Summary of 13 innovative drugs approved by the NMPA in 2020

Wen 〡 understood that since 2018, China's domestic innovative drugs into a booming period, domestic innovation drug review and approval continue to speed up.
2020, the sudden outbreak of new crown pneumonia spreads around the world.
outbreak, industries around the world pressed the pause button.
pharmaceutical industry, as the industry closest to the prevention and control of the epidemic, has also ushered in new opportunities for development.
, the small compilation collected and collated 13 new Class 1 drugs approved in China in 2020 for industry reference.
01, the State Drug Administration approved the listing and declaration company of Abtini tablets: Beijing No cheng Jianhua Pharmaceutical Technology Co., Ltd. target / mechanism of action: BTK inhibitor State Drug Administration approved Beijing No. Cheng Jianhua Pharmaceutical Technology Co., Ltd. declared a class 1 innovative drug abtinib tablets (trade name: Inokai) listed for treatment: (1) in the past at least one treatment of adult suite lymphoma (MCL) patients.
(2) patients with chronic lymphoblastic leukemia (CLL)/small lymphocytic lymphoma (SLL) who have received at least one treatment in the past.
abtinib as a selective Bruton tyrosine kinase inhibitor.
the new treatment options for patients with adult sleeve lymphoma, adult chronic lymphocytic leukemia, and small lymphocyte lymphoma.
The State Drug Administration requires the licensed holders of the varieties to continue to complete the relevant post-market research in accordance with the conditions and requirements attached.
02, the State Drug Administration approved phosphate Emitawe capsule listing declaration company: Yichang East Sunshine Changjiang Pharmaceutical Co., Ltd. target / mechanism of action: NS5A inhibitors recently, the State Drug Administration through the priority review and approval process approved Yichang East Sunshine Yangtze River Pharmaceutical Co., Ltd. declared a class of innovative drug phosphate imitawe capsules (commodity name: Dongweien) listed.
This drug is an innovative drug developed independently in China and has independent intellectual property rights, phosphate ethymethamitaver capsules need to be combined with sophosphobwe tablets for the treatment of chronic hepatitis C in adult gene type 1 non-liver hardening.
phosphate Emitavir is an unstructic protein (NS) 5A inhibitor that inhibits viral RNA replication and viral particle assembly.
the variety on the market to better meet the clinical needs of patients.
03, the State Drug Administration approved the listed declaration company: Liaoning Haisco Pharmaceutical Co., Ltd. target / mechanism of action: short-acting GABAA subject regulator recently, the State Drug Administration through the priority review approval process approved Liaoning Haisco Pharmaceutical Co., Ltd. declared a class of innovative drug cyclophenol injections (commodity name: Sisshuning) listed.
drug is an innovative drug with independent research and intellectual property rights in China, which is used for sedative sedative examination in the digestive tract endoscopy.
cyclophenols are GABAA-like astrologists, an anaesthetic sedative.
this variety on the market to provide patients with new treatment options.
04, the State Drug Administration approved the listing and declaration company of fluorine-palli capsules: Jiangsu Hengrui Pharmaceutical Co., Ltd. target / mechanism of action: PARP inhibitors recently, the State Drug Administration through the priority review and approval procedures conditional approval of Jiangsu Hengrui Pharmaceutical Co., Ltd. declared a class of innovative drug fluorine-palli capsules (commodity name: Ari-Yi) listed.
The drug is an innovative drug developed independently in China and has independent intellectual property rights, which is used for the treatment of patients with platinum sensitive relapsed ovarian cancer, fallopian tube cancer or primary peritaniment cancer who have underwent second-line and above chemotherapy with embryoline BRCA mutation (gBRCAm).
fluorine palate is a small molecule PARP inhibitor that inhibits the DNA repair process in BRCA1/2 abnormal cells and induces cell cycle blocking, which in turn inhibits tumor cell proliferation.
this variety on the market to provide patients with new treatment options.
05, Lanaliyu single anti-injection liquid approved listed manufacturers: Catalent Indiana, LLC (United States) target/ mechanism of action: target inhibition plasma kinetic peptide release enzyme in order to implement the spirit of the Executive Meeting of the State Council, the State Drug Administration continued to promote the acceleration of clinical urgent needs of overseas listed drugs imported registration in China.
recently, the State Drug Administration approved the import registration application for Lanalyu single anti-injection fluid.
