The West has the wrong mental model of innovation in China
December 29, 2024 5:26 PM Subscribe
The Rise of Chinese Biopharma. "The growth continues at a rapid clip, the Chinese investigational drug pipeline has doubled in size over the past three years (according to an analysis in Nature, the number of original Chinese drugs in development grew from 2,251 on July 2021 to 4,391 on January 2024). Again, Europe is the loser here; more novel drugs (new molecular entities) are originated in China now than in Europe....Ten years ago, a major pharmaCo seeking their next breakthrough molecule would have turned to an American or European biotech. Today, they’re just as likely to license a molecule from a Chinese company. Chinese companies will often run the phase I trial in China for cheap, then flip it to a Western pharmaCo to run the expensive US trials and bring the drug to market.."
"...we can trace the change to four main forces: regulatory reforms, returning talent, industrial evolution, and venture funding."
"But probably the most important change was slashing clinical trial start-up times, especially for first-in-human (phase I) trials. Before companies can test their drugs in humans, they need to submit an IND application to their country regulator. The Chinese IND process was slow and burdensome, regularly taking over a year for approval. The CFDA shifted to an “implied license” approval system for clinical trials in 2018 — if regulators didn’t raise concerns within 60 days of an IND, companies could proceed. As a result of the reforms, the average time for IND approval dropped from 501 days before the reforms to just 87 days after."
"...we can trace the change to four main forces: regulatory reforms, returning talent, industrial evolution, and venture funding."
"But probably the most important change was slashing clinical trial start-up times, especially for first-in-human (phase I) trials. Before companies can test their drugs in humans, they need to submit an IND application to their country regulator. The Chinese IND process was slow and burdensome, regularly taking over a year for approval. The CFDA shifted to an “implied license” approval system for clinical trials in 2018 — if regulators didn’t raise concerns within 60 days of an IND, companies could proceed. As a result of the reforms, the average time for IND approval dropped from 501 days before the reforms to just 87 days after."
Mod note: A quick note: This a post with a link to a blog post by Alex Telford. Storybored is not Alex Telford. The link is posted for us to read and discuss, and is not an original writing by storybored.
posted by taz (staff) at 12:50 AM on December 30 [3 favorites]
posted by taz (staff) at 12:50 AM on December 30 [3 favorites]
Not to worry, because "the west" is going all in on TCM
[snark aside, it's not really a problem if there are more scientists & companies with money producing novel & useful molecules faster and faster; it's (theoretically) to the benefit of all (just make sure the standards of oversight / testing / approval keep up)]
posted by chavenet at 1:27 AM on December 30
[snark aside, it's not really a problem if there are more scientists & companies with money producing novel & useful molecules faster and faster; it's (theoretically) to the benefit of all (just make sure the standards of oversight / testing / approval keep up)]
posted by chavenet at 1:27 AM on December 30
it's not really a problem if there are more scientists & companies with money producing novel & useful molecules faster and faster
Except for the fact that those same labs, or ones directly benefitting from the technology, are also supplying the black markets with untested opiates and other synthetic drugs.
Synthetic cannaboids are a hugely popular market and there's almost no regulation to control what's even in the shit being sent out, so drug users are taking substances that might not be anything like the drugs they usually get and may have incredibly harmful side effects. This whole industry is very, very dangerous.
posted by fight or flight at 2:14 AM on December 30
Except for the fact that those same labs, or ones directly benefitting from the technology, are also supplying the black markets with untested opiates and other synthetic drugs.
Synthetic cannaboids are a hugely popular market and there's almost no regulation to control what's even in the shit being sent out, so drug users are taking substances that might not be anything like the drugs they usually get and may have incredibly harmful side effects. This whole industry is very, very dangerous.
posted by fight or flight at 2:14 AM on December 30
This is a fascinating article. I think big pharma is one of the few industries where American superiority has not been seriously challenged yet; obviously that may not be true forever. It will be interesting to see what the shakeup will feel like. Pharma profits are so tempting. It’s always been my contention that a strong FDA is all that stands between us and useless/dangerous medicine. As American governmental regulation gets hacked away and international expertise increases, change is definitely coming.
posted by Vatnesine at 3:00 AM on December 30 [4 favorites]
posted by Vatnesine at 3:00 AM on December 30 [4 favorites]
Deregulation means profit over safety. People are going to die. We can only hope that eventually CEOs will pay the price.
posted by rikschell at 5:45 AM on December 30
posted by rikschell at 5:45 AM on December 30
Except for the fact that those same labs, or ones directly benefitting from the technology, are also supplying the black markets with untested opiates and other synthetic drugs.
