Toripalimab

Coherus and Junshi Present Interim Results of Toripalimab in P-III CHOICE-01 Trial as 1L Treatment for Non-Small Cell Lung Cancer at WCLC 2021

Shots: The P-III CHOICE-01 trial evaluates toripalimab + CT vs CT alone in 465 patients in a ratio (2:1) with advanced sq./nonsq. NSCLC without driver mutations The interim analysis met its 1EPs i.e., improvement in PFS, superior ORR & DoR, OS data are still maturing. The safety profile was consistent with PD-1 inhibitor while final …

Coherus and Junshi Present Interim Results of Toripalimab in P-III CHOICE-01 Trial as 1L Treatment for Non-Small Cell Lung Cancer at WCLC 2021 Read More »

Coherus and Junshi Report Interim Results of Toripalimab + CT in P-III CHOICE-01 Trial as 1L Treatment for Non-Small Cell Lung Cancer

Shots: The P-III CHOICE-01 trial evaluates toripalimab + CT vs PBO + CT in 465 patients in a ratio (2:1) with advanced sq./nonsq. NSCLC. The results of the study will be presented at WCLC 2021 Results: improvement in PFS with m-PFS (8.3 vs 5.6mos.), m-OS (21.0 vs 16.0mos.). In sq. & nonsq. NSCLC patients – …

Coherus and Junshi Report Interim Results of Toripalimab + CT in P-III CHOICE-01 Trial as 1L Treatment for Non-Small Cell Lung Cancer Read More »

Junshi and Coherus’s Toripalimab Receive the US FDA’s Breakthrough Therapy Designation as 1L Treatment of Nasopharyngeal Carcinoma

Shots: The designation is based on the P-III JUPITER-02 trial evaluating toripalimab + CT vs CT alone in patients with NPC. The result was presented at ASCO 2021 The results demonstrated an improvement in PFS. The trial also meets 2EPs of PFS assessed by the investigator and ORR as assessed by BIRC including higher DoR; …

Junshi and Coherus’s Toripalimab Receive the US FDA’s Breakthrough Therapy Designation as 1L Treatment of Nasopharyngeal Carcinoma Read More »

Insights+: Breakthrough Therapy Designation by the US FDA in 2020

Breakthrough Therapy (BT) Designation is an expedited review program introduced in Section 902 of the Food and Drug Safety and Innovation Act of 2012 The Breakthrough Designation is granted to the drug candidates as monotherapy or in combination with other drugs intended to treat serious or life-threatening diseases and has shown substantial improvement over available …

Insights+: Breakthrough Therapy Designation by the US FDA in 2020 Read More »

AstraZeneca Collaborates with Junshi to Commercialize Toripalimab in China

Shots: AstraZeneca to get exclusive promotion rights for toripalimab in mainland China for the urothelial carcinoma indications and all indications in non-core areas Junshi will continue responsible for the promotion of other approved indications and to be approved excluding urothelial carcinoma in core areas The companies will continue to explore overseas business collaborations including emerging …

AstraZeneca Collaborates with Junshi to Commercialize Toripalimab in China Read More »

Evotec, Chinook Teams Up for CKD Therapy; HitGen & UPPTHERA in Drug Delivery Research; Artiva’s $120 M Coup of NK Cell Therapy; Junshi & AZ with Toripalimab in China

Evotec, Chinook Therapeutics to Advance Chronic Kidney Diseases Therapy Market Evotec and Chinook Therapeutics have collaborated to develop and discover precision medicine therapies for patients with chronic kidney diseases (CKD). The duo plans to jointly identify, characterize and validate novel mechanisms and discover and develop precision medicines. The deal will help leverage Evotec’s proprietary PanOmics …

Evotec, Chinook Teams Up for CKD Therapy; HitGen & UPPTHERA in Drug Delivery Research; Artiva’s $120 M Coup of NK Cell Therapy; Junshi & AZ with Toripalimab in China Read More »