PharmaShots

AstraZeneca Divests Rights of Seroquel and Seroquel XR to Cheplapharm in Europe and Russia

AstraZeneca’s Imfinzi (durvalumab) Receives NMPA’s Approval for Unresectable Stage III Non-Small Cell Lung Cancer

December 12, 2019December 13, 2019Tuba Khan

Shots: The approval is based on P-III PACIFIC study assessing Imfinzi vs PBO in 713 ‘all-comer’ patients (regardless of PD-L1 status) with unresectable, [Read More...]

AffaMed Therapeutics’ AMT901 (biosimilar, trastuzumab) Receives NMPA’s Approval to Initiate P-III Clinical Study in China

December 11, 2019December 11, 2019Tuba Khan

Shots: The NMPA has granted CTA approval to AffaMed to conduct a clinical study evaluating AMT901/ SB3, a biosimilar referencing Roche’s Herceptin. The [Read More...]

Bio-Thera Reports NMPA’s Acceptance of IND for BAT2206 Proposed Biosimilar of Stelara (ustekinumab)

December 6, 2019December 6, 2019Tuba Khan

Shots: Bio-Thera to initiate P-I study to evaluate the PK and safety study of BAT2206 (proposed biosimilar) vs Janssen’s Stelara (ustekinumab) US & [Read More...]

AstraZeneca and MSD’s Lynparza (olaparib) Receive NMPA’s Approval as 1L Maintenance Therapy for BRCA-Mutated Advanced Ovarian Cancer

December 5, 2019December 5, 2019Tuba Khan

Shots: The approval is based on P-III SOLO-1 study assessing Lynparza (bid, 300mg) as maintenance therapy vs PBO in 391 patients in a [Read More...]

Chipscreen Bioscience’s Epidaza (chidamide) Receives NMPA Approval for Breast Cancer Indication

December 2, 2019December 2, 2019Shiwani Sharma

Shots: The approval follows P-III ACE study assessing chidamide + exemestane demonstrated PFS benefit and the includes Chidamide + aromatase inhibitor in postmenopausal [Read More...]

Astellas’ Xospata (gilteritinib) Receives FDA ‘s Approval for 1L R/R Acute Myeloid Leukemia (AML) in Adults

Astellas’ Xtandi (enzalutamide) Receives NMPA’s Approval for Metastatic Castration-Resistant Prostate Cancer in Men

November 27, 2019November 27, 2019Tuba Khan

Shots: The approval is based on P-III Asian PREVAIL study assessing Xtandi (160mg/day) vs PBO + GnRH therapy or after bilateral orchiectomy in [Read More...]

Merck’s Keytruda (pembrolizumab) + CT Receives NMPA’s approval as 1L Treatment for Metastatic Squamous Non-Small Cell Lung Cancer

November 26, 2019November 26, 2019Tuba Khan

Shots: The approval is based on P-III KEYNOTE-407 study assessing Keytruda + CT (carboplatin and either paclitaxel or nab-paclitaxel) in patients with metastatic [Read More...]

Bio Thera’s QLETLI (biosimilar, adalimumab) Receives NMPA’s Approval for Auto-Immune Diseases in China

November 7, 2019November 7, 2019Tuba Khan

Shots: The approval of QLETLI is based on P-III study resulted in meeting its 1EPs, demonstrating bio-similarity to the reference product, Humira (adalimumab) [Read More...]

Merck’s Keytruda Receives NMPA’s Approval as Monotherapy for 1L Treatment of Advanced Non-Small Cell Lung Cancer with PD-L1 Tumor Expression in China

October 3, 2019October 3, 2019Shiwani Sharma

Shots: The NMPA approval is based on the P-III KEYNOTE-042 study assessing Keytruda as monothx. vs CT in patients with stage III NSCLC [Read More...]

AstraZenca’s Tagrisso (osimertinib) Receives NMPA’s Approval as a 1L Therapy for EGFR-Mutated Non-Small Cell Lung Cancer in China

AstraZeneca’s Tagrisso (osimertinib) Receives NMPA’s Approval as a 1L Therapy for EGFR-Mutated Non-Small Cell Lung Cancer in China

September 4, 2019September 4, 2019Tuba Khan

Shots: The NMPA’s approval follows its PR pathway and is based on P-III FLAURA study assessing Tagrisso (80mg, qd) vs EGFR-TKIs (erlotinib [150mg, [Read More...]