In-depth review | Over 30 new drugs approved in China in the first quarter of 2021 contain 4 new crown vaccines

The first quarter of 2021 has just ended.

Highlight 1: 5 "official announcements", major new drugs are accelerating approval in China

According to statistics, there are 14 innovative drugs approved for marketing by the NMPA "official announcement" in 2020.

The 5 "official announcement" drugs are: 1) Kyowa Kirin's FGF23 targeted therapy brosoyuumab injection, used for the treatment of X-linked hypophosphatemia in adults and children aged 1 year and older; 2) The third-generation EGFR-TKI vometinib mesylate tablets of Allis Pharmaceuticals are used for the treatment of adult patients with locally advanced or metastatic NSCLC; 3) Rongchang Biotech's new mechanism of action for injection tedtacept for the system Adult patients with sexual lupus erythematosus; 4) Huahao Zhongtian Pharmaceuticals Class 1 new drug Utidrolone injection, used for patients with recurrent or metastatic breast cancer who have received at least one chemotherapy regimen in the past; 5) CStone Pharmaceuticals RET inhibition Platinib capsules are used for the treatment of adult patients with locally advanced or metastatic NSCLC with positive RET gene fusion.

NMPA "Official Announcement" New Drugs in the First Quarter of 2021

It is worth mentioning that among these 5 new drugs, except for Utidrolone injection, the other 4 are all new drugs that have passed the priority review and approval procedures with conditional approval.

Highlight 2: A variety of products set a record of "the first in China"

Among the new drugs approved in the first quarter, a number of products set the record of "the first in China".

In addition, this quarter, three domestically produced anti-PD-1 antibodies have been harvested for new indications, including BeiGene tislelizumab (squamous NSCLC), Xinda Bio-Sintilizumab (non-squamous NSCLC), Junshi Bio-Treplimumab (recurrent/metastatic nasopharyngeal carcinoma).

China-made Class 1 new drugs approved by NMPA in the first quarter of 2021 (including new indications)

Overall, in the first quarter, 7 domestically produced Class 1 new drugs were approved for marketing by the NMPA, which shows that China's innovative capabilities in the field of biomedicine are continuing to be transformed into results that benefit patients.

Highlight 3: 4 new crown vaccines approved for conditional marketing or emergency use

Since the outbreak of the new crown virus more than a year ago, with the solidarity and cooperation of all sectors of society, China's new crown virus vaccine research and development and production have made important progress.

It is worth mentioning that 4 of these 5 vaccines were approved for conditional marketing or emergency use in the first quarter of this year.

New crown vaccine approved by NMPA in the first quarter of 2021 (including emergency use)

Among them, the new coronavirus inactivated vaccines (Vero cells) from the China Biotech Wuhan Institute of Biological Products of Kexingzhong and Sinopharm Group are all inactivated vaccines.

CanSino Bio’s recombinant new coronavirus vaccine is an adenovirus vector vaccine.

Approved for emergency use is the recombinant new coronavirus vaccine (CHO cell) produced by Zhifeilong Kema.

We congratulate these new drugs for being approved for marketing in China or for new indications.