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    Home > Medical News > Latest Medical News > In August, the nine innovative drugs were approved in China, from Bayer, Takeda, Gilead Sciences and others.

    In August, the nine innovative drugs were approved in China, from Bayer, Takeda, Gilead Sciences and others.

    • Last Update: 2020-09-25
    • Source: Internet
    • Author: User
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    As of August 31, about a dozen innovative drugs had been approved for sale in China, including Bayer, Takeda, Mundi Pharma, Janssen and Gilead Sciences, according to the official website of China's State Drug Administration (NMPA) and a public press release.
    these innovative drugs are not only new therapies approved for the first time in China, but also new adaptive and biosynthetic drugs.
    this article, we have selected some of the innovative drugs (9) to share with you (in no order).
    First approved 1, Bayer: chlorinated radon (223Ra) chlorinated radon (223Ra) (Dofigo) is a radiation activity therapy drug that emits alpha particles, the active part of which simulates calcium ions, by forming a complex with hydroxyurea (HAP) in the bones, with a pro-bone, especially bone metastasis pathological bone hyperpluration active area.
    particles emitted by radon-223 can cause high-frequency double-stranded DNA fractures in adjacent tumor cells, resulting in a powerful cytotoxic effect.
    , the alpha particle emission radius is less than 100 microns (less than 10 cell diameters) to minimize damage to the surrounding normal tissue.
    August 27th, Bayer announced that the chlorinated palate injection had been approved by NMPA for the treatment of patients with despotic resistance prostate cancer (CRPC) with symptomatic bone metastasis and no known visceral metastasis.
    approval is based on data from key Phase 3 ALSYMPCA studies and Phase 3 Studies 15397 conducted in Asia.
    study showed that chlorinated radon (223Ra) significantly improved total survival (OS) compared to placebo, while delaying the occurrence of the first symptomatic skeletal event (SSE) and significantly improving the quality of life of patients in the treatment group.
    addition, chlorinated radon (223Ra) also shows good safety.
    2, Takeda: Aga glycosin alpha injection with a strong solution Agamase alpha injection with a strong solution is a drug for the treatment of Fabre disease (alpha-semi-lactosease A deficiency).
    is a rare X-series hereditary lysosome storage disease that has been included in The Rare Diseases List in China.
    first to be licensed in the European Union in 2001 with a strong solution for alpha injection of agagase alpha.
    in more than 63 countries as of April 2019.
    March 2018, the drug was added to the CDE's list of the second batch of clinically urgently needed new drugs from abroad.
    August 28, Takeda announced that Aga glycoenzyme alpha injection with a thick solution (commodity name: Ripja) has been approved by NMPA for long-term enzyme replacement therapy for patients diagnosed with Fabre disease.
    press release, this is the only human-based enzyme replacement therapy in China that provides long-term heart and kidney protection and slows the progression of the disease, improving the quality of life of patients and their families.
    3, Monty Pharma: Pratsa Pratsa is an anti-tumor folic acid-liketer metabolic inhibitor that competitively inhibits dehydroflytic acid reductase (DHFR).
    DHFR is a folic acid-dependent enzyme that is involved in building DNA and other processes.
    the drug is also a competitive inhibitor of polyglutamine synthesis enzymes with folic acid polyglutamine.
    inhibition leads to the consumption of thymus nucleosides and other biomolelemes, whose synthesis depends on monocarbon transfer.
    the drug, which was first approved by the FDA in 2009, is the first hydroflyctic acid reductase inhibitor to be used to treat exocytoblastoma (PTCL).
    , Pratsa submitted a listing application in 2019 and was included in the priority review on the grounds that it was "an innovative drug with clear therapeutic advantages".
    August 28, the NMPA website showed that Pratsa had been approved.
    4, Dongpei Pharmaceuticals: Senaigimin eye drops On August 20, Tongpei Pharmaceuticals (Dompé) announced that NMPA has approved its Senaigimin eye drops (Ocyvi) for the treatment of moderate or severe neurotrophic cornealitis (NK), a rare progressive eye disease that causes corneal scar formation and vision loss.
    press release, this is the first product approved by Dongpei Pharmaceuticals in China.
    Senaigimin is a new type of recombined human neurogrowth factor (rhNGF) that is structurally identical to the neurogrowth factor (NGF) protein produced in the human body and contained in eye tissue.
    this endogenous protein strongly supports corneal integrity through a variety of mechanisms and acts directly on corneal cells to stimulate cell growth and survival.
    addition, NGF is known to bind to the subjects on the tear glands to promote tear secretion, providing lubrication and natural protection for the eyes from pathogens and injuries.
    protein has been shown to support corneal nerve control, a nerve function that has been lost in neurotrophic cornealitis.
