Junshi

Coherus and Junshi Present Interim Results of Toripalimab in P-III JUPITER-06 Trial as 1L Treatment for Advanced Esophageal Squamous Cell Carcinoma at ESMO 2021

Shots: The P-III JUPITER-06 trial evaluates toripalimab + CT vs PBO + CT in a ratio (1:1) in 514 treatment-naive patients with advanced or metastatic ESCC The study met its co-primary 1EPs i.e., improvements in PFS & OS compared to CT alone. At a prespecified interim analysis on Mar 22, 2021 @median follow-up of 7.4 …

Coherus and Junshi Present Interim Results of Toripalimab in P-III JUPITER-06 Trial as 1L Treatment for Advanced Esophageal Squamous Cell Carcinoma at ESMO 2021 Read More »

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 »

PharmaShots Weekly Snapshots (August 16 – 20, 2021)

Janssen Presents Results of Rybrevant (amivantamab-vmjw) in P-I CHRYSALIS Study for Advanced NSCLC with METex14 Mutations at WCLC Published: Aug 20, 2021 | Tags: Astellas, FibroGen, Evrenzo, Roxadustat, EC, Approval, Symptomatic Anemia, Chronic Kidney Disease Astellas and FibroGen’s Evrenzo (roxadustat) Receive EC’s Approval for Symptomatic Anemia Associated with Chronic Kidney Disease Published: Aug 20, 2021 …

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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 »

PharmaShots Weekly Snapshots (Aug 09 – 13, 2021)

Junshi and Coherus’s Toripalimab Receive the US FDA’s Breakthrough Therapy Designation as 1L Treatment of Nasopharyngeal Carcinoma Published: Aug 13, 2021 | Tags: Junshi, Coherus, Toripalimab, US, FDA, Breakthrough Therapy Designation, Nasopharyngeal Carcinoma Celltrion’s Regdanvimab (CT-P59) Receives the ANVISA’s EUA for the Treatment of COVID-19 in Brazil Published: Aug 13, 2021 | Tags: Celltrion, Regdanvimab, …

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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 »

PharmaShots Weekly Snapshots (July 26 – 30, 2021)

Roche Publishes the Results of Evrysdi (risdiplam) in FIREFISH Study to Treat of Type 1 SMA at NEJM Published: July 30, 2021 | Tags: Roche, Evrysdi, risdiplam, FIREFISH Study, Type 1 SMA, NEJM BeiGene Reports Results of Brukinsa (zanubrutinib) in P-III SEQUOIA Trial for the Treatment of Chronic Lymphocytic Leukemia Published: July 30, 2021 | …

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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 …

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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 …

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PharmaShots Weekly Snapshot (Sept 28 – Oct 1, 2020)

Sobi & Selecta Report Results of SEL-212 in P-II COMPARE Study for Chronic Refractory Gout Published: Oct 1, 2020 | Tags: Chronic Refractory Gout, COMPARE Study, Important Clinical Improvement, P-II, patients, reports, results, SEL-212, Selecta Biosciences, Sobi 2. Moderna’s mRNA-1273 COVID-19 Vaccine Demonstrate Immune Responses in Older Adults Published: Oct 1, 2020 | Tags: COVID-19, …

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Junshi and Impact to Establish Joint Venture for Senaparib (IMP4297) in China

Shots: The two companies will co-develop and conduct clinical trials for senaparib across multiple cancer indications in China. Junshi to invest $43.4M in cash, representing 50% of the JV while Impact will supply senaparib in Mainland China, Hong Kong, and Macau representing the other 50% The JV will focus on the research, development & commercialization …

Junshi and Impact to Establish Joint Venture for Senaparib (IMP4297) in China Read More »