Yicai Global
SOURCE: Yicai
Zhang Yushuo
DATE: Nov 10 2025
https://www.yicaiglobal.com/news/ciie-simcere-to-start-producing-swiss-insomnia-drug-in-china-for-overseas-markets
(Yicai) Nov. 10 -- Simcere Pharmaceutical Group showed its redefined cross-border collaboration model at the eighth China International Import Expo, with the Chinese company to soon start manufacturing in China an insomnia drug it licensed from Swiss pharmaceutical firm Idorsia for domestic markets.
Simcere plans to produce daridorexant, a dual orexin receptor antagonist sleep medication next year at its plant in Hainan province in China, which has been inspected by the US Food and Drug Administration and the European Medicines Agency. It may also export the made-in-China version of daridorexant to the global markets, leveraging its internationally certified manufacturing capabilities, the company said at the CIIE.
Idorsia granted Simcere the rights to daridorexant in November 2022, with the drug receiving approval from China's National Medical Products Administration in June this year, helping nearly 100,000 Chinese patients within two months of launching.
"We have already submitted our application to the NMPA for locally manufacturing the drug in Hainan," said Shi Ruiwen, vice president of Simcere. “The goal is to lower the cost and bring affordable medicines to Chinese patients.”
Nearly 49 percent of adults in China suffer from insomnia. Unlike traditional sleep medicines, daridorexant is not a psychotropic substance and is the only drug of its class approved by the EMA to improve daytime function.
Daridorexant's efficacy and safety were confirmed during Phase III clinical trials in China, according to findings published in the World Sleep Society's official journal SLEEP. Before entering China, it had received approval in over 10 countries and regions, including the United States, the European Union, the United Kingdom, Switzerland, Canada, and Japan.
Simcere's new "license-in, manufacture-for-the-world" model highlights its evolution from importer to integrated partner for multinational firms. By producing daridorexant locally and supplying for overseas markets, it shows how Chinese pharmaceutical companies can serve the domestic and international markets.
"We are building our own research and development capabilities," Shi pointed out. "However, we know that we cannot innovate fast enough just by ourselves."
Simcere has been investing big in the new model, injecting CNY9 billion (USD1.3 billion) in research and development over the past five years, while planning to invest another CNY17 billion (USD2.4 billion) in the next five years. Its revenue from innovative products accounts for 77 percent of its total income, up from 44 percent five years ago.
In addition, Simcere had also introduced trilaciclib to China. The myloprotection drug that protects against chemotherapy-induced damage to bone marrow was approved in China only 17 months after making its debut in the US, leveraging Hainan's Free Trade Port policies and Lecheng’s real-world data study platform.
Outbound Innovation
"China has transformed from a follower in the past to a leader today, and this momentum will continue in the future," Shi noted, explaining that Simcere is also expanding overseas with self-developed drugs.
Simcere's subsidiary Simcere Zaiming out-licensed to Illinois-based AbbVie the rights of its trispecific antibody SIM0500 for multiple myeloma in a deal worth up to USD1.1 billion earlier this year, while penning similar agreements with Spain's Almirall and Maryland-based NextCure.
Simcere runs a national key laboratory and four innovation centers in Shanghai, Nanjing, Beijing, and Boston. It has implemented an artificial intelligence-assisted small-molecule design at its Shanghai facility, enabling one or two researchers to design 1,000 molecules in minutes instead of weeks.
Simcere has also established business development teams in the US, in Europe, and a commercialization team in Southeast Asia, with several products being registered and plans to launch these products by 2027.
"Southeast Asia is an emerging market, a growing market," Shi pointed out, noting the population of nearly 600 million, across Indonesia, Singapore, Malaysia, the Philippines, Thailand, and Vietnam.
Regarding challenges with overseas expansion, Shi said that "no matter where you are, you must maintain an open mind and a mutually beneficial relationship with your partners; otherwise, cooperation becomes a one-time deal.
"If you're too slow with a new drug with a new mechanism of action, you will lose market opportunity as patients cannot wait," he noted. “This often cannot be accomplished by one company's capabilities alone, requiring strong partnerships.”
The six-day CIIE ends today. This year's trade fair is being held at the National Exhibition and Convention Center, attracting over 4,100 overseas businesses to a more than 430,000-square-meter exhibition space, both new records.
Editor: Martin Kadiev