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    Home > Active Ingredient News > Digestive System Information > Discover new drugs! In 2020, China has approved 13 funds

    Discover new drugs! In 2020, China has approved 13 funds

    • Last Update: 2021-03-10
    • Source: Internet
    • Author: User
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    Back in 2020, China's State Drug Administration (NMPA) approved 13 innovative drugs.
    13 approved drugs, 10 domestic innovative products, so the tone of China's innovative drugs in 2021 will certainly be even hotter! 13 approved drugs: (1) Access to this health insurance has 4 Kain Technology's hydrochloric acid colo - the only hepatitis C drug in this health care negotiations to enter health insurance Haussen Pharmaceuticals Amethini - the world's second approved three-generation EGFR-TKI drug, direct VS AstraZeneur's Oishitini (Terisha) Novartis multiple sclerosis oral drug Sinimod - achieved a global simultaneous listing, and Novartis this time into the seven, ranked in the multinational pharmaceutical company Top1 Hundred Jesinta Zebtini - the first approved Chinese-made BTK Inhibitors (2) Multinational pharmaceutical companies approved 3 May 7, Novartis approved multiple sclerosis oral drug Sinimod June 3, Sanofi approved rare disease drug Laroni enzyme thick solution, the world's first and currently the only MPSI. treatment Special effects drug December 4, Takeda approved the rare disease drug Ranaliyu monoanti, is the world's first long-term prevention treatment for HAE monoclonal antibody 1 Kain technology approved hepatitis C drug is the only health care negotiations into the health care negotiations of hepatitis C drugs just ended, Among the hepatitis C drugs, Kain Technologies' colo-pai veli pressed Gilead's two older hepatitis C drugs, making it the only hepatitis C drug to enter the health care negotiations.
    technology broke the monopoly of foreign enterprises on domestic hepatitis C treatment drugs, to achieve import substitution.
    hydrochloric acid colopavir is a hepatitis C virus unstructured protein 5A (NS5A) inhibitor, which is used in association with sophosphobwe to treat chronic hepatitis C virus (HCV) infection in adults treated with primary or interferon.
    hydrochloric acid colopavir is a hepatitis C virus unstructured protein 5A (NS5A) inhibitor that greatly interferes with HCV replication.
    the drug was approved for sale by NMPA on February 12 this year.
    Technology is a biopharmaceutical company based on biotechnology focused on viral diseases.
    based on the production and sale of therapeutic drugs in the field of existing viral diseases, while actively carrying out research and development of innovative drugs.
    product line, at present, Kain Technology's existing products listed for sale mainly include recombinant human interferon alpha2b: Kayne probiotics ®, Jin Shuxi® compound glyphosate drug: Kainganle ®, glycerin Howson ® Pharmaceuticals, the world's second approved three-generation EGFR-TKI drug to be approved for the third-generation EGFR-TKI drug, is a strong competitor to AstraZeneone's Ogishini.
    AstraZeneta's Oghitini was included in Category B two years ago, the only three-generation EGFR-TKI drug previously included in China's health insurance.
    is the world's second approved third-generation EGFR-TKI drug after AZ Oghidini.
    the health-care talks, Amethini cut prices by another 64%, at 3,520 yuan per box, equivalent to 82% in a year.
    the drug was approved for sale by NMPA on March 31 today.
    is used in adult patients with local late stage or metastasis non-small cell lung cancer (NSCLC) who have been tested positive for EGFR T790M mutations during or after treatment with the treatment of the mesothionine kinase inhibitor (TKI).
    Today's Haussen realization of nitroquine, fluoromatininib, ametinib, polyethyl glycol locena peptide 4 class 1 innovative drugs were approved for market, 30 generic drugs with the first imitation, copy approval, forming the central nervous system, anti-tumor, anti-infection and diabetes four advantages of treatment areas.
    in building domestic innovative pharmaceutical enterprises at the same time, Howson takes into account the quality of production and international standards.
    since 2012, Howson's Changchun Ruibin injections, Gissithamin injections, and Aitibant injections have been approved by the U.S. FDA for listing.
    Silver Valley Pharmaceuticals approved phenylcycical ammonium bromide nasal spray on March 31, NMPA announced the approval of Silver Valley Pharmaceuticals Class 1 innovative drug benzodiazebenzene nasal spray (trade name: Bilitin) to improve the symptoms of runny nose, nasal congestion, nasal itching and sneezing caused by allergic rhinitis.
    Silver Valley Pharmaceuticals is an innovative pharmaceutical company engaged in innovative drug research and development, chemical (raw materials, injections, nasal spray) production, new drugs national sales market development and sales of innovative pharmaceutical companies.
    products currently on the market include salmon calcitonin injections (Gutaining) and their nasal sprays (Kinli).
