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    Home > Active Ingredient News > Drugs Articles > Under the continued favorable policy, domestic Class 1 new drugs may begin to break out

    Under the continued favorable policy, domestic Class 1 new drugs may begin to break out

    • Last Update: 2022-11-01
    • Source: Internet
    • Author: User
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    【Pharmaceutical Network Policies and Regulations】Recently, the Administrative Committee of Foshan High-tech Zone issued the "Measures for Promoting the High-quality Development of Yundonghai Biomedical Industrial Park" (Draft for Comments) (hereinafter referred to as the "Measures"
    ).
    It is reported that the Measures aim to accelerate the construction and development of the Yundonghai Biomedical Industrial Park and support the comprehensive, high-quality, sustainable and rapid development of
    Foshan's biomedicine and pharmaceutical and health industry.
    The Measures clearly state that new drugs that carry out clinical trials in China and are transformed in industrial parks will be funded
    in stages according to their research and development progress.
    Among them, for a class of chemical drugs, a class of biological products, a class of traditional Chinese medicines and natural medicines, up to 40% of the actual investment in R&D costs will be subsidized; For new drugs that have obtained clinical trial licenses, a subsidy of no more than 1 million yuan will be given, and the cumulative annual funding of a single enterprise shall not exceed 5 million yuan; For new drugs that complete phase I, II, III clinical trials, subsidies of no more than 10 million yuan, 20 million yuan and 30 million yuan will be given respectively, and the cumulative funding of a single enterprise shall not exceed 100 million yuan
    per year.
    Similar to Class I innovative drugs, Class II innovative drugs and generic drugs will also be funded
    in phases according to their research and development progress.
    Prior to this, Hangzhou also issued Several Measures to Accelerate the High-quality Development of Biomedicine.

    The Measures focus on supporting R&D, production and services
    in the fields of pharmaceuticals, high-end medical devices, advanced pharmaceutical equipment, new service outsourcing, digital medical care and medical cosmetology.
    Among them, the "Measures" also propose to provide funding in terms of improving innovation and R&D capabilities: for Class 1 chemical drugs, Class 1 biological products and Class 1 traditional Chinese medicines that have been carried out in phase I.
    , phase II and phase III clinical trials in China, and the registration applicant has obtained permission and industrialized them, according to the different stages of clinical trials, no more than 40% of the R&D investment will be given after evaluation, and the funding
    for a single variety shall not exceed 10 million yuan, 20 million yuan and 40 million yuan respectively 。 In addition, for Class 2 chemical drugs, Class 2 biological products and Class 2 traditional Chinese medicines that have been carried out in phase I, phase II and phase III clinical trials in China, and the registration applicant has obtained permission and industrialized them, according to the different stages of clinical trials, no more than 30% of the R&D investment will be given after evaluation, and the funding
    for a single variety shall not exceed 5 million yuan, 10 million yuan and 20 million yuan respectively.
    In order to seize the commanding heights of a new round of industrial development and enhance the core competitiveness of the pharmaceutical industry, in addition to the above-mentioned regions, Tianjin, Jinan, Yunnan and other places have recently issued various measures to support the development of pharmaceutical innovation and proposed incentive measures
    .
    Industry analysts believe that in fact, with the acceleration of new drug approval and review, domestic new drugs have accelerated into an intensive harvest period
    in recent years.
    According to statistics, from 2016 to 2021, the number of Class I new drugs accepted by the National Drug Review Center (CDE) increased from 184 to 1,379, an average annual increase of nearly 50%.

    In the future, with the continuous promotion of favorable documents issued by various places, it is expected that domestic Class 1 new drugs will gradually begin to break out, and a large number of pharmaceutical companies will enter the harvest period; And whether in terms of quantity, quality or market size, it will perform better and achieve further improvement
    .
    Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice
    to anyone.
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