Reforms accelerate launch of new medicines

Ding Yining
Expedited approvals from China's drug administrative body, combined with new regulations, are making it easier for pharma companies to bring products to market.
Ding Yining
Reforms accelerate launch of new medicines

Both domestic and foreign pharma companies are seeing accelerated new product launches as a result of the expedited approval process by the drug administrative body and new regulatory schemes to help translate research into products more efficiently. 

Shanghai-headquartered biopharmaceutical firm Zai Lab said over the weekend it has received the first approval on China's mainland for its oncology treatment Zejula for recurrent ovarian cancer. 

The application for Zai Lab's niraparib was filed in December 2018 and was included in the fast-track approval process by the Center for Drug Evaluation under the National Medical Products Administration of China. 

"We appreciate the NMPA for their partnership through this rapid and thorough assessment of the Zejula application, recognizing the high unmet medical need," said Founder and CEO of Zai Lab Samantha Du. 

The drug is also under clinical studies in China for treatment of small-cell lung cancer. 

The approval came after the new drug gained approval in Hong Kong in October last year, as Zai Lab gained a license from GlaxoSmithKline to commercialize the new pharma on China's mainland, Hong Kong and Macau.

NASDAQ and Hong Kong-listed BeiGene's new monoclonal antibody for treating Hodgkin lymphoma patients also gained NMPA approval over the weekend, the first approved drug for the company in China. 

It's working with Boehringer Ingelheim China to prepare for the commercial supply at the German drug company's biopharmaceuticals production facility in Zhangjiang in Shanghai, which makes the drug the first innovative biopharmaceutical drug commissioned under the Market Authorization Holder model in the country.

The Market Authorization Holder scheme, which has been officially recognized by the revised Drug Authorization Law since December 1, allows drug research institutes and individual researchers to become drug registration applicants.

President of BeiGene and general manager of Beigene China Wu Xiaobin said it's looking forward to further development of the drug for new indications in solid tumors and hematological malignancies. 

Drug applicants no longer have to set up their own manufacturing facilities and can outsource commercial manufacturing to eligible third parties. 

"The newly established model can be of great benefit for the Chinese health-care systems and finally provide Chinese patients broader access to more innovative drugs," commented Luo Jiali, General Manager and Site Head of Boehringer Ingelheim Biopharmaceuticals China. 

Denmark's biopharmaceutical company Novo Nordisk launched its latest insulin injection Ryzodeg in China earlier this month, which is already available in 29 overseas countries and regions.

Its innovative diabetes injection that contains both insulin degludec and insulin aspart received approval in a little over one year in China, while a previous insulin degludec injection by Danish company took about two years to receive approval. 

It aims to launch at least 10 innovative drugs treating diabetes and other chronic diseases in the next six to seven years in China. 

The International Diabetes Federation estimates there are around 120 million diabetes patients in China but less than half of them have been diagnosed, and very few of those who receive treatment have maintained a healthy blood glucose level, which are likely to result in complications. 

Special Reports