{ "schema_version": 1, "as_of": "2026-11-05", "year": 2026, "status": "MERGED_LOCAL_CANDIDATE_NOT_DEPLOYED", "counting_unit": "One new-active-substance approval event per country, ingredient and date; strengths/formulations grouped. Official local names retained.", "countries": { "CN": { "agency": "NMPA", "status": "partial_verified", "official_total": null, "official_total_url": null, "reason": "Partial records from designated official-source CSV; full-year totals unverified.", "latest_approval_date": "2026-08-25" }, "JP": { "agency": "PMDA / MHLW", "status": "partial_verified", "official_total": null, "official_total_url": null, "reason": "Official published lists; not a certified full-year total.", "latest_approval_date": "2026-09-16" }, "KR": { "agency": "MFDS", "status": "partial_verified", "official_total": null, "official_total_url": null, "reason": "Partial records from designated official-source CSV; full-year totals unverified.", "latest_approval_date": "2026-10-07" }, "TW": { "agency": "TFDA", "status": "partial_verified", "official_total": null, "official_total_url": null, "reason": "Partial records from designated official-source CSV; full-year totals unverified.", "latest_approval_date": "2026-07-07" } }, "records": [ { "id": "JP-eeaa9edd1df9", "approval_date": "2026-09-16", "country": "JP", "agency": "PMDA / MHLW", "generic_name": "アンセラミマブ（遺伝子組換え）", "official_product_name": "アミロペイブ点滴静注300 mg", "company": "アレクシオンファーマ（合）", "indication": "全身性ALアミロイドーシス（免疫グロブリン軽鎖がκ型優位の場合に限る）", "official_indication_full": "全身性ALアミロイドーシス（免疫グロブリン軽鎖がκ型優位の場合に限る）を効能・効果とする新有効成分含有医薬品 【希少疾病用医薬品】", "origin": null, "origin_note": "Not stated in the official approval list", "classification": "新有効成分含有医薬品", "domestic_serial": null, "global_first": null, "source_url": "https://www.pmda.go.jp/files/000281578.xlsx", "read_date": "2026-11-04", "source_locator": { "sheet": "承認品目9月分", "row": 12, "number": 9 }, "related_pages": [] }, { "id": "JP-e8e386a115ff", "approval_date": "2026-09-16", "country": "JP", "agency": "PMDA / MHLW", "generic_name": "ミルベツキシマブ ソラブタンシン（遺伝子組換え）", "official_product_name": "エラヒア点滴静注100 mg", "company": "武田薬品工業㈱", "indication": "葉酸受容体α陽性の白金系抗悪性腫瘍剤抵抗性の再発卵巣癌", "official_indication_full": "葉酸受容体α陽性の白金系抗悪性腫瘍剤抵抗性の再発卵巣癌を効能・効果とする新有効成分含有医薬品 【希少疾病用医薬品】", "origin": null, "origin_note": "Not stated in the official approval list", "classification": "新有効成分含有医薬品", "domestic_serial": null, "global_first": null, "source_url": "https://www.pmda.go.jp/files/000281578.xlsx", "read_date": "2026-11-04", "source_locator": { "sheet": "承認品目9月分", "row": 20, "number": 17 }, "related_pages": [] }, { "id": "JP-e759c0899a25", "approval_date": "2026-09-16", "country": "JP", "agency": "PMDA / MHLW", "generic_name": "インスリン エフシトラ アルファ（遺伝子組換え）", "official_product_name": "オンスイク注ミリオペン総量1500単位", "company": "日本イーライリリー㈱", "indication": "インスリン療法が適応となる2型糖尿病", "official_indication_full": "インスリン療法が適応となる2型糖尿病を効能・効果とする新有効成分含有医薬品", "origin": null, "origin_note": "Not stated in the official approval list", "classification": "新有効成分含有医薬品", "domestic_serial": null, "global_first": null, "source_url": "https://www.pmda.go.jp/files/000281578.xlsx", "read_date": "2026-11-04", "source_locator": { "sheet": "承認品目9月分", "row": 14, "number": 11 }, "related_pages": [] }, { "id": "JP-d67c2e3b929c", "approval_date": "2026-09-16", "country": "JP", "agency": "PMDA / MHLW", "generic_name": "トボラフェニブ", "official_product_name": "オジェンダドライシロップ300 mg 同 錠100 mg", "company": "ＩＰＳＥＮ㈱", "indication": "BRAF遺伝子変異又は融合遺伝子を有する低悪性度神経膠腫", "official_indication_full": "BRAF遺伝子変異又は融合遺伝子を有する低悪性度神経膠腫を効能・効果とする新有効成分含有医薬品 【条件付き承認】【希少疾病用医薬品】", "origin": null, "origin_note": "Not stated in the official approval list", "classification": "新有効成分含有医薬品", "domestic_serial": null, "global_first": null, "source_url": "https://www.pmda.go.jp/files/000281578.xlsx", "read_date": "2026-11-04", "source_locator": { "sheet": "承認品目9月分", "row": 19, "number": 16 }, "related_pages": [] }, { "id": "JP-baaff14a8224", "approval_date": "2026-09-16", "country": "JP", "agency": "PMDA / MHLW", "generic_name": "ペムブロリズマブ（遺伝子組換え）、ベラヒアルロニダーゼ アルファ（遺伝子組換え）", "official_product_name": "キイジェクト配合皮下注395 mg 同 配合皮下注790 mg", "company": "ＭＳＤ㈱", "indication": "悪性黒色腫 切除不能な進行・再発の非小細胞肺癌 非小細胞肺癌における術前・術後補助療法 再発又は難治性の古典的ホジキンリンパ腫 根治切除不能な尿路上皮癌 