[Click eStock] Green Cross Adjusts New Drug Approval and Launch... Target Price Down

[Asia Economy Reporter Yoonju Hwang] Daishin Securities maintained a 'Buy' rating on Green Cross Corporation on the 2nd but lowered the target price to 220,000 KRW due to adjustments in the new drug approval and launch schedule.

Researcher Yunjin Lim of Daishin Securities stated, "Green Cross announced a delay in approval after receiving a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) for 'Iviglobulin SN Injection 10% (IVIG-SN 10%)' (product name ALYGLO)."

Researcher Lim explained, "The new drug value of IVIG-SN 10% was adjusted from 898.7 billion KRW to 729.4 billion KRW due to the approval and launch schedule changes," adding, "This CRL is understood to request supplementation only for on-site inspection, with no other significant deficiencies, so rapid approval is possible after the inspection is completed."

He anticipated, "The specific inspection schedule can be confirmed after the BLA resubmission, but considering recent cases of other companies receiving FDA CRLs, a delay of at least six months is expected."

He continued, "Following the poor performance in the fourth quarter of last year and this approval delay, short-term stock price weakness is inevitable," but added, "However, the final approval possibility and growth potential of IVIG-SN 10% remain positive, and a mid- to long-term approach is necessary."

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