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Jiangsu Hengrui Pharmaceuticals has quietly become a top 25 biopharma company in the world by market value. Once virtually unknown outside of China, the company has made its name overseas via an R&D engine that has not only spawned over 20 approved drugs in China, but also new startups — including a billion-dollar obesity biotech — and expansive deals with Western drugmakers. But there’s still one big item on its bucket list: selling its own treatments outside of China. After all, it’s the capability to sell drugs, not just make them, that gives pharma companies their stature — and profits. “We have the ambition one day to have our own global development capabilities and therefore commercialization capabilities ex-China,” Hengrui chief strategy officer Frank Jiang said at Endpoints News ’ JPM event in January. In a separate interview, he crystallized the ultimate goal: “To have Hengrui-branded products sold in the US, the EU.” Hengrui is the largest and best example of a homegrown Chinese company mapping out a potential future as a large multinational drugmaker. With a valuation of about $61.2 billion, Hengrui is now larger than Takeda and Bayer. While it’s by no means alone — Innovent Biologics and Fosun Pharma , among others, show similar aspirations — Hengrui has become the player to watch because it’s so much larger than the others and is already shaking up the industry’s status quo. It won’t be an easy path, and it may still be years before any of them market their drugs outside China on their own, if ever. One potential obstacle lies in geopolitics. US regulators and lawmakers in particular are wary of opening the floodgates to Chinese drugs. Even so, some of the biggest names in pharma concede that momentum may be on China’s side. Just as Europe and later the US developed as centers of discovery in medicine, “the one country that is coming closest to now recreating that ecosystem is China,” Merck CEO Rob Davis told the Galien Forum in New York City in October. The nation is funding academic research, has “an ecosystem of small biotech, and they’re very quickly trying to drive the large pharma model.” “They’re not where we are yet, but they’re moving very quickly,” Davis said. Hengrui started over 50 years ago as a generic drugmaker. It’s only been in the past two decades or so that the company began focusing on researching and making new medicines, reflecting China’s big push to transform itself into an innovation hub. Today, Hengrui has more than 100 experimental treatments being studied across some 400-plus clinical trials. “What is our strength? Today it’s still R&D and efficiency,” Jiang said on stage at Endpoints’ event. “The timeline that we do science is very different from our competitors.” Speed, particularly in the early stages of drug development, has become a hallmark of China biotech’s rise. That’s helped the nation’s biotechs begin to outpace competitors in areas such as cancer and genetic medicines. Hengrui has a multipronged plan to expand outside of China. Partnerships with Merck and GSK are centered around big indications like lung or heart diseases that Hengrui might not have the resources to advance outside of China on its own. Another approach involves working with investment firms to set up new companies abroad, such as Kailera Therapeutics, the obesity startup Hengrui founded alongside Bain Capital. The Kailera model gives Hengrui a way to get assets abroad while providing “great learning,” Jiang told Endpoints. Hengrui is also working on getting FDA approvals on its own, though right now those efforts are limited to experimental drugs that require only “relatively modest” clinical trials and patient populations, Jiang said. But it hasn’t all been smooth sailing. The FDA has twice rejected Hengrui’s checkpoint drug for liver cancer over manufacturing problems, though the company and its partner Elevar Therapeutics resubmitted their application to the agency last week. The company last year hired Yu Liu, a former oncology VP at Bristol Myers Squibb, as its chief medical officer, international to help expand clinical development efforts in the US and outside of China. While there is a precedent for Hengrui’s push to spring from China as a large multinational pharma player selling its own treatments, that example comes with asterisks. The company now known as BeOne Medicines won FDA approval of a cancer treatment called Brukinsa in 2019, marking the first US approval of a cancer drug from China. But the drugmaker has worked to distance itself from its China roots, most notably by renaming itself last year from BeiGene, which was a wordplay on “Beijing.” BeOne, now domiciled in Switzerland, says it was “never formally headquartered in China” and currently doesn’t “​​claim a global headquarters.” Much has changed in the years since BeiGene emerged, and the path may not be so straightforward for Chinese companies sharing global ambitions, according to Qiang Lu, chairman of Shanghai-based GenFleet Therapeutics. “The globalization, the friendly capital environment, and also this kind of a regulatory picture is no longer there,” he said on a panel at an investor event on the sidelines of JPM. Tense geopolitical relations between the US and China loom large. US lawmakers in December passed a weakened version of the Biosecure Act, which was aimed at restricting Chinese biopharma suppliers deemed national security threats. It’s unclear if and how regulators and lawmakers would respond to a Chinese drugmaker trying to market its treatments in the US on its own. “Five years ago, people were saying Chinese companies were more innovative and were going to go overseas,’’ Bernstein analyst Rebecca Liang, who covers China biopharma, said in an interview with Endpoints. “But it’s not that easy. We’ve had more failures than successes.” Though there are few instances of drugs discovered in China making it big, aside from BeOne’s Brukinsa and Legend Biotech’s myeloma cell therapy Carvykti, last year’s deluge of deals between China biotechs and US companies means that is likely to change in the coming years. There are several thousand biotechs in China, so expect to see a “full spectrum” of the types of companies that will develop there, according to Fangning Zhang, a McKinsey partner who leads the consulting firm’s life sciences practice in Greater China. For both small and large drug developers in China alike, accessing the far more lucrative external markets via deals or other lanes is key. Out of all these companies, however, only a few including Hengrui have the prospects to truly become multinational. Another such aspirant is Innovent. “We have ambitions to become a global company,” Innovent CEO Michael Yu told Endpoints on the sidelines of the JPM conference. Innovent has an office in California and has been growing its clinical and research teams in the US. “There are a couple companies that are starting to become more thoughtful and intentional when they strike partnerships with Western players around assets,” Zhang said in an interview at JPM. Co-development and co-commercialization deals, rather than a “simple out-licensing transaction,” allow China-based biotechs to “learn from the best in industry.” For instance, Innovent reached a $1.2 billion upfront deal with Takeda last year to jointly develop and commercialize an immunotherapy for cancer. The companies started a Phase 3 trial of the treatment in lung cancer at the end of last year. But for now, with its size and all the “fanfare” about its pipeline, Hengrui is “one of a kind,” Bernstein’s Liang said. “The ambition is there. They want to be big, they want to be global.” Even so, much of the company’s assets are at an early stage, she said, and “that moment is yet to come.” Drew Armstrong, Jared Whitlock and Kyle LaHucik contributed reporting to this story.