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    Home > Active Ingredient News > Drugs Articles > Q3 A total of 25 new drugs were approved for sale, what are the highlights?

    Q3 A total of 25 new drugs were approved for sale, what are the highlights?

    • Last Update: 2020-11-11
    • Source: Internet
    • Author: User
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    According to incomplete statistics, the 2020Q3 State Drug Administration has approved 25 new drugs (including new adaptations) for the market, and another 2 biosimilar drugs have been approved.
    Q3 innovative drugs received a record number of approvals compared to Q1's seven new drugs (including new adaptations) and Q2's 22 new drugs (including new adaptations).
    addition to the expected increase in the number of approved drugs, the new drugs approved in the quarter were bright spots.
    For example, from the field of drug treatment, 25 new drugs, anti-tumor drugs accounted for 6, endocrine system and metabolic drugs accounted for 4, and immune system drugs, and treatment of hepatitis C, AIDS and other anti-infective drugs each 3 were approved.
    25 approved new drugs are mostly imported products, accounting for 21, including Bayer's chlorinated pyridoxe injections, Pfizer's new phosphate dylsterase 4 (PDE-4) inhibitor Kryboro ointment, Takeda's innovative drug Ripja, etc.; Innovative enterprises brought a total of 4 new drugs, including the full oral hepatitis C treatment program developed by Gori - Ravidavi combined with Danorive, Synthesic Pharmaceuticals developed a class 1 new drug in the field of cerebrovascular disease Idara feng right ol injection with a strong solution, and then Ding Pharmaceuticals PARP inhibitor Nirapali and so on.
    In specific product categories, there are several "first" products approved, such as Bayer's world's first α-particle radiation radiotherapy drug, Dofigo ® (chlorinated radon (223Ra) injections).
    August 27th, Bayer announced that the Dofigo chlorinated radon (223Ra) injection had been approved by the National Drug Administration for the treatment of descending resistance prostate cancer (CRPC) patients with symptomatic bone metastasis and no known visceral metastasis.
    it is understood that with the approval of the product, Bayer's oncology business unit will open a new field of treatment for prostate cancer in China, providing treatment options for Chinese prostate cancer patients at different stages of the disease.
    In addition, the new drugs approved in the quarter included a number of rare disease treatment drugs, such as the Fabre disease treatment drug agagaglyzyme α injection with a strong solution, the treatment of Hunter syndrome Ado sulfate enzyme β injection, as well as Dongpei Pharmaceuticals brought the rare disease drug Senaigmin eye drops.
    Among them, Takeda China announced on August 28th that its innovative drug Ripja (Aga glycosin α injected with a strong solution has been approved by the State Drug Administration for long-term enzyme replacement therapy for patients diagnosed with Fabre disease (α-semi-lactose glycosidease A deficiency), which can bring long-term heart, kidney protection and delay the disease process to patients with Fabre disease.
    Fabrey disease is a rare genetic disorder caused by a deficiency of lysosome enzyme α-semi-lactose glycosidease A (α-Gal A), which causes chronic kidney disease, kidney failure, cardiovascular disease and stroke due to the accumulation of GL-3 in blood vessels, kidneys, hearts, nerves and other organs.
    Aidu sulphate enzyme β injection is recombinant human Adu glycate-2-sulphate enzyme replacement therapy, is the first rare disease drug successfully commercialized in China, but also the first new generation of global treatment of Hunter syndrome enzyme replacement therapy, with FDA orphan drug qualification, and access to NMPA priority evaluation qualification for confirmed Hunter syndrome patients with enzyme replacement therapy.
    Hunt's syndrome is a rare, disabling, and fatal genetic disorder in which glycosamine (GAG) stored in patients can be spread through multiple organ systems due to the absence or deficiency of Adolfalic acid-2-sulfatease (IDS).
    incidence of the disease in East Asian countries is high, has been included in China's list of rare diseases.
    a rare disease drug approved by Italian pharmaceutical company Dongpei Pharmaceuticals, Senaigmin eye drops, is mainly used to treat moderate or severe neurotrophic corneitis (NK).
    is known to be a rare progressive eye disease that causes corneal scarring and vision loss.
    series of trials conducted by Dongpei Pharmaceuticals confirmed the safety and effectiveness of Senigmin in the treatment of neurotrophic corneitis.
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