Wockhardt的Zaynich(新抗生素)获得了林业发展局的认可,提升了股份,并标志着印度制药业的一个历史性里程碑。
Wockhardt’s Zaynich, a new antibiotic, gained FDA acceptance, boosting shares and marking a historic milestone for India’s pharma industry.
Wockhardt的股份在2025年12月1日上升了近19%, 因为美国食品及药物管理局接受了Zaynich的新药申请,
Wockhardt's shares rose nearly 19% on December 1, 2025, after the U.S. FDA accepted its New Drug Application for Zaynich, a first-in-class antibiotic for treating resistant bacterial infections.
该申请于2025年9月30日提交,标志着林业发展局首次从一家印度公司接受一个新化学实体,突显了印度制药部门的一个重要里程碑。
The application, submitted September 30, 2025, marks the first FDA acceptance of a New Chemical Entity from an Indian company, highlighting a major milestone for India’s pharmaceutical sector.
Zaynich获得了快速指定,强调它有可能解决严重医疗需求未得到满足的问题。
Zaynich received fast-track designation, underscoring its potential to address serious unmet medical needs.
批准体现了高监管和科学标准,提高了投资者的信心。
The approval reflects high regulatory and scientific standards and boosted investor confidence.