In the first half of 2020, nmpa approved a total of 27 new drugs, including 17 imported drugs and 10 domestic drugs. In terms of drug types,
there are 13 chemical drugs, 10 biological drugs, 3 traditional Chinese medicine and 1 vaccine product.
Note: the new drugs listed here mainly refer to the drugs approved for the first time in China by nmpa, including new molecular entities (and compound containing new molecular entities), biological drugs, traditional Chinese medicine and vaccines. Among them, the new molecular entities are mainly category 1 (innovative drugs that are not listed at home and abroad) and category 5.1 (the original research drugs listed abroad apply to be listed in China) under the classification of chemical drug registration; biological drugs are mainly category 1 (biological products not listed at home and abroad) and category 2 (monoclonal antibodies) under the classification of biological products registration. Biological analogues, new indications and new dosage forms are not included.
Among the 5.1 new drugs approved for listing in China in the first half of 2020, Xiansheng Pharmaceutical Co., Ltd. owns the Chinese rights and interests of abamip, Beihai Kangcheng owns the Chinese rights and interests of naratinib, and Fosun Pharmaceutical owns the Chinese rights and interests of avatriproppar. In addition, naftopidil of Asahi Kasei company and bupropion hydrochloride sustained-release tablets of GSK belong to the original research and are listed in China for the first time, and many generic drugs have been approved in China.
From the perspective of enterprises, in the first half of 2020, Roche, Takeda, Sanofi and kylin of Concord fermentation have been approved for listing
in China. Among them, Roche's emetrastuzumab was the first antibody coupled drug (ADC) approved in China, and atilitzumab was the second PD-L1
drug approved in China. Takeda's vebutuximab is the second ADC drug approved in China.
In addition, of the 17 imported drugs approved for marketing in 2020, 6 of them are in urgent need of overseas drugs. In terms of the approval
days, the average approval time of the other five drugs was 213 days, except that berdarumab was approved directly after clinical application.
Among them, DDB tablets were approved for marketing in China within 115 days.
Overseas drugs approved in the first half of 2020
Note: new indications are not included
The following is a brief introduction of some new drugs:
1. The first domestic approved antibody coupled drug
In January 2020, rometrazumab was approved in China. It is mainly used for adjuvant treatment of HER2 positive early breast cancer patients who
still have invasive lesions after neoadjuvant therapy based on taxanes and trastuzumab. It also fills in the treatment blank of HER2 positive breast
cancer patients who do not achieve complete pathological response (PCR) after neoadjuvant therapy.
The indications were approved in the United States and the European Union in May 2019 and December 2019, respectively, which achieved the
simultaneous approval of China and European and American countries.
2. The first new Chinese medicine for diabetes in recent 10 years
Wuhe Bo'ao mulberry branch total alkaloid tablets are mainly used in combination with diet control and exercise treatment of type 2 diabetes. It is
the first approved new Chinese medicine for diabetes in recent 10 years.
3. The first domestic third generation EGFR-TKIdrug
Hausen's ametinib mesylate tablets are mainly used in adult patients with locally advanced or metastatic non-small cell lung cancer who have been
treated with epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) or after treatment, and confirmed to have EGFR T790M mutation.
This is the third third generation of EGFR-TKI innovative drug in the world and the first domestic third generation EGFR-TKI drug.
4. The first deuterated drug
Teva's DDB tablets are mainly used to treat chorea associated with Huntington's disease and adult tardive dyskinesia. This is the first deuterium product approved by the FDA and the second drug in history to target chorea associated with Huntington's disease. China is the second country after the United States to approve the drug, which is also China's first deuterated drug to be approved.
5. The first domestic Btk inhibitor
Zabutinib of Baiji Shenzhou is the first domestic anti-cancer drug approved by FDA, and also the first domestic Btk inhibitor listed in China. At present,
Baiji Shenzhou has submitted an application for marketing permission of zebutinib in the treatment of patients with Fahrenheit macroglobulinemia in
the European Union.
6. The first targeted biological agent for atopic dermatitis
Sanofi dupilumab injection is the world's first approved targeted biological agent for the treatment of moderate to severe atopic dermatitis in adults. Dupixent is a monoclonal antibody drug targeting IL-4R, which was approved by FDA for the first time in March 2017. Its global sales revenue will reach 2.074 billion euro in 2019. Sanofi plans to build it into a blockbuster with annual sales of more than 10 billion euro.