Hey, Big Pharma stars: China wants you. Aiming to speed new drugs to market, China just came up with a target list of 48 treatments greenlighted abroad, including some of the industry’s biggest names.The idea? Persuade their makers to apply for Chinese approval based on foreign trial data.
The list of “clinically urgently needed new drugs” was developed by experts convened by China’s State Drug Administration. The group mainly considered medications already approved in the U.S., EU and Japan, but not yet marketed in China.
According to the agency’s Center for Drug Evaluation, the country is in urgent need of these drugs to fight rare diseases or life-threatening conditions, because no effective treatment exists in China or because they’ve shown clear advantages in clinical studies.
See more details on FiercePharma
Amid a public outcry over vaccine safety and efficacy, Chinese officials and law enforcement are pressing fast ahead with their investigations, and their initial findings point to systematic data fabrication and doctored surveillance tapes at one of the largest vaccine makers in China.
Local police are now asking prosecutors to approve the arrest of 18 people for producing and selling faulty drugs. These people, Changchun Changsheng Life Sciences’ chairwoman Gao Junfang included, were found linked to alleged illegal actives during Changsheng’s rabies vaccines production, Changchun city police said in a Sunday statement.
The move by police came right after the revelation of similar findings made by a central government investigation team dispatched by Premier Li Keqiang. (See more details on FiercePharma)
China’s drug regulator just pulled a manufacturing permit for the country’s second-largest maker of rabies vaccines over data falsification, marking the latest episode in China’s drug safety scandal.
During an inspection, China’s State Drug Administration found Changchun Changsheng Life Sciences forged production records for its Vero cell-based rabies vaccines. The agency immediately moved to revoke the company’s GMP license tied to the vaccine—just three months after its issuance—and dispatched a team to investigate the incident on site, according to a Sunday statement (Chinese).
In its announcement filed to Shenzhen Stock Exchange, the Changchun, China-based company said it has started recalling all unexpired rabies vaccines, even though the batches under question weren’t released to the market, and it hasn’t received any adverse event report related to the quality of the vaccines through years of monitoring.
A yearlong internal power struggle for control of Chinese vaccine maker Sinovac Biotech has spilled from the boardroom to the production floor, forcing the company to suspend manufacturing of its hepatitis A vaccine.
The company said on Tuesday that after repeated interruptions to the power supply at its manufacturing site in Shanghai, it was forced to halt production and “destroy the bulk of its hepatitis A vaccines.”
The company said it will now “fumigate and sterilize the facilities, and verify whether any equipment was damaged by the power outage in April.”
Just months after completing China’s largest single-use bioreactor manufacturing facility, WuXi Biologics is ready to take its technology to Europe with another large biologics facility that will employ 400 workers.
Wuxi-city based WuXi Biologics said it will invest €325 million ($392 million) to build a biologics facility in Dundalk, Ireland, and create a campus of 26 hectares (2.8 million square feet). The project, its first outside of China, has been in the works for several years and has snagged support from Ireland’s development agency. “We are all excited to initiate our first global site to enable local companies and expedite biologics development in Europe,” Wu Xi Biologics CEO Chris Chen said in a statement.
In a potential threat to foreign drugmakers profiting on innovative drugs, the Chinese government on Tuesday issued a new policy package—including tax breaks—to promote generics.
The package (Chinese) would allow certain qualified generics makers to be designated as high-tech enterprises, a label that comes with a 15% corporate tax rate, compared to 25% for other companies. The policy also makes clear that China considers compulsory patent licensing a bona fide option during public health emergencies or shortages of key drugs.
The government’s health department and recently rebranded drug regulator will compile and actively update a drug list that encourages companies to produce generic versions. That list will include medications for rare diseases, major infectious diseases and pediatric treatments, as well as important drugs that are running scarce.
Trade in chemicals between the U.S. and China is robust and roughly equal. See more details on the following chart.
No one knows yet what products will be hit as part of a Trump administration plan to impose tariffs on Chinese imports, but chemicals are unlikely to emerge unscathed from any U.S.-China trade conflict. Even before the U.S. announcement, chemicals were vulnerable to trade conflicts. President Donald J. Trump announced on March 22 that the U.S. will impose tariffs on about $60 billion worth of Chinese goods to punish the country for technology and trade-secret theft. The White House says it will reveal the list of goods within 15 days of Trump’s announcement.
In response to the March 22 announcement, China threatened a countermeasure that would target about $3 billion worth of American goods, including fresh fruit, nuts, and wine. Officials hinted that a fuller response could follow.
In a statement, the Chinese embassy in the U.S. vowed that “if a trade war were initiated by the U.S., China would fight to the end to defend its own legitimate interests with all necessary measures.”
chemical trade was roughly in balance last year.
Sources: Customs General Administration of the People’s Republic of China, C&EN calculations