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On November 10, a Chinese pharmaceutical company showcased its innovative cross-border drug partnership model at the eighth China International Import Expo. The company is set to begin manufacturing an insomnia medication, licensed from a Swiss research firm, for international markets.
It plans to produce daridorexant, a dual orexin receptor antagonist, at its facility in Hainan, which has been approved by the U.S. Food and Drug Administration and the European Medicines Agency. The product will be exported globally, while the company retains exclusive rights within China.
The license for daridorexant was granted in November 2022, and the drug received approval from China’s regulatory authority in June, helping nearly 100,000 patients in just two months.
“Our application has been submitted to the national regulator, and we’re preparing to start manufacturing in Hainan,” said a vice president of the company. “Our goal is to reduce costs and make affordable medicines accessible to Chinese patients.”
Insomnia affects nearly 49% of adults in China. Unlike traditional sleep aids, daridorexant isn’t a controlled psychotropic drug and is the only medication in its class approved by the European Medicines Agency for improving daytime functioning.
Clinical trials in China confirmed the drug’s safety and efficacy during Phase III studies, with approvals granted in more than ten countries, including the United States, the European Union, the UK, Switzerland, Canada, and Japan.
This new “license-in, manufacture-for-export” approach demonstrates the company’s evolution from an importer to a global partner. By producing the drug locally for export, it exemplifies how Chinese pharma companies are serving both domestic and international markets.
While developing its own research and development capabilities, the company recognizes that fast-paced innovation often requires collaboration. Over the past five years, it has heavily invested in R&D, pouring in about CNY 9 billion (roughly USD 1.3 billion), with plans to add another CNY 17 billion (around USD 2.4 billion) over the next five years. Innovative products now make up 77% of its total revenue, up from 44% five years ago.
The company also introduced trilaciclib to China—a chemotherapy-protecting drug approved in just 17 months after its US debut, benefiting from Hainan’s Free Trade Port policies and data platforms.
Global Innovation and Expansion
The company’s leadership notes that China has evolved from a follower in drug development to a leader, a trend set to strengthen further. It’s expanding internationally with self-developed medicines. Earlier this year, its subsidiary licensed a trispecific antibody for multiple myeloma to a U.S.-based firm in a deal potentially worth over USD 1 billion, with similar agreements made in Spain and the U.S.
The company operates a national key laboratory and four innovation centers in Shanghai, Nanjing, Beijing, and Boston. It has integrated AI-assisted design technology in Shanghai, enabling rapid development of new molecules—up to 1,000 designed in minutes, a process that used to take weeks.
It has established a business development team in Europe and a subsidiary in Singapore, along with commercial teams across Southeast Asia. Several products have been registered within two years, with plans to launch multiple drugs by 2027.
” Southeast Asia is a rapidly growing market, with a population of nearly 300 million across countries like Singapore, Malaysia, the Philippines, Thailand, and Vietnam,” explained the executive.
Regarding outward expansion challenges, he emphasized the importance of maintaining an open mindset and mutual benefits. “If you’re too slow to bring a new drug with a novel mechanism to market, patients won’t wait,” he said. “Strong partnerships are essential, as this kind of progress can’t be achieved alone.”
The six-day expo concludes today. It is held at the National Exhibition and Convention Center, featuring over 4,100 international exhibitors across more than 430,000 square meters—setting new records for the event.
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