(Yicai) Nov. 10 -- Simcere Pharmaceutical Group showed its redefined cross-border drug collaboration model at the eighth China International Import Expo, with the Chinese company to soon start manufacturing an insomnia drug it licensed from Swiss pharmaceutical research firm Idorsia in China for overseas markets.

Simcere plans to produce daridorexant, a dual orexin receptor antagonist, at its plant in Hainan province, which has been inspected by the US Food and Drug Administration and the European Medicines Agency, and export it to Idorsia's global markets, the Nanjing-based company said at the CIIE, noting that it will keep exclusive rights to the drug in China.

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 already submitted our applications to the NMPA and we gonna manufacture 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 aids, daridorexant is not a controlled 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-export" model highlights its evolution from importer to integrated partner for multinational firms. By producing daridorexant locally for overseas use, 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 using our own team."

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 has also introduced trilaciclib to China. The chemotherapy protection drug was approved by the country only 17 months after making its US debut, leveraging Hainan's Free Trade Port policies and real-world data platform.

Outbound Innovation

"China has transformed from follow-on innovation in the past to playing a leadership role, and this trend will continue to strengthen in the future," Shi noted, explaining that Simcere is also expanding overseas with self-developed drugs.

Simcere's subsidiary Zaiming granted Illinois-based AbbVie the rights to 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, allowing one or two researchers to design 1,000 molecules in minutes instead of weeks.

Simcere has also established a business development team in Europe and a subsidiary in Singapore. It has commercialization teams across Southeast Asia, with several products registered after two years of operations and plans to launch multiple drugs by 2027.

"Southeast Asia is an emerging market, a growing market," Shi pointed out, noting the population of nearly 300 million across 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 mutual benefit, 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