CDE Drug Evaluation Weekly Report (2015.7.12-2015.7.18)

In the review this week (2015.7.12-2015.7.18), 104 drugs (calculated by acceptance number) entered the review status, 101 chemicals, including 8 drugs in 1.1 category, 34 drugs in 3.1 category and 16 imported drugs In addition, there are 1 biological product for treatment, 1 biological product for prevention and 1 Traditional Chinese medicine The key points are as follows: 1 Hmpl-523 acetate tablets: hmpl-523 is a new high selective small molecule inhibitor of tyrosine kinase Syk (spleen tyrosine kinase) in B cell receptor signaling pathway, and it is the second immune drug in the research products of Hutchison Whampoa medicine, which has entered the clinical research stage It is mainly used to treat autoimmune diseases such as rheumatoid arthritis and lupus erythematosus 2 Tenofovir octadecanoxyethyl tablets: This product is modified according to the structure of tenofovir, an antiviral drug It changes the pharmacokinetic characteristics of tenofovir and makes it more easily absorbed and utilized by patients At present, the main structural modified tenofovir on the market is tenofovir dipivoxil, while the other structural modified by Gilead in the development is tenofovir eilaphenolamine, which is to increase the bioavailability of tenofovir prototype and reduce the adverse reactions of tenofovir 3 Qpi-1007: This product is a small nucleic acid drug, developed by raboquark in cooperation with quark company of the United States, for the treatment of non arteritis anterior ischemic optic neuropathy (NAION) Quark has completed phase I / IIa clinical research in the United States and Israel, and the research results preliminarily show the superior safety and effectiveness of qpi-1007 in the field of NAION treatment This product was undertaken by CDE in January 2014 It is a special approved product It is currently the review of reissued materials 4 Umeclidinium bromide: This product is a long-acting M-receptor blocker, which is used to treat chronic obstructive pulmonary disease GSK first declared this product and the preparation of vilanterol / fluticasone, and then the compound preparation of this product and vilanterol This time, it finally declared the single side of this product In the approval week (2015.7.12-2015.7.18), 53 drugs (calculated according to the acceptance number, the same below) entered the approval status, including 51 chemicals and 2 biological products for treatment Key drugs: 1 Pirotinib hydrochloride tablets: pirotinib is a new generation of broad-spectrum, irreversible tyrosinase target inhibitors for epidermal growth factor receptor (EGFR) family independently developed by Shandong xuanzhu (Shandong xuanzhu is a wholly-owned subsidiary of Sihuan pharmaceutical), which will be used to treat lung cancer, breast cancer, gastric cancer and other major clinical needs of malignant tumors with different EGFR family targets At the same time, the latest research found many new mutations in EGFR family, which lead to lung cancer, gastric cancer and other malignant tumors, but these mutations have no effective treatment at present, and pirotinib can effectively inhibit the carcinogenic effect of these mutations The product was submitted to FDA for ind on October 27, 2014 and approved for clinical use on November 28, 2014 In addition, this product was undertaken by CDE in December 2013 It is a special approved product without any supplement So far, it has been approved clinically Let's feel the time gap. In addition, zatoribuprofen tablets and capsules of Jinan bomaikang Pharmaceutical Technology Co., Ltd., fulinota capsules of Jinan Kehui Pharmaceutical Technology Co., Ltd., miplatin for injection of Jiangsu aosaikang Pharmaceutical Co., Ltd and tenofovir dipivoxil fumarate tablets of five manufacturers were approved for clinical use See attached table 1 for drug information under approval Approval completed: there are 12 drugs approved this week, including 9 chemicals, 2 biological products for treatment and 1 biological product for prevention Key drugs: 1 Azd9291: azd9291, developed by AstraZeneca, is an oral, irreversible, third-generation EGFR inhibitor (EGFR-TKI) It has a better therapeutic effect on non-small cell lung cancer (NSCLC) patients with EGFR-TKI resistance and T790M mutation For patients with advanced NSCLC, 50% of acquired resistance to EGFR treatment (such as the resistance of Iressa and trocar) is caused by T790M mutation, azd9291 can make this challenging mutation invalid In addition, azd9291 has little effect on wild-type EGFR, so it has less side effects than existing EGFR inhibitors 2 Nivolumab injection: This product is a PD1 inhibitor developed by Ono, and then developed in cooperation with Bristol Myers Squibb It has been listed in Japan and the United States for the treatment of melanoma and NSCLC In addition, the indications of this product in phase III clinical include renal cell carcinoma At present, the product has been approved for clinical use in China In addition, Bristol Myers Squibb's epimumumab injection and Beijing green bamboo biopharmaceutical Co., Ltd's 23 valent pneumococcal polysaccharide vaccine were also approved for clinical use See attached table 2 for approved drug information There are 22 drugs approved this week, including 15 chemical drugs, 2 traditional Chinese medicines, 1 biological product for treatment, and 4 pharmaceutical excipients Key drugs: 1 Abt-450 / ritonavir / abt-267: this three-way preparation was developed by Alberta, which is an effective anti hepatitis C cocktail therapy Abt-450 is an NS3 / 4A protease inhibitor, abt-267 is an NS5A inhibitor and ritonavir is a protease inhibitor Detailed data from a critical phase III m13-961 (pearl-iii) study showed that the cure rate of hepatitis C cocktail therapy for refractory hepatitis C population was almost 100% At present, the product has been approved for clinical use in China See attached table 3 for the drugs that have been prepared Attachment: