May 4th Week, 2025 Regulatory Events 🎯 The US FDA granted a Fast Track designation to CSPC Pharmaceutical Group ’s CPO301 (SYS6010; EGFR ADC) for the Tx of oncogenic driver mutation negative, non-squamous NSCLC patients who have progressed on prior platinum chemotherapy and anti-PD-(L)1 therapy. (Ref 1) ❓ Which other ADCs are being developed for this setting? 🎯 Zai Lab's ZL-1310 (DLL3 ADC) was granted a Fast Track designation by the US FDA for the Tx of ES-SCLC patients

March 4th Week, 2025 Regulatory Events 🎯 CStone Pharmaceuticals submitted a Type II variation application to the EMA for sugemalimab (Cejelmy; anti-PD-L1) to treat stage III NSCLC patients who have not progressed following concurrent or sequential platinum-based CRT. (Ref 1) ❓ How do sugemalimab’s outcomes compare with those of previously approved AstraZeneca’s durvalumab? Special Designations ⭐ Shandong Boan Biotechnology's BA1302 (a first-in-class CD228-directed ADC) has

March 3rd Week, 2025 Regulatory Events 🎯 The US FDA granted traditional approval to Merck & Co./MSD’s pembrolizumab (anti-PD-1) + trastuzumab (anti-HER2) + fluoropyrimidine- and platinum-containing chemo for the first-line treatment of adults with locally advanced, unresectable/metastatic HER2+ve gastric/gastroesophageal junction adenocarcinoma with PD-L1 CPS ≥1 (Ref 1). The regimen was previously granted accelerated approval for this indication in May’21. ❓ Which other re

February 4th Week, 2025 📝 Merck & Co/ MSD's sBLA for neoadjuvant pembro followed by adjuvant pembro + RT ± cisplatin in resectable, LA SCCHN has been accepted by the US FDA for priority review (PDUFA date: Jun 23, 2025) (Ref 1) ❓ It is set to be the first approved Tx option for perioperative LA SCCHN. What are its challengers in the pipeline? 📝 BMS’ sBLA for nivo + ipi as a 1L Tx for adult and pediatric patients with unresectable or metastatic, MSI-H/dMMR colorectal canc

Gastric cancer has remained one of the leading causes of cancer-related deaths globally. It was reported as the 5th most common cancer and the 4th leading cause of cancer death worldwide in 2020, with an observed trend of increasing incidence rates in younger adults (<50 years). Despite therapeutic progress, the survival rate for gastric cancer patients remains low, highlighting the unmet need for treatments of further potential. In this concise infographic, we highlight the