Amphastar Surges on FDA Approval of Generic Hypoglycemia Injection
Amphastar Surges on FDA Approval of Generic Hypoglycemia Injection
Shares of microcap pharmaceutical company Amphastar Pharmaceuticals( AMPH ) - Get Reportrose sharply Tuesday after the company said its glucagon injection emergency kit has been approved by the FDA for the abbreviated new-drug application (ANDA) required for generic drugs.
微市值制药公司股票Amphastar制药公司(安培)-Get Report周二大幅上涨，此前该公司表示，其胰高血糖素注射应急工具包已获得FDA批准，用于仿制药所需的简化新药申请(ANDA)。
Glucagon is indicated for the treatment of severe hypoglycemia and is also used as a diagnostic aid.
胰高血糖素可用于治疗严重低血糖，也可用作辅助诊断。
"This approval is yet another milestone for the Company and marks the first-ever FDA approval of a generic version of rDNA Glucagon," said Amphastar CEO Dr. Jack Zhang.
Amphastar首席执行官Jack Zhang博士说：“这一批准是该公司的又一个里程碑，标志着FDA首次批准rDNA Glucagon的仿制版本。”
Amphastar shares jumped 11.5% to $21.21 in pre-market trading on Tuesday. For the year, the stock is down about 1.5%.
在周二盘前交易中，Amphastar股价跳涨11.5%，报21.21美元.今年以来，该股下跌了约1.5%。
The company was able to demonstrate to the Food and Drug Administration that the synthetic peptide product was bioequivalent and therapeutically equivalent to Eli Lilly's( LLY ) - Get ReportGlucagon Emergency Kit for Low Blood Sugar.
该公司能够向美国食品和药物管理局(FDA)证明，这种合成肽产品与礼来公司(Eli Lilly)的产品具有生物等效性和治疗等效性。伊利)-获得低血糖报告胰高血糖素急救工具包。
"This further highlights Amphastar’s considerable abilities to bring complex generic drugs to the market, and more specifically, our strong peptide capabilities," Dr. Zhang said.
张博士说：“这进一步突显了美国之星™公司将复杂的仿制药推向市场的相当大的能力，更具体地说，是我们强大的多肽能力。”
The company estimates that U.S. sales for Eli Lilly's Glucagon kit were about $144 million and the overall U.S. sales of brand products containing glucagon for injection, 1 mg, were about $306 million for the 12 months ended September 30, 2020.
该公司估计，在截至2020年9月30日的12个月里，礼来公司的Glucagon套件在美国的销售额约为1.44亿美元，含有1毫克注射用胰高血糖素的品牌产品在美国的总销售额约为3.06亿美元。
The Rancho Cucamonga, California-based company expects to launch its Glucagon for Injection Emergency Kit within the next two months.
这家总部位于加利福尼亚州兰乔库卡蒙加的公司预计将在未来两个月内推出胰高血糖素注射急救工具包。
Amphastar currently has four ANDAs filed with the FDA targeting products with a combined market size of about $1.4 billion. The company also has three biosimilar products in development with a total addressable market (TAM) of $13 billion, and nine generic products with a TAM of $12 billion.
Amphastar目前向FDA提交了四份ANDA，目标产品的市场总规模约为14亿美元。该公司还有3种生物相似产品正在开发中，总潜在市场(TAM)为130亿美元，9种仿制药的TAM为120亿美元。
译文内容由第三方软件翻译。