Zai Lab Obtains Breakthrough Therapy Designation For Efgartigimod Alfa Injection In Patients With Chronic Inflammatory Demyelinating Polyneuropathy In China
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Zai Lab Limited (NASDAQ:ZLAB) has been granted Breakthrough Therapy Designation by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for its efgartigimod alfa injection for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP). The designation was supported by data from the ADHERE study, which demonstrated significant efficacy and a favorable safety profile. Zai Lab and argenx reported positive topline results from the ADHERE study in July 2023.
September 18, 2023 | 11:32 am
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Zai Lab's efgartigimod alfa injection has received Breakthrough Therapy Designation from China's CDE for the treatment of CIDP. This could potentially expedite the drug review process and bring the medicine to patients sooner.
The Breakthrough Therapy Designation is a significant regulatory milestone that could expedite the drug review process. This could potentially lead to faster market access for efgartigimod alfa injection, which would be beneficial for Zai Lab. The positive results from the ADHERE study further support the potential of this drug, which could have a positive impact on Zai Lab's stock in the short term.
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