First domestic product: Chia Tai Tianqing declares "Mepolizumab" similar drug

On October 19, the CDE official website showed that CP Tianqing had declared a class 3.
3 biosimilar drug for mepolizumab injection
.
Mepolizumab is an IL5 monoclonal antibody.

From CDE official website

Mepolizumab was developed by GlaxoSmithKline and was approved by the FDA in November 2015 to treat severe and eosinophilic phenotypic asthma in patients 12 years of age and older.
It became the first IL-5 antibody approved by the FDA under the trade name Nucala
.
In September 2019, its applicable population was expanded to children aged 6-11.

According to GlaxoSmithKline’s 2020 financial report, Nucala has continued to maintain a sales growth rate of more than 30% since its listing, and global sales in 2020 will reach 1.
285 billion US dollars
.

Global sales of mepolizumab

From the Insight database (http://db.
dxy.
cn/v5/home/)

In China, mepolizumab is an urgent clinical need.
In July 2020, GlaxoSmithKline submitted the drug's marketing application to NMPA and was included in the priority review and approval.
The indication is adult eosinophilic Wegener's granulomatosis (EGPA).
At present, its review is nearing completion and it is expected to be approved within this year (click here to view the current review status)
.
According to the Insight database, mepolizumab has launched 3 clinical trials in China

From the Insight database (http://db.
dxy.
cn/v5/home/)

CP Tianqing currently has 20 biological drug projects entering the clinical stage, including 9 original research projects and 7 similar drug projects
.
In terms of similar drugs, the fastest-growing bevacizumab (TQB2302) and adalimumab (TQZ2301) have been declared for marketing, rituximab (TQB2303), pertuzumab, trastuzumab ( TQB211) and liraglutide (TQZ2451) have already started phase III clinical trials