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Hanmi Pharmaceutical Co., Ltd.

http://www.hanmipharm.com/

Latest From Hanmi Pharmaceutical Co., Ltd.

Inspection Delay Puts Back Hanmi/Spectrum’s Rolontis

US FDA defers action on Spectrum’s approval application for neutropenia candidate Rolontis due to pandemic-related difficulties inspecting partner Hanmi’s plant. The action date has been put back by around four months although the companies stress no CRL has been issued. 

South Korea United States

US FDA Heads Into October With Calm Approvals Forecast

Decision on Regeneron’s Ebola virus therapy, which uses a similar monoclonal antibody cocktail approach as the company’s COVID-19 therapy candidate, stands out among the 10 user fee goal dates in the coming month.

US FDA Performance Tracker Drug Review

Deal Watch: Bausch Health Takes Option To Allegro Dry AMD Candidate

Bausch seeks to add eyecare assets in Allegro deal. AstraZeneca hopes preclinical PCSK9 inhibitor from Dogma can compete with dyslipidemia leaders. Exelixis options ADC candidates from Catalent and NBE.

Deals Business Strategies

US FDA Oncology Applications: Real-Time Review And Breakthrough Pathway Show Durable Appeal

Recent submissions include what could be the fourth novel agent approved under the RTOR pilot.

Cancer Review Pathway
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Company Information

  • Industry
  • Pharmaceuticals
  • Other Names / Subsidiaries
    • Beijing Hanmi Pharmaceutical Co., Ltd.
    • Hanmi Holdings Co., Ltd
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