News on China's scientific and technological development.

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MortyandRick

Senior Member
Registered Member
chgough34 said:
No. China’s EUA approval wasn’t a marketing approval, it’s more analogous to a Phase I trial. China gave marketing approval for Sinopharm late into 2020/early 2021 so the analogue Pfizer marketing approval came earlier. First to market on a more complex, effective, and first-in-class product. Main point is that China having the advantage in paper publishing is not at all a guarantee it will “win” the tech race/war/whatever in any amount of time given lags to commercialization, incumbent U.S. advantages (of which the COVID vaccine was illustrative and more widely known), and the business environment in which corporates operate, as well as the other variables that impact the business environment.

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Wrong. Marketing use doesn't mean anything. There is only emergency use approval and general use approval. So I don't know what your are trying to spin.

Pfizer had general FDA approval in August 2021. To my knowledge, August 2021 is LATER than December 2020. No?

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So in both cases later than China's vaccine no matter how you cope

Cansino and sinopharm had approval for general use by other countries by December 2020.

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mRNA vaccine are only 10 years old, and still experimental. We don't know the long term effects of related mRNA vaccinations. More and more reports have come out of blood clots, increased autoimmune activation, myocarditis with mRNA vaccines.

In medicine, we really care about hospitalization and deaths. In these cases, sinopharm efficacy is comparable to mRNA. That's what's really important.

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Additionally mRNA vaccines need deep freeze transport, and is more expensive to make, which severely limits it's access to people in need, which is one of the most important factors in vaccine use, while sinopharm and Sputnik V are cheaper and easier to store. In a pandemic, this is much more important.


US incumbent advantage doesn't translate to better production or necessarily more advanced technology, (eg. Electric cars). Since you mentioned China's more published papers doesn't guarantee a win in the tech war, neither does US incumbent advantage.
 
PiSigma

PiSigma

"the engineer"
chgough34 said:
No. China’s EUA approval wasn’t a marketing approval, it’s more analogous to a Phase I trial. China gave marketing approval for Sinopharm late into 2020/early 2021 so the analogue Pfizer marketing approval came earlier. First to market on a more complex, effective, and first-in-class product. Main point is that China having the advantage in paper publishing is not at all a guarantee it will “win” the tech race/war/whatever in any amount of time given lags to commercialization, incumbent U.S. advantages (of which the COVID vaccine was illustrative and more widely known), and the business environment in which corporates operate, as well as the other variables that impact the business environment.

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Double standards much?
 
A

anzha

Senior Member
Registered Member
PiSigma said:
Double standards much?
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uhm. perhaps, but possibly not.

The USA and PRC have different regulatory environments for medical tech. Each has its positives, negatives, and weird ass quirks. The company I work with regularly bring products to market in the US and deals with the FDA: this is a CRAZY effort to do and it's not without reason. The story of the regulation of medicine and medical devices in the US is actually horrifying and very well documented.

We recently brought some of our products to China. Walking through that was really, really different than working with the FDA. It was not bad. It was different. We are waiting to see if what we brought was worth the effort to do so. Our inexperience with working with the PRC's equivalent (NMPA, iirc, [*]) made this more painful than it needed to be. The reverse is likely to be the case and it may simply be a company like Pfizer who has a *LOT* of experience with the FDA can get to market faster than a Chinese company.

A paper not is sufficient for approval. In fact, it's basically step one of a long process in the US and likewise for the PRC for that matter. Pfizer, AstraZeneca, Bayer, Roche, etc. are monsters with a massive international machine used to dealing with the different regulatory bodies.

There was an aspirational period in the 90s where a treaty to allow for a set of international standards for drug and device approvals. The idea was if a drug or device was approved in one country, it would be approved in all the signatories' nations. It did not work out (vast understatement) and if you don't have a lot of experience "speaking" the local regulatory language for all its often absurd nuisances, you won't get to market as fast as others who do.

I would not immediately assume Chinese developed products are failing merely because other nations reject them outright due to double standards. While it is entirely possible, it's more probable there are other, more nuanced reasons.

*. I don't speak Mandarin, but my limited working with them was they were friendly, patient, and just wanted us to do the right thing in the right way. There were some subtle things both sides got hung up on, but we worked through it. This is no different than my experience with the FDA.

And, yes, this forum has some colorful characters with colorful backgrounds and colorful careers reading through its pages.
 
sunnymaxi

sunnymaxi

Captain
Registered Member
on September 1 that according to the China Institute of Atomic Energy on August 30, the China Institute of Atomic Energy recently used a 100MeV high-current proton cyclotron to irradiate the gallium-nickel alloy targets independently developed by the institute. Through a series of separation and purification processes, it successfully produced radioactive isotope germanium-68 (zhě) samples that meet medical requirements and have a nuclear purity greater than 99.9% , and passed third-party testing.

This is the first time in China that a medium-to-high energy, high-current proton cyclotron has been used to prepare the important medical radioactive isotope germanium-68, laying a technical foundation for its engineering production. It is expected to reverse the situation in which China has long relied on imports of medical germanium-68 and realize the localization of medical germanium-68 .

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