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    Home > Medical News > Medical World News > Osaikang has accumulated a lot to release the first class 1 new drug benchmarking 4 billion varieties!

    Osaikang has accumulated a lot to release the first class 1 new drug benchmarking 4 billion varieties!

    • Last Update: 2022-05-01
    • Source: Internet
    • Author: User
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      Recently, Osaikang has another class 1 new drug approved for clinical use, and ASKC202 tablets will be used in clinical trials for the treatment of advanced solid tumors
    .
    In recent years, Osaikang has strengthened research and development, and has initially completed the transformation and upgrading of products from "first generic drugs combined with imitation and innovation" to "innovative drugs mainly, supplemented by high-end first generic drugs".
    The company's first Class 1 new drug ASK120067 tablets It is expected to be approved this year.
    In addition, 4 new Class 1 drugs have been approved for clinical use, 3 of which are anti-tumor drugs.
    In the future, they will work together to grab the 100 billion market for the company
    .
    In addition, the seventh batch of Guocai, which has attracted much attention from the industry, has also officially "officially announced" recently that Osaikang will have 4 products to participate in a new round of fierce battles
    .
    Four anti-tumor "new stars" focus on the 100 billion market, and the first class 1 new drug has attracted much attention.
    In recent years, with the continuous improvement of the research and development capabilities of domestic pharmaceutical companies, domestic innovative drugs have sprung up.
    In the field of major diseases, domestic innovative anti-tumor drugs have also become a hot field of research and development
    .
    On the other hand, as new domestic drugs are launched one after another, patients are provided with more "high-quality and low-cost" medication options, which further promotes the growth of the domestic anti-tumor drug market.
    The market size of terminal anti-tumor and immunomodulatory agents in first-level public hospitals, urban community centers and township health centers (referred to as Chinese public medical institutions) is only 72.
    4 billion yuan, and it will rise to more than 160 billion yuan in 2020
    .
    Facing the drug market with huge potential, Osaikang has also stepped up the layout of innovative drugs
    .
    As of now, Osaikang has 1 class 1 new drug submitted for production and is under review, 2 chemical class 1 new drugs have been approved for clinical use, and 2 biological drug class 1 new drugs have been approved for clinical use.
    Among these 5 class 1 new drugs, 4 are concentrated In the field of anti-tumor, in addition, 1 new drug involves the hot ophthalmic drug field in recent years
    .
    Table 1: Category 1 new drugs declared by Osaikang since 2020 Source: Minet database, CDE official website ASK120067 tablet is a third-generation EGFR inhibitor targeting T790M for the treatment of non-small cell lung cancer, Osaikang in 2017 After obtaining the clinical approval in 2019, the company obtained the CDE license in 2019 based on the outstanding results of the Phase I/II clinical study.
    After the completion of the Phase II clinical study, conditional approval can be obtained.
    Good news will come as soon as this year
    .
    Table 2: Sales of the third-generation EGFR inhibitors listed in China It was approved for import in 2018, and then successfully entered the National Medical Insurance Catalog in 2018.
    According to the data of Minet, the total sales of terminals in Chinese public medical institutions and physical pharmacies in Chinese cities have exceeded 4.
    5 billion yuan in 2020
    .
    The first domestically produced third-generation EGFR inhibitor, Ametinib, was approved in 2020, and was subsequently negotiated to enter the National Medical Insurance Catalogue with a medical insurance payment price of 176 yuan (55mg/tablet); the second domestically produced third-generation EGFR inhibitor costs With Elis, fumetinib successfully entered the 2021 edition of the National Medical Insurance Negotiation Catalogue
    .
    ASK120067 tablet, as the first Class 1 new drug reported by Osaikang, has high expectations from the company
    .
    In March 2021, Osaikang announced to cooperate with Shanghai WuXi AppTec to develop new drugs.
    In addition to the treatment of Exon14-mutated non-small cell lung cancer, this project will also be used in combination with ASK120067 tablets in the future; in addition, the latest clinically approved ASKC202 tablets In the future, it will also be used in combination with ASK120067 tablets.
    .
    .
    It seems that Osaikang will use ASK120067 tablets as the starting point to expand non-small cell lung cancer as the target group, and gradually build the company's anti-tumor drug product group
    .
    The clinically approved ASKC202 tablet is a potent and highly selective oral small molecule c-MET inhibitor.
    At present, targeting c-MET has become a research and development hotspot in the field of tumor therapy.
    MET inhibitors are Merck's tepotinib and Novartis' capmatinib
    .
    Capmatinib was approved by the FDA in May 2020, and as of 2021, its cumulative global sales have reached US$125 million, and its potential should not be underestimated
    .
    The domestic new drug Sivotinib Tablets will be approved for marketing in 2021, and the domestic market still needs to be developed
    .
