作者:Medicina
近期,MNC企业相继发布了其第二季度的财务报告,笔者据此对各企业的管线变动情况进行了整理。
01 Pfizer
Programs Discontinued:1. PF-06425090, Prophylactic vaccine – protein subunit, Primary Clostridioides difficile (C. Difficile) Infection (艰难梭菌感染)2. Vepdegestrant (ARV-471) + VERZENIO® (abemaciclib), ER-targeting PROTAC® protein degrader + CDK4/6 inhibitor, ER+/HER2- 2L Metastatic Breast Cancer (VERITAC 4)3. Vedegestrant (ARV-471) + Atimocilib ER-targeting PROTAC® protein degrader + CDK4 inhibitor, ER+/HER2- 1L Metastatic Breast Cancer4. VELSIPITY™ (etrasimod), S1P inhibitor, Crohn's Disease5. PF-06954522, Glucagon-like peptide 1 receptor (GLP-1R) agonist, Chronic Weight Management6. PF-07293893, AMPKγ3 activator, Heart Failure7. PF-07820435, STING agonist, Advanced Solid Tumors8. felmetatug vedotin (PF-08046048) (B7H4V), B7H4-ADC, Advanced Solid Tumors
02 BMS
Removed
1. Phase I:IL2-CD25
2. Phase II:afimetrotan(TLR7/8拮抗剂)
New to Phase I
1. BMS-986500 in Solid Tumors (有人推测是CDK2 inhibitor?)
2. BMS-986517 in Solid Tumors
3. CD19 HD Allo CAR T in AID
4. RYZ401 in Solid Tumors
03 GSK
Removed from Phase III
1. belrestotug (GSK4428859): Anti-TIGIT antibody, Non-small cell lung cancer
2. ibrexafungerp (GSK458448): Antifungal glucan synthase inhibitor, Invasive candidiasis
Removed from Phase II
1. GSK3437949: Recombinant protein, adjuvanted, Malaria fractional dose
2. GSK3536852: GMMA, Shigella
3. sanfetrin cilexetil (GV118819): Serine beta lactamase inhibitor, Tuberculosis
Removed from Phase I
1. GSK3536867: Bivalent conjugate, Salmonella (typhoid + paratyphoid A)
New to Phase I
GSK5458514: PSMAxCD3 T cell engaging bispecific antibody, Prostate Cancer
04 Sanofi
Removed from Phase 2
1. amitelimab – HS (OX40L单抗,曾报道疗效不佳)
2. SAR444656 – AD/HS(SAR444656也称KT-474,为IRAK4降解剂;曾报道赛诺菲优先考虑临床前IRAK4降解剂KT-485,而不是推进KT-474,新候选药物KT-485在临床前显示出更高的选择性和活性,可能安全性更好)
New in Phase 1
1. SAR448501 – inflammatory indication(原研Dren Bio,Dectin-1/CD20)
05 AZ
Removed from Phase I
1. AZD5851: GPC3 CAR-T hepatocellular carcinoma (但AZD7003 China GPC3 CAR-T,hepatocellular carcinoma/squamous NSCLC,仍然在管线中,处于I期临床)
2. AZD6422: CLDN18.2 CAR-T solid tumors
3. NT-125: autologous, fully-individualised, multi-specific TCR-T targeting neoantigens solid tumors
Removed from Phase II
1. Additional indication: zibotentan/dapagliflozin: endothelin A receptor (ETA)antagonist/SGLT2 inhibitor liver cirrhosis
2. Life cycle management: Ultomiris, anti-C5 mAb proliferative lupus nephritis
New to Phase I
1. AZD0240: KRAS G12D armoured TCR-T solid tumours
2. AZD1613: inflammation and metabolism modulation kidney disease (anti-PAPPA单抗)
3. AZD4248: cellular health cardiorenal disease
4. AZD4360: CLDN18.2 ADC solid tumours (这是另一款新的CLDN18.2-ADC;此前从美雅珂/康诺亚获得的CLDN18.2 MMAE ADC AZD0901 现在处于临床III期)
5. AZD4954: Lp(a) inhibitor dyslipidaemia
6. Additional indication: AZD5492 CD20 TITAN T-cell engager systemic lupus erythematosus (CD20/CD8/TCR)
7. volrustomig avDLVF-RCC02: PD-1/CTLA4 bispecific mAb 1L advanced clear cell renal cell carcinoma (ccRCC)
06 Roche
Removed from phase I (4 NMES):
1. RG6279 eciskafusp alfa + T - solid tumors (RG6279为IL-2/PD1抗体融合蛋白)
2. RG6457 WRN covalent inhibitor - solid tumors
3. RG6414 USP1 inhibitor - solid tumors
4. RG7921 NME - RVO
Removed from phase III:
1NME:
1. RG6058 tiragolumab + T - stage III unresectable 1L NSCLC (tiragolumab 为anti-TIGIT单抗)
2 AIs:
1. RG6058 tiragolumab + T + Avastin - 1L HCC (tiragolumab 为TIGIT单抗)
2. RG7601 Veneclexta + azacitidine - 1L MDS (Veneclexta为Bcl-2抑制剂)
New to phase I (2 NMEs):
1. RG6505 PanRAS inhibitor - solid tumors(2025年3月,启动了I期临床,NCT06884618)
2. RG6327 NME - geographic atrophy (2025年5月,启动了I期临床NCT06961370)
New to phase II(1 AI):
1. RG6237 emugrobart (GYM 329) - obesity(2025年5月启动II期临床,NCT06965413,RG6237 +Tirzepatide vs. Tirzepatide )
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