FDA Novel Drug Approvals for 2025: Precision Therapies, Rare Diseases, and China’s Growing Footprint

As of August 8, 2025, the FDA has approved 24 novel drugs, emphasizing precision medicine, rare disease advances, and a notable increase in China-origin therapies gaining U.S. approval. This analysis covers key drugs, modalities, and the evolving China biotech footprint.

New Frontier of Bispecific Antibody BD in China After PD-(L)1/VEGF

China’s BsAb deals hit $9.26B in H1 2025. Innovent, Hengrui, and SystImmune shift beyond PD-(L)1/VEGF to Ang2/VEGF, T-cell engagers, and novel dual-pathway drugs.

China’s Nuclear Medicine Networks: Leaders, Challenges, and Growth Potential

China's nuclear medicine industry is growing fast due to innovation, policy support, and rising demand. This report compares key players—Yantai Dongcheng, CIRC, Grand Pharmaceutical, Shanghai Pharma—to global benchmarks like Novartis’ Pluvicto and Lutathera.

China’s CGT Surge: Unpacking A Nature Review on Regulatory Reform, Pipeline Trends & Global Implications

China’s cell and gene therapy (CGT) ecosystem is rapidly evolving with fast-track IND/NDA pathways, expanding pipelines, and global relevance. This analysis breaks down the key takeaways from a major Nature Reviews article and explores what they mean for developers, investors, and regulators.

China Pharma Pulse: Innovation, Reform & Global Dealmaking Surge

Outbound licensing surges as China’s biotech sector hits its stride. Key deals, IPOs, IND reform, GLP-1 momentum, and TCE/autoimmune advances.

XtalPi and DoveTree Ink $6 Billion AI-Powered Drug Discovery Deal

XtalPi teams up with DoveTree in a $6 billion AI-powered drug discovery partnership to develop new small molecules and antibodies across major disease areas.

Madrigal Secures $2B Deal for CSPC’s Preclinical GLP-1

Madrigal Pharmaceuticals has partnered with China’s CSPC in a $2B deal for SYH2086, an oral GLP-1 candidate for MASH and metabolic disease.