Norte Bio 688076: Bareketinib + injectable thymus method + new crown drug research and development
Hanyu Pharmaceutical, injected thymus Faxin + new crown drug research and development, in just one month has doubled! 688076 Notai Biologics, injecting thymus thymus + new crown drug research and development, is still at a low level!
Nuotai Bio is a market-oriented, R&D innovation-driven, focusing on the research and development, production and sales of peptide drugs and small molecule chemical drugs. The company is committed to solving the technical bottlenecks in the process of drug research and development and production through technological innovation, optimizing the process path, building a whole industrial chain from advanced pharmaceutical intermediates, APIs to preparations, and providing high-quality, efficient, green and low-cost pharmaceutical products and services for the global market.
At present, the formation of CDMO / CMO + high-end generic drugs + innovative drugs three-engine drive of a good pattern, Hangzhou branch is a small molecule CDMO / CMO-based, is the main source of the company's profits, in full production, service enterprises include the United States Incyte (Incyte), the United States Gilead (Gilead), Germany Boehringer Ingelheim (Boehringer Ingelheim), the United States Forte Pharmaceutical (Vertex), frontier biology, Zoetis and dozens of well-known innovative pharmaceutical companies at home and abroad. Lianyungang headquarters is based on peptide imitation and innovative drugs, has built a rich product pipeline, completed the research and development layout of 18 kinds of generic drug APIs and preparations.
The innovative drug part is the new drug research and development team led by the experts of the "Hundred Talents Plan" of the Chinese Academy of Sciences and the backbone of Dr. Liu mei, and the polypeptide anti-new coronavirus drugs will be laid out in 2020. The direction is 3CL protease inhibitor, Pfizer with the same target.
The company takes the novel coronavirus master protease as the target, uses Q-exactive to sequence the substrate peptide of the master protease, replaces the amide bond of the enzyme cutting point with heterozygous bond Q (CH2NH), etc., and designs and screens out the polypeptide candidate drug with high inhibitory activity; establishes an in vitro screening model for the selection of the polypeptide candidate drug by FRET technology and analyzes the activity of the inhibitory viral master protease of the candidate drug by fluorescence analysis, and screens out the highly efficient novel coronavirus master protease inhibitor drugs.
Upstream APIs of balecotinib
Barritinib, also known as barictinib, baricitinib (trade name Olumiant) is a Janus kinase (JAK) 1 and JAK2 inhibitor developed by Eli Lilly and Insett Pharmaceuticals.
On November 19, 2020, Eli Lilly and INCYTE jointly announced that the U.S. Food and Drug Administration (FDA) approved Eli Lilly Pharmaceuticals Barritinib's EUA (Emergency Use Authorization) for use in conjunction with remdesivir for use in adult inpatient patients, children aged 2 years and older who are suspected or laboratory-confirmed cases of Coronavirus Disease 2019 (COVID-19) and require supplementary oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation ( ECMO)。
Noitex Bio is the upstream API of baretinib, and with baretinib being urgently authorized for the treatment of the new crown virus, the demand will grow explosively, and the company will continue to benefit.
Not only that, Insite, including Gilead, is also the main customer of Norte Biotech.
The company is developing a number of new crown therapeutic drugs, with the main protease as the target of anti-new crown virus peptide innovation
Pfizer COVID-19 Oral Drug FDA Approved for Marketing (3CL Protease Inhibitor)
Current status of domestic 3CL protease inhibitors
Peptide anti-coronavirus drugs (3CL protease inhibitors, Pfizer co-targets)
Peptide innovative drugs is the company's future development direction, the company set up a new drug research and development team led by the "Hundred Talents Program" of the Chinese Academy of Sciences, Dr. Liu Mei as the backbone, adhere to the international vision, high starting point investment, keep up with the global industry science and technology frontier, to GLP-1/GIP/GCG receptor single target and multi-target agonist hypoglycemic weight loss Jiangsu Nuotai Aosano Biopharmaceutical Co., Ltd. drugs, peptide anti-coronavirus drugs, polypeptide targeted anti-tumor drugs as the research direction, and actively promote the research and development layout of innovative drugs.
At present, there is no specific drug for the new coronavirus pneumonia on the market, on January 10, 2020, the Wuhan Institute of Disease And Toxicology of the Chinese Academy of Sciences first determined the whole genome sequence of the new type of coronavirus virus (SARS-CoV-2) and shared it with the world, which provided important resource support for pharmaceutical companies to develop related therapeutic drugs.
The novel coronavirus genome encodes a master protease (3CLpro) that plays a key role in viral replication, and the development of inhibitors targeting master proteases is an effective way to develop related drugs. With the advantages of drug design and development accumulated in the field of polypeptide drugs and the synthesis of polypeptides and small molecules, the company aims at the three monomer domains of the main protease of the new coronavirus, transforms the "deformation key" theory through the amide bond transformation of the enzyme cutting site, and converts the substrate peptide into a master protease inhibitor for drug development to develop targeted innovative drugs for the treatment of new coronavirus pneumonia.