がん化学療法後に増悪した進行・再発の高頻度マイクロサテライト不安定性（MSI-High）を有する固形癌（標準的な治療が困難な場合に限る） 根治切除不能又は転移性の腎細胞癌 腎細胞癌における術後補助療法 再発又は遠隔転移を有する頭頸部癌 局所進行頭頸部癌における術前・術後補助療法 根治切除不能な進行・再発の食道癌 治癒切除不能な進行・再発の高頻度マイクロサテライト不安定性（MSI-High）を有する結腸・直腸癌 PD-L1陽性のホルモン受容体陰性かつHER2陰性の手術不能又は再発乳癌 ホルモン受容体陰性かつHER2陰性で再発高リスクの乳癌における術前・術後薬物療法 進行・再発の子宮体癌 がん化学療法後に増悪した高い腫瘍遺伝子変異量（TMB-High）を有する進行・再発の固形癌（標準的な治療が困難な場合に限る） 進行又は再発の子宮頸癌 局所進行子宮頸癌 再発又は難治性の原発性縦隔大細胞型B細胞リンパ腫 治癒切除不能な進行・再発の胃癌 治癒切除不能な胆道癌 切除不能な進行・再発の悪性胸膜中皮腫 白金系抗悪性腫瘍剤抵抗性の再発卵巣癌 ・新医療用配合剤", "official_indication_full": "悪性黒色腫 切除不能な進行・再発の非小細胞肺癌 非小細胞肺癌における術前・術後補助療法 再発又は難治性の古典的ホジキンリンパ腫 根治切除不能な尿路上皮癌 がん化学療法後に増悪した進行・再発の高頻度マイクロサテライト不安定性（MSI-High）を有する固形癌（標準的な治療が困難な場合に限る） 根治切除不能又は転移性の腎細胞癌 腎細胞癌における術後補助療法 再発又は遠隔転移を有する頭頸部癌 局所進行頭頸部癌における術前・術後補助療法 根治切除不能な進行・再発の食道癌 治癒切除不能な進行・再発の高頻度マイクロサテライト不安定性（MSI-High）を有する結腸・直腸癌 PD-L1陽性のホルモン受容体陰性かつHER2陰性の手術不能又は再発乳癌 ホルモン受容体陰性かつHER2陰性で再発高リスクの乳癌における術前・術後薬物療法 進行・再発の子宮体癌 がん化学療法後に増悪した高い腫瘍遺伝子変異量（TMB-High）を有する進行・再発の固形癌（標準的な治療が困難な場合に限る） 進行又は再発の子宮頸癌 局所進行子宮頸癌 再発又は難治性の原発性縦隔大細胞型B細胞リンパ腫 治癒切除不能な進行・再発の胃癌 治癒切除不能な胆道癌 切除不能な進行・再発の悪性胸膜中皮腫 白金系抗悪性腫瘍剤抵抗性の再発卵巣癌 を効能・効果とする新有効成分含有医薬品・新医療用配合剤", "origin": null, "origin_note": "Not stated in the official approval list", "classification": "新有効成分含有医薬品", "domestic_serial": null, "global_first": null, "source_url": "https://www.pmda.go.jp/files/000281578.xlsx", "read_date": "2026-11-04", "source_locator": { "sheet": "承認品目9月分", "row": 18, "number": 15 }, "related_pages": [] }, { "id": "JP-a1b93a91eb0d", "approval_date": "2026-09-16", "country": "JP", "agency": "PMDA / MHLW", "generic_name": "ピトリサント塩酸塩", "official_product_name": "ウエキクス錠5 mg 同 錠20 mg", "company": "ヴィアトリス製薬(同)", "indication": "①持続陽圧呼吸（CPAP）療法等による気道閉塞に対する治療を実施中の閉塞性睡眠時無呼吸症候群に伴う日中の過度の眠気 ②ナルコレプシー", "official_indication_full": "①持続陽圧呼吸（CPAP）療法等による気道閉塞に対する治療を実施中の閉塞性睡眠時無呼吸症候群に伴う日中の過度の眠気を効能・効果とする新有効成分含有医薬品 ②ナルコレプシーを効能・効果とする新有効成分含有医薬品 【②希少疾病用医薬品】", "origin": null, "origin_note": "Not stated in the official approval list", "classification": "新有効成分含有医薬品", "domestic_serial": null, "global_first": null, "source_url": "https://www.pmda.go.jp/files/000281578.xlsx", "read_date": "2026-11-04", "source_locator": { "sheet": "承認品目9月分", "row": 6, "number": 3 }, "related_pages": [] }, { "id": "JP-7b914bdb0438", "approval_date": "2026-09-16", "country": "JP", "agency": "PMDA / MHLW", "generic_name": "セノバメート", "official_product_name": "エキスコプリ錠12.5 mg 同 錠50 mg 同 錠100 mg 同 錠200 mg", "company": "小野薬品工業㈱", "indication": "てんかん患者の部分発作（二次性全般化発作を含む）", "official_indication_full": "てんかん患者の部分発作（二次性全般化発作を含む）を効能・効果とする新有効成分含有医薬品", "origin": null, "origin_note": "Not stated in the official approval list", "classification": "新有効成分含有医薬品", "domestic_serial": null, "global_first": null, "source_url": "https://www.pmda.go.jp/files/000281578.xlsx", "read_date": "2026-11-04", "source_locator": { "sheet": "承認品目9月分", "row": 4, "number": 1 }, "related_pages": [] }, { "id": "JP-6810c718dfe8", "approval_date": "2026-09-16", "country": "JP", "agency": "PMDA / MHLW", "generic_name": "エマパルマブ（遺伝子組換え）", "official_product_name": "ガミファント点滴静注液50 mg", "company": "Swedish Orphan Biovitrum Japan㈱", "indication": "全身型若年性特発性関節炎又は成人発症スチル病に伴うマクロファージ活性化症候群", "official_indication_full": "全身型若年性特発性関節炎又は成人発症スチル病に伴うマクロファージ活性化症候群を効能・効果とする新有効成分含有医薬品 【希少疾病用医薬品】", "origin": null, "origin_note": "Not stated in the official approval list", "classification": "新有効成分含有医薬品", "domestic_serial": null, "global_first": null, "source_url": "https://www.pmda.go.jp/files/000281578.xlsx", "read_date": "2026-11-04", "source_locator": { "sheet": "承認品目9月分", "row": 17, "number": 14 }, "related_pages": [] }, { "id": "JP-544f59e87c01", "approval_date": "2026-09-16", "country": "JP", "agency": "PMDA / MHLW", "generic_name": "ゲフルリマブ（遺伝子組換え）", "official_product_name": "クライジェファ皮下注300 mgオートインジェクター 同 皮下注300 mgシリンジ", "company": "アレクシオンファーマ(同)", "indication": "全身型重症筋無力症（ステロイド剤又はステロイド剤以外の免疫抑制剤が十分に奏効しない場合に限る）", "official_indication_full": "全身型重症筋無力症（ステロイド剤又はステロイド剤以外の免疫抑制剤が十分に奏効しない場合に限る）を効能・効果とする新有効成分含有医薬品", "origin": null, "origin_note": "Not stated in the official approval list", "classification": "新有効成分含有医薬品", "domestic_serial": null, "global_first": null, "source_url": "https://www.pmda.go.jp/files/000281578.xlsx", "read_date": "2026-11-04", "source_locator": { "sheet": "承認品目9月分", "row": 7, "number": 4 }, "related_pages": [] }, { "id": "JP-36cb1c70e175", "approval_date": "2026-09-16", "country": "JP", "agency": "PMDA / MHLW", "generic_name": "エプチネズマブ（遺伝子組換え）", "official_product_name": "ビエプチ点滴静注100 mg", "company": "ルンドベック・ジャパン㈱", "indication": "片頭痛発作の発症抑制", "official_indication_full": "片頭痛発作の発症抑制を効能・効果とする新有効成分含有医薬品", "origin": null, "origin_note": "Not stated in the official approval list", "classification": "新有効成分含有医薬品", "domestic_serial": null, "global_first": null, "source_url": "https://www.pmda.go.jp/files/000281578.xlsx", "read_date": "2026-11-04", "source_locator": { "sheet": "承認品目9月分", "row": 8, "number": 5 }, "related_pages": [] }, { "id": "JP-21e2caea7eb3", "approval_date": "2026-09-16", "country": "JP", "agency": "PMDA / MHLW", "generic_name": "ドルダビプロン塩酸塩", "official_product_name": "モデーソカプセル125 mg", "company": "大原薬品工業㈱", "indication": "びまん性正中膠腫", "official_indication_full": "びまん性正中膠腫を効能・効果とする新有効成分含有医薬品 【希少疾病用医薬品】", "origin": null, "origin_note": "Not stated in the official approval list", "classification": "新有効成分含有医薬品", "domestic_serial": null, "global_first": null, "source_url": "https://www.pmda.go.jp/files/000281578.xlsx", "read_date": "2026-11-04", "source_locator": { "sheet": "承認品目9月分", "row": 21, "number": 18 }, "related_pages": [] }, { "id": "JP-129fd6af0642", "approval_date": "2026-09-16", "country": "JP", "agency": "PMDA / MHLW", "generic_name": "イコトロキンラ塩酸塩", "official_product_name": "イコタイド錠200 ｍｇ", "company": "ヤンセンファーマ㈱", "indication": "既存治療で効果不十分な尋常性乾癬、膿疱性乾癬、乾癬性紅皮症", "official_indication_full": "既存治療で効果不十分な尋常性乾癬、膿疱性乾癬、乾癬性紅皮症を効能・効果とする新有効成分含有医薬品", "origin": null, "origin_note": "Not stated in the official approval list", "classification": "新有効成分含有医薬品", "domestic_serial": null, "global_first": null, "source_url": "https://www.pmda.go.jp/files/000281578.xlsx", "read_date": "2026-11-04", "source_locator": { "sheet": "承認品目9月分", "row": 16, "number": 13 }, "related_pages": [] }, { "id": "JP-c789f320cef3", "approval_date": "2026-08-24", "country": "JP", "agency": "PMDA / MHLW", "generic_name": "セトメラノチド酢酸塩", "official_product_name": "イムシブリー皮下注10 mg", "company": "リズムファーマ㈱", "indication": "後天性視床下部性肥満", "official_indication_full": "後天性視床下部性肥満を効能・効果とする新有効成分含有医薬品 【希少疾病用医薬品】", "origin": null, "origin_note": "Not stated in the official approval list", "classification": "新有効成分含有医薬品", "domestic_serial": null, "global_first": null, "source_url": "https://www.pmda.go.jp/files/000281578.xlsx", "read_date": "2026-11-04", "source_locator": { "sheet": "承認品目8月分", "row": 7, "number": 4 }, "related_pages": [] }, { "id": "JP-b17ab152b6db", "approval_date": "2026-08-24", "country": "JP", "agency": "PMDA / MHLW", "generic_name": "セバベルチニブ水和物", "official_product_name": "ヒアニュオ錠10 mg", "company": "バイエル薬品㈱", "indication": "HER2（ERBB2）遺伝子変異陽性の切除不能な進行・再発の非小細胞肺癌", "official_indication_full": "HER2（ERBB2）遺伝子変異陽性の切除不能な進行・再発の非小細胞肺癌を効能・効果とする新有効成分含有医薬品 【希少疾病用医薬品】", "origin": null, "origin_note": "Not stated in the official approval list", "classification": "新有効成分含有医薬品", "domestic_serial": null, "global_first": null, "source_url": "https://www.pmda.go.jp/files/000281578.xlsx", "read_date": "2026-11-04", "source_locator": { "sheet": "承認品目8月分", "row": 9, "number": 6 }, "related_pages": [] }, { "id": "JP-5be842eb8446", "approval_date": "2026-08-24", "country": "JP", "agency": "PMDA / MHLW", "generic_name": "ベピロビルセンナトリウム", "official_product_name": "ヒブサーゴ皮下注150 mgシリンジ", "company": "グラクソ・スミスクライン㈱", "indication": "B型肝炎ウイルス持続感染における機能的治癒", "official_indication_full": "B型肝炎ウイルス持続感染における機能的治癒を効能・効果とする新有効成分含有医薬品 【先駆的医薬品】", "origin": null, "origin_note": "Not stated in the official approval list", "classification": "新有効成分含有医薬品", "domestic_serial": null, "global_first": null, "source_url": "https://www.pmda.go.jp/files/000281578.xlsx", "read_date": "2026-11-04", "source_locator": { "sheet": "承認品目8月分", "row": 17, "number": 14 }, "related_pages": [] }, { "id": "JP-501565b6d14b", "approval_date": "2026-08-24", "country": "JP", "agency": "PMDA / MHLW", "generic_name": "オベポレクストン", "official_product_name": "オーゼイフル錠0.5 mg 同 錠1 mg 同 錠2 mg", "company": "武田薬品工業㈱", "indication": "ナルコレプシータイプ1", "official_indication_full": "ナルコレプシータイプ1を効能・効果とする新有効成分含有医薬品 【先駆的医薬品、希少疾病用医薬品】", "origin": null, "origin_note": "Not stated in the official approval