CDE publicized on December 2 the twelfth batch of registration applications of pharmaceutical products to be included in the priority review procedure, with 32 acceptance numbers in total included in the list.
Generic drugs that have been marketed overseas and are applied synchronously for marketing in China
In the list of acceptance numbers published this time, those selected by reason of "generic drugs that have been marketed overseas and are applied synchronously for marketing in China" are 9 acceptance numbers involved by separately 3 products: Jiangsu Huayi’s FLudeoxyglucose [18F] Injection, Guangzhou GreenSyn’s Montelukast Sodium, Shanghai Anbison Laboratory’s Montelukast Sodium Tablets and Montelukast Sodium Chewable Tablets, and Zhejiang Huahai’s Valsartan Tablets. It will mean that the above products will obtain the title of passing the "consistency evaluation" once they are approved.
According to Xanda V3.2, 4 enterprises of Montelukast Sodium Chewable Tablets entered the first batch for self-inspection, i.e., the self-inspection list on July 22, 2015, separately being Taiwan, China Biotech (acceptance numbers: JXHS1100042 and JXHS1100043), Yangtze River Pharmaceutical Group Nanjing Hailing Pharmaceutical Co., Ltd. (acceptance No.: CYHS1190015), Beijing Winsunny Harmony (acceptance No.: CYHS1190034), and Beijing Hanmi (acceptance numbers: CYHS1390027 and CYHS1390028), wherein, Beijing Winsunny Harmony’s acceptance No. was withdrawn in the No. 21 announcement in 2016, and Beijing Hanmi’s acceptance numbers were separately withdrawn in the No. 264 and No. 287 announcements in 2015. The Montelukast Sodium Chewable Tablets of Shanghai Anbison was co-applied for with Hangzhou Minsheng Binjiang Pharmaceutical, and is expected to be approved for the human bioequivalence test in this priority review. Enterprises marketing Montelukast Sodium Chewable Tablets and Montelukast Sodium Tablets currently in China include Lunan Better Pharmaceutical and Sichuan Otsuka Pharmaceutical, both of which need to accelerate the application for "consistency evaluation".
The application of Zhejiang Huahai Pharmaceutical’s Valsartan Tablets can be called full of twists and turns: it entered the first batch for self-inspection, and then was withdrawn in the No. 255 announcement in 2015; the drug has been approved by FDA and marketed in the U.S., but its human bioequivalence test is expected to be conducted again as required by this priority review. There is currently only 1 Chinese manufacturer, namely, Changzhou Siyao, marketing Valsartan Tablets in China, and the competition for the Valsartan Capsules is fiercer.
First generic varieties
Those among the first batch for self-inspection and included in the twelfth batch for priority review by reason of "first generic varieties" include Beijing Winsunny Harmony’s Moxifloxacin Hydrochloride (acceptance No.: CXHS1400150) and Moxifloxacin Hydrochloride Tablets (acceptance No.: CYHS1490056), and the variety is also listed in the Announcement on the Plan for On-site Inspection of Drug Clinical Trial Data (No. 8), corresponding to RMB 150 million size of sample hospital market in China. Such variety of Jiangsu Tianyishi Pharm and Chongqing Huapont Pharm also in the first batch for self-inspection has been withdrawn in the announcement. Furthermore, the PKU Healthcare’s Moxifloxacin Hydrochloride Tablets (CYHS1690001) has entered the fourth batch for self-inspection, i.e., the self-inspection list on November 4, 2016. Therefore, the era of competition for generic drugs of the Moxifloxacin Hydrochloride Tablets is upcoming.
Anti-AIDS drugs
Chiatai Tianqing’s Tenofovir Disoproxil Fumarate Tablets (acceptance No.: CYHS1600082) has entered the priority review by reason of "anti-AIDS drugs". This product of Chiatai Tianqing also entered the first batch for self-inspection, but was withdrawn in the No. 21 announcement in 2016; enterprises having the same case include Zhuhai United Laboratories Zhongshan Branch, Anhui Biochem Bio-pharmaceutical, and Supor South Ocean.
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