Also known as: China
FDA approves AstraZeneca and Daiichi Sankyo's Datroway for first-line TNBC patients not eligible for PD-1/L1 inhibitors, based on Phase III TROPION-Breast02 data showing a 21% reduction in risk of death versus chemotherapy.
Novartis reported Phase III PSMAddition data showing Pluvicto plus standard of care cut the risk of PSA progression by 58% in PSMA-positive metastatic hormone-sensitive prostate cancer. Regulatory decisions in the United States, China and Japan are expected in the second half of 2026.
China's regulatory reforms since 2015 have streamlined clinical trial and drug approval processes, accelerating development of advanced therapies like CAR-T and bispecific antibodies. These changes have boosted investor confidence and created opportunities for global pharmaceutical partnerships with Chinese biotech companies that have innovative pipelines but lack international marketing capabilities.
China's newly revised Implementation Regulations of the Drug Administration Law will take effect on May 15, 2026, representing the first comprehensive revision in over two decades. The regulations strengthen the marketing authorization holder system, improve drug development processes, and introduce new provisions for clinical trials, data protection, and market exclusivity for pediatric and rare disease drugs.
Kelun-Biotech reported 2025 revenue of RMB2.06 billion with four products now marketed in China. The company's TROP2 ADC received multiple regulatory approvals for breast and lung cancer indications. A Phase 3 trial combining the ADC with pembrolizumab met its primary endpoint in first-line NSCLC treatment.
