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标题: 2016年6月17日--6月19日药全资讯每天三分钟，知晓医药事 [打印本页]

作者: xiaoxiao 时间: 2016-6-19 07:34 PM
标题: 2016年6月17日--6月19日药全资讯每天三分钟，知晓医药事
            2016年6月17日--6月19日药全资讯每天三分钟，知晓医药事

                                    周末版

今天是周末的最后一天，全国大部分地方都很热，大家注意防暑！
这三天有什么医药资讯呢，xiaoxiao给你汇总了下，往下看

1、广西收回药品GMP证书公告（2016年第5号）
2016年06月17日发布
南宁市生源中药饮片有限责任公司因严重违反《药品生产质量管理规范》规定，根据《药品生产监督管理办法》第五十五条及《药品生产质量管理规范认证管理办法》第三十三条规定，我局依法收回其《药品GMP证书》，现予以公布。

证书编号	企业名称	地址	认证范围	证书收回日期	收回证书机关
GX20130018	南宁市生源中药饮片有限责任公司	南宁市邕宾路28号青秀区二塘工业园	中药饮片(净制、切制、炒制、炙制、煅制、蒸制)、毒性中药饮片(净制、切制、炒制、蒸制)	2016年6月17日	广西壮族自治区食品药品监督管理局

2、众生药业联手药明康德开发7个一类新药项目
广东众生药业股份有限公司（众生药业）在2015年7月13日与药明康德签订了战略合作协议，双方合作时限以5年为一个阶段。第一个合作阶段为2015-2019年，共同进行 1.1 类小分子化学创新药的研发。
众生药业之前已与药明康德陆续开展了“ 治疗耐药性肺癌的一类新药ZSYM003” 、 “ 治疗肿瘤的一类新药ZSYM004”、“治疗甲型流感和人禽流感的 ZSYM005”及“治疗肝癌的一类新药ZSYM006”项目。
6月16日，众生药业发布公告，宣布将与药明康德共同开展“治疗非酒精性脂肪性肝炎的一类新药ZSYM007、ZSYM008和ZSYM009”的合作研发项目。
项目介绍
非酒精性脂肪肝病在发达国家和地区患病率高，全球范围患病率约 15%～40%，其中 10～20%的非酒精性脂肪肝患者会进展为非酒精性脂肪肝炎（NASH)，
预计全球范围内 NASH 的发病率在 3%～5%，但在糖尿病人群中发病率会提高到22%，更值得注意的是 NASH 患者中约有 15～25%的病人会发展成为肝硬化，预测到 2025 年 NASH 将取代丙肝成为需要肝移植的主要疾病，NASH 已成为日趋普遍的世界性慢性肝病。
治疗 NASH 的新药已被全球各大药厂视为未来药品市场的新蓝海，德意志银行甚至预估，一旦有 NASH 的药物上市，到 2025 年时其在全球市场的规模，便可达到 350～400 亿美元，NASH 治疗市场潜力巨大，前景广阔。
NASH的病因复杂，发病机制至今仍不明确，目前尚无 FDA批准治疗该疾病的上市药物。非酒精性脂肪性肝炎疾病领域存在着巨大的未满足需求，研发治疗非酒精性脂肪性肝炎的创新药十分重要。由于 NASH 的复杂性，同时伴有肥胖、糖尿病及心血管风险，临床医生仅以一些胰岛素增敏剂、降脂药以及抗氧化剂治疗 NASH，但疗效甚微。随着科研人员对 NASH 的病理生理学和分子生物学发病机制的认知逐渐深入，治疗 NASH 的新型靶向药物逐渐进入临床研究，为 NASH 的治疗迎来了曙光。
ZSYM007、ZSYM008 和 ZSYM009 是公司和药明康德针对 NASH 不同作用
环节，共同研发的 3 个具有不同独特作用机制并具有自主知识产权的用于治疗非酒精性脂肪性肝炎创新药物。就像丙肝治疗一样，小分子联合用药是 NASH 治疗的一个重要方向。如经过临床研究确证疗效获准上市，将弥补非酒精性脂肪性肝炎疾病治疗领域的不足，单独治疗或者联合治疗 NASH，将具有更优的治疗效果。

