13 innovative drugs approved by the NMPA in 2020

From: NMPA Website Editor: Dandelion-Yu Xuan▍01, State Drug Administration approved the listing of abutinib tablets Release Date: 2020-12-25 Target/Action Mechanism: BTK Inhibitor National Drug Administration Adopts Priority The review and approval procedure is conditional on the approval of Beijing No cheng Jianhua Pharmaceutical Technology Co., Ltd. declared a class 1 innovative drug Aubutini tablets (commodity name: Inokai) listed for treatment: (1) adult suite lymphoma (MCL) patients who have received at least one treatment in the past.
(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 the listing of phosphate Emitawe capsule release date: 2020-12-22 target / mechanism of action: NS5A inhibitors recently, the State Drug Administration through the priority review and approval process approved YichangDong Sunshine Changjiang Pharmaceutical Co., Ltd. declared a class of innovative drug phosphate ethythamitawe capsules (commodity name: Dongwein) 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 listing of cyclophenol injection time: 2020-12-14 target / mechanism of action: short-acting GABAA subject regulator recently, the State Drug Administration through the priority review and approval process approved Liaoning Haisco Pharmaceutical Co., Ltd. declared a class of innovative drug cyclophenol injection (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 time: 2020-12-14 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 Pali capsules (commodity name: Ari) 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, Ranaliyu single anti-injection was approved for market release time: 2020-12-04 target / mechanism of action: targeted inhibition of plasma 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 of Nsatini capsule hydrochloric acid release date: 2020-11-20 target / mechanism of action: ALK inhibitors recently, the State Drug Administration through the priority review and approval process conditional approval of Beda Pharmaceutical Co., Ltd. declared a class 1 innovative drug Ensartini capsule hydrochloric acid (trade name: Bemena) is 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 have tested positive for terroid lymphoma kinase (ALK).
is a mesolytic lymphoma kinase (ALK) inhibitor.
this variety offers new treatment options for patients with non-small cell lung cancer.
▍07, the State Drug Administration approved the listing of hydrochloric acid Ravidavi tablets Release Date: 2020-07-31 target / mechanism of action: NS5A inhibitors recently, the State Drug Administration approved Goli Biotech (Hangzhou) Co., Ltd. through the priority review and approval process1 The innovative drug Avidavir tablet hydrochloride (trade name: Xinlilai) is available, and Unilitonavir-enhanced 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 capsules listed release date: 2020-06-03 target / mechanism of action: BTK inhibitors recently, the State Drug Administration through the priority review and approval process conditional approval of Baiji Shenzhou (Suzhou) Biotech Co., Ltd. Class 1 The innovative drug Zebutini capsule (trade name: Bai Yueze) is available for patients with adult sleeve lymphoma (MCL) who have received at least one treatment in the past and adult patients with chronic lymphocytic leukemia (CLL)/small lymphocyte lymphoma (SLL) 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 on the market Release Date: 2020-06-03 target / mechanism of action: enzyme replacement therapy recently, the State Drug Administration through priority review and evaluation The approval process approved Genzyme's injection of Laroniease thick solution (the trade name Aerzan/Aldurazyme) for long-term enzyme replacement therapy in patients with mucosal polysaccharide storing disorder Type I for the treatment of non-nervous system manifestations of the disease.
Mucosal polysaccharide accumulation type I (MPS I) is a rare disease of recessive inheritance of the normal chromosome, caused by the lack of α-L-Adu glycosidease, which can lead to excessive accumulation of glycosamine 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 overseas listed drugs in urgent clinical need, 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 the listing of Sinimod tablets Release Date: 2020-05-11 target / mechanism of action: S1P regulator recently, the State Drug Administration approved Nova through the priority review and approval process The Class 1 innovative drug Sinimod tablets (trade name: 100m) declared by Rtis Pharma AG are available for the treatment of 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 of benzodiaquine ammonium nasal spray release date: 2020-03-31 target / mechanism of action: M1/M3 choline energy regulatory antagonists recently The State Drug Administration approved the listing of a class 1 innovative drug, benzodiazean bromide ammonium nasal spray (commodity name: bilitin), through a priority review and approval process to improve the symptoms of runny nose, nasal congestion, itchy nose and sneezing caused by allergic rhinitis.
Pharmaceutical Co., Ltd. is the licensed holder of this product.
benzodiaquine 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.
this variety to provide patients with allergic rhinitis with new drug options, to better meet the clinical needs of patients.
▍12, the State Drug Administration approved the listing of methyl sulfonate ametinib tablets Release Date: 2020-03-31 target / mechanism of action: third generation EGFR-TKI recently, the State Drug Administration through the priority review and approval process conditional approval of a class 1 innovative drug methyndinib Tablets (trade name: Amell) are available for use in adult patients with local late stage or metastasis non-small cell lung cancer who have been treated with or after treatment with the skin growth factor inhibitor (EGFR) tyrosine kinase inhibitor (TKI), and have been tested and confirmed to be positive for EGFR T790M mutation.
, 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 colopawe capsule listing release date: 2020-02-12 target / mechanism of action: NS5A inhibitors recently, the State Drug Administration approved the Beijing Kaingel-Led Biotechnology Co., Ltd. 1 innovative drug kelopway capsule (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.
▍14, tumor electric field treatment instrument products were approved for market release: 2020-05-14 recently, the State Drug Administration after review, approved Novokule Co., Ltd. production of innovative products "tumor electric field treatment instrument" registration.
the product consists of an electric field generator, an electric field patch, a power adapter, a battery, a battery charger, a connecting cable box, and an option.
is suitable for relapsed on-screen glioblastoma and newly diagnosed on-screen glioblastoma diagnosed by histopathology or imaging at the age of 22 and above.
this product is the first medical device to use electric field to inhibit the principle of cell division, and to inhibit the filamentation process of tumor cells through the cross-change electric field, so as to achieve the inhibition effect of glioblastoma.
has not yet approved similar products for domestic listing.