    National Adaptive Disorders 5, Takeda: Injection with acetate bright propylene rhine microsphere injection with acetate bright propylene rin microsphere is a gonamogen-releasing hormone astrogen (GnRHa) class of drugs, through inhibition of the pituitary gland system, the role of sex hormone-dependent diseases.
    clinical studies have shown that bright propylene propylene acetic acid micro-balls can steadily and consistently reduce sex hormone levels.
    August 11th, Takeda announced that its three-month dosage form (size: 11.25mg) had been approved in China for the treatment of central precocious precociousness (CPP).
    press release, this is the third adaptive drug approved in China for the three-month dosage form and the first three-month reprieve long-acting preparation officially approved for CPP treatment in China. according to the
    press release, the frequency of visits required to suppress the three-month dosage form is consistent with the frequency of monitoring during the treatment of gonthetic hormone-releasing hormone drugs required by the Central Precocious Diagnosis and Treatment Consensus (2015) in China, and the number of injections can be increased from The 12 times per year reduction of the one-month dose form of acetic acetate to 4 times per year, and its approval will provide a more convenient choice for the standardized and continuous treatment of CPP, which will help to further improve the compliance and satisfaction of the treatment of children and improve the quality of life of families of children with the disease.
    6, Janssen Pharmaceuticals: Apatamine tablets Apatamine tablets (Ampathamine tablets) are a new generation of androgen-inhibitors first approved in China in September 2019 for the treatment of adult patients with high risk metastatic degenerative prostate cancer (NM-CRPC).
    , apathamine tablets were approved in China as a new adaptive disorder for the treatment of metastatic endocrine-sensitive adult patients with prostate cancer (mHSPC).
    press release, Anson is the second innovative solution to treat prostate cancer in Xi'an, after Zetsin (Abitron tablets of acetic acid).
    7, Gilead Science: Enturabinofowe Shufatai is a compound preparation developed by Gilead Science, each containing 200mg enqutabin and 300mg fumarate nofove dioxin.
    of these, Entourage and Tenofovir are a new type of nucleoside retrovirase inhibitor (NRTIs), the former has antiviral activity on HIV-1, HIV-2 and HIVV, and the latter inhibits HIV replication by inhibiting the activity of HIV-1 reverse transcriptase.
    , the drug had been approved in China to be used in association with other antiretroviral drugs to treat HIV-1 infections in adults and children over 12 years of age.
    August 11, Gilead Sciences announced that Shufatai has been approved by the NMPA for pre-exposure prevention (PrEP) in combination with safe sexual behavior measures to reduce the risk of HIV-1 gaining in adults and adolescents (weighing at least 35 kg or more) through high-risk sexual behavior.
    , Shufatai is the first drug approved in China for pre-exposure HIV prevention in unspoiled populations, according to a press release.
    Biosynthetic drug 8, Fuhong Hanjuan: Qutozhu single anti-Khloe bead monoanti (HLX02) is a specifically targeted molecular treatment drug for HER2-positive breast cancer, the original research drug Hercetin developed by Roche, since its birth, it has become the cornerstone of her2-positive breast and stomach cancer first-line treatment.
    this time developed and produced by Fuhong Hanjuan Quto Zhudan Anti-Biosychic Drug (HLX02) was approved for listing in China, the commodity named Hanquyou.
    it obtained all indications that the original product had been approved in China: 1) HER2-positive early breast cancer; 2) HER2-positive metastatic breast cancer; and 3) HER2-positive metastatic stomach cancer.
    note that HLX02 has just been approved for listing in the European Union, making it the first Chinese-made single-anti-biosynthic drug to be approved in China and Europe, according to the Fuhong Hanxuan press release.
    9, Baiotai: Glili (Adamo monoantigen injection) Adamo monoantigen is an anti-tumor necrotizer (TNF-alpha) monoclonal antibody, Greli is an Adamu monoantigen developed by Baiotai Biosychables, which were first approved for market by NMPA in November 2019, are the first Adamo monobial-like drugs to be listed in China for treatment of autoimmune diseases such as rheumatoid spina bifida, rheumatoid arthritis and psoriasis.
    , the drug was approved in China for a fourth adaptive disease, the treatment of Crohn's disease.
    On August 10, Biota announced that NMPA had approved Greeley (Adamo single anti-injection) for the treatment of adult non-infectious intermediate staphylococcitis, post-vineitis and whole vineitis patients, which is the fifth adaptive drug approved in China, marking Greerli after rheumatology immunology, dermatology, digestive medicine, into the field of ophthalmic diseases this new treatment.
    In addition to the above-mentioned drugs, several new drug listing applications have been approved, including Hanguang Pharmaceuticals' Zosi Mendan, Sanofi's Plosafu injections, Fresenius Kabi's phosphate tablets, Astellas' Tekmos particles, and so on.
    : The first-page approval of the government service portal of the State Drug Administration of China was published.
    public press releases from the companies of from the Company.
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