Drugnews|藥時事

亞洲 核藥

核藥:用放射性同位素當彈頭,精準照射腫瘤。

放射性藥物(核藥)
7追蹤資產
0已核准

這個賽道在做什麼

放射配體療法(RLT)把放射性同位素接在能辨識腫瘤的小分子或胜肽上,藥物到達腫瘤後在近距離放出輻射殺死癌細胞。Pluvicto 與 Lutathera 的成功,讓大藥廠爭相收購核藥公司。同位素供應、製造與配送網路是這個賽道的關鍵門檻。

階段分布

申請/審查11
第三期33
第二期11
第一/二期11
第一期11

國家分布

韓國22
中國44
日本11

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
1Lu-177-DGUL (pocubotide)pocubotide (per Korean press; INN spelling not confirmed on WHO list)Cellbion Co., Ltd.South KoreaPSMA177Lu-labelled small-molecule PSMA radioligand (beta emitter); theranostic pair with Ga-68-NGULRegistration — South Korea (MFDS conditional approval filed 2025-12-30; under review)PSMA-positive mCRPC refractory to standard therapy; Ph3 vs SOC approved; Ph1 combo with pembrolizumabNCT05547061None reported (partnering talks reported, no signed deal)———MFDS approved Phase 3 IND (150 pts, 1:1 vs standard care) in mCRPC; conditional approval decision still pending2026-09-291 2 3 2026-09-29
2FC705 ([177Lu]Ludotadipep)ludotadipepFutureChem Co., Ltd.South KoreaPSMA177Lu-labelled small-molecule PSMA radioligand (beta emitter)Phase 3 — South Korea (2026-01)mCRPC (Ph3 Korea, rPFS by BICR); Ph2a in USNCT07853209 | NCT04509557 | NCT05579184None reported for FC705 (FutureChem's China/Europe deals cover diagnostic FC303 only)———Randomized Phase 3 in mCRPC (started 2026-01-26) registered on ClinicalTrials.gov2026-10-011 2 2026-10-01
3HRS-4357—Jiangsu Hengrui PharmaceuticalsChinaPSMA177Lu-labelled PSMA-targeted radioligand (beta emitter)Phase 3 — China (2026-02)PSMA-positive progressive mCRPC vs switch of ARPI (Ph3, n=370); advanced prostate cancer (Ph1/2)NCT07311694 | NCT06006104None reported———Phase 3 vs novel ARPI in PSMA-positive mCRPC started enrolling2026-02-021 2 3 2026-02-04
4177Lu-NYM032—Norroy Bioscience (Wuxi Nuoyu Pharmaceutical Technology)ChinaPSMA177Lu-labelled small-molecule PSMA radioligand; theranostic pair with 68Ga-NYM032 (same precursor)Phase 3 — China (NMPA-cleared; registered 2026-08, not yet recruiting)Progressive PSMA-positive mCRPC vs best standard of care (Ph3, OS endpoint); mCRPC (Ph1/2)NCT07795268 | NCT06383052None reported———Norroy announced NMPA clearance for pivotal Phase 3 of 177Lu-NYM032 in mCRPC2026-09-021 2 3 4 2026-09-03
5177Lu-LNC1011—Yantai Lannacheng Biotechnology (LNC; Dongcheng Pharmaceutical subsidiary)ChinaPSMA177Lu-labelled small-molecule PSMA ligand (dansyl-modified PSMA ligand)Phase 2 — China (Ph1/2; Ph2 enrollment completed 2026-01)PSMA-positive mCRPC; Ph3 planned 1H 2027; 225Ac-LNC1011 follow-on in Ph1/2NCT06250244 (IIT) | NCT06377683 (IIT)None reported———LNC re-filed Hong Kong IPO application disclosing Ph2 enrollment completed (Jan 2026) and Ph3 planned for 1H 20272026-06-121 2 3 2026-09-10
6TRC003—C Ray Therapeutics (Chengdu) Co., Ltd.ChinaPSMA225Ac-labelled PSMA-targeted radiopharmaceutical (alpha emitter)Phase 1/2 — China (2026-05)Progressive PSMA-positive mCRPC after ARPI or taxane (randomized 3-dose Ph1/2, n=90)NCT07567521None reported———Randomized Phase 1/2 in PSMA-positive mCRPC started2026-05-221 2 2026-05-29
7PD-32766T (225Ac-PD-32766)—PeptiDream Inc.JapanCA9 (carbonic anhydrase IX)225Ac-labelled macrocyclic peptide (alpha emitter); theranostic pair with 64Cu-PD-32766DPhase 1 — US (2026-07)Relapsed/refractory CA9-positive clear cell renal cell carcinomaNCT07688187None reported (in-house PeptiDream / PDRadiopharma discovery)———Phase 1a/1b theranostic study (64Cu-PD-32766D imaging + 225Ac-PD-32766T therapy) started in the US2026-07-071 2 2026-09-18

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