美国生物技术公司专注于中国在那里建立制造工厂

StephenW

U.S. biotech focused on China to build manufacturing facility there
by Eric Palmer | Nov 19, 2018 11:23am
China flag against blue sky
Hepatitis B drug entecavir is among a portfolio of ANDAs that CASI Pharmaceuticals bought from Sandoz and intends to sell in China. (Pixabay)

A U.S. biotech that bought a portfolio of nearly 30 generic drugs from Sandoz in January says it has plans to build its first manufacturing facility in China, where it has focused much of its drug development efforts.  

Rockville, Maryland-based CASI said on Friday that it “has entered into framework agreements” to build a manufacturing site at the Wuxi Huishan Economic Development Zone in Jiangsu Province, China.

CASI provided no details about the agreements in terms of cost or size of a facility, saying only that it expects construction to begin in the middle of 2019 and the facility will be able to handle large-scale production.
Free Daily Newsletter
Like this story? Subscribe to FiercePharma!
Biopharma is a fast-growing world where big ideas come along daily. Our subscribers rely on FiercePharma as their must-read source for the latest news, analysis and data on drugs and the companies that make them. Sign up today to get pharma news and updates delivered to your inbox and read on the go.
SUBSCRIBE NOW

“We are excited about moving forward with building our own manufacturing site as part of our supply chain,” CASI Executive Chairman Wei-Wu He, Ph.D., said in a statement. “The facility will be a core component of our long-term growth strategy as it will give us significantly greater capacity in order to meet the company’s commercial needs, and also will allow us greater control over quality, cost of goods and to accelerate production schedules.”

RELATED: Novartis finally unloads 300 troubled U.S. generics to India’s Aurobindo for $1B

CASI, which has acquired a number of drugs for development in China, announced in January that it had bought a portfolio of ANDAs from Novartis' Sandoz, including 25 approved drugs and four pipeline ANDAs that are pending FDA approval. Among those is entecavir, an antiviral treatment for hepatitis B, which is a significant problem in China.

Sandoz sold off hundreds of its U.S.-approved generics this year as prices in the U.S. have crashed, making it difficult to earn a margin on many copies.

But CASI has other plans for the Sandoz portfolio. It expects to take advantage of China’s recent regulations accepting Western pharmaceutical and clinical data to get drugs approved there, which it believes will allow it to quickly get some of these medicines into the massive Chinese market.  

In June, the biotech announced it had a struck a long-term contract manufacturing deal with a subsidiary of Shijiazhuang Yiling Pharmaceutical to produce entecavir as well as cilostazol for the Chinese market.

StephenW

美国生物技术公司专注于中国在那里建立制造工厂
作者：Eric Palmer | 2018年11月19日上午11:23
中国旗子反对蓝天
乙型肝炎药物恩替卡韦是CASI Pharmaceuticals从Sandoz购买并计划在中国销售的ANDA组合之一。 （Pixabay）

1月份，一家美国生物技术公司从Sandoz购买了近30种仿制药的产品组合，称其计划在中国建立其第一家生产工厂，并将其大部分药物开发重点放在中国。

总部位于马里兰州罗克维尔的CASI周五表示，它“已签订框架协议”，将在中国江苏省无锡市惠山经济开发区建设生产基地。

CASI没有提供有关设施成本或规模的协议的详细信息，仅表示它预计将在2019年中期开始施工，并且该设施将能够处理大规模生产。

“我们很高兴能够将我们自己的生产基地建设成为我们供应链的一部分，”CASI执行主席Wei-Wu He博士在一份声明中表示。 “该设施将成为我们长期发展战略的核心组成部分，因为它将为我们提供更大的能力，以满足公司的商业需求，同时也将使我们能够更好地控制质量，货物成本并加快生产进度“。

CASI在中国已经收购了一些药物用于开发，1月份宣布已从诺华的Sandoz购买了一批ANDA，其中包括25种获批药物和4种正在等待FDA批准的管道ANDA。其中包括恩替卡韦，一种抗乙型肝炎的抗病毒治疗药物，这在中国是一个重大问题。

Sandoz今年销售了数百件美国批准的仿制药，因为美国的价格已经崩溃，因此难以在许多副本上赚取利润。

但CASI对Sandoz产品组合还有其他计划。它希望利用中国最近的法规，接受西方药品和临床数据，以获得在那里批准的药物，它相信这将使它能够迅速将这些药物进入中国大规模市场。

今年6月，该生物技术公司宣布与石家庄一鸣药业的子公司达成长期合同制造协议，为中国市场生产恩替卡韦和西洛他唑。