Hereditary angioedema (HAE) is an endosomal explicit genetic disease, which is considered a rare disease in Europe, America and China, nearly half of the patients can appear upper respiratory tract mucosal edema and cause asphyxiation and life-threatening, limited domestic treatment methods, there are unsolt clinical needs.
this product is an all-humanized monoclonal antibody (IgG1/K-light chain) originally developed by Dyax Corp., which binds to plasma peptide release enzymes to inhibit its protein hydrolysis activity in order to control excessive production of anti-peptides in HAE patients.
06, the State Drug Administration approved the listing and declaration company of Nsatini capsule hydrochloric acid: Beda Pharmaceutical Co., Ltd. target / mechanism of action: ALK inhibitors Recently, the State Drug Administration approved Beda Pharmaceutical Co., Ltd. declared a class of innovative drug Nsa pharmaceutical company through the priority review and approval procedure conditional approval of Beda Pharmaceutical Co., Ltd. Tini capsules (trade name: Bemena) are available for the treatment of patients with local late stage or metastatic non-small cell lung cancer (NSCLC) who have previously progressed after treatment with clostrini or who are resistant to cletitinib-resistant mesolytic lymphoma kinase (ALK).
is a mesolytic lymphoma kinase (ALK) inhibitor.
the new treatment options for patients with non-small cell lung cancer.
07, the State Drug Administration approved the listing and declaration company of lavidavi tablets hydrochloric acid: Goliath Biotech (Hangzhou) Co., Ltd. target / mechanism of action: NS5A inhibitors recently, the State Drug Administration approved Goliath Biotech (Hangzhou) Co., Ltd. 1 type of innovation through the priority review and approval process The drug lavidavir tablets (trade name: Xinlilai) are available, and Unilitonavir-fortified Danolive sodium tablets and libavirin are used to treat non-hepatitis C adult patients with the initial treatment of the gene 1b chronic hepatitis C virus infection and are not allowed to be treated as monotherapy.
is an NS5A inhibitor that inhibits viral RNA replication.
NS5A is a multi-functional protein that is an integral part of the HCV replication complex.
product will provide more drug options for non-cirrhosis adult patients with the initial treatment of the gene 1b chronic hepatitis C virus infection.
08, the State Drug Administration approved Zebtini capsule listing declaration company: Baiji Shenzhou (Suzhou) Biotech Co., Ltd. target / mechanism of action: BTK inhibitors recently, the State Drug Administration approved Baiji Shenzhou (Suzhou) Biotech Co., Ltd. 1 category of innovation through the priority review and approval process conditions The drug Zebutini capsule (trade name: Bai Yueze) is available for adult sleeve lymphoma (MCL) patients who have received at least one treatment in the past and adult chronic lymphoblastic leukemia (CLL)/small lymphocytic lymphoma (SLL) patients who have received at least one treatment in the past.
zebtinib is a selective inhibitor of Bruton's Tyrosine Kinase (BTK).
zebtini capsule is an innovative drug developed independently in China and has independent intellectual property rights.
offering will provide more drug options for adult patients with sleeve lymphoma, adult chronic lymphocytic leukemia/small lymphocyte lymphoma.
The State Drug Administration requires drug listing license holders to continue to complete corroical clinical studies as planned after the listing of this product.
09, the State Drug Administration approved the injection of Laroni enzyme thick solution listed declared company: Genzyme company target / mechanism of action: enzyme replacement therapy recently, the State Drug Administration through the priority review approval process approved Genzyme's injection of Laroni enzyme thick solution (commodity name Ayrezan / Aldurazyme) listed for long-term enzyme replacement therapy for patients with mucosal polysaccharide type I patients, for the treatment of non-neurological manifestations of the disease.
Mucosal polysaccharide accumulation type I (MPS I) is a rare disease of recessive genetics of the normal chromosome, caused by the lack of α-L-Adu glycosidease, which can lead to excessive accumulation of glycamine polysaccharides in all organs and tissues in the body, which can be life-threatening.
approved drug as an enzyme replacement therapy for such patients, has been included in the second batch of clinically urgent overseas listed drugs.
since the publication of the catalogue of drugs in urgent need of overseas listing, the State Drug Administration has approved the import registration of more than 30 varieties.
next step, the State Drug Administration will continue to implement the relevant requirements for deepening the reform of the drug review and approval system, and continuously speed up the listing of urgently needed clinical drugs in China to better meet the people's demand for drugs.
