[Yao Kejun] drug review trends: new drugs and rare disease drugs urgently needed in clinical practice are accepted; Parkinson's disease innovative therapy is listed in the United States; Xiehe Kirin, Bayer, Hengrui, Renfu

Focus on 1.10 years! Parkinson's disease innovation therapy has been approved by FDA; 2 The R & D of more than 30 million, Hengrui new drug has finally been approved by the U.S market; 3 Humanwell pharmaceutical industry is about to go on the market for the first time; 4 The clinical urgent need of the new drug broshumab to go on the market to accept the attack; 5 The clinical urgent need of Concorde fermentation Kirin rare disease new drug to go on the market; 6 Bayer's listing resistance drug to go on the market again to accept This week (August 23 to August 30), the FDA approved the launch of two pounds of drugs They are the innovative drug nourianz (Istra defylline) developed by Kyowa Kirin Co., Ltd Datormycin for injection of Hengrui medicine Recently, the US FDA announced the approval of innovative drug nourianz (istradfylline) developed by Kyowa Kirin Co., Ltd to be launched as an adjuvant therapy of L-dopa / carbidopa to treat adult patients with Parkinson's disease (PD) who have experienced "off" episodes Istradefylline is a selective adenosine A2A receptor antagonist, which can selectively block adenosine A2A receptor, slow down the degeneration of dopaminergic neurons, and has little side effects It can be used as an auxiliary treatment of levodopa drugs It's worth noting that in 2007, Xiehe Kirin submitted the application for listing of the new drug to the U.S FDA, but it was not approved After persisting for more than 10 years and not abandoning, it finally obtained FDA approval recently, which is expected to help improve the quality of life of PD patients On August 30, Hengrui pharmaceutical released an enterprise announcement, and its new drug, daptomycin for injection, was approved by the US FDA for listing Daptomycin is a cyclic lipopeptide antibiotic, and its indication is to treat complex skin and skin tissue infection (csssi) and Staphylococcus aureus infection in adult blood Daptomycin was initially studied by Lilly (Lilly) Company and developed by Cubist pharmaceutical company It is the only new structural antibiotic after oxazolidinone antibiotics It is mainly used in the treatment of complicated skin and soft tissue infection and bacteremia caused by Staphylococcus aureus In response to the urgent needs of patients for new drug-resistant antibiotics, in September 2003, the U.S FDA approved for the first time the use of daptomycin for injection (trade name: Cubicin ®) through the priority approval process At present, daptomycin for injection has been widely sold in the world According to the inquiry, in addition to Cubist pharmaceutical company, 12 foreign companies, including Hengrui pharmaceutical, have been approved to market their products of daptomycin for injection In China, the datomomycin for injection of Cubist pharmaceutical company has been approved for import, with the trade name of Cubicin ®, and the specification of 0.5g In addition, East China pharmaceutical, Haizheng pharmaceutical, and Hengrui pharmaceutical have been approved for listing of datomycin APIs and datomycin for injection According to IMS database, in 2018, the global sales volume of datomomycin is about US $870 million, and the sales volume in the United States is about US $680 million Up to now, Hengrui pharmaceutical has invested about 30.07 million yuan in the R & D project of the product Review and approval of the new trends this week 16 reported to the production drug acceptance number (10 varieties) processing status update Among them, 3 varieties have been approved, and 7 varieties have been approved Focus on the hydroxymorphine hydrochloride of Yichang humanwell Pharmaceutical Co., Ltd., which will be approved for production Hydromorphone hydrochloride is a derivative of morphine It is an agonist of opioid receptor, which has a strong analgesic effect It is commonly used in clinical anaesthesia It is mainly used for severe pain caused by trauma, surgery, burns, etc., as well as angina caused by myocardial infarction, and also as an analgesic, antitussive and antidiarrheal agent Hydromorphone hydrochloride was jointly developed by penwest company and endo company On January 1, 1982, FDA approved its injection to be listed under the trade name of opana; on June 22, 2006, FDA approved tablets and sustained-release tablets under the trade name of opanaer According to the registration and acceptance database of pharmaceutical and intellectual drugs, there is no domestic or imported hydromorphone hydrochloride at present At the same time, only HuaSu pharmaceutical and Yichang humanwell pharmaceutical have applied for registration The product of HuaSu pharmaceutical is still in the clinical stage This time, Yichang humanwell will be approved and will be listed for the first time The review and approval of the new acceptance of this week's CDE new acceptance report for the production of 16 drug acceptance numbers, 14 varieties; it is worth noting that broshumab injection of Xiehe fermentation Kirin and radium chloride injection of Bayer Broshumab injection of kylin fermented by Concorde is a rare and urgent new drug for the treatment of hypophosphatemia related to FGF23 This is the first drug approved by FDA for the treatment of X-linked hypophosphatemia (XLH) in children and adults aged 1 and over, which is listed in the second batch of new drugs urgently needed overseas in China Broshumab injection was applied for clinical application in China in July 2017, and it has been reviewed and approved quickly Now it is applied for listing, and it is expected to be included in the list of priority review and approval soon Bayer's radium chloride [223ra] injection radium chloride [223ra] (trade name xofigo), an α - particle radiation radiation therapy drug, was developed by Bayer On May 15, 2013, FDA was approved for marketing to resist prostate cancer patients with the trend of bone metastasis symptoms According to the industry forecast, the peak sales of xofigo can reach US $1.5 billion, but the global sales in 2017 are 408 million euros, and in 2018 are 351 million euros, showing a decline According to the drug intelligence registration and acceptance database, prior to that, on November 23, 2018, Bayer submitted to nmpa an application for listing of radium monochloride [223ra] injection acceptance number (jxhs1800063), which was given priority review and special review However, on May 17, this year, Bayer prostate cancer product was blocked in the market in China, and CDE showed that it had been approved, issued and failed to be approved Now that the variety has been applied for acceptance again, it remains to be seen whether it can be taken down at one stroke! 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