list", "classification": "新有効成分含有医薬品", "domestic_serial": null, "global_first": null, "source_url": "https://www.pmda.go.jp/files/000281578.xlsx", "read_date": "2026-11-04", "source_locator": { "sheet": "承認品目8月分", "row": 8, "number": 5 }, "related_pages": [] }, { "id": "JP-325cea7435d5", "approval_date": "2026-08-24", "country": "JP", "agency": "PMDA / MHLW", "generic_name": "ブレンソカチブ水和物", "official_product_name": "ブリヌスプリ錠25 mg", "company": "インスメッド（同）", "indication": "非嚢胞性線維症性気管支拡張症", "official_indication_full": "非嚢胞性線維症性気管支拡張症を効能・効果とする新有効成分含有医薬品", "origin": null, "origin_note": "Not stated in the official approval list", "classification": "新有効成分含有医薬品", "domestic_serial": null, "global_first": null, "source_url": "https://www.pmda.go.jp/files/000281578.xlsx", "read_date": "2026-11-04", "source_locator": { "sheet": "承認品目8月分", "row": 14, "number": 11 }, "related_pages": [] }, { "id": "JP-ff1cea14f005", "approval_date": "2026-06-19", "country": "JP", "agency": "PMDA / MHLW", "generic_name": "カミゼストラント", "official_product_name": "エトカマ錠75 mg", "company": "アストラゼネカ㈱", "indication": "内分泌療法中にESR1遺伝子変異が確認され疾患進行が認められないホルモン受容体陽性かつHER2陰性の手術不能又は再発乳癌", "official_indication_full": "内分泌療法中にESR1遺伝子変異が確認され疾患進行が認められないホルモン受容体陽性かつHER2陰性の手術不能又は再発乳癌を効能・効果とする新有効成分含有医薬品", "origin": null, "origin_note": "Not stated in the official approval list", "classification": "新有効成分含有医薬品", "domestic_serial": null, "global_first": null, "source_url": "https://www.pmda.go.jp/files/000281578.xlsx", "read_date": "2026-11-04", "source_locator": { "sheet": "承認品目6月分", "row": 18, "number": 15 }, "related_pages": [] }, { "id": "JP-bec0f625bc89", "approval_date": "2026-06-19", "country": "JP", "agency": "PMDA / MHLW", "generic_name": "レミブルチニブ", "official_product_name": "ラプシド錠25 mg", "company": "ノバルティスファーマ㈱", "indication": "特発性の慢性蕁麻疹（既存治療で効果不十分な患者に限る）", "official_indication_full": "特発性の慢性蕁麻疹（既存治療で効果不十分な患者に限る）を効能・効果とする新有効成分含有医薬品", "origin": null, "origin_note": "Not stated in the official approval list", "classification": "新有効成分含有医薬品", "domestic_serial": null, "global_first": null, "source_url": "https://www.pmda.go.jp/files/000281578.xlsx", "read_date": "2026-11-04", "source_locator": { "sheet": "承認品目6月分", "row": 14, "number": 11 }, "related_pages": [] }, { "id": "JP-ace739eb081a", "approval_date": "2026-06-19", "country": "JP", "agency": "PMDA / MHLW", "generic_name": "ネタルスジルメシル酸塩", "official_product_name": "ロープレッサ点眼液0.02 %", "company": "参天製薬㈱", "indication": "次の疾患で、他の緑内障治療薬が効果不十分又は使用できない場合：緑内障、高眼圧症", "official_indication_full": "次の疾患で、他の緑内障治療薬が効果不十分又は使用できない場合：緑内障、高眼圧症 を効能・効果とする新有効成分含有医薬品", "origin": null, "origin_note": "Not stated in the official approval list", "classification": "新有効成分含有医薬品", "domestic_serial": null, "global_first": null, "source_url": "https://www.pmda.go.jp/files/000281578.xlsx", "read_date": "2026-11-04", "source_locator": { "sheet": "承認品目6月分", "row": 8, "number": 5 }, "related_pages": [] }, { "id": "JP-a04a0b28e847", "approval_date": "2026-06-19", "country": "JP", "agency": "PMDA / MHLW", "generic_name": "ジロキシメルフマラート", "official_product_name": "ブメリティカプセル231 mg", "company": "バイオジェン・ジャパン㈱", "indication": "再発寛解型多発性硬化症の再発予防及び身体的障害の進行抑制", "official_indication_full": "再発寛解型多発性硬化症の再発予防及び身体的障害の進行抑制を効能・効果とする新有効成分含有医薬品", "origin": null, "origin_note": "Not stated in the official approval list", "classification": "新有効成分含有医薬品", "domestic_serial": null, "global_first": null, "source_url": "https://www.pmda.go.jp/files/000281578.xlsx", "read_date": "2026-11-04", "source_locator": { "sheet": "承認品目6月分", "row": 5, "number": 2 }, "related_pages": [] }, { "id": "JP-59d978149fc2", "approval_date": "2026-06-19", "country": "JP", "agency": "PMDA / MHLW", "generic_name": "イソトレチノイン", "official_product_name": "イソトレックスカプセル8 mg 同 カプセル16 mg", "company": "サンファーマ㈱", "indication": "大量化学療法後の神経芽腫", "official_indication_full": "大量化学療法後の神経芽腫を効能・効果とする新有効成分含有医薬品 【希少疾病用医薬品】", "origin": null, "origin_note": "Not stated in the official approval list", "classification": "新有効成分含有医薬品", "domestic_serial": null, "global_first": null, "source_url": "https://www.pmda.go.jp/files/000281578.xlsx", "read_date": "2026-11-04", "source_locator": { "sheet": "承認品目6月分", "row": 21, "number": 18 }, "related_pages": [] }, { "id": "JP-3d20e4579f5e", "approval_date": "2026-06-19", "country": "JP", "agency": "PMDA / MHLW", "generic_name": "クレスロビマブ（遺伝子組換え）", "official_product_name": "エヌフロンシア筋注シリンジ105 mg", "company": "MSD㈱", "indication": "1. 