Shots: The NDA submission is based on data from P-III PROTECTIVE-2 study evaluating Plinabulin + Neulasta vs Neulasta alone for the prevention of CIN The study met its 1EPs and 2EPs with an improvement in the rate of prevention of grade 4 neutropenia from 13.6% to 31.5%, the 2 EPs include DSN and ANC. The […]Read More
Shots: The NMPA has approved Lee pharma to initiate P-III clinical trials to evaluate Socazolimab + CT as a 1L treatment of ES-SCLC. The study is expected to initiate patient recruitment in Q2’21 The clearance is based on the results from P- Ib trial in which Socazolimab + carboplatin and etoposide demonstrated a promising efficacy […]Read More
Shots: NMPA has granted BTD to socazolimab for cervical cancer. Socazolimab is licensed from Sorrento to COF for the greater China territory Lee intends to file an NDA to the NMPA and request a fast-track conditional approval of socazolimab to treat cervical cancer in Q2’21. Additionally, the companies are planning to expand their partnership for […]Read More
Shots: The approval is based on P-III DAPA-HF trial involves assessing of Forxiga (10mg, qd) + SOC (ACEi or ARB) vs PBO + SOC in 4,744 patients with HFrEF (LVEF ≤ 40%) with/ out T2D The study demonstrated 26% reduction in the risk of the composite of CV death or worsening of HF events, including […]Read More
Shots: The approval was based on P-III ADMIRAL assessing gilteritinib (120mg, qd) vs CT in 319 patients with relapsed or refractory AML. The study showed patients had significantly longer overall survival OS, mOS (9.3 vs 5.6mos.) Additionally, Chinese patient PK data from the ongoing P-III COMMODORE trial were also reviewed. The accelerated approval follows PR […]Read More
Shots: The approval follows P-III ORIENT-11 study assessing Tyvyt (sintilimab) vs PBO + Almita (pemetrexed) and platinum CT in 397 participants in a ratio (2:1) as 1L therapy for advanced or recurrent nsqNSCLC Results: Improvement in PFS, as assessed by IRC; mPFS (8.9 vs 5.0mos.); safety profile is consistent with previously reported studies with no […]Read More
Shots: The BT designation is based on P-II CodeBreaK 100 study assessing Sotorasib in 126 patients with KRAS G12C-mutated locally advanced or metastatic NSCLC who have received at least one prior systemic therapy. The findings will be presented at the IASLC 2020 WCLC Presidential Symposium The company is currently recruiting in a P-III study (CodeBreaK […]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: The BT (breakthrough therapy) Designation was based on initial data for ongoing single-arm, open-label, non-randomized, dose-escalation, P-I study for safety and efficacy in B-ALL The BT Designation procedure is under NMPA’s revised Drug Registration Regulation with effect from Jul 1, 2020. It is designed to expedite the development of treatment of diseases with no […]Read More
Shots: The NMPA has approved Byvasda for the treatment of adult recurrent Glioblastoma which is the third approved indication of Byvasda in China The launch of Byvasda has provided Chinese patients with high quality and relatively more affordable bevacizumab biosimilar injection Byvasda is a bevacizumab biosimilar and a recombinant humanized anti-VEGF monoclonal antibody drug. Byvasda […]Read More
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