3、罗氏抗血癌新药应战生物类似药
　　Gazyva
　　罗氏公司（Roche）一些上市较早的药品即将面临竞争。好消息是，该公司新型抗血癌药物的试验取得了积极结果，使投资者对公司的产品线增添了信心。
　　滤泡性淋巴瘤是一种非霍奇金氏淋巴瘤，试验数据表明，对于该病患者来说，罗氏的新药Gazyva比该公司现有的美罗华（Rituxan）效果更好。
　　去年，美罗华的销售额为56亿瑞士法郎，在罗氏的产品中位列第三。在生物类似药对美罗华的竞争威胁步步紧逼的背景下，罗氏在治疗几种血癌方面需要依靠Gazyva来捍卫自己的市场地位，这款药可能最早于明年上市。
　　随着生物类似药越来越得到监管机构、医务人员和患者的认可，竞争也正在逼近罗氏另一只重磅产品——抗乳腺癌药物赫赛汀（Herceptin），该药去年的销售额达到65亿瑞士法郎。
　　罗氏最畅销的药物阿瓦斯汀（Avastin）也难逃“厄运”。目前，已有几家制药商正在研制美罗华、赫赛汀和阿瓦斯汀的生物类似药。其中，美罗华与赫赛汀已在欧洲专利到期，阿瓦斯汀将于2019年在美国失去专利保护。这些情况都给罗氏带来了压力，促使其研发出具有足够优势的新药品。
　　罗氏称今年晚些时候，公司将提供有关Gazyva研究的更加详尽的结果。在先前的一项研究中，服用这款新药的慢性淋巴细胞白血病患者平均在26.7个月的时间里病情没有恶化。相比之下，服用美罗华的患者平均在14.9个月的时间里病情没有恶化。
　　贝伦堡银行分析师阿利斯泰尔·坎贝尔（Alistair Campbell）表示：“这个结果带给罗氏一个关键机会，使其可以对美罗华已开辟的市场进行拓展升级，并以此来抵抗生物类似药的竞争。”坎贝尔预测，Gazyva的年销售峰值会达到30亿~40亿瑞士法郎。
　　目前，销售出去的美罗华有将近一半用于治疗滤泡性淋巴瘤。根据报告，全球每年大约有75,000个滤泡性淋巴瘤病例。
　　编译/胡德良来源/FT

4、国内首个长效抗艾原创药即将上市
来源: 南都报
位于江宁高新园的“千人计划”企业、前沿生物药业(南京)股份有限公司上周宣布，其自主研发的国家一类新药艾博卫泰的验证性临床三期试验已提前达到所有预设的临床终点指标，将在近期向国家食品药品监督管理总局申报新药上市许可。这是我国本土开发的第一个抗艾新药，也是全球首个治疗艾滋病的长效药。
记者了解到，全球当前有近30款抗艾滋病原创药，但是没有一款产地是中国。为此，约翰·霍普金斯大学博士谢东、哈佛医学院博士后陆荣健、美国肯塔基大学药学院博士王昌进等3位留美精英毅然回国，投身于抗艾滋病原创药开发。他们的团队顶住巨大的研发、资金压力，在国产原创新药研发的艰苦环境中咬牙坚持了13年。
艾滋病毒对单一的药物会产生耐药性，如果把3种或者更多种不同的药放在一起，对艾滋病毒“群起攻之”，就不会产生抗药性。所以当前治疗艾滋病用的是“鸡尾酒”疗法，患者好几种药混合在一起吃，一吃一大把，一日1—3次。而前沿生物研发的是长效药，将把用药频率改为一周一针，价格也会比欧美现有的抗艾滋药低60%。
2014年2月起，前沿生物陆续在全国12个临床中心启动中国第一个治疗艾滋病新药的临床三期试验。经国家食药监总局批准，三期临床试验用于治疗标准一线治疗失败的艾滋病毒感染者。根据对已完成24—48周治疗的208例患者的中期数据分析显示，每周注射一次艾博卫泰联合洛匹那韦/利托那韦治疗“一线配方治疗失败的HIV感染者”的疗效，与世界卫生组织推荐的二线配方(三药组合)相当或更优。
前沿生物董事长、首席科学家谢东博士说：“艾博卫泰是全球第一个进入三期临床试验的长效抗艾新药，它的新分子作用机制使其对主要流行HIV—1病毒以及耐药病毒有效。当前，我国治疗艾滋病药物品种匮乏，无自主创新药物，艾博卫泰有望为广大患者提供一个新的治疗选择。在发达国家，艾滋病已成为药物可控的慢性病，艾博卫泰可改变目前全部是口服药的治疗策略，为HIV感染者摆脱终生每日服药提供一个全新的治疗方案。”
据介绍，艾博卫泰三期临床试验按国际标准设计，主要终点指标为治疗48周血液中HIV病毒载量小于50拷贝/毫升的患者百分比。中期数据显示，艾博卫泰组有80.4%的患者达到主要终点指标

