얀센(J&J)

주관 임상 단계 분포

• 정책이벤트2026-07-18

  리브리반트·빌로이 약가협상 시작…병용·동반진단 급여 과제 남아

  한국얀센의 리브리반트(아미반타맙)와 한국아스텔라스의 빌로이(졸베툭시맙)가 국민건강보험공단과 약가협상을 시작했다. 지난달 약제급여평가위원회 통과 후 약 한 달 만에 협상 단계에 진입했다. 리브리반트는 백금 기반 화학요법 치료 중 또는 이후 질병이 진행된 EGFR 엑손 20 삽입 변이 진행성 또는 전이성 비소세포폐암 적응증으로 협상을 시작했다. 두 약제 모두 병용요법 및 동반진단기기의 급여 적용 등 후속 절차가 남아있어 협상 결과가 주목된다.

  히트뉴스 ↗

• 신약개발2026-07-15

  J&J, 안질환 유전자치료제 2b상 결과 검토 후 개발 중단

  Johnson & Johnson이 안질환 대상 유전자치료제 개발을 중단했다. 이번 결정은 2026년 주요 임상 결과 중 하나로 예정됐던 2b상 데이터를 검토한 후 내려졌다. 구체적인 약물명, 적응증, 임상 수치 등 세부 내용은 원문에 명시되지 않았다.

  Fierce Biotech ↗

FDA 승인

• 2026-03-17

  ICOTYDE

  ICOTROKINRA HYDROCHLORIDE

  NDA220149
• 2026-02-13

  RYBREVANT FASPRO

  AMIVANTAMAB AND HYALURONIDASE-LPUJ

  BLA761484
• 2025-12-17

  RYBREVANT FASPRO

  AMIVANTAMAB AND HYALURONIDASE-LPUJ

  BLA761433
• 2025-09-09

  INLEXZO

  GEMCITABINE HYDROCHLORIDE

  NDA219683
• 2025-04-29

  IMAAVY

  NIPOCALIMAB-AAHU

  BLA761430
• 2024-08-19

  LAZCLUZE

  LAZERTINIB MESYLATE

  NDA219008
• 2023-08-11

  AKEEGA

  ABIRATERONE ACETATE

  NDA216793
• 2023-08-09

  TALVEY

  TALQUETAMAB-TGVS

  BLA761342
• 2022-10-25

  TECVAYLI

  TECLISTAMAB-CQYV

  BLA761291

진행 중인 임상

• 3상모집 예정· Multiple Myeloma

  A Study of Ramantamig Plus Daratumumab Versus Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (DVRd) or Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Participants With NDMM For Whom Stem Cell Transplant is Not Planned

  NCT07665450
• 단계 미표기모집 예정협력· Venous Thromboembolism

  A Study to Observe the Pattern of Use and Safety of Rivaroxaban in Children Under 2 Years Old With Venous Thromboembolism (VTE)

  NCT05900388
• 2상모집 중협력· Cytokine Release Syndrome

  Infliximab for Cytokine Release Syndrome Prophylaxis During Teclistamab or Talquetamab Therapy in Patients With Relapsed or Refractory Myeloma

  NCT07657312
• 2상모집 중· Multiple Myeloma

  A Study Evaluating the Prophylactic Use of Tocilizumab to Prevent Cytokine Release Syndrome With Ramantamig Administration in Participants With Relapsed/Refractory Multiple Myeloma

  NCT07589634
• 2상모집 중· Carcinoma, Non-Small-Cell Lung

  A Study of Neoadjuvant Amivantamab With Either Lazertinib or Chemotherapy in Participants With Resectable EGFR-Mutated NSCLC

  NCT07586202
• 2상모집 예정협력· Multiple Myeloma (MM)

  MMulti-Immune HR; Multi-Target Immunotherapy for High-Risk Multiple Myeloma

  NCT07029776
• 1상모집 중· Healthy

  A Study to Assess Nipocalimab Concentrations in Breast Milk of Healthy Lactating Women

  NCT07669077
• 4상모집 예정· Psoriasis

  A Study to Assess Concentration of TREMFYA in Breast Milk of Lactating Women Who Are Receiving TREMFYA Therapeutically

  NCT07654751
• 단계 미표기모집 중· Non-Muscle Invasive Bladder Neoplasms

  A Study to Assess Real-World Use and Outcomes of TAR-200 for Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) in the United States

  NCT07309445
• 3상모집 중· Multiple Myeloma

  A Study Comparing JNJ-79635322 and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

  NCT07518186
• 3상모집 중· Colitis, Ulcerative

  A Study of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis

  NCT07577856
• 3상모집 중· Crohn Disease

  A Study of JNJ-78934804 in Participants With Moderately to Severely Active Crohn's Disease

  NCT07577843
• 단계 미표기모집 중· Leukemia, Lymphocytic, Chronic, B-Cell

  A Real-world Study of Ibrutinib and Venetoclax (I+V) First-Line Treatment Given for Fixed-duration of Time in Participants With Chronic Lymphocytic Leukemia

  NCT07602088
• 단계 미표기모집 중· Psoriasis

  A Study of Persistence to Guselkumab Treatment in Participants With Moderate-to-Severe Plaque Psoriasis in Romania

  NCT07582783
• 1상모집 중· Hematologic Neoplasms

  A Study of JNJ-95804306 for Relapsed or Refractory Hematological Malignancies

  NCT07572006
• 단계 미표기모집 중· Colitis

  A Real-World Study of Guselkumab in Ulcerative Colitis and Crohn's Disease in Saudi Arabia

  NCT07541261
• 3상모집 중· Depressive Disorder, Major

  A Study of Seltorexant as Monotherapy in Adults and Elderly Participants With Major Depressive Disorder

  NCT07573176
• 3상모집 중· Crohn Disease

  A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease

  NCT07499232
• 3상모집 중· Lupus Erythematosus, Systemic

  A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus

  NCT07438496
• 1/2상모집 중· Carcinoma, Non-Small-Cell Lung

  A Study of Amivantamab and Olomorasib Combination Therapy in Participants With Metastatic Non-Small Cell Lung Cancer

  NCT07227025