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国家食品药品监管局：09年批准药品主要集中在十大领域
2010年10月02日 16:11:09 来源： 新华网
新华网北京１０月２日电 防治甲型Ｈ１Ｎ１流感药品、治疗ＨＩＶ感染药品、治疗肿瘤的药品、治疗乙肝的药品……国家食品药品监督管理局９月底发布的《２００９年药品注册审批年度报告》显示，２００９年批准的药品主要集中十大重要领域。
这些领域还包括治疗心血管疾病的药品、治疗糖尿病的药品、抗感染药品、抗排斥免疫抑制药品、抗疟疾药品以及中西药复方制剂。
根据报告，按照“特别审批程序”，国家食品药品监管局批准了国内１０家疫苗生产企业研发的甲型Ｈ１Ｎ１流感病毒裂解疫苗。在疫情肆虐期，全球甲型Ｈ１Ｎ１流感药品短缺的情况下，批准了国产磷酸奥司他韦扩大生产规模、缩短生产工艺的补充申请；批准了磷酸奥司他韦扩大用药人群的补充申请，为特殊人群（儿童、婴幼儿）提供了甲型Ｈ１Ｎ１流感防控的手段；批准了扎那米韦吸入性粉雾剂的进口申请。疫苗和药品的上市，为甲型Ｈ１Ｎ１流感防控提供了有效保障。
治疗ＨＩＶ感染药品方面，目前用于治疗ＨＩＶ感染患者的鸡尾酒疗法的主要药品已在我国批准上市，其中大部分药品已经国产。根据世卫组织推荐的最新版“艾滋病治疗指南”，以及我国“中国艾滋病病人抗病毒治疗研究”的成果，国家食品药品监管局批准了国产奈韦拉平、齐多夫定、拉米夫定联合用药的研究申请。这对阻断艾滋病的母婴传播以及临床治疗耐药具有重要意义。此外，国家食品药品监管局还批准了拉替拉韦钾片与其他抗逆转录病毒药物联合用于对多种抗逆转录病毒药物耐药的患者，这是第一个在我国批准上市的ＨＩＶ－１整合酶抑制剂；批准了非核苷类逆转录酶抑制剂依曲韦林片用于治疗以前曾接受过抗逆转录病毒药物治疗的ＨＩＶ－１感染成年患者（包括对非核苷类逆转录酶抑制剂耐药的患者）。这些药品为耐药的ＨＩＶ感染患者提供了新的治疗手段。
治疗肿瘤的药品方面，国家食品药品监管局批准了国内生产企业研发的非洛他赛进入临床试验，这可能对多西他赛耐药的患者提供新的治疗手段。国家食品药品监管局还批准尼洛替尼进口，为对伊马替尼耐药或不能耐受的慢性髓性白血病患者提供了新的治疗手段；批准了多靶点酪氨酸激酶抑制剂舒尼替尼用于治疗晚期、不可手术的肾癌。
报告显示，国家食品药品监管局批准了境内抗乙型肝炎治疗药品恩替卡韦的生产。国产药品的获准上市，降低了患者的治疗费用，增加了乙肝治疗药品的可获得性。
治疗心血管疾病的药品方面，国家食品药品监管局批准了国内企业研发的依普立酮的临床试验，该药是目前发现的首个高选择性盐皮质激素受体阻断剂，对高血压和心肌梗塞后心衰患者的治疗具有重要意义；批准了全新作用机制的高血压治疗药品阿利吉仑进口，该药为高效选择性人类肾素抑制剂，为高血压的治疗提供了新的手段。
治疗糖尿病的药品方面，国家食品药品监管局批准了磷酸西格列汀片和艾塞那肽注射液的进口申请。前者属高选择性ＤＰＰ－Ⅳ抑制剂，目前为糖尿病的一线治疗药物。后者为肠促胰岛素分泌激素类似物，有与肠促胰岛素分泌激素类似的增强葡萄糖依赖性胰岛素分泌和其他抗高血糖作用，为口服降糖药疗效不佳的Ⅱ型糖尿病患者提供了新的治疗手段。
抗排斥免疫抑制的药品方面，国家食品药品监管局批准了咪唑立宾片仿制药的生产。该药品用于预防肾移植后的器官排斥反应。这一品种的国产化大大降低了肾移植患者临床治疗费用，提高了患者用药的可获得性。
报告还指出，２００９年批准的中药新复方制剂涉及骨伤科、呼吸科、五官科、妇科等多个治疗领域，为这些治疗领域提供了新品种。
State Food and Drug Administration: 2009 approved drugs mainly in the top ten areas
October 2, 2010 16:11:09 Source: Xinhua
Xinhua Xinhua Beijing October 2 Influenza H1N1 influenza prevention and control medicines, treatment of HIV infection drugs, the treatment of cancer medicines, treatment of hepatitis B drug ... ... the State Food and Drug Administration by the end of September release of "2009 Annual Report for regulatory approval" showed that drugs approved in 2009 focused on ten key areas.
