Who will be the first to break through the listing of the domestic NDA project hosted by CDE in 2020?

In 2020, although the world has been hit by the new crown virus, China is the first to suffer, but the pace of research and development of new drugs has not stalled.
domestic new drug innovation is more difficult to meet the difficulties, completed a number of heavy-weight new drug species on the market, for domestic patients to provide a better choice of clinical drug use.
for a new drug species, the harvest period to come to the important sign, that is, the NDA application for acceptance, then, in 2020 the whole of the domestic have what independent research and development of NDA varieties reported? What are the expectations of the domestic new drug market in 2021? 1, 2020 the whole year 17 varieties into the NDA stage through the CDE official website query, in 2020 a total of 17 varieties of domestic 1 new drugs into the NDA stage, variety classification to tumor, metabolism, infection as the main development direction.
development company, the largest number of NDA varieties of enterprises for Jiangsu Hengrui, a total of 3 varieties into the NDA stage, respectively, sea curvapa ethanolamine tablets, phosphate reglitin tablets, proline hengle net tablets.
addition, Hesco's NDA variety cyclophenol emulsion has been approved for the market.
PS: 2020 domestic NDA varieties profile can be found in the table below.
1.1 Domestic NDA Project hosted by CDE in 2020 (with: 2020 Representative Acceptance Number information of new domestic drug NDA varieties) 2, 2020 full year 17 NDA Variety Details According to the chronological order in which the NDA obtained the contractor, the 17 varieties are contaminated tablets, cyclophenol emulsions, ZL-2401 pairs of toluene sulfonate tablets (another dosage form - injection ZL-2401 parabens), abtinib tablets, toluene donafinib tablets, voliteni tablets, hypopapaethanol tablets, azfding tablets, Parmipali capsules, ACC00 7 tablets, amphenolamine nofowe tablets, Sovantini capsules, phosphate reglitin tablets, proline hengleni tablets, oribatin tablets, bati non-class injections, and Lebwe tablets.
the above 17 varieties are described in detail below.
NO1: Contexamine Contamin, developed by the development company for Amethyst Pharmaceuticals (an antibacterial drug focused on the discovery/development/commercial treatment of multi-drug-resistant "superbug" infections), is an oral antimicrobial antimicrobial drug designed to treat infections caused by drug-resistant bacteria such as methicillin-resistant Staphylococcus aureus and vancomycin enterococci.
the development of the variety in China received special support for "significant new drug creation" and was recognized by the FDA-granted QIDP and Fast Track in the United States.
2015, Aramco successfully completed two separate Phase II studies of contaminants in the United States and China, and phase III studies of complex skin and soft tissue infections in China in 2019.
icingazole phosphate (MRX-4) is a pre-drug for contexamine, and its oral and injection forms are planned for global development for multi-drug-resistant Terrain-positive bacterial infections.
, both contexamine and contaminant phosphate were awarded QIDP and rapid review by the FDA.
Figure 2.1 Union Medicine - Part antimicrobial drug pipeline (Photo: Union Medicine Official Website) NO2: Cyclophenol Cyclophenol (HSK3486), a new intravenous narcotic drug developed by Hesco with independent intellectual property rights, Its active ingredient cyclophenol is (R)-form isomer small molecule drug, which is a GABAA-induced astrogen, which increases the conduction of current and causes superpolarization of neurons by acting on the chlorine ion channel mediated by GABAA.
this hyperpolarization causes neural signaling to be consistent, reducing the success rate of motion likelihood, thereby suppressing the central nervous system and creating anesthesia.
cyclophenol injection overall safety tolerance is good, the drug activity is about 5 times propofol, fast and stable effective, wake up quickly and completely, injection pain rate is very low, the effect on breathing is better than propofol, the effect on heart rate and blood pressure is not inferior to propofol, lipid input is less than propofol.
December 2020, Liaoning Haisco Pharmaceutical Co., Ltd., a wholly owned subsidiary of Hesco, received the "Drug Registration Certificate" issued by the State Drug Administration and was officially approved for production.
Figure 2.2 Hesco-Small Molecular Chemicals (Photo: Hesco's official website) NO3:ZL-2401 ZL-2401, developed by Reding Pharmaceuticals in collaboration with Paratak corporation of the United States, is the first antibiotic in aminomethyl cycline compounds to effectively overcome common drug resistance mechanisms for tetrycline drugs.
the study showed that it was very active against methicillin-resistant Staphylococcus aureus, penicillin-resistant Streptococcus pneumoniae, penicillin-resistant enterococci, etc.