生後初回のRSウイルス（Respiratory Syncytial Virus）感染流行期の重篤なRSウイルス感染症のリスクを有する新生児及び乳児における、RSウイルス感染による下気道疾患の発症抑制 2. 生後初回のRSウイルス感染流行期の1．以外のすべての新生児及び乳児におけるRSウイルス感染による下気道疾患の予防", "official_indication_full": "1. 生後初回のRSウイルス（Respiratory Syncytial Virus）感染流行期の重篤なRSウイルス感染症のリスクを有する新生児及び乳児における、RSウイルス感染による下気道疾患の発症抑制 2. 生後初回のRSウイルス感染流行期の1．以外のすべての新生児及び乳児におけるRSウイルス感染による下気道疾患の予防 を効能・効果とする新有効成分含有医薬品", "origin": null, "origin_note": "Not stated in the official approval list", "classification": "新有効成分含有医薬品", "domestic_serial": null, "global_first": null, "source_url": "https://www.pmda.go.jp/files/000281578.xlsx", "read_date": "2026-11-04", "source_locator": { "sheet": "承認品目6月分", "row": 17, "number": 14 }, "related_pages": [] }, { "id": "JP-36d70ae0efad", "approval_date": "2026-06-19", "country": "JP", "agency": "PMDA / MHLW", "generic_name": "リルザブルチニブ", "official_product_name": "ウェイリズ錠400 mg", "company": "サノフィ㈱", "indication": "持続性及び慢性免疫性血小板減少症", "official_indication_full": "持続性及び慢性免疫性血小板減少症を効能・効果とする新有効成分含有医薬品 【希少疾病用医薬品】", "origin": null, "origin_note": "Not stated in the official approval list", "classification": "新有効成分含有医薬品", "domestic_serial": null, "global_first": null, "source_url": "https://www.pmda.go.jp/files/000281578.xlsx", "read_date": "2026-11-04", "source_locator": { "sheet": "承認品目6月分", "row": 10, "number": 7 }, "related_pages": [] }, { "id": "JP-0a9d1678c662", "approval_date": "2026-06-19", "country": "JP", "agency": "PMDA / MHLW", "generic_name": "アナキンラ（遺伝子組換え）", "official_product_name": "キネレット皮下注100 mgシリンジ", "company": "Swedish Orphan Biovitrum Japan㈱", "indication": "○全身型若年性特発性関節炎 ○成人発症スチル病", "official_indication_full": "○全身型若年性特発性関節炎 ○成人発症スチル病 を効能・効果とする新有効成分含有医薬品 【希少疾病用医薬品】", "origin": null, "origin_note": "Not stated in the official approval list", "classification": "新有効成分含有医薬品", "domestic_serial": null, "global_first": null, "source_url": "https://www.pmda.go.jp/files/000281578.xlsx", "read_date": "2026-11-04", "source_locator": { "sheet": "承認品目6月分", "row": 15, "number": 12 }, "related_pages": [] }, { "id": "JP-d2ba12e9b814", "approval_date": "2026-05-18", "country": "JP", "agency": "PMDA / MHLW", "generic_name": "SARS-CoV-2のスパイクタンパク質のN－末端部位及び受容体結合部位をコードするmRNA", "official_product_name": "エムネクスパイク筋注シリンジ12歳以上用", "company": "モデルナ・ジャパン㈱", "indication": "SARS-CoV-2による感染症の予防", "official_indication_full": "SARS-CoV-2による感染症の予防を効能・効果とする新有効成分含有医薬品", "origin": null, "origin_note": "Not stated in the official approval list", "classification": "新有効成分含有医薬品", "domestic_serial": null, "global_first": null, "source_url": "https://www.pmda.go.jp/files/000281578.xlsx", "read_date": "2026-11-04", "source_locator": { "sheet": "承認品目5月分", "row": 10, "number": 7 }, "related_pages": [] }, { "id": "JP-d0e00823f040", "approval_date": "2026-05-18", "country": "JP", "agency": "PMDA / MHLW", "generic_name": "ネランドミラスト", "official_product_name": "ジャスケイド錠9 mg 同 錠18 mg", "company": "日本ベーリンガーインゲルハイム㈱", "indication": "特発性肺線維症 進行性肺線維症", "official_indication_full": "特発性肺線維症 進行性肺線維症 を効能・効果とする新有効成分含有医薬品 【希少疾病用医薬品】", "origin": null, "origin_note": "Not stated in the official approval list", "classification": "新有効成分含有医薬品", "domestic_serial": null, "global_first": null, "source_url": "https://www.pmda.go.jp/files/000281578.xlsx", "read_date": "2026-11-04", "source_locator": { "sheet": "承認品目5月分", "row": 8, "number": 5 }, "related_pages": [] }, { "id": "JP-9c09a12e6133", "approval_date": "2026-05-11", "country": "JP", "agency": "PMDA / MHLW", "generic_name": "弱毒生麻しんウイルス（ＡＩＫ－Ｃ株）、弱毒生ムンプスウイルス（ＲＩＴ４３８５株）、弱毒生風しんウイルス（高橋株）", "official_product_name": "ミムリット皮下注用", "company": "第一三共㈱", "indication": "麻しん、おたふくかぜ及び風しんの予防", "official_indication_full": "麻しん、おたふくかぜ及び風しんの予防を効能・効果とする新有効成分含有医薬品及び新医療用配合剤", "origin": null, "origin_note": "Not stated in the official approval list", "classification": "新有効成分含有医薬品", "domestic_serial": null, "global_first": null, "source_url": "https://www.pmda.go.jp/files/000281578.xlsx", "read_date": "2026-11-04", "source_locator": { "sheet": "承認品目5月分", "row": 4, "number": 1 }, "related_pages": [] }, { "id": "JP-6c46a04315ac", "approval_date": "2026-03-23", "country": "JP", "agency": "PMDA / MHLW", "generic_name": "ガドクアトラン水和物", "official_product_name": "アムベルビスト静注2 mL 同 静注シリンジ5 mL 同 静注シリンジ7.5 mL 同 静注シリンジ10 