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Recently, Zhengda Tianqing 3 classes of generic drug "Pomadamine capsule" listing application (related acceptance number CYHS1800187/188) in the status of NMPA changed to "in approval", which means that the "first imitation king" is expected to be the next city, take the first imitation of Pomadamine.
pomalidomide is a new generation of amine-based drugs after salidomide and lysamine, suitable for patients with multiple myeloma (MM) who have previously received at least two drugs (including lysolamine, boronitzomi) and have recently been treated or have completed the progression of the disease within 60 days.
compared to salidamine and lysamine, posamine can effectively treat MM at very low doses, and low-dose therapy can significantly reduce the risk of adverse drug reactions occurring.
, Pomadamine also responds to MM patients who are ineffective in the treatment of meridoamine and salidamide, as well as other MM patients who are difficult to treat with new drugs.
was originally developed by the new base, first approved by the FDA in February 2013, the product is called Pomalyst, in August of the same year was approved by the EMA, the product is called Imnovid.
sales of Pomadamine have skyrocketed since the company went public, to more than $2 billion in 2018.
In addition, in May, Pomalyst was approved by the FDA for the treatment of HIV-related and antiretroviral therapy (HAART) resistant caposic sarcoma patients, as well as HIV-negative Caposi sarcoma patients, becoming the first new FDA-approved kaposi sarcoma drug in nearly 20 years.
, the original research of amine has not been approved in China.
However, according to the official website of CDE, at present, a number of domestic enterprises have begun to lay out the Pomadoamine generic drug market, which Zhengda Tianqing, Yangzijiang Pharmaceuticals and Qilu Pharmaceuticals have submitted applications for listing (see table below).
this time, Zhengda sunny positamine capsule listing application to take the lead in completing administrative approval, which means that Zhengda Sunny is expected to be the next city, take pomadamine first imitation.
So far this year, Zhengda Qing has obtained five first imitation products, namely, inhalation with Budinide mixed suspension, phosphate siglitin tablets, dabiga group ester capsules, entourta binotinofove tablets and fluovis group injections production batches (see table below).
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sigletin is an oral DPP-4 inhibitor that is approved for single-drug or combined with metformin and pyrethroids to control blood sugar in people with type 2 diabetes.
. Dabiga group esters belong to β-Alanine-type clotting enzyme inhibitors, is a new, synthetic direct clotting enzyme inhibitors, is a prelude drug of the dabiga group.
In February 2013, its original drug was approved by the NMPA for stroke and systemic embolism prevention in adult non-valve atrial fibrillation patients, and in October 2017 it was used to treat acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and prevent related deaths;
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. . . fluorovirs are new estrogen-like (ER) antagonists that block the nutritional action of estrogen and are clinically used for relapse after anti-estrogen-assisted treatment, or for post-menophageal estrogen-positive breast cancer, including localized late-stage or metastasis breast cancer, which progresses in anti-estrogen therapy.