Amphastar Surges on FDA Approval of Generic Hypoglycemia Injection
Amphastar Surges on FDA Approval of Generic Hypoglycemia Injection
Amphastar shares jumped 11.5% to $21.21 in pre-market trading on Tuesday. For the year, the stock is down about 1.5%.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.
微市值製藥公司股票Amphastar製藥公司(安培)-Get Report週二大幅上漲，此前該公司表示，其胰高血糖素注射應急工具包已獲得FDA批准，用於仿製藥所需的簡化新葯申請(ANDA)。
Glucagon is indicated for the treatment of severe hypoglycemia and is also used as a diagnostic aid.
胰高血糖素可用於治療嚴重低血糖，也可用作輔助診斷。
"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首席執行官Jack Zhang博士説：“這一批准是該公司的又一個里程碑，標誌着FDA首次批准rDNA Glucagon的仿製版本。”
Amphastar shares jumped 11.5% to $21.21 in pre-market trading on Tuesday. For the year, the stock is down about 1.5%.
在週二盤前交易中，Amphastar股價跳漲11.5%，報21.21美元.今年以來，該股下跌了約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.
該公司能夠向美國食品和藥物管理局(FDA)證明，這種合成肽產品與禮來公司(Eli Lilly)的產品具有生物等效性和治療等效性。伊利)-獲得低血糖報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.
張博士説：“這進一步突顯了美國之星™公司將複雜的仿製藥推向市場的相當大的能力，更具體地説，是我們強大的多肽能力。”
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.
該公司估計，在截至2020年9月30日的12個月裏，禮來公司的Glucagon套件在美國的銷售額約為1.44億美元，含有1毫克注射用胰高血糖素的品牌產品在美國的總銷售額約為3.06億美元。
The Rancho Cucamonga, California-based company expects to launch its Glucagon for Injection Emergency Kit within the next two months.
這家總部位於加利福尼亞州蘭喬庫卡蒙加的公司預計將在未來兩個月內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，目標產品的市場總規模約為14億美元。該公司還有3種生物相似產品正在開發中，總潛在市場(TAM)為130億美元，9種仿製藥的TAM為120億美元。
譯文內容由第三人軟體翻譯。