mL", "company": "バイエル薬品㈱", "indication": "磁気共鳴コンピューター断層撮影における下記造影 脳・脊髄造影 躯幹部・四肢造影", "official_indication_full": "磁気共鳴コンピューター断層撮影における下記造影 脳・脊髄造影 躯幹部・四肢造影 を効能・効果とする新有効成分含有医薬品", "origin": null, "origin_note": "Not stated in the official approval list", "classification": "新有効成分含有医薬品", "domestic_serial": null, "global_first": null, "source_url": "https://www.pmda.go.jp/files/000277966.xlsx", "read_date": "2026-11-04", "source_locator": { "sheet": "2025年度承認品目", "row": 45, "number": 42 }, "related_pages": [] }, { "id": "JP-3e620c3decaa", "approval_date": "2026-03-23", "country": "JP", "agency": "PMDA / MHLW", "generic_name": "リソバリシブメシル酸塩水和物", "official_product_name": "ハイツエキシン錠10 mg", "company": "海和製薬㈱", "indication": "がん化学療法後に増悪したPIK3CA遺伝子変異を有する卵巣明細胞癌", "official_indication_full": "がん化学療法後に増悪したPIK3CA遺伝子変異を有する卵巣明細胞癌を効能・効果とする新有効成分含有医薬品 【希少疾病用医薬品】", "origin": null, "origin_note": "Not stated in the official approval list", "classification": "新有効成分含有医薬品", "domestic_serial": null, "global_first": null, "source_url": "https://www.pmda.go.jp/files/000277966.xlsx", "read_date": "2026-11-04", "source_locator": { "sheet": "2025年度承認品目", "row": 123, "number": 120 }, "related_pages": [] }, { "id": "JP-1fc8f5989202", "approval_date": "2026-03-23", "country": "JP", "agency": "PMDA / MHLW", "generic_name": "トリヘプタノイン", "official_product_name": "ドジョルビ内用液100%", "company": "Ultragenyx Japan㈱", "indication": "長鎖脂肪酸代謝異常症", "official_indication_full": "長鎖脂肪酸代謝異常症を効能・効果とする新有効成分含有医薬品 【条件付き承認】【希少疾病用医薬品】", "origin": null, "origin_note": "Not stated in the official approval list", "classification": "新有効成分含有医薬品", "domestic_serial": null, "global_first": null, "source_url": "https://www.pmda.go.jp/files/000277966.xlsx", "read_date": "2026-11-04", "source_locator": { "sheet": "2025年度承認品目", "row": 25, "number": 22 }, "related_pages": [] }, { "id": "JP-03eaa9c7ecc8", "approval_date": "2026-03-23", "country": "JP", "agency": "PMDA / MHLW", "generic_name": "レニオリシブリン酸塩", "official_product_name": "ジョエンジャ錠10 mg 同 錠30 mg 同 錠70 mg", "company": "㈱オーファンパシフィック", "indication": "活性化PI3Kδ症候群", "official_indication_full": "活性化PI3Kδ症候群を効能・効果とする新有効成分含有医薬品 【希少疾病用医薬品】", "origin": null, "origin_note": "Not stated in the official approval list", "classification": "新有効成分含有医薬品", "domestic_serial": null, "global_first": null, "source_url": "https://www.pmda.go.jp/files/000277966.xlsx", "read_date": "2026-11-04", "source_locator": { "sheet": "2025年度承認品目", "row": 15, "number": 12 }, "related_pages": [] }, { "id": "JP-ef65f4c169b1", "approval_date": "2026-03-06", "country": "JP", "agency": "PMDA / MHLW", "generic_name": "ドラビリン／イスラトラビル水和物", "official_product_name": "イドビンソ配合錠", "company": "MSD㈱", "indication": "HIV-1感染症", "official_indication_full": "HIV-1感染症を効能・効果とする新有効成分含有医薬品及び新医療用配合剤 【希少疾病用医薬品】", "origin": null, "origin_note": "Not stated in the official approval list", "classification": "新有効成分含有医薬品", "domestic_serial": null, "global_first": null, "source_url": "https://www.pmda.go.jp/files/000277966.xlsx", "read_date": "2026-11-04", "source_locator": { "sheet": "2025年度承認品目", "row": 78, "number": 75 }, "related_pages": [] }, { "id": "JP-a61b05284aad", "approval_date": "2026-02-19", "country": "JP", "agency": "PMDA / MHLW", "generic_name": "ツカチニブ エタノール付加物", "official_product_name": "ツカイザ錠50 mg 同 錠150 mg", "company": "ファイザー㈱", "indication": "化学療法歴のあるHER2陽性の手術不能又は再発乳癌", "official_indication_full": "化学療法歴のあるHER2陽性の手術不能又は再発乳癌を効能・効果とする新有効成分含有医薬品", "origin": null, "origin_note": "Not stated in the official approval list", "classification": "新有効成分含有医薬品", "domestic_serial": null, "global_first": null, "source_url": "https://www.pmda.go.jp/files/000277966.xlsx", "read_date": "2026-11-04", "source_locator": { "sheet": "2025年度承認品目", "row": 117, "number": 114 }, "related_pages": [] }, { "id": "JP-687fcf58adf9", "approval_date": "2026-02-19", "country": "JP", "agency": "PMDA / MHLW", "generic_name": "パロバロテン", "official_product_name": "ソホノスカプセル1 mg 同 カプセル1.5 mg 同 カプセル2.5 mg 同 カプセル5 mg 同 カプセル10 mg", "company": "IPSEN㈱", "indication": "進行性骨化性線維異形成症", "official_indication_full": "進行性骨化性線維異形成症を効能・効果とする新有効成分含有医薬品 【希少疾病用医薬品】", "origin": null, "origin_note": "Not stated in the official approval list", "classification": "新有効成分含有医薬品", "domestic_serial": null, "global_first": null, "source_url": "https://www.pmda.go.jp/files/000277966.xlsx", "read_date": "2026-11-04", "source_locator": { "sheet": "2025年度承認品目", "row": 