Jun 08, 2026
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.
May 20, 2026
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.
Apr 20, 2026
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.
Apr 02, 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.
Mar 24, 2026
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.
Mar 13, 2026
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.
Mar 13, 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.
Mar 11, 2026
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.
Mar 10, 2026
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.
Mar 05, 2026
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.
Feb 27, 2026
Izalontamab brengitecan demonstrated statistically significant improvements in progression-free survival and overall survival compared to chemotherapy in patients with previously treated metastatic triple-negative breast cancer, marking the third Phase III success for the bispecific ADC.
Feb 20, 2026
FDA Commissioner Marty Makary identified hospital contracting, IRB processes, and IND application timelines as key bottlenecks slowing US early-phase trials. China now conducts more clinical trials than the US and accounts for nearly a third of new global drug approvals.
Feb 25, 2026
Cytokinetics launches MYQORZO for obstructive hypertrophic cardiomyopathy following FDA approval, while C4 Therapeutics doses first patient in Phase 2 trial of cemsidomide for relapsed/refractory multiple myeloma.
Feb 24, 2026
The global CRISPR and prime editing market is forecast to grow at 24.1% CAGR through 2031, driven by therapeutic advances and regulatory progress. Scribe Therapeutics achieved a second milestone with Eli Lilly, while new RNA production and gene editing technologies accelerate research.
Feb 23, 2026
iRegene Therapeutics has dosed the first U.S. patient in a Phase IIa trial of NouvNeu001 for Parkinson's disease and enrolled the first patient in a China trial of NouvNeu004 for Multiple System Atrophy.
Feb 17, 2026
The European Commission approved MYQORZO (aficamten) for treating symptomatic obstructive hypertrophic cardiomyopathy in adults, completing global regulatory approvals following FDA and China NMPA clearances. First European launch planned in Germany in Q2 2026.
Feb 15, 2026
Alphamab Oncology dosed the first patient in its Phase III trial of JSKN003, a biparatopic HER2-targeting antibody-drug conjugate, for HER2-positive advanced colorectal cancer on February 14, 2026.
Feb 14, 2026
Alphamab Oncology has dosed the first patient in a Phase III study of JSKN003, a biparatopic HER2-targeting ADC, for HER2-positive advanced colorectal cancer. The drug demonstrated a 68.8% response rate in earlier trials.
