Member Info for gixer

Slam01,
Thanks.
I just hope that some of my recent posts show that By-Health seem to be spending a lot of time, effort and cash on Fruitflow and its not just a "gimmick" as someone said earlier.

DP64 "So what conclusions you made out of all these?"

As I said in my previous post this is just my opinion but would explain the "and they provide strong evidence for
By-Health in its blue cap and other regulatory submissions to the SAMR for Fruitflow" statement in the interim results.

In my opinion By-Health are not only in the process of obtaining Blue Cap for a fruitflow product but also trying to get a new health function into the Health Function Directory.

and the link
https://www.binh.cn/aboutUs?id=713b66daab974fafab39d8b09002b2e3&title=%E5%85%B3%E4%BA%8E%E6%96%B0%E5%8A%9F%E8%83%BD%E7%A0%94%E7%A9%B6&navTitle=%E9%A6%96%E9%A1%B5%20%3E%20%E6%96%B0%E5%8A%9F%E8%83%BD%E7%A0%94%E7%A9%B6%20%3E%20%E5%85%B3%E4%BA%8E%E6%96%B0%E5%8A%9F%E8%83%BD%E7%A0%94%E7%A9%B6%20%3E%20%E8%AF%A6%E6%83%85&menuItemId=b04733902fc64eaa80a0b7e54e39a200

1/2

With the gradual improvement of national residents' living standards and health awareness, as an important part of the "Healthy China" strategy, it is imperative to conduct research on new functions of health foods.

The new function of health food is a health function that is not within the scope of the current health function published by the State Food and Drug Administration, and is fundamentally different from the name of the current health function and its functional evaluation method.

In order to better meet people's health needs, the Institute integrates the resources of authoritative nutrition and health research institutions at home and abroad, and continuously explores the innovative research field of "new functions, new materials, and new technologies", and has been in the field of new functional products for cardiovascular health. Achieved certain results.





Research Background



In 2009, EFSA approved the first health claim study on "Water-soluble tomato concentrate helps maintain normal platelet aggregation and helps healthy blood flow". This is the first product that has passed the European Food Safety Authority (EFSA) Act 13.5 on the claims of new functions, and has been approved by EFSA's first new health care function. The scientific opinion issued by the European Food Safety Agency (EFSA) in 2011 pointed out that cardiovascular health function claims include adjusting blood lipids, lowering blood pressure, maintaining normal endothelial function, and reducing platelet aggregation. In this scientific opinion, it is pointed out that "in subjects with higher cardiovascular (CV) risk factors (such as smokers, hypercholesterolemia subjects, obesity, diabetes), their platelets are prone to be overactive and hypercoagulable. And it is closely related to the occurrence and development of atherosclerosis and its complications.

In the 2018 China Cardiovascular Disease Risk Assessment and Management Guidelines, increased platelet aggregation has been listed as a potential risk factor for cardiovascular disease. Therefore, the development of different interventions against platelet aggregation has now become a goal of maintaining cardiovascular health. Among them, the research on the new functions of health food in the cardiovascular field has extremely high necessity and feasibility.

2/2

Research progress



In recent years, the company has taken "Fruitflow® (water-soluble tomato concentrate)" as its main direction, focusing on the development of new functional products that help maintain cardiovascular health.

The project brought together domestic authoritative scientific research resources such as the Institute of Chinese Materia Medica of the Chinese Academy of Chinese Medical Sciences and the School of Public Health of Sun Yat-Sen University, and adopted By-Health ® Xinluo Su Tablets (the main functional ingredients are the same as those approved by EFSA, all are water-soluble tomato concentrates). Experimental samples, refer to domestic and foreign literature and methods approved and published by EFSA, and conducted in-depth investigations around related issues, and finally determined to establish a new function of "help maintain normal platelet aggregation and contribute to healthy blood flow". Animal function test evaluation of health food Methods and evaluation methods of the population test.



At present, this method has been repeatedly verified in Beijing Hospital, Peking University Third Hospital, Dongzhimen Hospital of Beijing University of Chinese Medicine, China Academy of Chinese Medical Sciences, Sun Yat-sen University and other domestic research institutions. The test results prove that the method has wide applicability, easy operation and detection. The results are reproducible. The project seeks safer antiplatelet substances to maintain normal platelet aggregation, reduces the risk factors for the occurrence and development of cardiovascular diseases, and makes an effective exploration for the research on new functions of health foods and the profound significance of maintaining public health.



In the future, the Institute will carry out more exploration and research in health areas such as reducing the end-products of glycosylation in the body to meet the health needs of different populations in different life cycles.

By-Health were ready to launch there first Fruitflow product in the second half of 2017 before deciding Blue Cap was the best way to go with it.
Studies in China were then required for Blue Cap submission and the last we were told was that BY-HEALTH were intending to make its first submission to the SAMR for Fruitflow® in February 2019. We all know that Blue Cap registration can be a slow process and the time scale is out with By-Healths control, 2 to 3 years has been quoted in previous info posted on here.

