Shots: The US FDA has approved the IND application of oral Asieris’ APL-1202 + BeiGene’s tislelizumab as neoadjuvant therapy in patients with MIBC The P-I/II study will evaluate the safety of the dual regimen in MIBC patients, determine the RP2D and assess the efficacy of combo as neoadjuvant therapy for MIBC. Asieris will accelerate the […]Read More
Shots: The sBLA submission is based on results from a P-II study evaluating the efficacy & safety of tislelizumab (200 mg, IV, q3w) as monothx in 80 patients with previously treated LA, unresectable or metastatic MSI-H or dMMR solid tumors The results demonstrated that the therapy treatment was consistent & durable across tumor types and […]Read More
Shots: The P-III RATIONALE 309 study involves assessing tislelizumab + gemcitabine + cisplatin vs PBO combined with gemcitabine + cisplatin as a 1L treatment in 263 patients in a ratio (1:1) with recurrent or metastatic NPC The study met its 1EPs of PFS at the interim analysis while the safety profile is consistent with its […]Read More
Shots: BeiGene and Asieris collaborate to evaluate the safety and efficacy of APL-1202 + tislelizumab as neoadjuvant therapy in patients with MIBC. APL-1202 has been approved to treat patients with locally advanced or metastatic UC and high expression of PD-L1 who failed to receive platinum-based CT Asieris plans to submit INDs in China and the […]Read More
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
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