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    Home > Active Ingredient News > Drugs Articles > Domestic hypertension drugs have been approved, and this product is expected to be declared and listed in 2023

    Domestic hypertension drugs have been approved, and this product is expected to be declared and listed in 2023

    • Last Update: 2022-10-02
    • Source: Internet
    • Author: User
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    【Pharmaceutical network product information】Hypertension is a chronic disease of increased arterial blood pressure, with the intensification of aging, the number of hypertension patients in China is becoming more and more large, and the demand for antihypertensive drugs market continues to grow
    .

    Some data predict that by 2022, the sales scale of China's antihypertensive drug market will reach nearly 115 billion yuan
    .

    In the face of the broad space of the antihypertensive drug market, domestic pharmaceutical companies have actively laid out, and products have been approved for listing
    since this year.

    In August, the State Food and Drug Administration information showed that the Azisartan tablets declared by BIAO Pharmaceutical were approved for listing
    on August 12, 2022 as the second in the country to obtain production approval.

    Azisartan belongs to the new generation of selective AT1 subtype angiotensin II receptor antagonists (ARBs) class antihypertensive drugs, developed by Takeda Pharmaceutical of Japan, with the advantages of stable blood pressure reduction, high antihypertensive amplitude, good oral absorption, etc.
    , which can greatly improve the long-term medication compliance of
    patients with hypertension.

    Huahai Pharmaceutical has successively approved the listing of hypertension drugs this year, for example, on July 11, the company issued an announcement that enalapril maleate tablets were approved for listing
    by the FDA.

    Enalapril maleate tablets were developed by Merck, and the major manufacturers in the United States include Wockhardt, Taro, and Northstar
    .

    IMS database data shows that in 2021, the sales of enalapril maleate tablets in the US market are about 50.
    24 million US dollars; On July 8, Huahai Pharmaceutical issued an announcement that losartan potassium hydrochlorothiazide tablets for the treatment of hypertension were approved for marketing
    .

    Losartan potassium hydrochlorothiazide tablets are mainly used for the treatment of hypertension and are suitable for patients treated with
    combination drugs.

    The original research enterprise of the drug is Merck
    .

    The domestic manufacturers of the drug also include Lepu Pharmaceutical, Dongrui Pharmaceutical, Fuyuan Pharmaceutical and so on
    .

    According to the statistical estimates of the Rice Intranet data, the domestic sales of losartan potassium hydrochlorothiazide tablets in 2021 will be about 1.
    87 billion yuan
    .

    On March 31, the NMPA released a new batch of drug approval documents to be received, among which, Nanjing Yiheng Pharmaceutical's felodipine extended-release tablets passed the consistency evaluation of generic drugs, becoming the third enterprise to evaluate the antihypertensive drug species, and will share more than 1 billion varieties of market share
    .

    News on January 20, Hengrui Pharmaceutical submitted 3 classes of generic drugs "nimodipine oral solution" was approved for listing
    .

    Nimodipine belongs to the second-generation dipine class and is one of the commonly used antihypertensive drugs in clinical practice, suitable for patients with cerebrovascular spasm, headache-type hypertension caused by insufficient cerebral blood supply and ischemic sudden deafness
    .

    In addition to the above-mentioned drugs, there are also some pharmaceutical companies in the research project is advancing, is expected to be approved soon
    .

    For example, Shanghai Pharmaceutical recently mentioned in an investor survey that 269 cases have been enrolled in the second phase of the clinical phase III of hypertension indications of the self-research I001 project, and it is expected to complete the enrollment in the near future, and it is expected to be declared for listing
    in 2023.

    It is reported that Shanghai Pharmaceutical is accelerating innovation and transformation
    .

    In the field of hypertension treatment, in addition to 1001, on September 8, Shanghai Pharmaceutical also announced that the "SPH3127 tablets" developed by the company received the "Drug Clinical Trial Approval Notice" approved and issued by the relevant departments, and will start domestic Phase II clinical trials
    in the near future.

    According to the announcement, SPH3127 tablets are a novel oral renin inhibitor with hypotensive effects, and the project is currently conducting phase III clinical trials
    in China for the treatment of primary mild to moderate hypertension.

    At present, the majority of hypertension patients still have a large unmet clinical treatment needs, with the domestic drugs have been approved for listing, it can be expected to bring more treatment options to many patients and improve drug accessibility
    .

    Disclaimer: Under no circumstances does the information herein or the opinions expressed in this article constitute investment advice
    to any person.

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