This is were it gets a bit vague . Currently there are 27 health functions in China most of which are not applicable to Fruitflow. One that is is "Assisting blood pressure reduction" and By-Health have a patent for a product that contains fruitflow to facilitate blood pressure reduction.
https://patentscope.wipo.int/search/en/detail.jsf?docId=WO2020077747&_cid=P11-KJGTMR-22408-1
https://patentscope.wipo.int/search/en/detail.jsf?docId=CN238963528&_cid=P11-KJGTMR-22408-1

So a blood pressure reduction product would be a prime candidate (IMO) for the first Blue Cap submission.
We have been told By-Health will launch "a number of Fruitflow based products" but what health function out of the list of 27 can they then use?
In my opinion By-Health are not only in the process of obtaining Blue Cap for a fruitflow product but also trying to get a new health function into the Health Function Directory. What that will be I don't know but something like assisting the reduction of platelet aggregation might open up a lot more opportunities for Fruitflow in China.

All we can do is wait.

Asim Duttaroy new book.
Includes a section on Fruitflow.

https://www.elsevier.com/books/evidence-based-nutrition-and-clinical-evidence-of-bioactive-foods-in-human-health-and-disease/duttaroy/978-0-12-822405-2

32. Cardioprotective properties of water-soluble compounds of Tomato

I don't think the bid or ask changed from open so mid is still the same but looks like the UT trade pulled us down.

Up 5.88% on the other side though.
https://www.lse.co.uk/ShareTrades.asp?shareprice=PXS.GB.PL&share=Provexis-Plc

Released 2 days ago is hardly stale.

This is a post from BINH (BY-HEALTH Institute of Nutrition and Health) and refers to our review that was published in "Medical Hypotheses" magazine.
"Platelet hyperactivity in COVID-19: Can the tomato extract Fruitflow® be
used as an antiplatelet regime?"
https://www.provexis.com/wp-content/uploads/2021/04/Platelet-hyperactivity-in-COVID-19-Can-the-tomato-extract-Fruitflow-be-used-as-an-antiplatelet-regime-04-Jan-21.pdf

"The new coronavirus causes excessive activation of platelets, and water-soluble tomato extract may relieve it"
https://zhuanlan.zhihu.com/p/387011525

"This article was originally edited by the content team of BY-HEALTH Institute of Nutrition and Health"

Unfortunately there is a multi-party confidentiality arrangement surrounding Blue Cap and the launch of products by By-Health. So the chances of the company giving us any meaningful news on the progress is slim.

Slam01, "Have you been able to eek out any additional information on this?"

I will post anything of interest that i find on Blue Cap (or other) but tbh its just a waiting game.

Just to add...
The studies are not only for Blue Cap.
This is from the interim results.

"The five completed studies showed excellent results in use for Fruitflow, and they provide strong evidence for
By-Health in its blue cap and other regulatory submissions to the SAMR for Fruitflow, supported by the
Company’s existing European Food Safety Authority (‘EFSA’) health claim for Fruitflow."

What these "other regulatory submissions" are is still unclear (at least to me) but I have a theory.

From the 2019 results
" The planned launch of a number of Fruitflow based products in the Chinese market, with potential volumes at a significant multiple of existing Fruitflow sales, is progressing well, with activities driven at present by the need to obtain ‘blue cap’ health claim status for Fruitflow as a dietary supplement with the State Administration for Market Regulation (SAMR), a new Chinese market regulator which has taken over the responsibilities of the former China Food and Drug Administration (CFDA). "

IMO all By-Health is waiting on is the green light from SAMR.

From By-Health Institute of Nutrition and Health website.

"Research progress



In recent years, the company has taken "Fruitflow® (water-soluble tomato concentrate)" as its main direction, focusing on the development of new functional products that help maintain cardiovascular health.

The project brought together domestic authoritative scientific research resources such as the Institute of Chinese Materia Medica of the Chinese Academy of Chinese Medical Sciences and the School of Public Health of Sun Yat-Sen University, and adopted By-Health ® Xinluo Su Tablets (the main functional ingredients are the same as those approved by EFSA, all are water-soluble tomato concentrates). Experimental samples, refer to domestic and foreign literature and methods approved and published by EFSA, and conducted in-depth investigations around related issues, and finally determined to establish a new function of "help maintain normal platelet aggregation and contribute to healthy blood flow". Animal function test evaluation of health food Methods and evaluation methods of the population test.



