A little over a decade ago, a class of drugs to treat blood cancers arrived on the scene. Known as BTK inhibitors, they block a key enzyme needed by cancer cells to survive.
“These drugs turn the engine of cancer cells off,” said Dr. Mazyar Shadman, a professor at the University of Washington’s Fred Hutchinson cancer center. He had patients on these drugs, “and they were responding but they had side effects that they had to come off treatment; major joint problems and skin rash for example.” There were even reports of sudden cardiac arrest.
Then a few years ago, along came a new version of these drugs, one called Zanubrutinib, on which Shadman ended up conducting clinical trials that included some of his patients. “They did really well and continued to benefit from the drug without having side effects,” he said.
That newer, better, and safer drug was developed by pharma company BeiGene. That, in itself, was something new.
“China has historically been very backward in the pharmaceutical market,” said Tim Opler, a managing director at the health care investment banking group at Stifel. China’s pharma industry a decade ago concerned itself with low value generics. That image has been shed. Stifel travels to China frequently, looking for new drugs. “What is so striking to me in my interactions is how quickly things are changing,” he said.
China’s government has long prioritized biotech as a strategic industry. Opler estimates there are now around 5,000 therapeutic biotech companies in China, compared to around 3,000 to 4,000 in the U.S.
“If you walked around and asked the typical U.S. biotech CEO about China a year ago, they say, ‘you know, they're smart, they work hard, but they're just copying us,’” said Opler. “And so the U.S. biotechs are increasingly finding that their Chinese competitors are very rapidly becoming the innovators.”
Take for example a class of drugs called bispecific antibodies, they bind to both immune cells and cancer cells, physically bringing them into close proximity so the immune cells can kill the cancerous ones. According to Mark Lansdell, a director at pharmaceutical intelligence firm Citeline, 48% of all bispecifics in clinical trials have been developed by China headquartered companies. And “35% of all gene therapies have been developed in China, 30% of cell therapies, and 21% of RNA products,” he said.
In some ways, China’s development in drug discovery began at the same time its dominance in manufacturing was ascendant, and for similar reasons.
“A big, important factor in that is the extent to which drug discovery activities were outsourced by Western pharmaceutical companies to Chinese contract research organizations in the very late ‘90s and into the early 2000s,” Lansdell said. “Not necessarily the design work, but the lab work that was done. Also the clinical testing as well clinical trials also shifted to other countries, most notably India and and China, but many other Eastern European countries.” A great deal of fundamental research ended up being done in China, “and so what happened was China was upskilled.”
There were complaints of industrial espionage along the way, but what we see today “is novel drug discovery, these are not simply ripping off molecules that have already been discovered in the West,” Lansdell said.
International pharmaceutical companies are feasting on the results. This year, 37% of all molecules in general being licensed by big pharma, are being licensed from Chinese companies. These aren’t necessarily final drugs, they’re mostly compounds in the research pipeline. Only about 24 completely novel drugs developed by Chinese firms have been approved in the U.S. or Europe, according to Citeline.
For some U.S. drug makers, this is an opportunity.
“It takes less time to develop a drug and less cost,” said Bob Goldberg, vice president of the Center for Medicine in the Public Interest.
For example, New York-based pharmaceutical company Regeneron didn’t have a Wegovy or Ozempic of it’s own, so it’s licensing one in the clinical trial pipeline in China.
“Then that gives you a market globally that you normally wouldn't have,” said Goldberg.
China’s production, while innovative, remains focused on existing classes of drugs. “They won't be totally new. They won't be cures for anything, but they will be versions of drugs that are on the market for which there's a larger global need,” he said.
But the surge in Chinese pharma is still ringing alarm bells.
“China’s rise in biotech is a threat to the United States,” according to Michelle Rozo, vice chair of the National Security Commission on Emerging Biotechnology and a molecular biologist by training.
“The deals signed just this year represent billions of dollars in potential payouts being directed in the Chinese ecosystem and Chinese biotech. And that is money that is not going into the U.S.,” she said.
Biotechnology is “a flywheel,” in Rozo’s words, from which many different technologies and products can spin off. A few drugs developed today are just a hint of what may come from other corners of biotech tomorrow.
“If you're the best in biotech and health care and therapeutics. You're also developing a bunch of other capabilities with biotechnology. This is, you know, experience, people, talent that can flow to other applications of biotech,” she said.
Rozo sees in Chinese pharma and biotech the same playbook that China has used to become dominant in rare earths, magnets, solar panels and electric cars, but in an industry that is much more diffuse and foundational. “Having more potential frontline therapeutics is not a bad thing, but the issue is the broader trend of sort of the innovation ecosystem, moving to China.”
The commission is calling for more investment in the U.S. and allies, and limits on certain investments to and from China.
There’s something else the U.S. could do, according to Roel van den Akker, who leads pharmaceutical and life sciences deals at PWC. “It’s also an opportunity now to change in the regulatory domain to kind of speed up how long it takes to get products through the clinic in the U.S.” he said. “And I think we're seeing some initiatives with some of the new regulators at the FDA.”
That may not be enough. Citeline’s Mark Lansdell says the U.S. should focus on its strengths.
“China is excelling in developing lots of similar drugs that follow well known mechanisms of action, and they can do it quickly. They can do it efficiently. They get into clinical trials quickly and efficiently and at low cost,” he said. China’s population and resources are its strengths, “and I don't think it makes much sense for U.S., and European biotech companies trying to compete with that long term,” he said.
“So I think the place to compete is on the biology. It's coming up with innovative biology, mechanisms of action that have not been identified previously, that have not been pursued previously,” Lansdell said.
That’s where, he said, Western biotech still has an edge. For now.