The United States Food and Drugs Administration (

美国食品药品监督管理局 (

USFDA

美国食品药品监督管理局

) has formally accepted

) 已正式接受

Wockhardt Ltd

沃克哈特有限公司

’s

的

New Drug Application

新药申请

(NDA) for its breakthrough antibiotic

（NDA）为其突破性抗生素

Zaynich

扎伊尼奇

, the Indian drug maker said in a statement.

，印度制药商在一份声明中表示。

This is the first time ever that an NDA from a new chemical entity (NCE) from an Indian pharma company has been filed and accepted by the USFDA. The NDA was originally filed on September 30.

这是印度制药公司首次从新化学实体（NCE）提交并被美国食品药品监督管理局（USFDA）接受的新药申请（NDA）。该NDA最初于9月30日提交。

Shares of

股票

Wockhardt

沃克哈特

Ltd ended Monday 19% higher than previous close at Rs 1,471 on BSE.

有限公司周一在BSE收盘时较前一交易日上涨19%，报收于1,471卢比。

The drug is being seen as a game-changing drug in treating drug-resistant gram-negative pathogens (pathogens that are difficult to kill) and has a market opportunity of about $9 billion.

这种药物在治疗耐药性革兰氏阴性病原体（难以杀灭的病原体）方面被视为一种改变格局的药物，拥有约 90 亿美元的市场机会。

Zaynich has been granted “fast track” designation by the US regulator and the FDA has committed to assign priority to the drug’s NDA review, recognising its potential to address urgent unmet need, the company noted. Earlier talking to ET Wockhardt chairperson Habil Khorakiwala had said he expects the drug to be launched in the first half of 2026.

扎伊尼奇已获得美国监管机构的“快速通道”指定，美国食品药品监督管理局（FDA）承诺将优先审查该药物的新药申请（NDA），认可其解决紧急未满足需求的潜力，该公司指出。此前，沃克哈特董事长哈比尔·科拉基瓦拉在与《经济时报》交谈时曾表示，他预计该药物将在2026年上半年推出。

.

。

Live Events

现场活动

The pharma major is making big plans for Zaynich (zidebactam + cefepime), a breakthrough drug that works on superbugs or bacterial infections that show resistance against a range of existing antibiotic treatments.

这家制药巨头正在为Zaynich（齐德巴坦+头孢吡肟）制定重大计划，这是一种针对超级细菌或对多种现有抗生素治疗产生耐药性的细菌感染的突破性药物。

Khorakiwala had said that the treatment cost for most new products launched in the last 10 years in the US have been in the range of $10,000-$15,000 per treatment and the Zaynich price will also hover in that range. India prices will be significantly lower.

霍拉基瓦拉曾表示，过去十年中美国上市的大多数新产品的治疗费用都在每次治疗 10,000 至 15,000 美元之间，Zynteglo 的价格也将处于这一范围内。而印度的价格将显著降低。

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