22/06/2026 Exelixis’ STELLAR-303 trial showed OS benefit in ITT, non‑significant trend in NLM in mCRC; FDA decision due Dec 2026 SystImmune secures world’s first bispecific ADC approval with iza-bren in China CARsgen secures NMPA approval for satri-cel, the world’s first CAR-T therapy in solid tumors, targeting Claudin18.2-positive advanced gastric cancer Sigvotatug vedotin in metastatic non-squamous NSCLC missed OS in the overall population but showed promising efficacy in s

21/05/2026 Junshi Biosciences secures NMPA approval for toripalimab + disitamab vedotin in HER2+ urothelial carcinoma Kelun-Biotech's Phase III sac-TMT Trial meets Primary PFS Endpoint in First-Line Advanced TNBC Junshi Biosciences secures NMPA approval for toripalimab + disitamab vedotin in HER2+ urothelial carcinoma (Ref) China’s NMPA approved toripalimab + disitamab vedotin for first-line treatment of HER2-expressing locally advanced or metastatic urothelial carcinoma (UC)

11/05/2026 FDA grants Fast Track to Zai Lab’s DLL3‑targeting ADC Zocilurtatug Pelitecan (Zoci) for epNECs Hansoh Pharma’s HS-20093 B7-H3 ADC wins NMPA Breakthrough Therapy nod in ESCC Innovent’s IBI363 secures third Breakthrough Therapy Designation in China, advancing to Phase III for MSS/pMMR colorectal cancer with Takeda partnership FDA grants Fast Track to Zai Lab’s DLL3‑targeting ADC Zocilurtatug Pelitecan (Zoci) for epNECs (Ref) Zai Lab's : Zocilurtatug pelitecan (Zoci,

April 2nd Week, 2026 Regulatory Events 🎯 CARsgen Therapeutics Therapeutics’ satri-cel (Claudin18.2 targeted autologous CAR-T) is anticipated to be available in China by H1’26 for the treatment of patients with advanced gastric and gastroesophageal cancers (Ref 1) ❓ What is the current SOC for GEJ/GC in China? 🎯 The NDA for Duality Biologics and BioNTech SE's trastuzumab pamirtecan (T-Pam; HER2 ADC) has been accepted by China’s National Medical Products Administration f

09/04/2026 NMPA Accepts NDA for DB-1303/BNT323 in HER2+ Metastatic Breast Cancer Celltrion Wins Dual FDA Fast Track Approvals for ADC Pipeline Satri-cel: First CAR-T Therapy for Solid Tumors Set to Launch in China 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 Administ

29/12/2025 HUTCHMED's fanregratinib received priority review status in China for second-line intrahepatic cholangiocarcinoma Genmab discontinued the clinical development of acasunlimab following a portfolio review HUTCHMED's fanregratinib received priority review status in China for second-line intrahepatic cholangiocarcinoma (Ref) China's NMPA accepted and granted priority review status to HUTCHMED Limited's NDA for fanregratinib (FGFR 1/2/3 inhibitor) for the treatment of a

23/09/2025 Kelun Biotech's NDA for A400/EP0031 in RET +ve NSCLC was accepted by China's NMPA (Ref) China's NMPA has accepted Sichuan Kelun-Biotech's NDA for A400/EP0031 (RET kinase inhibitor) for the treatment of adult patients with RET-fusion positive locally advanced, or metastatic NSCLC The acceptance for review was based on the positive results from the two pivotal Ph2 cohorts of the KL400-I/II-01 study for both 1L and 2L+ advanced RET-fusion positive NSCLC To note, in Ma

01/09/2025 Boehringer’s zongertinib received accelerated approval in China for HER2-mutant advanced NSCLC ( Ref ) China’s National...

March 1st Week, 2025 ⭐ Regulatory Events 🎯 China’s NMPA granted Breakthrough Therapy Designation (BTD) to CARsgen Therapeutics’ satricabtagene autoleucel (satri-cel; CT041; an autologous, anti-CLDN18.2 CAR-T) for the treatment of Claudin18.2-positive ≥third-line G/GEJ cancer (Ref 1) ❓ What are CARsgen’s next steps in advancing satri-cel? Has CARsgen obtained similar designations in other markets? 🎯 The US FDA accepted Bioheng Therapeutics’ IND application for CTD402 (anti-