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    Home > Medical News > Latest Medical News > Domestic new drugs "Jinbao" accelerated, and 14 varieties such as Hengrui and Rongchang became the focus

    Domestic new drugs "Jinbao" accelerated, and 14 varieties such as Hengrui and Rongchang became the focus

    • Last Update: 2022-11-26
    • Source: Internet
    • Author: User
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    A few days ago, the National Health Insurance Administration announced that the expert review process for the adjustment of the national medical insurance catalogue in 2022 has ended, which means that the new round of national negotiations is about to enter the sprint stage
    of negotiation bidding and result announcement.
    According to official sources, the national medical insurance negotiations in 2022 will be tilted towards rare disease drugs and children's drugs, and 25 drugs such as Takeda's veraside α for injection and Viticinone capsules from Guangzhou Hanguang Pharmaceutical are among them
    .
    Domestic new drugs have entered an intensive period of "insurance", and in the 2021 national medical insurance negotiations, the number of domestic new drugs admitted exceeds that of imported new drugs
    for the first time.
    According to Minai.
    com statistics, 14 domestic new drugs such as Hengrui, Rongchang, and WuXi Junuo are about to "break through" the 2022 national talks, and finally which drugs can successfully break through and enter the new version of the medical insurance catalog, this month is expected to be known!
     
    Domestic "anti-surpass" imports, innovative drugs "insurance" comprehensive acceleration
     
    So far, China has conducted a total of six rounds of medical insurance drug negotiations for innovative drugs, and the average reduction rate of innovative drugs selected for the first time is basically between
    40% and 62%.
     
    In 2016, a total of 3 drugs were successfully negotiated in the first medical insurance negotiation, with an average reduction of 58.
    7%; In 2017, a total of 36 drugs were included in the negotiations, with an average reduction of 44%; In 2018, 18 drugs were included in the negotiation, and 17 anticancer drugs were successfully negotiated, with an average reduction of 56.
    7%; In 2019, medical insurance negotiations were expanded to 97 drugs, with an average reduction of 60.
    7% for 70 new drugs; In 2020, 119 new drugs were added to the medical insurance negotiation, with an average decrease of 50.
    64%; In 2021, a total of 94 drugs were successfully negotiated in medical insurance negotiations, and the average price of 67 new drugs was reduced by 61.
    71%.

     
    Analysis of National Health Insurance Negotiations (New) from 2016 to 2021 (: pcs)
    Source: National Health Insurance Administration, National Health and Family Planning Commission, etc.
    , compiled by Minai.
    com
     
    In the six rounds of national medical insurance negotiations, the number of access to listed foreign-made drugs has been increasing year by year, of which a total of 38 domestically produced drugs were included in the national talks in 2021, surpassing the number of imported drugs outside the list (26)
    for the first time.
     
    Comparison chart of domestic drugs and imported drugs included in national medical insurance negotiations from 2016 to 2021 (: pcs)
    Source: Minai.
    com China Medical Insurance Catalogue Database
     
    It is estimated from the number of products included in previous rounds of national talks, and the number of domestic drugs may be about 50 and the number of imported drugs will be about
    30 for the off-the-list products that will eventually enter the medical insurance in 2022 through negotiation/bidding.
     
    At present, China is in the golden period of pharmaceutical innovation, with the reform and optimization of the drug review system, more domestic innovative drugs with outstanding efficacy advantages have been launched one after another, and their "insurance" speed has been comprehensively improved
    in recent years.
     
    In 2022, 25 rare disease drugs and children's drugs were shortlisted
     
    A few days ago, the National Health Insurance Administration officially announced that the expert review process in the adjustment of the national medical insurance catalogue in 2022 has ended, and it will soon enter the negotiation and bidding process
    .
    If all goes well, the new version of the national medical insurance catalogue will be officially released in November and implemented
    on January 1 next year.
     
    List of documents related to the adjustment of the 2022 edition of the national medical insurance catalog
    Source: National Health Insurance Administration, Minai.
    com
     
    Judging from the schedule of the arrangement, this year's timeline is slightly advanced
    .
    On the basis of the normalized adjustment of the medical insurance catalogue every year, a dynamic adjustment mechanism has been established, and the interval between the adjustment of the catalogue has been continuously shortened and the adjustment is more flexible
    .
    Therefore, drugs with significant clinical value will enter the catalog faster, and drugs with poor auxiliary drugs and drug economy will be transferred out, accelerating the replacement of medical insurance funds
    .
     
    In 2022, 343 of the 490 declared drugs passed the preliminary review, compared with 2021 (271 of the 474 drugs passed), the number of drugs declared and passed the preliminary formal review has increased to a certain extent, compared with the previous rounds of catalog adjustment, this adjustment is appropriately tilted
    towards special groups such as rare diseases and children.
     
    According to the statistics of Minai.
    com, 19 rare disease treatment drugs outside the list have passed the formal review and are about to enter a new round of national talks; Among them, 2 are both rare disease drugs and children's drugs, including Takeda's type I Gaucher disease treatment drug veranosidase for injection α, and Guangzhou Hanguang Pharmaceutical's type I tyrosinemia treatment drug Nitisinone capsule.

