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Onco-Summaries: Daily Oncology Updates at a Glance
- Oncofocus Team
- 5 hours ago
- 2 min read
09/04/2026
NMPA Accepts NDA for DB-1303/BNT323 in HER2+ Metastatic Breast Cancer (Ref)
The New Drug Application (NDA) for DualityBio and BioNTech's DB-1303/BNT323 (Trastuzumab Pamirtecan, T-Pam; HER2‑targeted ADC) has been accepted by China’s National Medical Products Administration (NMPA) for unresectable or metastatic HER2-positive adult breast cancer
Clinical evidence:
Based on the pivotal Phase III trial (DB-1303-O-3001) comparing DB-1303 to T-DM1
The trial met its primary endpoint of progression-free survival (PFS), showing statistically and clinically significant improvement
Safety profile was favorable and well tolerated
Celltrion Wins Dual FDA Fast Track Approvals for ADC Pipeline (Ref)
Celltrion received FDA Fast Track Designation for its antibody-drug conjugate (ADC) oncology drug candidate CT-P71 for the treatment of patients with locally advanced or metastatic urothelial carcinoma
Celltrion began first dosing in a Phase 1 clinical trial of CT-P71 in September last year for patients with solid tumors with limited treatment options, including urothelial carcinoma
CT-P70 (another ADC), also received FDA Fast Track designation in December last year for the treatment of metastatic non-squamous Non-small cell lung cancer (NSCLC)
Satri-cel: First CAR-T Therapy for Solid Tumors Set to Launch in China (Ref)
Satri-cel (CT041): The world’s first CAR-T therapy designed for solid tumors, specifically targeting Claudin18.2, a biomarker found in gastric and pancreatic cancers
Expected to be available in China in the first half of 2026
Clinical studies conducted in China have demonstrated encouraging outcomes for patients with advanced gastric and gastroesophageal cancers
Satri-cel achieved ~41% response rate and extended progression-free survival to ~4.7 months vs ~1.7 months with standard care
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