List Of The Top Ten Approved New Drugs In China In 2020

21 Lu Shan, senior researcher of new Institute of health

In 2020, China drug administration will approve 48 new drugs under the pressure of epidemic situation. Since 2017, China's State Drug Administration has made a more active attempt to accelerate the review and approval, which also drives the development of domestic innovative pharmaceutical enterprises and the innovation investment and transformation of traditional pharmaceutical enterprises.

The new drugs approved by China drug administration mainly focus on "cancer". In terms of disease field, tumor accounted for 34% (16 / 48) of new drugs approved by nmpa in 2020, and the other high proportion included infectious diseases (15%), nerve (13%), bone (6%) and endocrine metabolism (6%). Among the new drugs approved in 2020, 21 new health research institute considers these 10 drugs to be the most noteworthy blockbuster drugs in 2020.

01 clomivir hydrochloride capsules (Caine Technology)

Time of approval: February 2020

21 antidote: clomivir inhibits hepatitis C virus replication by targeting nonstructural protein NS5A. Both dacetavir and this strain are NS5A replication complex inhibitors. It can be used with or without compensatory cirrhosis to treat chronic hepatitis C virus (HCV) infection in newly diagnosed or interferon treated adults with genotype 1, 2, 3 and 6. This is also the second drug after danorevir sodium tablets, the first domestic drug for chronic hepatitis C treatment, has been approved for the market since then, and the three drugs are all HCV NS5A protein specific inhibitors can meet the needs of clinical treatment of chronic hepatitis C virus infection by combining with other antiviral drugs.

02 ametinib mesylate tablets (hausen pharmaceutical)

Time of approval: March 2020

21 antidote: the drug is approved for use 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 positive in adult patients with locally advanced or metastatic non-small cell lung cancer.

03 cinemod tablets (Novartis)

Time of approval: May 2020

Antidote: for the treatment of adult relapsing multiple sclerosis, including clinical isolated syndrome, relapse remission disease and active secondary progressive disease. Cinimode is a sphingosine-1-phosphate (S1P) receptor regulator. It selectively binds to S1P receptor subtypes 1 (S1P1) and subtype 5 (S1P5) with high affinity, which prevents lymphocytes from escaping from lymph nodes and reduces the number of peripheral blood lymphocytes.

04 Genzyme for injection

Time of approval: June 2020

Antidote: the drug has been listed through the priority review and approval process for long-term enzyme replacement therapy in patients with mucopolysaccharidosis type I, and for the treatment of non neurological manifestations of the disease. Mucopolysaccharidosis type I (MPS I) is a rare autosomal recessive disease, which is caused by the deficiency of α - l-edusidosidase. It can lead to excessive accumulation of glycosaminoglycans in all organs and tissues in vivo, and then endanger life. As an enzyme replacement therapy for such patients, the approved drugs have been listed in the second batch of clinically urgent overseas listed drugs. Since the release of the list of drugs listed abroad, the State Drug Administration has approved the import registration of more than 30 varieties.

05 zebutinib capsule (Baiji Shenzhou)

Time of approval: June 2020

Antidote: the drug is conditionally approved through the priority review and approval process for adult mantle cell lymphoma (MCL) patients who have previously received at least one treatment and adult chronic lymphoblastic leukemia (CLL) / small lymphoma (SLL) patients who have received at least one treatment. Zebutinib is a selective inhibitor of Bruton's tyrosine kinase (Btk). Zebutinib capsule is an innovative drug independently developed and has independent intellectual property rights in China. The marketing of this product will provide more choices for adult mantle cell lymphoma and adult chronic lymphoblastic leukemia / small cell lymphoma patients. Zebutinib is also the first Chinese innovative drug approved by FDA for breakthrough therapy.

06 ensatinib hydrochloride capsule (Beida pharmaceutical)

Time of approval: November 2020

Antidote: the drug is conditionally approved through the priority review and approval process for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) patients who have been previously treated with clotriminib or who are ALK positive. Ensatinib is an inhibitor of anaplastic lymphoma kinase (ALK). It provides a new treatment option for patients with non-small cell lung cancer and fills the blank of alk-tki targeted drugs in China.

07 lanarizumab injection (Takeda pharmaceutical)

Time of approval: December 2020

Antidote: thanks to the continuous promotion of the State Food and drug administration, lanarizumab injection was approved. Hereditary angioedema (HAE) is an autosomal dominant hereditary disease, which is considered to be a rare disease in Europe, America and China. Nearly half of the patients may suffer from upper respiratory tract mucosal edema, causing asphyxia and life-threatening. The domestic treatment methods are limited and there are unmet clinical needs. This product is an all humanized monoclonal antibody (IgG1 / K-light chain) originally developed by dyax Corp., which can combine with plasma kallikrein to inhibit its proteolytic activity, so as to control the excessive production of bradykinin in hae patients.

08 octinib tablets (Novartis)

Time of approval: December 2020

Antidote: the drug is approved conditionally through the priority review and approval process. It is suitable for the treatment of: (1) Adult mantle cell lymphoma (MCL) patients who have received at least one treatment in the past. (2) Adult patients with chronic lymphoblastic leukemia (CLL) / small cell lymphoma (SLL) who have received at least one treatment. Obutilinib is a selective inhibitor of Bruton tyrosine kinase. It provides a new treatment option for adult mantle cell lymphoma, adult chronic lymphoblastic leukemia and small lymphocytic lymphoma. The SFDA requires the holder of the marketing license of the variety to continue to complete the relevant post marketing research work according to the attached conditions and requirements.

09 sufentinib capsule (Hutchison Whampoa medicine)

Time of approval: December 2020

Antidote: the drug has been approved for marketing through the priority review and approval process. It is an innovative drug independently developed in China with independent intellectual property rights. It is suitable for locally advanced or metastatic, non functional and well differentiated (G1, G2) neuroendocrine tumors that cannot be surgically removed. Sufentinib is a small molecule inhibitor of vascular endothelial growth factor receptor (VEGFR) and fibroblast growth factor receptor 1 (FGFR1). It provides a new treatment option for patients with neuroendocrine tumor. In China, there are an estimated 67600 newly diagnosed cases of neuroendocrine tumors in 2018. According to the ratio of incidence to prevalence in China, there may be as many as 300000 patients with neuroendocrine tumors in China.

10 new type of inactivated coronavirus vaccine (Vero cell) (Sinopharm, Beijing)

Time of approval: December 2020

Antidote: the vaccine is the first domestic new coronavirus inactivated vaccine approved, which is suitable for the prevention of diseases caused by new coronavirus infection (covid-19). According to the relevant provisions of the vaccine administration law and the drug administration law, the State Food and drug administration administration administration shall conduct emergency review and approval, and approve the application for listing registration with conditions. The SFDA requires the holder of the marketing license of the vaccine to continue to carry out relevant research work, complete the conditional requirements, and submit the follow-up research results in a timely manner. The approval of the vaccine closed the whole year's new drug approval and opened a new stage for the fight against the new crown.

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