    In addition, 6 children's drugs were encouraged to be developed, including Nimodipine oral solution from Hengrui Pharmaceutical, and procarbazine hydrochloride capsules from Lee's Pharmaceutical
    .
     
    In 2022, the national medical insurance negotiation passed the preliminary review of rare disease drugs and children's drugs
    Source: National Health Insurance Administration, Minai.
    com
     
    14 domestic new drugs have become the focus, Hengrui, Rongchang, JW Therapeutics.
    .
    .
    Ready to go
     
    In 2022, the new innovative drugs or indications added by Guotan are mainly in the field of anti-tumor and digestive system treatment, including PD-1 monoclonal antibody/dual antibody, PPAR inhibitor, ADC and other drug types, of which domestic new drugs occupy 14 seats and imported new drugs are shortlisted for 7 products
    .
     
    List of some popular innovative drugs in the national medical insurance negotiations in 2022
    Source: Minainet database
     
    In terms of the number of shortlisted products, Hengrui Pharmaceutical has become the largest player, with 4 exclusive varieties of dalcilib, hengliflozin, pyrotinib and reverutamide shortlisted for the 2022 national talks
    .
     
    Hengrui's dalciglide tablets and proline hengliflozin tablets were approved at the end of 2021, and reverutamide tablets were approved at the end of June this year, meeting the conditions
    for access to the adjustment of the medical insurance catalog in 2022.
    Dalcilib isethionate tablets are the first domestic CDK4/6 inhibitors, proline hengliflozin tablets are the first domestic SGLT2 inhibitors, and revilumide tablets are the first domestic AR inhibitors, with huge market potential, if successfully enter medical insurance, it will usher in a large volume
    .
     
    Pyrotinib maleate tablets entered the national medical insurance catalog in 2019 and are restricted to the treatment
    of second-line HER2-positive metastatic breast cancer.
    According to data from Minai.
    com, the sales scale of the drug in China's three major terminal markets in recent years (see the end of this article for statistical scope details) has expanded year by year, exceeding 1.
    9 billion yuan in 2021, a year-on-year increase of 26.
    81%.

    If the new HER2-positive breast cancer neoadjuvant therapy indications can be negotiated into medical insurance, the sales revenue of pyrotinib maleate tablets is expected to achieve another good result
    .
     
    In recent years, the sales trend of pyrrotinib maleate tablets in China's three major terminal markets (: million yuan)
    Source: Minai Grid Bureau database
     
    Remegen's vedicitumab for injection (trade name: Aidishi ®) is the first self-developed ADC drug in China for the treatment of HER2 overexpression gastric cancer/gastroesophageal junction adenocarcinoma, and entered the national medical insurance catalog
    through negotiation in December 2021.
     
    With the help of medical insurance, the terminal sales of the drug in China's public medical institutions in the first half of 2022 exceeded 60 million yuan, and the sales growth rate far exceeded market expectations; Another indication for the new second-line treatment of HER2 overexpression urothelial carcinoma has been included in the scope of simple renewal negotiations, and the price reduction is not expected to be too large, and the market prospect is worth looking forward to
    .
     
    Quarterly sales of vedicitumab since its launch (: million yuan)
    Source: Minai.
    com Competition Pattern of Drug Terminals in China's Public Medical Institutions
     
    WuXi JW Therapeutics' relma-cel injection (CAR-T) has also entered the preliminary review list of this national talks, and as a representative of expensive new technologies, the negotiation results will closely affect the pricing
    of new technology products.
     
    Especially in last year's national talks, another CAR-T product, Fosun Kite's Aquilencel injection, also entered the preliminary review list, but finally failed to enter the formal negotiation process; At the same time, this year, the product did not enter the preliminary review list
    .
    Therefore, the "insurance" dynamic of a single relmacel injection priced up to 1.
    29 million yuan has attracted much attention
    .
     
    epilogue
     
    The national medical insurance drug negotiation has not only reduced the burden on patients and greatly improved the accessibility of drugs, but also encouraged China's pharmaceutical innovation and upgrading
    .
    In the future, multiple policies such as medical insurance negotiation, payment methods, review and approval, volume procurement and commercial insurance will profoundly affect the development of the pharmaceutical industry during the 14th Five-Year Plan period, and also bring many opportunities
    for enterprises.
    In the end, which enterprises and which varieties can enter the 2022 edition of the national medical insurance catalogue and enjoy the policy dividends released by the medical insurance reform? We'll see!
     
    Source: Minainet database, National Health Insurance Administration, etc
     
    Note: The statistical scope of "China's Three Major Terminals and 6 Major Markets Competition Pattern" by Minai.
    com is: urban public hospitals and county-level public hospitals, urban community centers and township health centers, urban physical pharmacies and online pharmacies, excluding private hospitals, private clinics, village clinics, excluding county and rural pharmacies; The above sales are calculated
    based on the average retail price of the product at the terminal.
    Data statistics as of November 11, if there is any omission, welcome to correct!
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