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    Home > Medical News > Latest Medical News > [drug Kajun] drug review trends: the first class of new drug, losartan, imported patozumab injection "has completed the preparation of the certificate"; the Yangtze River has fought the market of 10 billion yuan, and the listing of lenalidomide has been accepted; and

    [drug Kajun] drug review trends: the first class of new drug, losartan, imported patozumab injection "has completed the preparation of the certificate"; the Yangtze River has fought the market of 10 billion yuan, and the listing of lenalidomide has been accepted; and

    • Last Update: 2019-08-26
    • Source: Internet
    • Author: User
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    Highlights: 1 Application for listing of class 1 new drug losartan "issued" 2 The first domestic imitation of quetiapine fumarate sustained-release tablets will be approved soon 3 The import of losartan (China) patozumab injection is around the corner 4 Yangtze River joined the war, and the application for listing of lenalidomide has been accepted for review and approval This week (August 16 to August 23), 23 reports were submitted to the production acceptance No for status update, and 5 products were approved, including class 1 new drug of fabergin (China) Pharmaceutical Technology Development Co., Ltd [losarta capsule], imported monoclonal antibody of Roche (China) Investment Co., Ltd [patozumab injection], and quetiapine fumarate sustained-release tablets of Foshan derico Pharmaceutical Co., Ltd The approval is coming soon, which is worthy of attention On August 20, according to the registration and acceptance data of pharmaceutical intelligent drugs, the two application and listing acceptance numbers of vasasta of vasasta company were in the status of "issued" and "approved pending", which means that the first in class new drug launched in China is about to have two new indications approved, It is worth mentioning that in December 2018, rosarista was approved to treat anemia caused by chronic kidney disease (CKD) in patients undergoing dialysis treatment by virtue of its priority review and approval qualification Now it is also included in the priority review procedure by CDE with obvious treatment advantages, and also included in the special approval channel After rapid approval, it is about to be approved for marketing, increasing drug market advantages Potential In addition, according to the Chinese clinical trial database of Yaozhi, the two new indications of Rosa Sita capsule to be approved may be anemia caused by chronic kidney disease in non dialysis patients and anemia caused by relatively low-risk myelodysplastic syndrome (MDS) According to the clinical experiment details of losartan capsule, pertuzumab is a kind of epidermal growth factor receptor-2 protein (HER2) antagonist It targets HER2, blocks cell cycle and induces apoptosis by inhibiting ligand dependent heterodimerization between HER2 and other members of her family Pertuzumab was developed by Genentech (a subsidiary of Roche), approved by FDA on June 8, 2012, EMA on March 4, 2013, approved by PMDA on June 28, 2013, and listed by Roche (Genentech in the United States, both at home and abroad in Japan) Pharmaceutical) is sold in the US, Europe and Japan under the trade name of perjeta Since its listing, sales have increased steadily, reaching a new high in 2018, reaching CHF 2773 million, equivalent to RMB 18.302 billion At the end of last year, the State Drug Administration approved the application for import registration of patozumab injection from Roche (Shanghai), which was used in combination with trastuzumab and chemotherapy for adjuvant treatment of early breast cancer patients with high recurrence risk of human epidermal growth factor receptor 2 (HER2) Now, the first acceptance no of Roche (China) has been reviewed and approved preferentially, and it is in the state of "certificate preparation - approval to be issued", or it will be used in solid tumors in combination with other anti-cancer treatment Details of clinical trials of patozumab injection the sustained-release tablets of quetiapine fumarate is a non classical antipsychotic drug It is mainly used to treat schizophrenia The original research enterprise is AstraZeneca, which was first approved by FDA in 1997 In 2000, it was approved to import quetiapine fumarate ordinary tablets, and in 2013, it was approved to import sustained-release tablets In 2018, the sales of public medical institutions in China reached 1.755 billion yuan According to the domestic database of pharmaceutical intelligence, at present, there are 17 domestic approvals for quetiapine fumarate, which are produced by only four enterprises It is worth mentioning that the first quetiapine fumarate tablet of Hunan Dongting pharmaceutical has passed the consistency evaluation, and the supplementary application of Suzhou first pharmaceutical is still under review However, no sustained-release dosage form of the product has been listed in China Foshan derico's product was included in the priority review in December 2017, which was approved first and will be the first domestic imitation of the sustained-release dosage form This week, there are 19 CDE new acceptance reports with production acceptance number, including 1 new drug, 8 imported drugs and 10 generic drugs The details are shown in the following figure: among them, lenadomide capsule from Yangtze River is worth mentioning Lenalidomide is an immunomodulator anti-tumor drug developed by American new base biopharmaceutical company It was approved by FDA on December 27, 2005, and was used to treat myelodysplastic syndrome Later, it was expanded and approved by FDA to treat multiple myeloma and mantle cell lymphoma In 2018, the global sales of lenalidomide in new base pharmaceutical industry reached US $9.685 billion, an increase of 18.3% year-on-year, accounting for 72% of the overall performance of new base According to analysts, the sales of lenalidomide in 2019 can reach US $10.8 billion, an increase of 12% year-on-year According to the domestic database of pharmaceutical intelligence, there are 5 market approvals for domestic lenalidomide capsules The manufacturers are Zhengda Tianqing, Beijing Shuanglu and Qilu pharmaceutical Among them, Zhengda Tianqing has been declared and approved for production according to 6 categories of generic drugs, Beijing Shuanglu has been approved according to 3.1 categories of new drugs, Qilu has been approved according to 4 categories of chemical drugs Now, Yangzi River is the same as Qilu, lenalidomide capsule has been accepted as 4 categories of chemical drugs, striving for 10 billion market It is worth mentioning that, according to the relevant policies, the generic drugs approved for production by registration and classification of new chemical drugs are deemed to have passed the consistency evaluation, which means that once approved, the Yangtze River variety is consistent with the original research quality and efficacy For some information, please refer to: enterprise announcement, FDA official website data source: drug intelligence data statement: this point of view only represents the author, not the position of drug intelligence website, welcome to exchange and supplement in the message area; if you need to reprint, please be sure to indicate the author and source of the article.
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