10, the State Drug Administration approved Sinimod tablets listed declaration company: Novartis Pharma AG target / mechanism of action: S1P regulator recently, the State Drug Administration approved Novortis through the priority review and approval process Pharma AG's declared Class 1 innovative drug Sinimod tablets (trade name: 10,000) are available to treat adult multiple sclerosis, including clinical isolation syndrome, relapse-relieving diseases, and active secondary progressive diseases.
Sinimod is an acetaminophen-1-phosphoric acid (S1P) subject regulator that selectively binds to S1P subject subtypes 1 (S1P1) and subtype 5 (S1P5) high affinity, preventing lymphocytes from escaping from the lymph nodes and reducing the number of outer blood lymphocytes.
this variety provides new treatment options for patients with multiple sclerosis, better meeting the clinical needs of patients.
11. The State Drug Administration approved the listing and declaration company of benzodiazebenzene ammonium nasal spray company: Silver Valley Pharmaceutical Co., Ltd. target/action mechanism: M1/M3 choline energy-energy antagonist recently, the State Drug Administration approved the listing of a class of innovative drug benzodiazean ammonium nasal spray (commodity name: Bilitin) to improve the symptoms of runny nose caused by allergic rhinitis.
Pharmaceutical Co., Ltd. is the licensed holder of this product.
benzoquine is a selective Mcholine-energy antagonist that may alleviate the symptoms of mutant rhinitis by inhibiting gland secretion and inflammatory responses mediated by choline-induced nerves.
ammonium bromide nasal spray is an innovative drug developed independently in China and has independent intellectual property rights.
the market to provide new drug options for patients with allergic rhinitis, better meeting the clinical needs of patients.
12, the State Drug Administration approved the listing and declaration company: Jiangsu Hausen Pharmaceutical Group Co., Ltd. target / mechanism of action: the third generation EGFR-TKI recently, the State Drug Administration through the priority review and approval process conditional approval of a class 1 innovative drug methosotini tablets (commodities) Name: Amele) is listed for use in adult patients with local late stage or metastasis non-small cell lung cancer who have been tested positive for EGFR T790M mutation in adult patients who have developed disease progression during or after treatment with the methionine kinase inhibitor (TKI) of EGFR.
, Jiangsu Haussen Pharmaceutical Group Co., Ltd. is the licensed holder of this product.
is methamphetinib as a kinase inhibitor for the skin growth factor receptor.
is an innovative drug developed independently in China and with independent intellectual property rights.
launch of this product will help improve drug access for patients with T790M-positive non-small cell lung cancer who have progressed after treatment with the first generation of EGFR-TKI, providing new drug options for non-small cell lung cancer patients.
The State Drug Administration requires drug-listed licensees to continue to complete ongoing clinical studies as planned after the product is listed.
13, the State Drug Administration approved the chronic hepatitis C treatment drug hydrochloric acid colopeve capsule listing declaration company: Beijing Kaiinger-Led Biotechnology Co., Ltd. target / mechanism of action: NS5A inhibitors recently, the State Drug Administration approved the Beijing Kaingel-Led Biotechnology Co., Ltd. 1 class of innovative drug colopevir capsules (commodity name: Kellogg) listed.
This product is used in combination with sophosphobwe to treat chronic hepatitis C virus (HCV) infection in adults with primary treatment or interferon treatment, which can be combined or not combined with compensated cirrhosis.
is an NS5A inhibitor that blocks the replication and assembly of the HCV virus by inhibiting the NS5A protein.
the listing of colopive capsules of hydrochloric acid will help to increase the access of domestic anti-HCV drugs and meet the needs of clinical drug use.
addition, the high-profile field of oncology, the innovative product "tumor electric field therapy instrument" has also been approved for the market.
is the engine of the pharmaceutical economy's continued growth, and the value of innovative medicines is expected to continue to dominate the global drug market for a long time to come.
of the 13 approved drugs approved by the NMPA in 2020, 10 are domestic innovative products, so under this tone, China's innovative drugs in 2021 will certainly be even hotter!