CDE drug review weekly report (2016.04.11-2016.04.17)

Abstract: this week, the production application review of two 3.1 chemicals was completed, and it should be approved for production by visual inspection In addition, Changzhou Yinsheng, Zhengda Tianqing and Beida pharmaceutical have also applied for 1.1 chemicals This issue focuses on: 1 Shortly after obtaining the clinical approval of fubitavir tablets, another class 1.1 anti hepatitis C drug, amphetamine Hewei soft capsule in Changzhou Yinsheng, has entered the queue for review; 2 After Zhengda Tianqing obtained the clinical approval of two class 1.1 new drugs in succession last month and this month, the first class 1.1 new drug tq-f3083 capsule declared this week has entered the review stage; 3 Beida pharmaceutical company declared the first 1.1 new drug BPI-7711 capsules of the year 4, the Wuhan Bijie biological pharmaceuticals declared the bispecific antibody: recombinant anti HER2 and CD3 humanized bispecific antibodies for injection, 5, the 1.1 New Drugs Department of Li's pharmaceutical factory finished the evaluation of the leuvastatin gel, and the details should not be approved 6 After more than ten years, the evaluation of epipiride / iodine [131I] epipiride injection for class 1.1 chemical medicine of Jiangsu Institute of atomic medicine has finally been completed; 7 The application of palonosetron hydrochloride injection for class 3.1 of Shenzhen Haiwang Pharmaceutical Co., Ltd has completed the three in one audit, and then it is in the process of approval The new version of GMP of the injection has also passed, which should be batch production by visual inspection, and will not be sold far away 8 Shanghai GM's 3.1 new drug ticonazole ointment has also completed the three in one review and is currently in the state of approval, which is estimated to be approved 9 72 drugs entered the review stage this week, 319 drugs were reviewed and approved, of which 3.1 categories accounted for 213; the key drug anfihewei soft capsule: This product was jointly developed by Changzhou Yinsheng, Sichuan University and China Pharmaceutical University, which is an NS4B inhibitor for anti HCV It is understood that Yinsheng Pharmaceutical Co., Ltd and Sichuan University have developed two kinds of anti hepatitis C drugs, namely, the forbitavir tablet (NS5A inhibitor) and this product, which obtained the clinical approval last month It is worth mentioning that the two kinds of compounds have very good characteristics of combined drug use, which can achieve a strong synergistic effect of reducing virus resistance, shortening the treatment cycle and improving the drug efficacy We sincerely hope that we can take the anti HCV drugs developed by domestic enterprises as soon as possible, instead of relying on the new drugs from foreign enterprises Tq-f3083 capsule: This product was declared by Zhengda Tianqing No accident occurred Xiaobian still didn't find any clues about this product Does Tianqing do such a good job in confidentiality? No information can be found in the latest batch of clinical patients Please let me know if you know By the way, since 2015, Zhengda Tianqing has declared five class 1.1 chemicals in the name of the company, all of which are capsules, namely tq-b3234 capsules, tq-b3395 capsules, tq-b3139 capsules, tq-b3101 capsules and tq-f3083 capsules The first two of them have been approved this month and last month Xiaobian has a pair of bitter tears None of the five medicines let me find out the details! Bpi-7711 capsule: This product was declared by Beida Pharmaceutical Co., Ltd no relevant information has been found at present Xiaobian has studied the company's public pepline, which has the most anti-tumor drugs, but there is no such number! So it's up to everyone In addition, since 2015, Beida pharmaceutical has also declared four 1.1 chemicals, bpi-3016 injection (diabetes), bpi-15086 tablets (anti-tumor), x-396 capsule (anti-tumor) and bpi-7711 capsule However, none of these products is in its public pepline Recombinant anti HER2 and CD3 humanized bispecific antibody for injection: This product was declared by Wuhan youzhiyou biopharmaceutical Co., Ltd the company used the antibody gene engineering construction technology to independently innovate and establish the youzhiyou bispecific antibody engineering construction platform, and developed a series of new generation therapeutic double targeted antibody drugs for tumor In addition to this product, pepline also includes drugs targeting EpCAM / CD3, CD20 / CD3, EGFR / CD3, emp2 / CD3, CD133 / CD3 and HER3 / CD3 In addition, at the end of 2014, Xianda published an article about bispecific antibody: "now the hot bispecific antibody, do you catch up?" Gellipin gel: This product is declared by the Siu Ke pharmaceutical company, a wholly owned subsidiary of Li's large pharmaceutical company, for vulvovaginal candidiasis and partial vulvar vagina administration This product entered the CDE evaluation center in August 2014 It is a special approved product After a supplement, it seems that it is still not approved at present Epipiride for injection / iodine [131I] epipiride injection: epipiride is a good ligand for dopamine D2 receptor with high affinity Its [123I] iodine standard has been successfully used in single photon emission computed tomography of dopamine D2 receptor, providing an effective means for the research of brain life science This product was declared by Jiangsu Institute of atomic medicine in 2005 It has been a long time since it was reviewed after a supplement.