The company's peptide new drug research and development team plans to use Q-exactive to sequence the substrate peptides of the master protease, replace the amide bonds of the enzyme cutting point with heterozygous bonds Q (CH2NH), etc., and design and screen out the peptide candidates with high inhibitory activity, using FRET technology to establish an in vitro screening model for the screening of the peptide candidates and use fluorescence analysis to analyze the activity of the inhibitory viral master protease of the candidate drugs. Screening for highly effective novel coronavirus master protease inhibitors.
Hanyu Pharmaceutical is also a new champion drug for peptide nasal spraying
Antiviral generic drugs (oseltamivir combination)
Oseltamivir is recognized globally as one of the most effective influenza drugs, and has been confirmed to be effective after a combination of oseltamivir and lopinavir/ritonavir in a few clinical cases of novel coronavirus infection.
The company makes use of the R & D technology advantages of the whole industry chain, independent research and development, production of APIs and preparations, has completed the verification of the production of APIs, the verification production of multiple batches of oseltamivir capsules, comprehensive pharmaceutical comparative research results show that the quality of the original research agent is consistent, and the BE test will be launched in the near future.
Nuotai Bio said that the anti-new coronavirus polypeptide innovative drug targeting protease is still in the stage of polypeptide design and synthesis, and the follow-up needs to undergo preclinical studies such as in vitro activity screening and primate safety evaluation, and there is uncertainty about whether it can be approved for clinical trials and whether there will be enough patients to carry out clinical trials at that time. At the same time, in the generic drug project of oseltamivir, it is also necessary to go through BE testing, drug registration declaration and approval, and there is uncertainty about the time for the product to be approved and listed.
The thymus can be used to fight the new crown virus
The company's independent research and development and production of the fully synthetic, high-purity injection of the thymus Faxin has been in November 2019 to obtain the drug registration approval issued by the State Drug Administration, the dosage form is an injection, the specification is 1.6mg, the drug approval number: National Pharmaceutical Quasi-word H20193335, and in December 2019 passed the GMP inspection of the Jiangsu Provincial Food and Drug Administration, the product has been listed in batches of batch production samples, which can be used to resist the new coronavirus epidemic and enhance the immunity of the human body.
The new thymus method is often used clinically for the treatment of chronic viral infections, tumors and adjuvant therapy of immunodeficiency patients, as well as a vaccine enhancer, and has a wide range of application value in hepatitis B, hepatitis C, cancer, immunodeficiency and other diseases. Based on the new immunomodulatory function of the thymus method, it is widely used in the prevention and control of the new coronavirus pneumonia epidemic, in the absence of specific drugs, prospective or targeted to patients or susceptible populations to give immune enhancers thymus macrosyn, remodeling normal in vivo immune function has great clinical significance for the prevention and treatment of infection.
II. Summary
The company makes use of the R & D technology advantages of the whole industry chain to independently develop and produce APIs and preparations. There are three products in terms of COVID-19 treatment:
- Noitex Bio produces the upstream API of baretinib, and then baretinib is urgently authorized to be used in the treatment of the new crown virus, the demand will increase explosively, and the company will continue to benefit.
2. Anti-coronavirus peptide innovative drugs targeted by master proteases;
3. Oseltamivir antiviral generic drugs;
4. The company's independent research and development and production of the fully synthetic, high-purity injection of the thymus method has obtained the drug registration approval issued by the State Drug Administration in November 2019, and in December 2019 passed the GMP inspection of the Jiangsu Provincial Food and Drug Administration, the product has been listed in batches of mass production samples, which can be used to resist the new coronavirus epidemic and enhance the immunity of the human body.
Attached company detailed product line:
1. Among the company's CDMO projects, 16 projects are already in the commercialization stage, 16 projects are in the clinical phase III, and more than 30 projects are in the clinical phase II and the previous stage, forming a well-structured product echelon.
2. The drugs independently selected by the company are mainly used in the treatment of diabetes, cardiovascular diseases and tumors. Up to now, the company has laid out 18 kinds of generic API products. Among them, the API products that have been registered at home and abroad are as follows:
3. The main varieties of the company:
Up to now, the company has completed the research and development layout of 18 kinds of generic drug APIs and preparations. In terms of preparations, the company's injection of thymus faxin, alogliptin benzoate tablets have obtained registration approval, of which the injection of thymus faxin has been sold, etibalide injection, oseltamivir phosphate capsules are under review and approval by the State Food and Drug Administration. In terms of APIs and intermediates, during the reporting period, the company's many varieties of APIs and intermediates have been sold, supporting the formulation research and development or registration declaration of downstream formulation manufacturers, of which the varieties with large sales revenue include liraglutide, fulvestrant, oseltamivir phosphate, lanripeptide acetate and etibalide.
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