The U.S. Congress is advancing three legislative and regulatory measures to scrutinize and potentially restrict partnerships between American biopharma companies and Chinese biotech firms, citing national security concerns. These actions target the flow of U.S. capital and technology to China amid a surge in deals, with innovative drug out-licensing transactions exceeding $60 billion in the first quarter of 2026 alone.
Research and Markets added two cell and gene therapy publications, including a tools and reagents market report forecasting growth from $12 billion in 2025 to $19.8 billion by 2030. The reports track approvals, financing, deals, and manufacturing developments.
Phase III data showed dirozalkib improved progression-free survival and intracranial efficacy versus crizotinib in first-line ALK-positive advanced NSCLC. The drug received NMPA approval in August 2025.
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.
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.
Junshi Biosciences reported total revenue of approximately RMB2,498 million in 2025, a 28% increase year-over-year, driven by toripalimab sales growth. Absci Corporation announced it will report fourth quarter and full year 2025 financial results on March 24, 2026.
China's NMPA approved Desidustat Tablets on March 13, 2026, for treating anemia in non-dialysis CKD patients. Clinical trials showed the oral HIF-PHI was non-inferior to erythropoietin in maintaining hemoglobin levels with improved quality of life.
Sagimet Biosciences reported fourth quarter and full year 2025 financial results, announcing plans to initiate a Phase 2 trial of denifanstat and resmetirom combination in F4 MASH patients in the second half of 2026, with a 26-week biomarker readout expected in the first half of 2028.
Shanghai Henlius Biotech received approval from China's National Medical Products Administration to begin a phase 1 clinical trial of HLX316, a B7-H3-targeting sialidase Fc fusion protein for advanced or metastatic solid tumors.
CSPC Pharmaceutical Group has received approval from China's National Medical Products Administration to begin clinical trials for three drug candidates: a hemophilia A biosimilar, a long-acting pain medication, and an injection designated SYH9089.
