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Beijing Hanmi (acceptance numbers: CYHS1390027 and CYHS1390028), wherein, Beijing Winsunny Harmony’s acceptance No. was withdrawn in the No. 21 announcement in 2016, and Beijing Hanmi’s acceptance numbers were separately withdrawn in the No. 264 and No. 287 announcements in 2015.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Valsartan Tablets can be called full of twists and turns: it entered the first batch for self-inspection, and then was withdrawn in the No. 255 announcement in 2015; the drug has been approved by FDA and marketed in the U.S., but its human bioequivalence test is expected to be conducted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.

The drug of Chengdu Brilliant Pharmaceutical also in the first batch for self-inspection is reported to have been approved for production after going through the 2016 No. 1 Plan for On-site Inspection of Drug Clinical Trial Data. The indications applied for clinical trial by Chengdu Brilliant in 2013 included chronic hepatitis B (for adult patients and child patients aged above 12) and HIV-1 infection (in combination with other antiretroviral drugs for adult patients and child patients aged 2 and above). If Chengdu Brilliant has been approved the indication of its anti-AIDS drug, the reason for the priority review of Chiatai Tianqing’s Tenofovir Disoproxil Fumarate Tablets is questionable.

The drug reapplied for by Anhui Biochem Bio-pharmaceutical entered the third batch for self-inspection, i.e., the self-inspection list on September 1, 2016, and the drug of Qilu Pharmaceutical also entered the third batch for self-inspection, and both companies will be checked separately according to the No. 8 Plan for On-site Inspection of Drug Clinical Trial Data and the No. 7 Plan for On-site Inspection of Drug Clinical Trial Data.

There have been 5 relevant products of anti-AIDS drug that receive the priority review and approval qualification since 2015, and besides the Tenofovir Disoproxil Fumarate Tablets, there is also the ACC007 API applied for by Jiangsu Aidea in the twelfth batch for priority review. ACC007 is a new non-nucleoside reverse transcriptase inhibitor for AIDS virus, and is reported to have been completed the Phase I human single ascending dose (SAD) and multiple ascending dose (MAD) clinical study with healthy volunteers in South Korea.

Rare diseases

The Recombinant Coagulation Factor Ⅷ for Injection of Beijing Northland and Bayer HealthCare AG has received priority review by reason of "rare diseases", being the third product expected to receive priority review due to rare diseases, with the target indication of hemophilia A.

More clinical advantages

9 products have received priority review due to having more clinical advantages, and there are 4 in the twelfth batch alone, separately being Pfizer’s Apixaban Tablets, Beijing Novartis’ Sacubitril/Valsartan Sodium Tablets, Bayer’s Riociguat Tablets, and Xi’an Janssen’s Ibrutinib Capsules, all of which are applied for production.

Co-developed by BMS and Pfizer, Apixaban Tablets were marketed by BMS in China, but the right to market the drug in China has recently been transferred to Pfizer. The application of Pfizer this time is expected to increase the indication of reduction of leg deep vein blood clot (i.e., deep venous thrombosis) and pulmonary embolism recurrence following initial treatment on the basis of "prevention of VTE of adult patients who received elective hip joint or knee joint replacement and prevention of stroke and systemic embolism of NVAF adult patients".

Sacubitril/Valsartan Sodium Tablets and Riociguat Tablets entered the third batch for self-inspection, with the former, i.e., LCZ696, being the compound combination of valsartan, an angiotensin II receptor blocker, and AHU-377, an enkephalinase inhibitor, with the indication of reduction of heart disease death and heart failure hospitalization risks of chronic heart failure patients, and the latter approved by FDA on October 8, 2013 for treating pulmonary arterial hypertension. The indication of Ibrutinib Capsules is the newly diagnosed, and recurrent or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.

Pediatric drugs

There have been 14 products in total that receive priority review by reason of pediatric drugs, and the pediatric drug among the twelfth batch that receives priority review is the live oral pentavalent reassortant rotavirus vaccine (Vero cells) developed by MSD. There have been 2 imported vaccines approved in the recent half year in China: Pfizer’s 13-valent pneumococcal conjugate vaccine was approved in November 2016, also mainly used in children; GSK’s human papillomavirus absorbed vaccine was approved in July 2016.

Click to read: Update on Priority Review by CDE: Acceptance of First CAR-T Therapy Clinical Application

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