Tags : NMPA

AstraZeneca and FibroGen’s Roxadustat Receive NMPA’s Approval for the Treatment

Shots: The NMPA’s approval is based on P-III study result assessing Roxadustat vs PBO in non-dialysis-dependent (NDD) patients with CKD demonstrating improvement in hemoglobin levels with a mean change of (1.9 g/dL vs -0.4 g/dL) on 7-9wks. treatment In 2013, AstraZeneca and FibroGen collaborated for the development & commercialization of Roxadustat in China. The NMPA’s […]Read More

Innovent and Eli Lilly Report NMPA’s Acceptance of NDA for

Shots: The NDA is based on two P-III studies evaluating the safety, efficacy & PK of IBI301 vs MabThera/Rituxan (rituximab) in patients with DLBCL & CD20-positive B-cell lymphoma respectively  The two P-III studies resulting in meeting its 1EPs demonstrating the bio-similarity b/w IBI301 and branded rituximab IBI301 is a biosimilar of rituximab targeting CD20 antigen […]Read More

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