It is likely that there are Chinese companies that do in-house (recreational) drug design now but this started, to use the article’s framing, with China as manufacturing powerhouse, not China as innovator - the late 00s to early 10s “research chemical” boom was fueled by enterprising individuals discovering that globalization and disintermediation of supply chains meant they could contract out synthesis of drug analogs dug out of the literature or given some tweaks of their own to Chinese chemical companies. And I suspect increasingly to chemical companies anywhere else that doesn’t watch them too closely. “The technology” is pretty much a chemical industry and the internet.
posted by atoxyl at 6:33 AM on December 30
It is likely that there are Chinese companies that do in-house (recreational) drug design now but this started, to use the article’s framing, with China as manufacturing powerhouse, not China as innovator - the late 00s to early 10s “research chemical” boom was fueled by enterprising individuals discovering that globalization and disintermediation of supply chains meant they could contract out synthesis of drug analogs dug out of the literature or given some tweaks of their own to Chinese chemical companies. And I suspect increasingly to chemical companies anywhere else that doesn’t watch them too closely. “The technology” is pretty much a chemical industry and the internet.
posted by atoxyl at 6:33 AM on December 30
I lived in China in the early 90s and even then it seemed clear to me they were destined to surpass the US in my lifetime. What I find eternally funny is our capitalist corporate overlords constantly preaching that competition is the only path to innovation ... but not from China, that's different!
posted by birdsongster at 12:53 PM on December 30 [1 favorite]
posted by birdsongster at 12:53 PM on December 30 [1 favorite]
I'm in biopharma research. From what I've seen I think the article is correct about the general trend of more research being done in China; they've been working to supply manufacturing and contract synthesis to support western pharma for a while, but now they are applying those skills to "new chemical entities" (NCEs, or NMEs in the article) on their own. (NCEs entering clinical trials might become drugs in five to ten years, but about 90% fail.) I have a few quibbles with specific numbers and interpretation in the article, but they'd be nitpicks to anyone not in the industry.
I do have a personal financial interest in the US being in the lead in this kind of work, so I get a bit wistful looking at the trend lines. Speaking impartially, China should be doing what, 5 times as much invention as the US? The global research gap isn't China starting to catch up, it's Africa and Latin America and even India being still far behind.
Deregulation means profit over safety. People are going to die. We can only hope that eventually CEOs will pay the price.
This isn't deregulation. The Chinese changes to IND timing move it in line with the US, although at 60 days it is still twice as slow than what we have here IIRC. The IND is what you file after you have discovered the NCE, done all the animal testing for safety, etc., etc. It's followed by a small single dose in humans to see how the drug is absorbed and look for safety markers. In between the IND filing and approval basically no research work happens.
There is no benefit to humanity in having approval take 16 months. It means everyone is sitting around, not getting any closer to a treatment or cure of what is being studied. It doesn't take 16 months to review the data in an IND filing.
Except for the fact that those same labs, or ones directly benefitting from the technology, are also supplying the black markets with untested opiates and other synthetic drugs.
The article you linked doesn't suggest that any of the labs doing research are exporting fentanyl. The Chinese could stop novel pharma research overnight and none of those labs making controlled substances would even blink.
posted by mark k at 7:19 PM on December 30 [6 favorites]
I do have a personal financial interest in the US being in the lead in this kind of work, so I get a bit wistful looking at the trend lines. Speaking impartially, China should be doing what, 5 times as much invention as the US? The global research gap isn't China starting to catch up, it's Africa and Latin America and even India being still far behind.
Deregulation means profit over safety. People are going to die. We can only hope that eventually CEOs will pay the price.
This isn't deregulation. The Chinese changes to IND timing move it in line with the US, although at 60 days it is still twice as slow than what we have here IIRC. The IND is what you file after you have discovered the NCE, done all the animal testing for safety, etc., etc. It's followed by a small single dose in humans to see how the drug is absorbed and look for safety markers. In between the IND filing and approval basically no research work happens.
There is no benefit to humanity in having approval take 16 months. It means everyone is sitting around, not getting any closer to a treatment or cure of what is being studied. It doesn't take 16 months to review the data in an IND filing.
Except for the fact that those same labs, or ones directly benefitting from the technology, are also supplying the black markets with untested opiates and other synthetic drugs.
The article you linked doesn't suggest that any of the labs doing research are exporting fentanyl. The Chinese could stop novel pharma research overnight and none of those labs making controlled substances would even blink.
posted by mark k at 7:19 PM on December 30 [6 favorites]
« Older “Wherever life takes us, there are always moments... | "It was disgusting, like fellating the Wicker Man" Newer »
posted by metametamind at 8:15 PM on December 29