[New Drug Spotlight] Dactolisib - A Novel Dual PI3K/mTOR Inhibitor in Clinical Development

Dactolisib is a “first-in-class” dual PI3K/mTOR inhibitor developed by Novartis.

[Commercial Synthesis Spotlight] First-Generation Process Synthesis and Optimization of S-892216

S-892216 is a second-generation covalent 3CL protease inhibitor developed by Shionogi & Co., Ltd., intended for the treatment of COVID-19. It targets the SARS-CoV-2 3CL protease, an enzyme essential for viral replication. Compared to earlier compounds like ensitrelvir, S-892216 shows superior efficacy and an optimized drug metabolism and pharmacokinetics (DMPK) profile, allowing for lower dosing and enhanced activity.

[New Drug Spotlight] Onradivir: A First-in-Class PB2 Inhibitor Approved for Influenza A Treatment

Onradivir (trade name: Anruiwei®) was approved by China’s NMPA in May 2025 as a treatment for adult patients with acute uncomplicated Influenza A. Developed by Guangdong Zhongsheng Pharmaceutical, Onradivir is the first oral PB2 inhibitor to reach the global market. Its novel cap-snatching mechanism delivers dual antiviral and anti-inflammatory effects, positioning it as a breakthrough therapy against resistant influenza strains.

[Commercial Synthesis Spotlight] Process Optimization of Sotorasib’s Key Intermediate rac-4

rac-4 is a key intermediate in the synthesis of Sotorasib (AMG 510), the first-in-class KRAS G12C inhibitor approved for the treatment of various solid tumors, including non-small cell lung cancer (NSCLC).

[New Drug Spotlight] Ensifentrine - A New Dual PDE3/4 Inhibitor Approved for COPD Treatment

Ensifentrine (trade name: Ohtuvayre) was approved by the U.S. FDA in June 2024 as a maintenance treatment for adult patients with COPD.