13 innovative drugs approved by the NMPA in 2020

▍01, State Drug Administration approved the listing of abtinib tablets Published: 2020-12-25 Target/ Mechanism of Action: BTK Inhibitors State Drug Administration approved conditional approval through the priority review and approval process Beijing No cheng Jianhua Pharmaceutical Technology Co., Ltd. declared a class 1 innovative drug abtini tablets (commodity name: Inocy) 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 the listing of phosphate Emitawe capsules Published time: 2020-12-22 target / mechanism of action: NS5A inhibitors Recently, the State Drug Administration approved Yichangdong Sunshine Changjiang Pharmaceutical Co., Ltd. declared a class of innovative drug phosphate iveway capsules (commodity name: Dongwein) listed.
This drug is an innovative drug developed independently in China and has its own intellectual property rights, phosphate ethymethamitawe capsules need to be combined with sophosphobubwe tablets for the treatment of chronic hepatitis C in adult gene type 1 non-liver hardening.
phosphate ethythamitavir 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 injections Published: 2020-12-14 target / mechanism of action: short-acting GABAA subject regulator recently, the State Drug Administration approved the 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 for anaesthetic sedatives.
this variety on the market to provide patients with new treatment options.
▍04, the State Drug Administration approved the listing of fluoroopapari capsules Published: 2020-12-14 target / mechanism of action: PARP inhibitors Recently, the State Drug Administration approved Jiangsu Hengrui Pharmaceutical Co., Ltd. declared the first class of innovative drug fluorine palli capsules (commodity name: Ari) listed.
The drug is an innovative drug developed independently in China and has independent intellectual property rights, and 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 functionally 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 listing Release Date: 2020-12-04 target/ mechanism of action: target suppression 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 into China registration.
recently, the State Drug Administration approved the import registration application for Lanalyu single anti-injection fluid.
genitive angioedema (HAE) is an endosomal explicit genetic disease, in Europe and the United States and China are considered rare diseases, nearly half of 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-exciting peptides in HAE patients.
▍06, the State Drug Administration approved the listing of Nsatini capsule hydrochloric acid Published: 2020-11-20 target/ mechanism of action: ALK inhibitors Recently, the State Drug Administration approved Bayda Pharmaceutical Co., Ltd. declaration of 1 type of innovation with conditions through the priority review and approval process The drug Nsatini 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 ketinib or who are resistant to ketamine."
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 Avidave hydrochloride tablets Published: 2020-07-31 target / mechanism of action: NS5A inhibitors Recently, the State Drug Administration approved Goli Biotech (Hangzhou) through the priority review and approval process The Company's Class 1 innovative drug Ravidavir tablets (trade name: Xinlilai) are available, and Unilitonavir-enhanced Danolive sodium tablets and libavirin, used to treat non-hepatitis C adult patients with the initial treatment of the gene 1b chronic hepatitis C virus infection, may not be treated as a single drug.
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 Published: 2020-06-03 target / mechanism of action: BTK inhibitors Recently, the State Drug Administration approved Baiji Shenzhou (Suzhou) Biotech Co., Ltd. through the priority review and approval process conditions Class 1 innovative drug Zebutini capsules (trade name: Bai Yueze) are 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 lymphoblastic 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 laroniase thick solution on the market Published: 2020-06-03 target / mechanism of action: enzyme replacement therapy Recently, the State Drug Administration adopted priority The review approval process approved Genzyme's injection-based Laroni enzyme-enriched solution (trade name Aerzan/Aldurazyme) for long-term enzyme replacement therapy in patients with mucosal polysaccharide sepsis 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 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 list of drugs listed abroad 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 Published: 2020-05-11 target / mechanism of action: S1P subject regulator Recently, the State Drug Administration through the priority review and approval procedures Approved for the launch of Novortis Pharma AG's class 1 innovative drug Sinimod tablets (trade name: 100m) 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 the high affinity of S1P subject subtype 1 (S1P1) and subtype 5 (S1P5), 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 Published: 2020-03-31 target / mechanism of action: M1/M3 choline energy antagonist Recently, the State Drug Administration approved the listing of a class 1 innovative drug, benzodiazean bromide ammonium nasal spray (commodity name: Bilitin), 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.
benzoquine is a selective M choline-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 of methyl sulfonate ametini tablets Published: 2020-03-31 target/ mechanism of action: third generation EGFR-TKI Recently, the State Drug Administration approved the first class of innovative drug methyl sulfonate Ame through the priority review and approval process conditions Tini tablets (commodity name: Ameyle) 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 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 receptor of the growth factor of the skin.
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 colopewe capsule listing Release date: 2020-02-12 target/ mechanism of action: NS5A inhibitors Recently, the State Drug Administration approved the Beijing Kaingel Biotechnology Co., Ltd. 1 innovative drug colopivir capsule (commodity name: Keli wei) 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 Date: 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 glioblastomas diagnosed by histopathology or imaging at age 22 and older, and newly diagnosed on-screen glioblastomas.
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 listing in China.