吉利德科学公司获得了中国FDA的Sovaldi的批准

StephenW

              Gilead nabs Chinese nod for Sovaldi, eyeing world's largest hepatitis C patient base  
                                                                      by                                    Angus Liu                                |             Sep 25, 2017 12:00pm
                          
                                                                                
      
                                                                      Gilead Sciences’ has received approval for Sovaldi from China's FDA, gaining a foothold in the world's largest hepatitis C market.
                     
                        
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                                        When Gilead Sciences cut deals for generics makers to sell its pricey hepatitis C cures in emerging markets at superdeep discounts, it left China out of the mix, saving it for itself. Now, as sales of its hep C franchise have gone soft in developed markets, it has gotten approval to market to China’s 10 million infected patients.   
               
The company announced Monday that China’s FDA has given the go-ahead in China for Sovaldi, the company’s first HCV medication, based on a China-specific phase 3 that showed the drug could treat 92% to 100% patients with genotype 1, 2, 3 or 6. Gilead also is examining single-tablet regimens Harvoni and Epclusa in the clinic at sites across China, hoping to gain approvals in the near future.
For China, hepatitis B already has long been seen as a big problem, with its infected population nearing 100 million, and until recently, authorities have channeled much of its resources in controlling that disease. But now it is trying to quickly address the emerging public health concerns over hepatitis C. While public education is still playing catchup, the CFDA has speeded up treatment approvals, putting applications on its priority review pathway.
Bristol-Myers Squibb’s dual-drug regimen Daklinza and Sunvepra, just approved in April, became the first direct-acting antiviral agents approved in the country.  A pair from AbbVie, ombitasvir and dasabuvir, was approved at the same time as Sovaldi. And perhaps a more imminent threat to Sovaldi lies in Merck’s Zepatier, whose application for approval was accepted by CFDA last month.
When Gilead launched Sovaldi in the U.S., its sky-high, $1,000-per-pill price aroused wide criticism. FiercePharma previously reported that Gilead started talks in 2015 with the Chinese government on pricing for Sovaldi ahead of its approval. That was on the backdrop of China being excluded from a deal that saw Gilead cut the drug’s cost to about $10 per pill that covers many emerging markets.
China’s estimated 10 million HCV patient base, as compared to the U.S.’ 3-4 million estimate by the CDC, is definitely more enticing. But as China is quite sensitive about prices, in order to reach a large enough population to compensate for sales losses in the U.S., Gilead will have to work out a careful pricing plan for those new hep C medications.
               
How Gilead will price Sovaldi in China is yet unknown, but the company has already found the person to accelerate its launch plans. Last September, it tapped former Roche China’s VP of corporate affairs and market access, Rogers Luo, as its new China GM. His task was pretty much laid out at that time: to “lead the build out of the commercial team across China to support the anticipated launches of Sovaldi, Harvoni, Epclusa and single agent TAF for HBV over the next several years.”
To support that effort, the company also quietly revealed earlier this year that it is building a new manufacturing site in the city of Hangzhou near Shanghai.
In the U.S., even though Gilead returned a better-than-expected $2.86 billion from its hep C business in the second quarter after sales plummeted consecutively in 2016, it is facing even more competition in the form of AbbVie’s recently approved Mavyret, which requires shorter treatment time—eight weeks vs. 12 weeks—and more importantly, a cheaper price tag.

StephenW

Gilead nabs为Sovaldi打中国人，眼中世界上最大的丙型肝炎患者基地
由安格斯·刘| 2017年9月25日下午12:00
索瓦尔迪打包
吉利德科学公司获得了中国FDA的Sovaldi的批准，在世界上最大的丙型肝炎市场上占有一席之地。


当吉利德科学公司削减了泛型制造商的交易，以超级折扣在新兴市场出售其昂贵的丙型肝炎治疗药，使中国摆脱了困境，为自己省力。现在，由于其在C C专营店的销售在发达市场上走软，已经获得了对中国1000万感染患者的市场批准。

该公司周一宣布，中国FDA已经在中国推出了该公司第一个HCV药物Sovaldi，基于中国特定阶段3，显示该药物可以治疗92％至100％的基因型1,2的患者，吉利德还正在中国各地的诊所检查单片方案Harvoni和Epclusa，希望在不久的将来获得批准。

对于中国来说，乙型肝炎早已被视为一个大问题，其感染人口接近1亿，直到最近，当局已经投入大量资源来控制这种疾病。但现在正在努力快速解决新兴的公共卫生对丙型肝炎的担忧。虽然公共教育仍然在追赶，但CFDA已经加快了对治疗的批准，将其应用于优先审查途径。

Bristol-Myers Squibb双重药物Daklinza和Sunvepra于4月份获得批准，成为该国首批通过直接作用的抗病毒药物。来自AbbVie，ombitasvir和dasabuvir的一对，在Sovaldi的同时获得批准。也许对Sovaldi的更为迫在眉睫的威胁在于默克的Zepatier，上个月被CFDA接受了其批准申请。

当吉利德在美国推出Sovaldi时，其天价高达1,000美元的价格引起了广泛的批评。 FiercePharma之前曾报道说，基列在2015年开始与中国政府就Sovaldi进行定价谈判。那是因为中国被排除在一个交易之外，吉利德将药物的成本降低到每片药物10美元以上，这涉及许多新兴市场。

中国估计有1000万HCV患者基数与美国CDC预测的3-4百万次相比肯定更为诱人。但是由于中国对价格非常敏感，为了达到足够的人口来弥补美国的销售损失，吉利德必须为这些新的C型药物制定一个谨慎的定价计划。

吉亚德在中国的价格如何价格尚未知道，但该公司已经找到了加快发布计划的人。去年九月，罗氏中国公司事务和市场准入副总裁罗杰斯（罗杰斯·罗）作为新的中国通用汽车公司。他的任务当时已经很明确：要“引导中国各地的商业团队建设，以支持在未来几年内预期推出Sovaldi，Harvoni，Epclusa和单身代表性乙型肝炎疫苗。

为了支持这一努力，公司还在今年早些时候悄悄地透露，它正在上海附近的杭州市建设一个新的生产基地。

在美国，尽管吉赛德在二季度连续第二季度从其C类业务中回落了超过预期的28.6亿美元，但2016年仍然呈现出更加竞争的形式，即AbbVie最近批准的Mavyret，这需要更短的时间治疗时间 - 八周与十二周 - 更重要的是，一个更便宜的价格标签。

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