23, "number": 20 }, "related_pages": [] }, { "id": "JP-0f67ce8b157f", "approval_date": "2026-02-19", "country": "JP", "agency": "PMDA / MHLW", "generic_name": "アトゲパント水和物", "official_product_name": "アクイプタ錠10 mg 同 錠30 mg 同 錠60 mg", "company": "アッヴィ(同)", "indication": "片頭痛発作の発症抑制", "official_indication_full": "片頭痛発作の発症抑制を効能・効果とする新有効成分含有医薬品", "origin": null, "origin_note": "Not stated in the official approval list", "classification": "新有効成分含有医薬品", "domestic_serial": null, "global_first": null, "source_url": "https://www.pmda.go.jp/files/000277966.xlsx", "read_date": "2026-11-04", "source_locator": { "sheet": "2025年度承認品目", "row": 35, "number": 32 }, "related_pages": [] }, { "approval_date": "2026-07-21", "country": "CN", "agency": "NMPA", "generic_name": "奥普雷顿片", "official_product_name": "奥泽悦/ORZEYFUL", "company": "Takeda Pharmaceuticals U.S.A., Inc.", "indication": "16岁及以上青少年和成人1型发作性睡病患者", "origin": null, "classification": "1类创新药", "domestic_serial": null, "global_first": null, "source_url": "https://www.nmpa.gov.cn/zhuanti/zt2023/ypgzhlfzh/shypqxgg/ggjzcx/20260723092018174.html", "read_date": "2026-11-05", "id": "CN-aaa6f533b5c3", "source_locator": { "file": "豆包_CN_KR_TW_2026_累計24筆_20261105_1457.csv", "row": 2 }, "related_pages": [] }, { "approval_date": "2026-07-21", "country": "CN", "agency": "NMPA", "generic_name": "琥珀酸思普可泮片", "official_product_name": "", "company": "四川海思科制药有限公司", "indication": "治疗既往未接受过补体抑制剂治疗的阵发性睡眠性血红蛋白尿症（PNH）成人患者", "origin": null, "classification": "1类创新药", "domestic_serial": null, "global_first": null, "source_url": "https://www.nmpa.gov.cn/directory/web/nmpa////zhuanti/cxylqx/cxypxx/20260723091948184.html", "read_date": "2026-11-05", "id": "CN-45115f48c8fa", "source_locator": { "file": "豆包_CN_KR_TW_2026_累計24筆_20261105_1457.csv", "row": 3 }, "related_pages": [] }, { "approval_date": "2026-08-25", "country": "CN", "agency": "NMPA", "generic_name": "盐酸伊可白滞素片", "official_product_name": "", "company": "Janssen-Cilag International NV", "indication": "适合系统治疗或光疗的中重度斑块状银屑病成人患者和12岁及以上且体重40公斤及以上的儿童患者", "origin": null, "classification": "1类创新药", "domestic_serial": null, "global_first": null, "source_url": "https://www.nmpa.gov.cn/zhuanti/cxylqx/cxypxx/20260831155346124.html", "read_date": "2026-11-05", "id": "CN-39cd7f6fac78", "source_locator": { "file": "豆包_CN_KR_TW_2026_累計24筆_20261105_1457.csv", "row": 4 }, "related_pages": [] }, { "approval_date": "2026-03-31", "country": "CN", "agency": "NMPA", "generic_name": "盐酸去甲乌药碱注射液", "official_product_name": "", "company": "珠海润都制药股份有限公司", "indication": "心脏负荷试验药物，适用于核素心肌灌注显像（MPI），以评估心肌缺血。", "origin": null, "classification": "1类创新药", "domestic_serial": null, "global_first": null, "source_url": "https://www.nmpa.gov.cn/zhuanti/zt2023/ypgzhlfzh/shypqxgg/ggjzcx/20260402112046173.html?m=&type=pc", "read_date": "2026-11-05", "id": "CN-f9ca248f439f", "source_locator": { "file": "豆包_CN_KR_TW_2026_累計24筆_20261105_1457.csv", "row": 5 }, "related_pages": [] }, { "approval_date": "2026-09-08", "country": "KR", "agency": "MFDS", "generic_name": "레코플라본수화물", "official_product_name": "라티카점안액5%", "company": "", "indication": "각결막 상피 장애 개선", "origin": "國產", "classification": "신약", "domestic_serial": "44", "global_first": null, "source_url": "https://www.mfds.go.kr/brd/m_1256/view.do?company_cd=&company_nm=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&page=1&seq=111&srchFr=&srchTo=&srchTp=&srchWord=", "read_date": "2026-11-05", "id": "KR-abd22caf7ac9", "source_locator": { "file": "豆包_CN_KR_TW_2026_累計24筆_20261105_1457.csv", "row": 6 }, "related_pages": [] }, { "approval_date": "2026-07-01", "country": "KR", "agency": "MFDS", "generic_name": "서플루리맙", "official_product_name": "서플루마주", "company": "알보젠코리아(주)", "indication": "확장 병기 소세포폐암(extensive-stage small cell lung cancer, ES-SCLC) 성인 환자의 1차 치료로서 카보플라틴 및 에토포시드와의 병용요법", "origin": null, "classification": "신약(유전자재조합의약품 및 세포배양의약품)", "domestic_serial": null, "global_first": null, "source_url": "https://nedrug.mfds.go.kr/pbp/CCBBB01/getItemDetail?itemSeq=202601922", "read_date": "2026-11-05", "id": "KR-8b65e1ea1fb5", "source_locator": { "file": "豆包_CN_KR_TW_2026_累計24筆_20261105_1457.csv", "row": 7 }, "related_pages": [] }, { "approval_date": "2026-04-29", "country": "KR", "agency": "MFDS", "generic_name": "안발캅타젠오토류셀", "official_product_name": "림카토주(안발캅타젠오토류셀)", "company": "주식회사 큐로셀", "indication": "두 가지 이상의 전신 치료 후 재발성 또는 불응성 미만성 거대 B 세포 림프종(DLBCL) 및 원발성 종격동 거대 B 세포 림프종(PMBCL) 성인 환자의 치료", "origin": "國產", "classification": "유전자치료제; [희귀신약]", "domestic_serial": null, "global_first": null, "source_url": "https://nedrug.mfds.go.kr/pbp/CCBBB01/getItemDetail?itemSeq=202601287", "read_date": "2026-11-05", "id": "KR-109cf5aced54", "source_locator": { "file": "豆包_CN_KR_TW_2026_累計24筆_20261105_1457.csv", "row": 8 }, "related_pages": [] }, { "approval_date": "2026-10-07", "country": "KR", "agency": "MFDS", "generic_name": "에페글레나타이드", "official_product_name": "에페오토인젝터주2·4·6·8·10밀리그램", "company": "한미약품(주)", "indication": "당뇨를 동반하지 않은 성인 비만 및 과체중 환자의 만성 체중 관리", "origin": "國產", "classification": "신약", "domestic_serial": "45", "global_first": null, "source_url": "https://www.mfds.go.kr/brd/m_1256/view.do?company_cd=&company_nm=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&page=1&seq=147&srchFr=&srchTo=&srchTp=&srchWord=", "read_date": "2026-11-05", "id": "KR-b1528c61b25f", "source_locator": { "file": "豆包_CN_KR_TW_2026_累計24筆_20261105_1457.csv", "row": 9 }, "related_pages": [] }, { "approval_date": "2026-05-28", "country": "KR", "agency": "MFDS", "generic_name": "컨시주맙", "official_product_name": "알헤모프리필드펜15mg/1.5mL", "company": "노보노디스크제약(주)", "indication": "성인 및 소아(12세 이상)인 다음의 환자에서 출혈 빈도 감소 또는 예방을 위한 일상적인 예방요법: 혈액응고 제8인자(FVIII)에 대한 억제인자를 보유한 A형 혈우병(선천성 제8인자 결핍); 혈액응고 제8인자(FVIII)에 대한 억제인자를 보유하지 않은 중증 A형 혈우병(선천성 제8인자 결핍); 혈액응고 제9인자(FIX)에 대한 억제인자를 보유한 B형 혈우병(선천성 제9인자 결핍); 혈액응고 제9인자(FIX)에 대한 억제인자를 보유하지 않은 중증 및 중등증 B형 혈우병(선천성 제9인자 결핍)", "origin": null, "classification": "신약(유전자재조합의약품 및 세포배양의약품)", "domestic_serial": null, "global_first": null, "source_url": "https://nedrug.mfds.go.kr/pbp/CCBBB01/getItemDetail?itemSeq=202601551", "read_date": "2026-11-05", "id": "KR-f45e7e211e76", "source_locator": { "file": "豆包_CN_KR_TW_2026_累計24筆_20261105_1457.csv", "row": 10 }, "related_pages": [] }, { "approval_date": "2026-06-22", "country": "TW", "agency": "TFDA", "generic_name": "Atrasentan Hydrochloride (Atrasentan)", "official_product_name": "穩腎優0.75 毫克膜衣錠 / VANRAFIA 0.75 mg Film-coated tablets", "company": "台灣諾華股份有限公司", "indication": "Vanrafia is indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥ 1.5 g/g.", "origin": null, "classification": "新成分新藥", "domestic_serial": null, "global_first": null, "source_url": "https://www.fda.gov.tw/tc/includes/GetFile.ashx?id=f639191946211810335&type=2&cid=51304", "read_date": "2026-11-05", "id": "TW-bc2b24863970", "source_locator": { "file": "豆包_CN_KR_TW_2026_累計24筆_20261105_1457.csv", "row": 11 }, "related_pages": [] }, { "approval_date": "2026-01-08", "country": "TW", "agency": "TFDA", "generic_name": "Aumolertinib Mesilate (Eq. to Aumolertinib)", "official_product_name": "普肺康膜衣錠 55 毫克 / Pulmivex Film-Coated Tablets 55 mg", "company": "台灣東洋藥品工業股份有限公司", "indication": "Pulmivex as monotherapy is indicated for: • the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations. • the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC. This indication is approved under accelerated approval based on anticipated clinical benefit. Continued approval for this indication may be contingent upon description of clinical benefit in postmarketing study.", "origin": null, "classification": "新成分新藥", "domestic_serial": null, "global_first": null, "source_url": "https://www.fda.gov.tw/tc/includes/GetFile.ashx?id=f639130704585694044&type=2&cid=50705", "read_date": "2026-11-05", "id": "TW-d3b598f0098e", "source_locator": { "file": "豆包_CN_KR_TW_2026_累計24筆_20261105_1457.csv", "row": 12 }, "related_pages": [] }, { "approval_date": "2026-03-11", "country": "TW", "agency": "TFDA", "generic_name": "Belantamab mafodotin", "official_product_name": "倍力銳凍晶注射劑 / BLENREP Powder for Concentrate for Solution for Infusion", "company": "荷商葛蘭素史克藥廠股份有限公司台灣分公司", "indication": "適用於治療下列多發性骨髓瘤成人病人： ･ 與 bortezomib 及 dexamethasone 併用，治療先前曾接受至少一種療法治療的病人。 ･ 與 pomalidomide 及 dexamethasone 併用，治療先前曾接受至少一種含 lenalidomide 之療法治療的病人。", "origin": null, "classification": "新成分新藥", "domestic_serial": null, "global_first": null, "source_url": 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