’s where all the best and freshest Fruitflow comes from.
Lets hope so sphinx.
I posted this one a few weeks ago.
https://npcitem.jd.hk/10066614829347.html?cu=true&utm_source=jd.hooos.com&utm_medium=tuiguang&utm_campaign=t_1000789476_&utm_term=5c6a67c6d00e437b84f77f1e96294844
Good find gixer ,looks like Cbec are getting it out there and reassuringly not just in China
Sent from West Jakarta
????
https://www.tokopedia.com/ausiefood/fruitflow-omega-3-supports-healthy-blood-flow-from-eu
Nice spot Dr
Today I got 2 packs for FF+ for less than £11 each from Holland & Barret
Buy1, get 1 half price - £30
Apply Love14 discount code - £25.78 (free delivery over £25)
Topcashback 20% off - £20.62
Interestingly the site said, "selling fast, 12 purchased in last 48 hrs". - not many, but presumably many get FF for the first time from H&B then move on to subscription.
So H&B still making a profit at £11 a pack
W$