At present, this method has been repeatedly verified in Beijing Hospital, Peking University Third Hospital, Dongzhimen Hospital of Beijing University of Chinese Medicine, China Academy of Chinese Medical Sciences, Sun Yat-sen University and other domestic research institutions. The test results prove that the method has wide applicability, easy operation and detection. The results are reproducible. The project seeks safer antiplatelet substances to maintain normal platelet aggregation, reduces the risk factors for the occurrence and development of cardiovascular diseases, and makes an effective exploration for the research on new functions of health foods and the profound significance of maintaining public health."

https://www.binh.cn/aboutUs?id=713b66daab974fafab39d8b09002b2e3&title=%E5%85%B3%E4%BA%8E%E6%96%B0%E5%8A%9F%E8%83%BD%E7%A0%94%E7%A9%B6&navTitle=%E9%A6%96%E9%A1%B5%20%3E%20%E6%96%B0%E5%8A%9F%E8%83%BD%E7%A0%94%E7%A9%B6%20%3E%20%E5%85%B3%E4%BA%8E%E6%96%B0%E5%8A%9F%E8%83%BD%E7%A0%94%E7%A9%B6%20%3E%20%E8%AF%A6%E6%83%85&menuItemId=b04733902fc64eaa80a0b7e54e39a200

the company (By-Health) has taken "Fruitflow® (water-soluble tomato concentrate)" as its main direction, focusing on the development of new functional products that help maintain cardiovascular health.

Says it all really.

Here is some info (links) to look through if you are interested.
By-Health website Institute of Nutrition and Health
http://www.binh.cn/#/index3?id=2b1d9f2bbde14a8b9f34b425cb40515f

Studies.

Water-soluble tomato extract improves platelet function in subjects with metabolic syndrome: a randomized clinical trail
Date of Registration:2020-12-02
http://www.chictr.org.cn/showprojen.aspx?proj=64530

Effect of combination of Fruitflow and aspirin on platelet function and endothelial cells
Date of Registration:2020-07-13
http://www.chictr.org.cn/showprojen.aspx?proj=56370

Human intervention study on dietary intake of water-soluble tomato extract
Date of Registration:2017-10-10
http://www.chictr.org.cn/showprojen.aspx?proj=22104

Effect of water-soluble tomato extract on hypercholesterolemia
Date of Registration:2018-04-27
http://www.chictr.org.cn/showprojen.aspx?proj=27052

Investigation of the Anti-hypertensive Role of Specific Plant Extracts in Hypertenison Patients
Date of Registration:2018-05-04
http://www.chictr.org.cn/showprojen.aspx?proj=27048

Publications
The water-soluble tomato concentrate Fruitflow inhibits its activation, aggregation and thrombosis by regulating the platelet PI3K/Akt and MAPKs signaling pathways
http://www.cnki.com.cn/Article/CJFDTotal-ZSYK202002011.htm

Inhibitory effect of Fruitflow on platelet function: a randomized placebo-controlled trial in elderly subjects
https://www.researchsquare.com/article/rs-95541/v1
Fruitflow attenuates human platelet granule secretion through down-regulating Src/PLC?2/PKC signaling pathway
https://www.researchsquare.com/article/rs-17401/v1

Toxicological Evaluation of Edible Safety of Water-soluble Tomato Concentrate (Fruitflow?)
http://www.fx361.com/page/2019/1205/6076972.shtml

Effects of water-soluble tomato concentrate on platelet aggregation
https://www.wjtcm.net/article.asp?issn=2311-8571;year=2019;volume=5;issue=4;spage=260;epage=268;aulast=Zhan

Study on the Antioxidant and Auxiliary Effects of Water-soluble Tomato Concentrate in Lowering Blood Lipid
https://r.cnki.net/kcms/detail/detail.aspx?filename=SPAJ202013071&dbcode=CRJT_CJFD&dbname=CJFDAUTO&v=

Study on the anti-platelet aggregation effect of water-soluble tomato concentrate
http://cdmd.cnki.com.cn/Article/CDMD-84502-1019240650.htm

Patents
WO2020077747 - COMPOSITION FACILITATING LOWERING OF BLOOD PRESSURE AND DIETARY SUPPLEMENT
https://patentscope.wipo.int/search/en/detail.jsf?docId=WO2020077747&_cid=P11-KJGTMR-22408-1

CN109380728 - COMPOSITION AND HEALTH-CARE FOOD WITH AUXILIARY BLOOD PRESSURE LOWERING EFFECT
https://patentscope.wipo.int/search/en/detail.jsf?docId=CN238963528&_cid=P11-KJGTMR-22408-1

Not all studies will have been published and there is no direct link for all the info.

By the end of September
https://www.provexis.com/shareholder-information/

https://www.mdpi.com/2072-6643/13/7/2184/htm?fbclid=IwAR3rpsQOTHoIVaPw-5kc_JLSdskMD59PTDZMOX6EeGSIrCPRtLOJyTPK5TQ

Dietary Antiplatelets: A New Perspective on the Health Benefits of the Water-Soluble Tomato Concentrate Fruitflow®