Eisai寻求中国批准全新的癌症药物

StephenW

   
July 5, 2017 12:47 pm JST
Eisai to seek China's approval for brand-new cancer drug

Regulation reform gives drugmakers reason to tap huge market early

NATSUKI YAMAMOTO, Nikkei staff writer

Eisai's Lenvima is already available for treating certain types of thyroid and kidney cancer.

TOKYO -- Eisai intends to apply in China as soon as October for marketing approval for its new liver cancer drug Lenvima, which the company only just submitted in Japan in June and will submit in Western nations later this month.

Including China among the first target markets for a new drug is a first for Eisai and a rarity among foreign drug companies because of the regulatory hurdles there. But China appears ready to change its rules on the use of multiregional clinical data, and that has the drug companies speeding up their efforts to tap into the huge and growing Chinese market.

Eisai is developing Lenvima for the treatment of hepatocellular carcinoma, which accounts for some 80% of the 800,000 global cases of liver cancer each year and is concentrated in Asia, home to four out of five patients with this type.

Eisai conducted multiregional phase III clinical trials on Lenvima on 954 subjects, including 100 from China. It will use that data when submitting the drug to the Chinese regulators for approval.

Up until now, most drugs submitted for marketing approval in China by multinational drug companies have been accompanied by data from clinical trials conducted inside China. That is because the only way to use data from multiregional trials has been to apply ahead of time for an exemption, which takes nearly 20 months to receive.

But now China is considering doing away with the exemption requirement and letting drug companies use the data from their multiregional trials, provided that the trials include a certain number of Chinese patients. Eisai is acting on the assumption that the new policy will soon come into effect.

China's drug market was worth an estimated 12.9 trillion yen ($114 billion) in 2016, about 20% more than Japan's, and with rising incomes fueling the demand for new medications, the market could approach 19 trillion yen by 2021, according to a forecast by market research firm by QuintilesIMS.

Japan's pharmaceutical companies are now actively working to introduce products into this growth market. Astellas Pharma has applied in China for approval to market its prostate cancer drug Xtandi, and Takeda Pharmaceutical is busy with phase III clinical trials on Azilva to treat high blood pressure and on Takecab for acid-related diseases, including gastric ulcers and acid reflux.

Because of the regulatory hurdles, pharmaceutical companies have tended to wait to introduce drugs in China until after the products have demonstrated some success in other markets.

But given the size of the Chinese market, drugmakers are expected to act to release product simultaneously in China, Japan and the West in order to capture as much business as possible.

StephenW

2017年7月5日下午12:47 JST
Eisai寻求中国批准全新的癌症药物

监管改革使药物制造商有理由早日挖掘巨大的市场

日本的日本工作人员作家

Eisai的Lenvima已经可以治疗某些类型的甲状腺和肾癌。

东京 - Eisai打算在10月份在中国申请营销批准其新的肝癌药物Lenvima，该公司仅在6月份在日本提交，并将在本月晚些时候在西方国家提交。

包括中国在内的第一个新药的目标市场是伊斯兰的第一个，外国药物公司的罕见，因为监管的障碍。但中国似乎已经准备好改变使用多地区临床数据的规定，而且这些药物公司也加快了进军中国市场的巨大发展。

Eisai正在开发Lenvima用于治疗肝细胞癌，其占全球80万例全球肝癌病例的80％左右，集中在亚洲，其中有5例患有这种类型的4例。

Eisai对Lenvima进行了多地区III期临床试验，共有954项科目，其中100项来自中国。在将药物提交给中国监管机构批准时，将使用该数据。

到目前为止，多数药物公司在中国提交营销批准的大多数药物都伴随着在中国进行临床试验的数据。那是因为使用多地区试验数据的唯一办法是提前申请豁免，这需要近20个月的时间才能收到。

但是现在中国正在考虑消除免除要求，让药物公司使用多方面试验的数据，只要试验包括一定数量的中国患者。 Eisai正在考虑新政策即将生效的假设。

据中国药物市场估计，2016年价值估计为12.9万亿日元（约合1140亿美元），比日本高出约20％，收入增加加剧了新药的需求，到2021年，市场可能接近19万亿日元。 QuintilesIMS的市场研究公司。

日本的制药公司正在积极地将产品引入这个增长市场。 Astellas Pharma已在中国申请批准上市其前列腺癌药物Xtandi，武田药业正在忙于Azilva进行III期临床试验以治疗高血压和Takecab用于与酸相关的疾病，包括胃溃疡和酸反流。

由于监管方面的障碍，制药公司往往等待在中国引进毒品，直到产品在其他市场上取得了一些成功。

但鉴于中国市场的规模，制药商预计将在中国，日本和西方同时发布产品，以尽可能多地获得业务。

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