    ASKC852 tablet is a small-molecule immunomodulatory drug jointly developed by the company and WuXi AppTec.
    Preclinical studies have shown that the new drug can inhibit tumor as a single drug.
    , combined with PD-1/L1 antibody showed a significant synergistic anti-tumor effect, and also effectively inhibited the metastasis of cancer cells
    .
    In the field of anti-tumor drugs, Osaikang's first class 1 biological drug, ASKB589 injection, mainly kills tumor cells through ADCC and CDC, and is intended to be used for gastric and gastroesophageal junction adenocarcinoma, pancreatic cancer and other indications.
    Phase clinical trials are in progress
    .
    The company's second class 1 biological drug is ASKG712 injection, which is a bispecific antibody that can target both VEGF and ANG2.
    While controlling the formation of new blood vessels, it can effectively improve vascular stability and relieve retinal pain.
    inflammation
    .
    The preclinical results show that ASKG712 injection is safe and has stronger binding activity to VEGF and ANG2, which is expected to achieve better clinical efficacy and reduce the number of intravitreal injections
    .
    Osaikang has continued to increase R&D investment in recent years.
    From 2018 to 2020, the R&D investment was 290 million yuan, 393 million yuan, and 408 million yuan respectively, accounting for 7.
    38%, 8.
    69%, and 10.
    79% of its operating income.
    In the third quarter, the company's R&D investment also increased by 45.
    74% year-on-year
    .
    At present, in addition to the field of anti-tumor and ophthalmic drugs, the class 1 new drugs deployed by Osaikang are also progressing rapidly in innovative drugs against drug-resistant infections
    .
    It is reported that ASK0912 injection is an innovative drug jointly developed by Osaikang and the Institute of Medicinal Biotechnology, Chinese Academy of Medical Sciences.
    The new drug has broad-spectrum activity against Gram-negative bacteria with severe clinical drug resistance.
    A number of in vitro and in vivo efficacy studies have shown that antibacterial The activity is stronger than that of polymyxins B and E, and the toxicity is reduced.
    The new drug is expected to be submitted for clinical application this year
    .
    Generic drugs have been comprehensively upgraded, and 4 major products have impacted the first imitation.
    In 2021, 7 of the generic drugs that Osaikang has been approved for marketing are deemed to have passed the evaluation according to the new classification.
    Among them, two won the domestic exclusive + domestic first generic, and two were The second domestic company, in addition, there are 4 generic drugs that are reported for production and are under review are expected to impact the first domestic imitation
    .
    Table 3: Osaikang's products approved for marketing in 2021 Source: Minet MED2.
    0 Chinese Drug Evaluation Database Osaikang has aggressively attacked the anti-tumor field in recent years.
    Among them, temozolomide for injection won the second domestic company
    .
    The systemic antifungal drug posaconazole injection is a blockbuster product of Merck & Co.
    Osaikang has won the first domestic imitation.
    At the same time, the company has previously obtained the exclusive right to promote posaconazole enteric-coated tablets in mainland China.
    The two can form a sequential treatment with a strong product portfolio advantage
    .
    In addition, the company has also won the second domestically produced polymyxin E sodium mesylate for injection.
    It is reported that Osaikang Pharmaceutical is the only company that uses imported APIs, and it is expected that it will be able to better meet clinical needs after listing
    .
    And deferasirox dispersible tablets were included in the "First Batch of Encouraged Generic Drug List", and Osaikang successfully won the first domestic imitation
    .
    Table 4: Source of products reported by Osaikang for production and under review: Minet MED2.
    0 China Drug Evaluation Database At present, Osaikang still has 9 high-end generic drugs reported for production and under review, involving five categories, of which 4 are The product is expected to impact the first domestic imitation
    .
    There will be 3 oral preparations for anti-tumor and immunomodulatory agents to be approved for marketing, among which ceritinib capsules are ALK, insulin-like growth factor 1 receptor (IGF-1R), insulin receptor (INSR) and ROS1.
    Targeted kinase inhibitor, the original research drug company Novartis was approved to enter the Chinese market in 2018 and successfully negotiated to enter the national medical insurance catalog.
    In 2020, the sales of terminal original research products in public medical institutions in China exceeded 260 million yuan
    .
    Osaikang said that the company is the first company to complete the bioequivalence test, and will be the first to report for production in February 2021.
    It has a great time advantage to grab the first domestic imitation
    .
    As a leader in domestic PPI preparations, Osaikang will also have two blockbuster first imitations coming soon
    .
    Dex-rabeprazole sodium is the dextro-enantiomer of rabeprazole sodium, with better efficacy, less dose and longer half-life
    .
    In 2018, Osaikang submitted a 3-type generic listing application for dextro-rabeprazole sodium for injection.
