Tags : CFDA

Novartis’ Cosentyx (secukinumab) Receives NMPA’s (CFDA) Approval for Patients with

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

Sumitomo Dainippon’s Latuda (lurasidone HCl) Receives NMPA’s (CFDA) Approval for

 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

Zai Lab Receives Priority Review for Zejula’s (niraparib) NDA from

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

Innovent Biologics Reports Acceptance of BLA for IBI-305 (bevacizumab, biosimilar)

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

Gilead’s Descovy (Emtricitabine, Tenofovir Alafenamide) Receives NMPA ‘s (CFDA) Approval

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