Shots: Biomarin has received approval for its Vimizim, as a first approval by NMPA for patients with mucopolysaccharidosis type IVA (MPS IVA), also known as Morquio A syndrome In May 2018, Chinese Drug Evaluation Center issued a list of rare diseases including MPS and in Aug 2018 is also released a list of 48 drugs […]Read More
Shots: The approval is based on P-III CAIN457A2318 study results assessing Cosentyx (300/150 mg, q4w) vs PBO in 543 patients with moderate-to-severe plaque PsO. Additionally, P-III study in China assessed Cosentyx (300mg, q4w) in 10 Psoriasis patients P-III CAIN457A2318 study results: @12 wks. PASI 75/90 (97.7%, 87.8%/ 80.9%, 66.4%); @16wks. PASI 90 87.0%, well tolerated […]Read More
Shots: The approval is based on P-III KEYNOTE-189 trial assessing Keytruda + pemetrexed & Pt CT in patients with 1L metastatic non-sq NSCLC, with no EGFR or ALK genomic tumor aberrations regardless of PD-L1 tumor expression status The P-III KEYNOTE-189 trial resulted in improvement in OS, reduction in the risk of death by half, improvement […]Read More
Shots: The approval is based on P-II NURTURE study results assessing Spinraza in 300 infant patients who were genetically diagnosed with SMA and had not experienced any symptoms by the time of first dose aged 6 wks. The study resulted in early treatment allow 100% progressive gains in motor function, reduction in mortality in infants, […]Read More
Shots: The approval is based on P-III clinical studies results assessing Latuda (n=245) vs Placebo (n=233) in 483 patients with schizophrenia The study results: PANSS @6weeks (-19.3 vs -12.7); AEs (47.0% vs 51.1%); discontinued patients (5.7% vs 6.4%); improvement in CGI-S @6 weeks; well tolerated in patients Lurasidone (40/80 mg/day; flexible dose) is an antipsychotic […]Read More
Shots: The priority review is granted to Zai Lab’s Zejula as a maintenance treatment for recurrent epithelial ovarian, fallopian tube, or primary peritoneal ovarian cancer who are in a complete or partial response to Pt-based CT in adults The NMPA’s Priority Review is granted to the drugs to accelerate drug’s registration and approval in China […]Read More
Shots: The BLA is based on two P-III study results assessing efficacy, safety and PK of IBI-305 vs bevacizumab in patients with advanced non-sq NSCLC and has demonstrated in meeting 1EPs with bio-similarity Innovent has received three NMPA acceptance including IBI-305 namely Tyvyt (sintilimab injection) and IBI-303 (adalimumab, biosimilar) in H2’18 for ankylosing spondylitis (AS), […]Read More
Shots: The expanded indication approval is based on the results of P-III FOURIER study assessing Repatha (140mg q2w, 420 mg/month) vs PBO + statin therapy in patients with cardiovascular events The study resulted in a reduction in risk of heart attack by 27%, risk of stroke by 21%, the risk of coronary revascularization by 22% […]Read More
Shots: The approval is based on ORIENT-1 study results assessing Tyvyt in patients with 2L+ Hodgkin’s lymphoma The ORIENT-1 study resulted in effective complete response rates for CT + radiotherapy in patients Tyvyt is an IgG4 mAb, which helps in binding with PD-1 in T cells further blocking PD-L1. In 2015, Innovent Biologics and Eli Lilly collaborated to […]Read More
Shots: The approval is based on three P-III study (104,111 & 109) results assessing Genvoya (elvitegravir/ cobicistat /emtricitabine /tenofovir alafenamide /150 / 150/ 200/ 10mg, E/C/F/TAF) vs Stribild (E/C/F/TDF,150 mg/ 150 mg/ 200 mg/tenofovir disoproxil fumarate 300 mg) in adults for 144 wks. The pooled study demonstrated non-inferiority data, meeting 1EPs compared with Stribild and […]Read More
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