    Novartis won the wholesale sclerosis drug the world's first to make progress on the disease of multiple patients to achieve neuroresurgery, delay the progress of disability oral DMT drug this time into health insurance also Novartis multiple sclerosis oral drug Sinimod (commodity name: Universal) Novartis this time into 7 health insurance, ranked in the multinational pharmaceutical company Top1.
    May 7, Novartis' new generation of multiple sclerosis oral drug Sinimod was approved in China on May 7th, achieving a simultaneous global launch.
    it has a dual mechanism: on the one hand, it can prevent lymphocytes from entering the central nervous system of MS patients, play an anti-inflammatory role, on the other hand, it can directly play a role in the central nervous system to promote myelin regeneration to provide nerve protection.
    Sanofi was approved as a rare disease drug on June 3, NMPA announced the approval of Sanofi's injection-based Laroniase thick solution, a long-term enzyme replacement therapy for patients with mucosal polysaccharide sepsis type I. for the treatment of non-nervous system manifestations of the disease.
    (MPS) is a rare genetic disease that has been included in China's First List of Rare Diseases.
    he quit diabetes, Sanofi's ace product Lanuts is once again on a patent cliff, focusing on immune inflammation, vaccines, and rare diseases.
    in the multi-plate pull, back to a game, offsetting most of the impact.
    2020, Sanofi China is shifting its focus to its specialist drug portfolio.
    is also the only rare disease drug approved in China this year.
    , Baiji Shenzhou approved anti-cancer drugs this time Baiji Shenzhou Zebutini (commodity name: Bai Yueze) also entered health insurance.
    the pre-negotiation price was 176.6 yuan/80mg/granules, and the annual treatment cost of the adaptation was 258,000 yuan.
    , Zebtini is the first Chinese-made BTK inhibitor to be approved.
    it is characterized by maximizing the specific binding of BTK targets, thereby minimizing the toxic side effects of off-target effects.
    June 3, NMPA announced conditional approval of the listing of Zebutini capsules, a class 1 innovative drug in Baiji Shenzhou, for the treatment of adult patients with chronic lymphoblastic leukemia/small lymphocyte lymphoma.
    currently, Zebtini's biggest competitor in Baiji Shenzhou is the Johnson/AbbVie jointly developed Ibtini, the world's first domestic BTK inhibitor, which was approved in China in August 2017.
    then entered the 2017 National Health Insurance Category B directory through negotiations, with a winning bid of 189 yuan/140 mg/granules and an annual treatment cost of 207,000 yuan for CLL/SLL.
    Geli was approved for hepatitis C drugs this time the health care catalog negotiations, unfortunately Goliath 1 innovative drug avidave tablets (commodity name: Xinlilai) failed to win the bid.
    July 31, NMPA announced the approval of the goliathic acid Ravidavir tablets, combined with danolive sodium tablets and libavirin, for the treatment of non-hepatic cirrhosis adult patients with the initial treatment of the gene 1b chronic hepatitis C virus infection.
    as China's domestic hepatitis C new drug legion, its payment price has also become the focus of attention.
    , many hepatitis C patients are located in underdeveloped areas, the pricing of hepatitis C drugs is of great significance to them.
    , this health insurance gift did not enter the health insurance catalog as expected, the future of its new Lilai commercial road is not easy! Bayda Pharmaceuticals was approved for anti-cancer drugs on November 20, NMPA announced conditional approval of Beda Pharmaceuticals' Class 1 innovative drug Nsatini capsule hydrochloride (trade name: Kemina) for the treatment of patients with locally advanced or metastatic non-small cell lung cancer.
    its listing broke the domestic ALK-positive non-small cell lung cancer targeted treatment drugs are imported drugs monopoly situation.
    So far, in addition to Beda Pharmaceuticals' Nsatinib, there are three approved ALK inhibitors listed in The Nation, namely Pfizer's kerotinib (commodity name: Secori), and in October 2018 the National Cancer Drug Negotiations entered The National Health Insurance Category B at an annual cost of 16-190,000; In October 2018, the National Cancer Drug Negotiations entered the National Health Insurance Category B, with an annual cost of 217,000 after the price reduction; Roche's Aledini (commodity name: Ansanza), a 70% drop into the 2019 National Health Insurance Category B list, the price from 49,980 yuan a box to 15,235 yuan a box.
    1358 yuan/bottle (specs: 25mg x 7 capsules/bottle) and 7644 yuan/bottle (size: 100mg x 14 capsules/bottle) for the end price of ensarini capsules (commodity name: Bemena).
    advantage over the other three foreign companies, but there was no chance of health care negotiations this year because of the late approval of Beda Pharmaceuticals' Nsatini.
    However, some analysts said that with its outstanding efficacy and the price advantages of domestic innovative drugs, next year's dynamic adjustment of the health care catalog, it will be one of the heavyweights in the health care negotiations, is expected to achieve rapid release through health care.
