Clinical Trials
1
0 active
Approvals
66
Total approvals
Agencies
2
Regulatory bodies
Founded
N/A
Recruiting
1
100.0%
- Shanghai Henlius Biotech has received FDA approval for two denosumab biosimilars, BILDYOS and BILPREVDA, marking the company's sixth overseas product approval. - The biosimilars are approved for eight indications related to osteoporosis and bone conditions, specifically targeting postmenopausal women at high risk for fractures. - FDA approval was based on comprehensive comparative studies demonstrating similarity to the reference product Prolia in quality, safety, and efficacy. - The products will be commercialized outside China through a partnership with Organon LLC, expanding the company's global market reach.
- Bio-Thera Solutions has dosed the first patient in a pivotal phase 3 trial for BAT8006, an antibody-drug conjugate targeting folate receptor α for platinum-resistant ovarian cancer treatment. - Early clinical data from 133 patients showed BAT8006 achieved a median progression-free survival of 7.63 months with a 40.7% objective response rate and no cases of interstitial lung disease or ocular toxicity. - The therapy has potential to treat the full spectrum of platinum-resistant ovarian cancer patients regardless of folate receptor α expression levels, addressing a significant unmet medical need. - BAT8006 represents one of the first folate receptor α-targeting ADCs in China to enter pivotal phase 3 testing, potentially offering a novel therapeutic option for this difficult-to-treat patient population.