5、FDA 发布咀嚼片的临时指导原则
Michael Mezher 美国FDA新药和仿制药注册
The US Food and Drug Administration (FDA) on Thursday issued new draft guidance covering the quality attributes drugmakers should consider when developing chewable tablets.
The guidance also includes recommendations for what information drugmakers should include when submitting developmental, manufacturing and labeling information to FDA.
FDA says the new guidance is needed, as "numerous approved drug product applications for chewable tablets revealed that in certain cases critical quality attributes such as hardness, disintegration, and dissolution were not given as much consideration as may have been warranted."
Specifically, the agency says that some applications contained insufficient data on quality attributes or used "widely ranging values that were not justified as acceptance criteria."
While the guidance is mostly targeted at new drug applications (NDAs), abbreviated new drug applications (ANDAs) and some chemistry, manufacturing and controls (CMC) supplements, FDA says some of its recommendations also apply to investigational new drug applications (INDs) as well.
FDA says the quality attributes and information discussed in the draft guidance apply to both types of chewable tablets recognized by the United States Pharmacopoeia (USP): "those that may be chewed for ease of administration, and those that must be chewed or crushed before swallowing to avoid choking and/or to ensure the release of the active ingredient."
According to FDA, a chewable tablet should have the following four characteristics:
Easy to chew
Palatable (taste masked or of acceptable taste)
Of appropriate size and shape
Able to disintegrate readily to maximize aspiration and facilitation of dissolution
"Critical quality attributes for chewable tablets should include hardness, disintegration, and dissolution, as well as all factors that may influence drug bioavailability and bioequivalence. In addition, careful attention should be given to tablet size, thickness, and friability, as well as taste, which may impact the ability or willingness of a patient to chew the chewable tablet," FDA writes.
As such, FDA says that reliance on a single quality characteristic is insufficient, and calls on companies to ensure they have a proper balance of quality attributes.
For NDAs specifically, FDA says that sponsors should be able to answer the following questions:
Were the chewable tablets swallowed intact (i.e., without breaking) or after being thoroughly chewed?
If swallowed intact, does the shape and size of the chewable table pose a choking or bowel obstruction risk?
If water was used to aid swallowing, what was the volume?
What was the subject's sensory experience (e.g., taste, mouth feel, and aftertaste?
And for ANDAs, the agency says sponsors should focus on sensory experience, such as taste and mouthfeel, and ease of swallowing when conducting bioequivalence studies.
Additionally, FDA says that companies with already-approved products in chewable tablet form should reevaluate their products' critical quality attributes, and warns that the agency will take "appropriate action … to alleviate the risk to public health" posed by any tablets that do not meet FDA's quality expectations.

Critical Quality Attributes
Hardness	The hardness of chewable tablets should be such that they withstand the rigors of manufacturing, packaging, shipping, and distribution, as well as be easily chewed by the intended patient population. Hardness is generally measured as the force needed to break the tablet in a specific plane. Tablet hardness may be measured and expressed in a variety of units. Applications submitted to FDA should use the same unit of measure in reporting results and specifications. including: kilopond (kp), kilogram-force (kgf), Newton (N), and Strong-Cobb Units(scu). 1 kp = 93 1 kgf = 9.8 N = 1.4 scu. Public standards also exist to ensure consistent measurement of the tablet hardness (Tablet Breaking Force).
Disintegration	The time required for a tablet to break up into small particles is its disintegration time. For chewable tablets, disintegration time should be short enough to prevent GI obstruction in the event a tablet is not completely chewed by the patient. Usually, the presence of the correct type and amount of a disintegrant facilitates rapid disintegration of the tablet. In vitro disintegration testing should be conducted using intact tablets in suitable medium using established disintegration equipment (such as USP Disintegration Apparatus) and methods.
Dissolution	Drug absorption from chewable tablets depends on the release of the drug substance(s) from the intact or the chewed tablets; therefore, in vitro dissolution testing of chewable tablets should follow the principles of dissolution testing of conventional IR tablets. That is, the active pharmaceutical ingredient(s) of the chewable tablets should adequately dissolve out of the tablet with or without chewing. For product characterization during development in vitro dissolution testing should be conducted on intact tablets in at least four media, such as water, aqueous media at pH 1.2, buffer pH 4.5, and buffer pH 6.8, with established dissolution methods using equipment such as USP Apparatus 1 (basket), USP Apparatus 2 (paddle), or USP Apparatus 3 (reciprocating cylinder).
Performance in Simulated Physiological Media	Chewable tablets should also be evaluated using dissolution media such as simulated fasted and fed state gastric and intestinal fluids with enzymes (biorelevant dissolution media). Hardness should also be tested after brief (30-120 s) exposures to small quantities (1-2 mL) of human or simulated saliva. Such studies may provide a better understanding of in vivo performance of the chewable tablets. In vitro testing in physiological media, consistent with the targeted patient population characteristics may support further characterization of the drug product and its critical quality attributes.
Biowaiver and Postapproval Considerations	The solubility and permeability characteristics of the drug substance may be used to determine where the drug fits within the Biopharmaceutics Classification System (BCS). Depending on the BCS classification of the drug substance, proposals for waiver of bioequivalence (BE) studies may be considered for chewable tablets. Changes in the chemistry, manufacturing and controls after approval of the chewable tablets should be made in conformance with the principles outlined in the Scale-up and Post-Approval Changes Immediate Release (SUPAC IR) guidance.

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作者: phoenix0328 时间: 2016-6-20 08:54 AM
谢谢分享！

作者: hnyueer 时间: 2016-6-20 09:28 AM
谢谢分享！

作者: 薛小胖 时间: 2016-6-20 10:02 AM
感谢分享！

作者: wangying 时间: 2016-6-23 12:20 PM
谢谢分享！

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