    On December 4th, NMPA announced the approval of the launch of the Lanadelumab (trade name: Dazeyou) injection for the treatment of rare genetic diseases of hereditary angioedema (HAE).
    the drug was approved in the U.S. in 2018, making it the world's first monoclonal antibody for HAE long-term preventive treatment.
    The drug is one of Takeda's rare diseases, and its rare disease business is divided into three sub-businesses, namely, hematology rare disease drugs, metabolic rare disease drugs, and hereditary angioedema drugs.
    Takeda merged with Shire, it has focused on five main areas: digestion, rare diseases, blood products, oncology, neuroscience, and the growth is largely due to the acquisition of Shire.
    only one new drug has been approved in China by 2020, referring directly to rare diseases.
    can see that Takeda "digested" Shire, began to formally enter the domestic rare disease market.
    Hengrui was approved for anti-ovarian cancer drugs on December 14, NMPA announced conditional approval of Hengrui Pharmaceuticals heavy class 1 new drug fluorine Pali capsules on the market.
    the drug is the first PARP inhibitor independently developed by domestic enterprises, used to treat patients with relapsed ovarian cancer who have underwent second-line and above chemotherapy with BRCA1/2 pathogenic or suspected pathogenic mutations.
    data, there are currently four PARP inhibitors on the market worldwide: AstraZeneca's Olapali, GSK's Nirapali, Pfizer's Razopali, and Clovis's Lukapali.
    Olapali and GSK Nirapali have been approved for domestic listing in 2018 and 2019 respectively.
    note that AstraZeneta's Olapali global sales have grown year-on-year to $1,642 million in 2019, up 94.8% year-on-year, with great market potential.
    in China, it cut its price by 61.8% in the 2019 health care negotiations to enter The Health Insurance Category B list, with a medicare payment rate of 169.00 yuan (150 mg/piece).
    he was approved at this time fluorine Pali capsules are undoubtedly under great pressure, however, Hengrui has carried out 26 clinical studies against fluorine Pali.
    the disease involves small cell lung cancer, solid tumor, relapsed metastatic triple yin breast cancer, prostate cancer, relapsed ovarian cancer, advanced stomach cancer and so on.
    , 15 clinical trials are still in the process, including 4 Phase III clinical trials.
    Haisco Pharmaceuticals was approved as an anaesthetic on December 14, NMPA announced the approval of Hesco Pharmaceuticals Class 1 innovative drug cyclophenol injections (trade name: Sisshuinen) for the diagnosis and treatment of sedatives and/or anesthesia in the digestive tract endoscopy.
    this is the first innovative intravenous anesthetic drug developed by Hesco Pharmaceuticals in China over an eight-year period, and the first new Class 1 drug approved for sale by Hesco Pharmaceuticals.
    , the drug is currently registered in China for 20 Phase I-III clinical studies, of which 16 have been completed and 4 are in progress.
    's adaptations include painless endoscopy sedation and/or anesthesia (NDA declaration), general anaesthetic induction (NDA declaration), sedation and/or anesthesia (Phase III), general anaesthetic induction and maintenance (Phase III), ICU sedation (Phase III), etc.
    the main market for the drug is owned by Fessen Yuscabi, and only Jiangsu Yingke Biopharmaceuticals and Colum Pharmaceuticals have been evaluated consistently in China.
    estimates that its domestic market size is expected to exceed 3 billion yuan.
    approved for the market and is expected to have an impact on the existing market for propofol.
    East Sunshine Pharmaceuticals was approved for hepatitis C on December 22, NMPA announced that it has approved Dongsun Pharmaceuticals' Class 1 innovative drug phosphate emitavir capsules (trade name: Dongweien) to be listed in a joint use with Sophos Buwe (an NS5B polyester nucleoside inhibitor) tablet for the treatment of chronic hepatitis C in adult genotropine type 1 non-hepatitis 1.
    is one of the first chinese companies to successfully develop and successfully market a new drug DAA (hepatitis C virus drug).
    East Sunshine Pharmaceuticals is a Chinese pharmaceutical company focusing on the development, production and sale of products in the fields of antiviral, endocrine and metabolic diseases and cardiovascular diseases, producing, promoting and selling a total of 33 pharmaceutical products in China.
    Noshing Jianhua was approved to treat lymphoma after Baiji Shenzhou on June 3, approved Zebutini capsules, becoming the first approved Chinese-made BTK inhibitor.
    December 25, NMPA announced the approval of Novartic's innovative class 1 drug, Aubtini, to be marketed for the treatment of patients with lymphoma.
    this is the second BTK inhibitor approved by the NMPA this year.
    , 4 BTK inhibitors have been approved worldwide.
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