Akeso Biopharma, based in Zhongshan, China, has become one of the country’s biggest breakout innovators this year. Led by co-founder and CEO Michelle Xia, the company has surged onto the international scene with drugs focused on cancer and immunology. In March, a phase 3 study published in The Lancet showed Akeso’s ivonescimab outperformed Merck’s blockbuster cancer drug Keytruda (pembrolizumab) pushing the FDA to fast-track its approval review of ivonescimab. And in April, the FDA approved Akeso’s drug candidate penpulimab-kcqx—its first approval in the U.S.—for some types of head and neck cancer, four years after it was approved in China.
Just a decade ago, this kind of success was unimaginable to Xia. When she started the company with her cofounders in March 2012, there was little drug innovation in China. “We started from nothing,” she says. They built a lab, started drug discovery programs, moved products into development, manufacturing, clinical trials, and commercialization. In the past 10 years, they’ve tested dozens of candidates and brought seven drugs to market. They’re currently eyeing cancer treatment cadonilimab, first approved in China in 2022, as their next drug to expand globally. The drug significantly improved survival rates for patients with cervical cancer compared to chemotherapy alone, according to results presented at the European Society for Medical Oncology meeting in November.
The company’s sudden global influence is indicative of China’s spreading power in medicine. Akeso is running several phase 3 studies to expand the approval of ivonescimab in China, but it’s also collaborating with Summit Therapeutics to bring ivonescimab to clinical trials in the U.S., Europe, and more. Despite the fraught geopolitical climate, Xia’s optimistic about a future where treatments can be exchanged between countries. For example, drugs Akeso developed in China have already accrued lots of patient data, which can shorten the development and approval timeline in the U.S.. “We can contribute innovation globally,” Xia says. “I think that's very satisfying.”