These areas include the treatment of cardiovascular diseases, drugs, diabetes drugs, anti-infective products, anti-rejection immunosuppressive drugs, anti-malarial drugs and the western medicine preparations.
According to the report, in accordance with the "special approval process", the State Food and Drug Administration approved the vaccine production of domestic R & D 10 the cleavage of influenza virus H1N1 influenza vaccine. Outbreak of the epidemic, the global shortage of influenza A H1N1 influenza cases drugs, approved oseltamivir phosphate made to expand production scale, shorten the production process, supplementing the application; approved oseltamivir phosphate groups added to expand drug application for special populations (children, infants and young children) provides a means of Influenza A H1N1 influenza prevention and control; approved Fen Wuji inhaled zanamivir import applications. Listing of vaccines and drugs for influenza A H1N1 influenza prevention and control provided effective protection.
Treatment of HIV infection medicines, for the treatment of HIV infected patients present a cocktail of the main drugs approved for marketing in China, most of which drugs have been made. According to the latest version of WHO-recommended "AIDS treatment guidelines," and China's "anti-viral treatment of AIDS patients in China Study" results, the State Food and Drug Administration approved a domestic nevirapine, zidovudine, lamivudine combination therapy of application. This block to child transmission of HIV drug resistance and clinical significance. In addition, the State Food and Drug Administration also approved the drawing for the Labbe potassium tablets with other antiretroviral drugs in combination for a variety of antiretroviral drug resistance in patients, this is the first approved for marketing in China's HIV- 1 integrase inhibitors; approved non-nucleoside reverse transcriptase inhibitor, ribavirin tablets for the treatment of songs previously received antiretroviral drug therapy in patients with HIV-1 infected adults (including non-nucleoside reverse transcriptase inhibitor resistant patients). These drugs to HIV-infected patients resistant to provide a new treatment.
The treatment of cancer drugs, the State Food and Drug Administration approved the research and development of non-domestic production Luo his race to enter clinical trials, which may be resistant to docetaxel in patients offer new treatment. State Food and Drug Administration also approved the import of nilotinib for imatinib resistant or intolerant chronic myelogenous leukemia patients provide a new treatment; approved a multi-target tyrosine kinase inhibitor Shu Nepal erlotinib for the treatment of advanced, inoperable kidney cancer.
The report shows that the State Food and Drug Administration approved the anti-hepatitis B therapy within the drugs entecavir production. Allowed domestic drug market and reduce the cost of treatment of patients, hepatitis B treatment increased the availability of drugs.
Drug treatment of cardiovascular diseases, the State Food and Drug Administration approved the research and development of domestic enterprises by Premier ketone clinical trials, the drug is found in the first highly selective mineralocorticoid receptor antagonist, on blood pressure and the treatment of patients with heart failure after myocardial infarction is important; approved a new mechanism of action of aliskiren treatment of hypertension drugs imported the drug for the high selectivity of human renin inhibitors for the treatment of hypertension offers a new means.
Diabetes medicines, the State Food and Drug Administration approved the phosphate Sigma, Januvia tablets and injection exenatide import applications. The former is a highly selective inhibitor of DPP-Ⅳ, the current first-line treatment for diabetes. Secretion of the latter incretin hormone analogues, with incretin hormone secretion with a similar enhancement of glucose dependent insulin secretion and other anti-high blood sugar, poor efficacy of oral hypoglycemic agents in patients with type Ⅱ diabetes provides new treatment.
Anti-rejection immunosuppressive drugs, the State Food and Drug Administration approved the generic drug mizoribine film production. The drugs used to prevent organ rejection after kidney transplantation reaction. Localization of this species greatly reduced cost of clinical treatment of renal transplant patients, improve patient access to pharmaceutical.
The report also pointed out that in 2009 approved the new combination of traditional Chinese medicine preparations involving orthopedic, respiratory, ENT, gynecology and other multiple therapeutic areas, as these provide a new variety of therapeutic areas. |
