Drugnews|藥時事

亞洲 自體免疫與發炎藥物

自體免疫藥:讓攻擊自己身體的免疫系統冷靜下來。

8追蹤資產
6已核准

這個賽道在做什麼

乾癬、異位性皮膚炎、紅斑性狼瘡、類風濕性關節炎等自體免疫與發炎疾病,是免疫系統攻擊自己的組織。舊藥大範圍壓低免疫力;新藥只阻斷單一訊號,例如細胞內的 JAK、TYK2,或細胞外的 IL-4R、IL-17、BAFF/APRIL。中國在這個領域進展很快,多個中國原研的抗體與 JAK 抑制劑已在國內核准,國際藥廠也開始授權引進到海外市場。

階段分布

已核准66
第三期22

國家分布

日本22
中國66

資產表

排名資產國際非專利名稱原研公司國家標的機轉最高階段適應症試驗登錄號海外權利人交易日期首付款總額上限最新事件最新事件日期來源來源日期
1Peficitinib (ASP015K; Smyraf)peficitinibAstellas Pharma Inc.JapanJAK familyOral pan-JAK inhibitorApproved — Japan (2019-03)Rheumatoid arthritisNCT02308163 | NCT02305849Menarini Asia-Pacific — Taiwan; option for select Southeast Asian markets2023-09-13 (announcement)Not disclosed€5.5 million (upfront + milestones; royalties additional)Menarini announces Taiwan licensing agreement, with option for select Southeast Asian markets2023-09-131 2 3 4 5 2023-09-13
2Delgocitinib (JTE-052; Corectim / Anzupgo)delgocitinibJapan Tobacco Inc.JapanJAK familyTopical pan-JAK inhibitorApproved — Japan (2020-01); US (2025-07)Atopic dermatitis (Japan ointment); chronic hand eczema (US cream)NCT05355818 | NCT06004050LEO Pharma — topical dermatology worldwide excluding Japan2014-11Not disclosedNot disclosedFDA approves Anzupgo cream for adult moderate-to-severe chronic hand eczema2025-07-231 2 3 4 5 6 2025-07-23
3Telitacicept (RC18; Taiai)telitaciceptRemeGen Co., Ltd.ChinaBAFF (BLyS); APRILTACI-Fc fusion protein inhibiting B-cell survival signalsApproved — China (2021-03; conditional); full approval 2023-11Systemic lupus erythematosus; rheumatoid arthritis; generalized myasthenia gravisNCT03016013 | NCT05737160Vor Biopharma Inc. (Vor Bio) — worldwide excluding Greater China2025-06-25US$45 million cash + US$80 million warrants (US$125 million initial consideration)US$125 million initial consideration + up to US$4,105 million milestones; royalties additionalRemeGen announces exclusive ex-Greater China license to Vor Bio2025-06-251 2 3 4 5 2025-06-25
4Vunakizumab (SHR-1314; Andajing)vunakizumabJiangsu Hengrui Pharmaceuticals Co., Ltd. / Suzhou Suncadia Biopharmaceuticals Co., Ltd.ChinaIL-17AHumanized monoclonal antibody neutralizing IL-17AApproved — China (2024-08)Moderate-to-severe plaque psoriasis; active ankylosing spondylitisNCT04839016None reported———Suzhou Industrial Park reports approval for active ankylosing spondylitis2025-05-071 2 3 4 2025-05-07
5Stapokibart (CM310; Kangyueda)stapokibartKeymed Biosciences Inc.ChinaIL-4RαHumanized monoclonal antibody blocking IL-4 and IL-13 signaling via IL-4RαApproved — China (2024-09)Atopic dermatitis; chronic rhinosinusitis with nasal polyps; seasonal allergic rhinitisNCT05265923None reported———Company annual results report three approved stapokibart indications2025-03-261 2 3 4 2025-03-26
6Ivarmacitinib (SHR0302; Aisuda)ivarmacitinibJiangsu Hengrui Pharmaceuticals Co., Ltd. / Reistone BiopharmaChinaJAK1Selective JAK1 small-molecule inhibitor; oral and topical developmentApproved — China (2025-03)Active ankylosing spondylitis; rheumatoid arthritis; atopic dermatitis; severe alopecia areataNCT04481139 | NCT05470413Arcutis — topical dermatology in US, Japan, UK, EU and Canada; ARQ-255 development halted2018-01 (option agreement); 2019-12 (license exercised)US$0.4 million upfront + US$1.5 million option exerciseUp to US$20.5 million development/regulatory + US$200 million sales milestones; initial payments and royalties additionalHengrui announces China approval for severe alopecia areata2025-06-301 2 3 4 5 6 2025-06-30
7Soficitinib (ICP-332)soficitinibInnoCare Pharma Limited / Beijing InnoCare Pharma Tech Co., Ltd.ChinaTYK2 (JH1)Oral ATP-site TYK2 inhibitorPhase 3 — China (2024-11)Moderate-to-severe atopic dermatitis; other inflammatory skin diseases in earlier-stage trialsNCT06775860None reported———Company Q3 results report primary endpoints met in atopic dermatitis Phase 32026-10-261 2 3 4 2026-10-26
8Fadeucravacitinib (ICP-488)fadeucravacitinibInnoCare Pharma Limited / Beijing InnoCare Pharma Tech Co., Ltd.ChinaTYK2 (JH2)Oral allosteric TYK2 inhibitorPhase 3 — China (2025-03)Moderate-to-severe plaque psoriasis; cutaneous lupus and Sjögren syndrome in Phase 2NCT06842199None reported———Company Q3 results report primary endpoints met in psoriasis Phase 32026-10-261 2 3 4 2026-10-26

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