Shots: The approval is based on Tislelizumab + CT regimen vs CT as monothx. in 360 patients with a ratio (1:1:1) as a 1L for patients with advanced squamous NSCLC The trial met the 1EP, i.e. improvement in PFS, as assessed by IRC in the pre-planned interim analysis. The safety profile of tislelizumab in both […]Read More
Shots: BieGene to receive $650M up front, $1.55M as milestones along with royalties and retain rights to Tislelizumab in China & other countries. BeiGene has the option to co-detail Tislelizumab in NA Novartis to get the development & commercialization rights to Tislelizumab in the US, Canada, Mexico, EU, UK, Norway, Switzerland, Iceland, Liechtenstein, Russia, & […]Read More
Shots: The two companies collaborated to evaluate the safety, tolerability and efficacy of Chi-Med’s surufatinib and fruquintinib, with BeiGene’s tislelizumab against multiple solid tumor cancer indications in the US, EU, China and Australia. Both the companies will mutually supply drug and other support Tislelizumab is an anti PD-1 mAb, specifically designed to minimize binding to […]Read More
Shots: The approval is based on P-II BGB-A317-203 (NCT03209973) trial which involves assessing of tislelizumab with median follow up of 14 months The study resulted in ORR as 76.9% and CR as 61.5% with no fatal adverse reactions. BieGene’s Tislelizumab is the first drug to be approved in China and the candidate’s NDA has also […]Read More
Shots: The sNDA follows clinical, non-clinical, chemistry, manufacturing and controls (CMC) data and P-II study results assessing Tislelizumab in 113 patients with LA or metastatic UC prior treated with PD-L1+ in China & South Korea The NMPA granted second PR designation to Tislelizumab following the two PR designation of Zanubrutinib for r/r MCL and r/r […]Read More
Shots: BeiGene to receive $150M and regains WW rights for tislelizumab with their mutual termination of WW development & commercialization agreement with Celgene, following the pending acquisition of Celgene by BMS In Jul’17, BeiGene granted exclusive WW rights (Ex- Asia) of tislelizumab for solid tumor and retained global rights for hematology & solid tumor in […]Read More
Shots: The P-II (NCT03209973) study result involves assessing of tislelizumab (200mg, IV, q3w) as a monothx. in 70 patients with R/R to autologous stem cell transplantation (ASCT) or 2L+ r/r cHL The P-II study results: high anti-tumor activity in patients; ORR (87.1%); CR (62.9%); PR (24.3%); @12mos. PFS (73.8%); well tolerated; presented at 24thCongress of […]Read More
Shots: BioAtla to receive $20M upfront, $249M as WW development & regulatory milestones, commercial milestones and royalties in Beigene’s territory (Asia (ex-Japan), Australia and New Zealand). Beigene to get WW co-exclusive & exclusive development & commercialization rights respectively for BioAtla’ BA3071 in combination with Beigene’s tislelizumab Beigene to take care of all development & commercialization […]Read More
Shots: Boehringer Ingelheim (BI) and BeiGene are in collaboration since 2013 for the development of tislelizumab BI BioXcellence is providing CMC services and also helping BeiGene with process & analytical method, supply of GMP clinical material, and CMC filing support with the NMPA Boehringer claims to provide manufacturing support to BeiGene for tislelizumab for global […]Read More
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