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The purchase to support the Onsite Verifications would not necessarily be a game changer, perhaps £100k? totally guessing.

Yeh the initial stocking would likely have to be significant and a game changer. No evidence at all that it has happened.

Hopefully we will get answers soon, perhaps tomorrow?

BH will have purchased a chunk to pass the SAMR Onsite Verification, the first product being in January. Each product would need to evidence the production of 3 batches. Those batches would need to be of a size that proves that they can maintain the quality when producing at the required volumes. For BH this would be quite substantial size batches. We believe there are 4 products, so that is 12 significant batches they would need to run. They would have had to purchase this from the October FF production run/delivery.

Then I assume they would have purchased a large chunk of FF from the Feb run, this would then feed the initial launch volumes. However, we have no evidence of that, but it makes sense. They are not going to order only when approval is in, as it would then take them months to get the FF before they can even start making their final products. Unlikely they would do that, so must have been a substantial order for Feb/March delivery.

I’ve no idea, but we’ll find out :)

AI:

If the State Administration for Market Regulation (SAMR) is going to follow its classic structural routine and push out a Friday batch release to clear the decks for the end of May, those system updates traditionally start hitting the public portals between 3:00 PM and 6:00 PM Beijing time.

That translates to 8:00 AM to 11:00 AM London time today. If the Chinese data drops during this window, the Provexis board and their Nomad will be in a race against the clock to process and verify the registration codes for an intraday Friday RNS.

If it were to be today it would be a little later, end of the day in Beijing would be typical. 8am to 11am in the UK.

And if they do have approval as we suspect, they would surely have the production line fired up. They have already made large batches, but I would think they will likely be full steam ahead now.

I don’t mean to ramp, but there is an advert and the language has changed, I say they now know for certain they have approval. Earlier in the year we did not know

About the NMPA changes that would open a drug pathway for FF.

If we’re correct about NMPA submission, which I feel certain we are, then they will have submitted around 15th and then getting agreements to the scope of data exclusivity, which I suspect would be done sometime around now.

It’s the final countdown, as per Willysang timeline below.

Given the change of language from BH and the release of their marketing video (all posted by Gixer), we know it is now SAMR approved. It’s switched from legal language to marketing language. The factory will now be at full speed using FF from the Feb run.

I’ve been thinking that the drug application will be for IRI or DIC given the awesome pre-clinical trials with urgent and unmet need. However, we haven’t yet found any translational study where it’s been used for IRI or DIC treatment in humans. That could be part of the emergency route, or it could have happened and we don’t know about it. It makes me think though, would it not be more likely that the first application is for the treatment of platelet hyperactivity, or preventing abherrant clots (anti-thrombotic). That would have all the human data and would be the bigger prize, Aspirin replacement. That’s more likely isn’t it?

Not data exclusivity though. Drugs app would allow them to protect their data.

Why do we need to wait for drug submission to get SAMR approval? What's that all about? I've been pondering that and I think BH/SAMR strategy is quite cunning. With SAMR approval comes a 5 year exclusivity for the health claim. When that is approved their data will be available and others can use that exact data in reference to how their product may do the same or similar, they can build on it for supplements or drugs etc. However, when BH apply to NMPA for a drug status under the new rules, they get data exclusivity for 6 years as part of that deal, it would become classified as undisclosed, independently obtained trial data for innovative products.

So any competitor would not get access to BH data to see how they did it, it will be undisclosed. They can't get a head start and build on BH data to make their own anti-platelet drugs.

The SAMR and NMPA processes will dovetail, creating a much tougher regulatory moat for FF.

With this in mind, that's why FF can't be approved until at least 15th May and until they submit a drug submission to NMPA.

That's my theory anyway.

It doesn’t mean it’s fully approved, it got the G when Technical Review was complete.

It’s got it here in December, number 14:

https://www.cfe-samr.org.cn/sldt/sdxx/bjsp_174/pjyj_271/202512/t20251216_6257.html

Has it changed since then?

Decree 828 overview, what it actually does:

https://cisema.com/news/china-revises-drug-law-regulations

December 16th - Technical Review Complete

January 20th - Indian amendment to the New Drugs and Clinical Trials (NDCT) Rules

January 24th - Onsite Verification complete

January 27th - Decree 828 signed into law (allowing FF dug submission)

April 18th - Provexis FourPillars India registered (allowing FF drug submission)

May 15th - Forecast for SAMR Approval

May 15th - Decree 828 take effect

May 15th to 22nd - Forecast announcement of SAMR approval and drug submissions in China and India.

One missing date there, the India drug process changes on January 20, 2026.

December 16th - Technical Review Complete

January 24th - Onsite Verification complete

January 27th - Decree 828 signed into law (allowing FF dug submission)

April 18th - Provexis FourPillars India registered (allowing FF drug submission)

May 15th - Forecast for SAMR Approval

May 15th - Decree 828 take effect

May 15th to 22nd - Forecast announcement of SAMR approval and drug submissions in China and India.

They could even submit in India at the same time for both drugs. India has a rapid approval path at 45 days under new changes that also were introduced this year. Could possibly see a mega blockbuster RNS.

It all seems to point to the 15th and not by coincidence I think, it’s when decree 828 comes into law. It will be a blockbuster RNS if it arrives shortly after 15th and includes IRI and DIC drug submissions on 15th/16th.

Also coincidence is that SAMR Technical Review completed around Dec 16th, then NMPA process (Decree 828) was signed into law in Jan. It feels like alignment to me. Probably released for final review and sign off following Dec 16th.

SAMR created the new implementation rules for FF it seems. I don’t think it’s coincidence that NMPA changes were signed into law in January, but don’t take effect until May 15th. I suspect FF is the poster child for both new processes. These things are normally industry lead, it just seems it FF leading it.