Within two weeks, 47 new drugs were approved for clinical use, 80% domestically produced, and 132 drugs made new progress in research and development

Source: People's Daily Health Client Li Xuanzhang

According to the public information of the State Food and Drug Administration, in the past half a month, 4 new drugs have applied for listing, 21 new drugs have been updated in the registration status, 47 new drugs have been approved for clinical trials, and 60 new drug clinical applications have been undertaken.

47 new drugs were approved for clinical use, and domestic products accounted for 80%.

According to the data on the official website of the State Food and Drug Administration, the Health Times reporter combed and found that from November 27 to December 12, 47 new drugs were implicitly licensed for clinical trials in two weeks. Among them, 39 varieties are domestic new drugs and 8 varieties are imported new drugs. From the perspective of drug types, there are 31 chemical drugs, 15 therapeutic biological products, and 1 proprietary Chinese medicine. Among the 39 domestic new drugs, there are 28 new drugs of class 1.

Among them, Hengrui Pharmaceutical has led the domestic pharmaceutical companies with 4 new drugs approved clinically: HRS8179 for injection is the first approved clinical, the drug by reducing sodium ion inflow, the treatment of large-scale ischemic stroke after severe cerebral edema, there is no similar product market at home and abroad; famitinib malate capsules, SHR-1802 for injection and carrelizumab for injection three new drugs are combined for the treatment of advanced solid tumor patients.

60 clinical applications for new drugs were undertaken: chemical drugs and biological products were mainstream, and only 1 proprietary Chinese medicine was undertaken

In the past half a month, the clinical applications for 60 new drugs have been accepted by the State Food and Drug Administration. Among them, 46 varieties are domestic new drugs and 14 varieties are imported new drugs. From the perspective of drug types, there are 29 chemical drugs, 30 therapeutic biological products, and 1 chinese patent medicine.

The only proprietary Chinese medicine that has been clinically applied for is the psoralen total glycoside capsule of the Jiangsu Academy of Traditional Chinese Medicine, and the therapeutic field is the use of drugs for diseases of the skeletal musculoskeletal system.

4 new drugs applied for listing, and domestic and foreign pharmaceutical companies were equally divided

In the past half a month, the listing applications of 4 new drugs have been undertaken by the State Food and Drug Administration, and domestic and foreign pharmaceutical companies account for half of them: Triracil for injection of Simcere Pharmaceutical, methotrexate injection (pre-filled) of Kangzhe Biologics, vibotuzumab for injection by Roche, and ashiopipone tablets for injection by Yoshio Shiono in Japan.

Treracilly, the world's first and only CDK4/6 inhibitor with comprehensive bone marrow protection, is a new therapy that can reduce the bone marrow suppression (CIM) caused by chemotherapy, which has been recognized by the US FDA as a "breakthrough therapy" and launched in the US in February this year.

The first indication of this application is prophylactic use in patients with widespread small cell lung cancer receiving a platinum-containing drug plus etoposide regimen to reduce the incidence of chemotherapy-induced bone marrow suppression.

Roche's Vibotozumab (Polivy) is a First-in-Class anti-CD79b antibody conjugated drug (ADC) and the first anti-CD79b antibody conjugated drug to be marketed in China. Vibotozumab was first approved for marketing in the United States in June 2019.

The registration status of 21 new drugs has been updated, and Qilu is expected to sprint to the second domestic one

According to the public information of the State Food and Drug Administration, in the past half a month, the registration status of 21 new drugs has been updated. Among them, 12 new drugs were approved for listing, 7 new drugs were registered and the status was changed to "under approval", and 2 were not approved.

Among the approved and marketed drugs, Qilu Pharmaceutical's injectable recombinant human follicle-stimulating hormone is used to treat infertility. According to data from the Intranet, sales of recombinant human follicle-stimulating hormone in China's urban public hospitals, county-level public hospitals, urban community centers and township health centers exceeded 1.2 billion yuan in 2020.

At present, only 1 domestic enterprise in China has been approved for listing of recombinant human follicle-stimulating hormone, that is, Changchun Kinsey Pharmaceutical, and Qilu is expected to sprint to the second domestic one.