October 2018, ZL-2401 received FDA priority review and approval for the treatment of community-approved bacterial pneumonia and acute bacterial skin and skin structure infections.
2018, Reding Pharmaceuticals launched a briddle study with a view to shortening the time to market.
February 2020, NDA applications were accepted by China's CDE contractor.
Figure 2.3 Reding - Anti-infection and autoimmune development varieties (Photo source: Reding Pharmaceuticals Official Website) NO4: Abtini Abtini, the development company for Noshing Jianhua, is a highly selective new BTK inhibitor for the treatment of lymphoma and autoimmune diseases, and access to the country's major new drug creation project support.
currently, two adaptive listing applications for CLL/SLL and MCL patients have been included in the CDE's priority review.
PS: No cheng Jianhua, focusing on malignant tumors and autoimmune diseases in the field of treatment of a new class of drugs, suitable for Chinese patients with high incidence of lymphoma, liver cancer, stomach cancer and other malignant tumors and autoimmune diseases.
company has branches in Beijing, Nanjing, Shanghai, Guangzhou, New Jersey and Boston.
Figure 2.4 Noshing Jianhua - Product Pipeline (Photo Source: Noshing Jianhua Official Website) NO5: Donafini toluene sulphate donafinib, development company for Zetsin Pharmaceuticals, the NCE nature of the variety is "Tsedesorafini", by inhibiting the Raf family's serine-suminine Enzymes cascade downstream with the classic Raf/MEK/ERK signaling pathline that directly inhibits the proliferation of tumor cells, and indirectly inhibits the growth of tumor cells by inhibiting the activity of tyrosine kinases, a variety of subjects such as VEGFR and plate-derived growth factors (PDGFR).
Pharmaceuticals owns the independent intellectual property rights of the variety, and it is worth noting that although the variety is not listed, but has entered the domestic treatment guide! At the same time, other cancers such as advanced rectal cancer, thyroid cancer, stomach cancer, esophageal cancer, nasopharyngeal cancer, non-small cell lung cancer and other clinical trials are in progress.
Figure 2.5 Zetam Pharmaceuticals-Donaphini Clinical Progress (Photo Source: Zeitone Pharmaceuticals Official Website) NO6: Volitini Volitini (Sevotini, Savolitinib), developed by the development company and Huang Pharmaceuticals, is a powerful selective MET inhibitor, met is an enzyme that has been shown to behave abnormally in many solid tumors.
is designed to address the nephrotoxicity associated with human metabolites, which is the main cause of the development of other selective MET inhibitors.
To date, 1,000 patients have participated in clinical trials, and Sevoltini has also shown better clinical efficacy and acceptable safety in patients with non-small cell lung cancer, pap nipple renal cell carcinoma, colorectal cancer and stomach cancer with metocytes of the MET gene mutation.
is currently working with AstraZeneone Global to test the efficacy of Sevotini as a single-drug treatment as well as combined immunotherapy and other targeted therapies.
Figure 2.6 and the clinical progression of yellow medicine-volitini (photo source: and yellow medicine official website) NO7: hypopharmic ethanolamine hypoptopaethanolamine, developed by Jiangsu Hengrui, is an oral absorption of small molecules of non-peptide-promoting platealine-producing hormone (TPO-R) astigtor, which is effective and safe in adult immunocompetitive plate reduction patients.
, compared with placebo, the variety can effectively improve plate count, reduce the risk of bleeding, and show no significant liver toxicity.
Based on the results of phase III clinical studies in adult ITP patients, Hengrui Pharmaceuticals plans to conduct phase III clinical studies on the safety and effectiveness of chronic ITP patients in children and adolescents, and is expected to be used in children and adolescent patients for a long time, without affecting children's growth and development, and is easy to use orally, improve drug compliance, have obvious therapeutic advantages, and can fill the treatment gap in children aged 6-11 years.
Figure 2.7 Jiangsu Hengrui - Innovative Drug Part of the Information (Photo Source: Hengrui Pharmaceutical Website) NO8: Azfding Azfding (FNC), a development company for real life, is the world's first HIV retrovirase and auxiliary protein Vif dual-target inhibitor drug, the first anti-HIV oral drug with independent intellectual property rights, access to the national "major new drug creation" technology major project support.
if Azfding is successfully listed, it will become the first oral anti-HIV class 1.1 drug with independent intellectual property rights in China, which will make a significant contribution to the treatment and prevention of AIDS in China.
