药物批准丙肝考生不够快在中国

StephenW

4. Drug approvals for hep C candidates not fast enough in China

Friday, December 18, 2015 | By EJ Lane


If China is indeed improving its drug regulatory system, it isn't happening fast enough for hundreds of thousands of hepatitis C patients still reliant on expensive imports for a good treatment, or who can't travel abroad for cutting-edge therapies. That, in a country with 10% of the world's cases of the liver-destroying disease.

The situation leaves those who cannot afford the imports with what is still the standard treatment in China: interferon/ribavirin, both antiretroviral with side effects that half the recipients cannot tolerate.

If mainland China patients could step across into Hong Kong or go elsewhere, they could obtain what has become the standard treatment, direct-acting antivirals (DAAs) capable of curing 95% of hep C cases.

In a lengthy, several-part article, the state-run newspaper, China Daily, noted the gap in treatment and access and blamed it on China FDA's slow approval process that usually takes more than 5 years, longer than some patients can live without proper treatment.

As elsewhere, 80% of hep C patients develop a chronic infection that can develop into cirrhosis or scarring of the liver, in turn leading to its failure or cancer within three decades. The interferon/ribavirin treatment, which has to be injected, keeps the disease under control at a low infection level, but has only a 70% cure rate.

In addition, a recent survey by 28 China hospitals showed that half the antiretroviral patients have serious reactions to the treatment. Local specialists in treating the disease said patients were in a "race against death," and joined various organizations and patient groups in pushing for faster CFDA reviews.

Mainland China counted 350,000 people diagnosed with liver cancer last year and counts 380,000 cancer-related diseases annually. Its surveys also show that 80% of those cancer cases were caused chronic hepatitis in general, not just C.

In the midst of revising its rules and guidelines for conducting clinical trials, the agency has several types of direct-acting antivirals stuck in its lengthy review process.

At the same time, because it has not approved such drugs for use in China, the CFDA considers imported drugs to be fake and illegal, leading desperate patients to defy the law and order the drugs online from abroad.

One drug under review is Gilead Sciences' ($GILD) oral Sovaldi (sofosbuvir), which has a 95% cure rate with fewer side effects and costs $84,000 for a 12-week course, or $1,000 per pill in the U.S.

Pricing for the HCV treatment, if approved, in China is in sharp focus as Gilead is still working with Chinese regulators on approval for Sovaldi and is in talks separately with China on possible pricing, the company recently told FiercePharmaAsia.

The focus in China for chronic hepatitis C is genotype 1b, experts say, with nearly two-thirds of the 30 million estimated cases in that category.

A patient-group leader, who said he was cured by DAAs he bought online from abroad, said most patients would trade all they have for a cure, so they should at least have that choice to buy sofosbuvir or as part of combinations.

China authorities could join the 20-year-old International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use that lets member countries rely on the results of trials conducted by other members to be used in deciding whether to approve a drug without duplicating the trials in China. China still has not joined and insists its lengthy process must be followed.

India, with an equal population, was able to negotiate an agreement with Gilead to allow 9 generics makers to market Sovaldi at $900 per course in emerging markets, but Gilead excluded China as well as Brazil, Mexico and Thailand from the deal.

The newspaper said similar problems exist with many other diseases in China, including HIV/AIDS. To make matters worse, experts estimate that only 10% of the nation's hep C cases are detected, and only half of those seek treatment.

- here's the story from China Daily

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StephenW

4.药物批准丙肝考生不够快在中国

周五，2015年12月18日|通过EJ巷


如果中国确实提高了药品监管系统，它是速度不够快成千上万丙型肝炎患者昂贵的进口好的治疗方法，还是谁也不能出国旅游的尖端疗法仍然依赖的。也就是说，在用的肝疾病破坏的全球箱子10％的国家。

这种情况离开那些谁买不起什么仍是标准的治疗在中国进口：干扰素/利巴韦林，抗逆转录病毒既具有副作用有一半的收件人无法容忍。

如果中国大陆患者可跨一步进入香港或其他地方去，他们能得到什么已经成为了标准治疗，直接作用抗病毒药物（的DAA）能够固化95％的丙肝病例的。

在一个漫长的，有几个部分的文章，国营报纸，中国日报，注意治疗和访问的差距，并指责其在中国FDA的缓慢的审批过程通常需要5年以上的，超过部分患者可以没有适当的治疗。

与其他地方一样，80％的丙肝患者发展为慢性感染，可以发展成肝硬化或肝脏上的疤痕，进而导致其故障或肿瘤内的三十年。干扰素/利巴韦林治疗，其中有被注入，保持疾病得到控制在低的感染水平，但仅具有70％的治愈率。

此外，最近的一项调查28中国医院发现，一半的抗逆转录病毒的患者有严重反应的治疗。在治疗疾病的当地专家说，患者是在一个“对死亡竞赛”，并加入各种组织和患者团体在推动更快的CFDA评论。

中国大陆数35万人确诊为肝癌，去年，每年计38万癌症相关的疾病。其调查还显示，80％的那些癌症病例引起慢性肝炎在一般情况下，不只是C.

在修订其规则和指南进行临床试验之中，该机构有几种类型的卡在其漫长的审查过程直接作用的抗病毒药物。

同时，因为它没有批准这种药物在中国使用的CFDA认为进口药是假的和非法的，导致绝望的病人以身试法，并从国外订购的药品网上。

审查一种药物是吉利德科学公司“（$ GILD）口服Sovaldi（索非布韦），其中有95％的治愈率副作用较少，收费为12周的课程$ 8万4,000人或$ 1,000美元丸在美国

定价为HCV治疗，如获批准，在中国形成了鲜明的重点，因为吉利德仍正与中国监管机构的批准Sovaldi，并在可能的定价单独会谈，中国，该公司最近告诉FiercePharmaAsia。

慢性丙型肝炎在中国的重点是基因1b型，专家说，有近三分之二的该类别3000万估计病例。

以病人为组长，谁说，他是治愈的DAA他在网上买了国外的说，大多数病人会交易他们所为治疗，所以他们至少应该有选择地购买索非布韦或作为组合的一部分。

中国当局可以参加20岁的国际理事会的技术要求协调的人用药品，让成员国依赖于其他成员进行审判的决定是否批准一种药物，而不重复试验中使用的结果在中国。中国还没有加入，并坚称其漫长的过程，必须遵循。

印度拥有平等的人口，是能够通过谈判与Gilead公司的协议，允许9仿制药制造商向市场推出Sovaldi为$ 900美元过程中的新兴市场，但吉利德排除中国以及巴西，墨西哥和泰国的交易。

这家报纸说，与许多其他疾病在中国，包括艾滋病毒/艾滋病问题存在类似的问题。更糟糕的是，专家估计，只有10％的国家的丙肝病例中检测到，只有一半的人寻求治疗。

- 这里是中国日报的故事

相关文章：
Ascletis获得$ 20M高盛在比赛中中国HCV批准
BMS得到一条腿在中国丙肝的比赛用是Phl的Daklinza
中国的药明康德，吉利德重点分析测试更广泛的合作伙伴关系
香港药房吸引中国客户对癌症，丙肝药物

csfluke

批准了也没意义，国内又不能仿制，会贵的完全吃不起，毕竟在美国，最便宜的丙肝药物完整疗程也要6万多美元