    At present, only 1 company is under review and approval, and it has a high probability of winning the first domestic imitation
    .
    In addition, Esomeprazole Magnesium Enteric-Coated Dry Suspension is the only PPI preparation approved by the FDA for use in pediatric patients.
    Application for listing, but no company has been approved yet, Osaikang still has the opportunity to reverse the situation
    .
    At the same time, after the approval of these two new blockbuster PPI preparations, the company's leadership in this field will be further enhanced
    .
    In addition, in the field of blood and hematopoietic system drugs, Osaikang is also the first company to complete the bioequivalence test and apply for production of Eltrombopag ethanolamine tablets
    .
    Eltrombopag ethanolamine tablets, as the first oral drug for the treatment of ITP (primary immune thrombocytopenia), is more convenient to administer, has high patient compliance, and can significantly reduce the bleeding rate
    .
    At present, only Novartis has been approved for import in China.
    In 2020, the terminal sales in China's public medical institutions will be about 180 million yuan.
    It is now the 2021 version of the National Medical Insurance Negotiation Catalogue
    .
    At present, in addition to Osaikang, there are also domestic star pharmaceutical companies such as Chia Tai Tianqing Pharmaceutical Group, Qilu Pharmaceutical, Sichuan Kelun and other domestic star pharmaceutical companies pending approval.
    The competition for the first imitation of this product is extremely fierce. .
    Judging from the high-end generic drugs pending approval, Osaikang is continuously consolidating the leading PPI preparation market.
    The two major types of markets attacked the first imitation and blockbuster varieties, which also confirmed the company's product transformation and upgrading strategy of "mainly innovative drugs, supplemented by high-end first generic drugs"
    .
    The seventh batch of national mining is coming as scheduled, and the fierce battle of 5 billion large varieties has begun.
    Recently, the seventh batch of national mining was officially "officially announced", and another 58 varieties and 208 specifications are about to start the market battle
    .
    Osaikang actively participated in the fourth and fifth batches of national procurement, and won the bids for parecoxib sodium for injection, pantoprazole sodium for injection, docetaxel injection, decitabine for injection, saxagliptin Tablets, Palonosetron Hydrochloride Injection, Esomeprazole Sodium for Injection, Lansoprazole for Injection 8 products
    .
    Table 5: Source of products that Osaikang has reviewed/deemed to have reviewed: Minet.
    com MID Drug Index Comprehensive Database Up to now, Osaikang has reviewed 20 products, including 4 products involved in the seventh batch of national procurement catalogues.
    Including lenvatinib mesylate capsules, temozolomide for injection, tigecycline for injection, and omeprazole sodium for injection
    .
    Figure 1: Osaikang's seventh batch of domestically sourced products (unit: 100 million yuan) Source: Minet.
    com China's public medical institutions' terminal competition landscape Entering the Chinese market, sales skyrocketed after entering the national medical insurance negotiation catalog in 2020, and exceeded 600 million yuan in the first half of 2021
    .
    In July 2021, domestic generic drugs began to be approved for the market one after another.
    So far, 8 domestic pharmaceutical companies, including Osaikang, CSPC Ouyi, Hunan Kelun, and Qilu, have been approved according to the new classification and deemed to have been reviewed.
    On the same starting line
    .
    Temozolomide for injection was first approved by Hengrui in 2018.
    At present, this product is led by Hengrui.
    In 2021, three domestic pharmaceutical companies including Oxykang will be added to participate in the market competition.
    The sales growth rate in the first half of the year is as high as 414%.
    Potential is being unleashed fast
    .
    Tigecycline for injection is a large variety of systemic antibacterial drugs with over 2 billion.
    In the first half of 2021, Hansoh leads the market with a market share of 36.
    54%, Pfizer ranks second (24.
    64%), and Osaikang ranks sixth (2.
    78%).
    , Up to now, there are 7 companies that have reviewed the product
    .
    Omeprazole enteric-coated capsules were included in the third batch of national procurement.
    Hainan Hailing and Shandong Luoxin Pharmaceutical Group successfully won the bids.
    To 8.
    59% and 18.
    60%, the two winning bidders achieved great success by exchanging price for quantity
    .
    The seventh batch of Guocai focused on omeprazole injection, and the only product that has been reviewed so far is omeprazole sodium for injection, but there are as many as 24 companies that have reviewed it
    .
    Figure 2: 2021H1 TOP5 enterprise landscape of omeprazole sodium for injection AstraZeneca is only 13.
    07%, while Lingkang Pharmaceutical, North China Pharmaceutical and Conba have also been reviewed
    .
    As the company's flagship product, Osaikang is expected to go all out to protect it, but at the same time, it is foreseeable that a fierce battle for this nearly 5 billion yuan heavy injection is inevitable
    .
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