PS: Real life owns the drug's own intellectual property rights.
phase I clinical approval was obtained in April 2013 and Phase II clinical trials were conducted in 2016-2019.
clinical studies showed that the oral dose of Azfding was extremely small (only 1 percent of the amount of ramif), and the concentration of FNC-TP was still higher than that of half of the virus after 5 days of use.
its low-dose, multi-target, long-acting oral, and has the advantages of 100% inhibition of HIV replication more than 4 days after drug use, it is expected to become the first choice for future pre-exposure prophylaculation.
December 2019, Azfding held a Phase III. Clinical Symposium to say that in mid-2019 CDE had agreed to the early declaration of Azfding's Phase II clinical trial results.
2.8 Chinadrugtrials Registered Azfding Clinical Project (Photo: Drug Clinical Trial Registration and Information Disclosure Platform) NO9: Pamipali Pamiparib (BGB-290), The development company, Baiji Shenzhou, is a small molecule inhibitor in PARP1 and PARP2, and is currently conducting a key clinical trial in China of pamiparib as a single drug for platinum-sensitive ovarian cancer maintenance therapy and BRCA embryonic mutation ovarian cancer.
Baiji Shenzhou's product pipeline includes oral small molecule preparations and monoclonal antibody anti-cancer drugs, the company is committed to the development of cancer patients with valuable and long-term effects of joint therapies;
Figure 2.9 Baiji Shenzhou-Pamipali Clinical Progress (Photo: Baiji Shenzhou Official Website) NO10:ACC007 ACC007, developed by Jiangsu Eddy Pharmaceuticals, is a non-nucleoside retrovirase inhibitor that prevents viral transcription and replication by non-competitive binding and inhibition of HIV retrovirase activity.
AC007 has now completed Phase III clinical trials, the test results are good, reached the main clinical endpoint indicators, ACC007 and control group are not inferior to each other, in adverse reactions, especially the occurrence of various types of neurological and psychiatric adverse events, ACC007 is better than the control group.
Table 2.10 Clinical Stage Varieties of Jiangsu Eddy Pharmaceutical Co., Ltd. (Source: Eddie Pharmaceuticals Official Website) NO11: Amphenolamine Nofove HS-10234, Development Company for Jiangsu Haussen, I Nucleoside retrovirase inhibitors, a new generation of monophosphamide monoesters, are very stable in plasma and therefore provide a new type of tynofovir pre-drug that improves efficacy while reducing toxicity and side effects.
September 2020, Howson Pharmaceuticals filed a market application for a new class of drugs, Amephenol amine nofowe tablets, to be included in the priority review for treatment in adult patients with chronic hepatitis B.
PS: This variety is a major new drug creation project.
of the study showed that 25 mg of HS-10234 tablets and 300 mg of tinofovir dipyride (TDF) antiviral activity were equivalent.
same time, the prospectus shows that Howson holds a patent for HS-10234 compounds, which expire in 2033.
December 2018, Howson launched HS-10234 multi-center Phase III clinical treatment for the sexuality and sex of chronic hepatitis B, primarily to evaluate the sex and treatment of the new drug in the study compared to fumaric acid novovotalfide (TDF), which took five years from approval to filing a listing application.
Figure 2.11 Amphenolamine Nofovir - Domestic Clinical Registration Data (Photo Source: Drug Clinical Trial Registration and Information Disclosure Platform) NO12: Surufatinib, Development Company and Yellow Medicine, is a selective inhibitor of tyrosine kinase activity associated with endothoste growth factor and fibroblast growth factor subjects and The oral candidate drug for the set-up stimulation factor-1-1000 (CSF-1R); the fibroblast growth factor-in-the-form (FGFR) is a protein that works in tumor growth, and the set-up stimulation factor-1-1R is involved in blocking the signaling path of tumor-related macrophage activity, which protects cancer cells from T-cells.
, the company is conducting clinical trials in several disease areas, such as pancreatic and non-pancreatic neuroendocrine tumors and bile tube cancers, and retains all rights to Sovantinie worldwide.
is Hutchison Whampoa Pharmaceuticals' first cancer candidate to independently complete a concept validation trial in China and expand to the United States for clinical research.
2.12 and the clinical progress of Huang Medicine-Sovantini (Photo Source: and Huang Pharmaceuticals Official Website) NO13: Rigletin Reglitin, development company for Jiangsu Hengrui, is its