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[Featured Stock] HanAll Biopharma Declines Following Clinical Results Announcement

[Featured Stock] HanAll Biopharma Declines Following Clinical Results Announcement

As of 9:30 AM on the 20th, HanAll Biopharma's stock price on the KOSPI market recorded 32,025 KRW, down 8.76% from the previous closing price. This appears to be due to the announcement of the Phase 3 clinical trial results for the treatment of myasthenia gravis (MG).


On the same day, HanAll Biopharma announced that the global Phase 3 clinical trial results for 'Batoclimab (IMVT-1401/HL161)' in myasthenia gravis, conducted with 240 patients across 16 countries in partnership with the US company Immunovant, achieved the primary endpoint. HanAll Biopharma stated, “We plan to carefully analyze the Phase 3 clinical trial for myasthenia gravis and decide to apply for approval as a new autoimmune disease treatment drug in Japan.”


The issue lies in the competitive landscape. IMVT-1401/HL161 had the advantage of being a subcutaneous (SC) injection formulation that allows self-administration. However, Belgian company Argenx has developed a prefilled syringe (PFS) formulation of 'Vyvgart' and is reportedly awaiting FDA approval in the US in April.


Nonetheless, the earlier clinical results of Batoclimab’s pipeline IMVT-1401 demonstrated efficacy, raising expectations for the follow-up pipeline IMVT-1402 being developed by Immunovant. Immunovant is conducting clinical trials for IMVT-1402 targeting expanded indications such as myasthenia gravis (MG), chronic inflammatory demyelinating polyneuropathy (CIDP), and thyroid eye disease (TED).


On the same day, Daol Investment & Securities lowered HanAll Biopharma’s target stock price from 53,000 KRW to 46,000 KRW. Analyst Park Jong-hyun analyzed, “Ultimately, the corporate value of HanAll Biopharma is expected to recover depending on the announcement of the IMVT-1402 clinical trial results.”


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