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| Of the 17 varieties, 3 of the 17 varieties have shown signs |
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| Author：中國銘鉉 企劃部 Release Time：2017-8-10 8:27:03 Number Browse：852 |
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Medical website August 9
In this paper,
New registrations of registered drugs fell back in July.
Chenxin pharmaceutical first diabetes 1 class new drug enters CDE to begin technical review.
There are 17 varieties of generic applications for the present and 3 varieties have the sign of the application.
In July, five new class of new drugs were approved for clinical use, and the nwah's sarkuba valsartan sodium was approved for import.
New registrations in July fell slightly from last month
According to m Intranet MED drug approval database statistics, CDE for new drug registration in July 434, more than last month retreat, which belongs to the applications to accept the number 49, clinical applications of accepted number 99.
In terms of application types, new drug applications and import applications increased in July, among which import applications increased significantly, while copycat applications declined.
Domestic new drug declaration: chenxin pharmaceutical first diabetes 1 new drug entry into CDE
According to the database of meds, 67 new drugs were applied in July 2017, all of which were clinical applications. There were 53 applications for one class of new drugs, involving 25 varieties. Nanjing SAN pharmaceutical and board are reporting the weather is fine this year to the second class 1 new drug, respectively is SH - 1028 API and tablets and TQ05510 capsule, the temporary not retrieved the two varieties. Here is a brief introduction to a new class of new drugs in July --
Xin greetine (r&d code: DC291407) was developed by the Shanghai institute of medicine of the Chinese academy of sciences and developed for diabetes treatment. It is understood that the drug is Chen xin pharmaceutical first class 1 new drug, in the field of diabetes is also the third class 1 new drug, this year's declaration (after two class 1 new drug is WX - 081 raw material and its tablets, WXFL10030390 raw material and its tablets).
For injection GB251: by Watson biological subsidiary jia and independent research and development, jia and biology with the core independent intellectual property rights, the drug research and development for before received by bead sheet resistance monotherapy and/or type of combination therapy of yew HER2 - positive metastatic breast cancer patients.
, the drug is jiangsu MPH degree for resistance, drug research and development co., LTD., the first independent declaration and with independent intellectual property rights of class 1 new drug, resistant to help with the CFDA years approved of Mr Bush for the same target, research and development for the treatment of brain metastatic non-small-cell lung cancer (NSCLC). A new type of new drug, maleate sutetini, which has been developed by jiangsu mindu and jiangsu su zhong pharmaceutical group, is currently undergoing clinical trials.
Domestic generic declaration: 3 varieties have a cluster declaration
In July, a total of 42 applications were made in China, covering 30 varieties, and the generic varieties were all chemical agents, mainly in 3 categories and 4 applications.
/ ceftriaxone sodium for injection and sodium chloride injection, a hydrate API donepezil HCL, Paris yesterday cloth API, succinic acid sodium reed card will be the active pharmaceutical ingredients, active pharmaceutical ingredients, amino acids (15) AnLiSheng peritoneal dialysate, tadalafil apis, treatment with iodine (131 I) sodium capsule, and nine varieties in China, there is no related production approval.
Trimetazidine hydrochloride zyban, d Glenn dean, sand Glenn dean pills the treatment, active pharmaceutical ingredients, compound polymyxin B ointment, oxaliplatin into injection, succinic acid, reed card will slice, moxifloxacin hydrochloride, nmda ornithine injection, AnLiSheng temple piece, ray for active pharmaceutical ingredients and its injection, fluticasone propionate nasal spray, tadalafil, inhaled use acetylcysteine solution, l-carnitine apis, treatment with iodine (131 I), sodium acetate, sodium capsule salinger injection, 17 varieties for exclusive varieties in China.
It is worth noting that in July, according to the variety of generic paranal yesterday cloth sodium API, nmda ornithine ampoule and vial orchid sola azole ongoing review of application are more than 20, have cluster declare.
Import declaration: 8 varieties are declared at home for the first time
In July, there were 39 new applications for CDE, covering 27 varieties, including 8 varieties for the first time.
RO7034067 oral solution used powder (RG7916) was developed by roche for the treatment of spinal muscular atrophy, which is currently in phase II clinical trials in the United States.
For injection for imogen sheet resistance IDEC company developed by the United States, for the first time in the United States in 2002, trade name Zevalin ®, used in the treatment of recurrent or refractory low-grade, follicular and metastatic B cell non-hodgkin's lymphoma, including rituxan less faorable outcomes after treatment of follicular non-hodgkin's lymphoma.
Approved conditions: 5 new drugs were approved for clinical practice, and the sodium of valsartan was approved for shipment
In July, five new drugs were approved for clinical use, and nwah's shahaba-valsartan sodium was approved for import, according to the minnet MED review database.
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