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Wednesday, November 19, 2025

OBI-902、米国FDAより胆管癌治療を対象とした希少疾病用医薬品指定を取得
臨床段階のオンコロジー企業であるOBI Pharma（4174.TWO）は、胆管癌の治療を目的として申請していたTROP2 ADC「OBI-902」が、米国食品医薬品局（FDA）より希少疾病用医薬品指定を取得したと発表しました。OBI-902は、OBI独自の糖鎖部位特異的結合型ADC創製技術を初めて組み込んだOBI初のADCです。 more info >>

Monday, November 17, 2025

OBI-902 has been granted by US FDA for Orphan Drug Designation for the Treatment of Cholangiocarcinoma
OBI Pharma, a clinical-stage oncology company (4174.TWO) received notification from the US FDA stating that the request for Orphan Drug Designation of OBI-902 TROP2 ADC for the treatment of Cholangiocarcinoma has been granted. OBI-902 is the first OBI-developed ADC that incorporates our proprietary site-specific glycan-conjugated ADC enabling technology. more info >>

OBI-902 獲美國 FDA 審核通過治療膽管癌的「孤兒藥」資格認定
台灣浩鼎（4174.TWO）今（11/16）日宣布，接獲美國食品藥物管理局（US FDA）通知，旗下以 TROP2 為靶向的ADC新藥 OBI-902 ，已獲審核通過治療膽管癌（Cholangiocarcinoma）的「孤兒藥（Orphan Drug Designation）」資格認定。OBI-902 為浩鼎首款自主開發、採用醣位點專一性鍵結的新型 ADC。 more info >>

OBI-902获美国FDA审核通过用于治疗胆管癌的“孤儿药”资格认定
more info >>

OBI-902 has been granted by US FDA for Orphan Drug Designation for the Treatment of Cholangiocarcinoma
OBI Pharma, a clinical-stage oncology company (4174.TWO) received notification from the US FDA stating that the request for Orphan Drug Designation of OBI-902 TROP2 ADC for the treatment of Cholangiocarcinoma has been granted. OBI-902 is the first OBI-developed ADC that incorporates our proprietary site-specific glycan-conjugated ADC enabling technology. more info >>


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