Tags : NMPA

Bio-Thera Reports NMPA’s Acceptance of IND for BAT2206 Proposed Biosimilar

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 & EU-sourced in normal healthy candidates The clinical study will enroll ~ 270 healthy volunteers. The initiation of the study implies Bio-Thera’s commitment to develop & commercialize biosimilars for patients across the globe […]Read More

AstraZeneca and MSD’s Lynparza (olaparib) Receive NMPA’s Approval as 1L

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 ratio (1:1) with a deleterious or suspected deleterious germline or somatic BRCA/BRCA2 mutated ovarian cancer following 1L platinum-based CT The P-III SOLO-1 study result: reduction in disease progression or death by 70%; […]Read More

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

Shots: The approval follows P-III ACE study assessing chidamide + exemestane demonstrated PFS benefit and the includes Chidamide + aromatase inhibitor in postmenopausal patients with HR+, HER2- advanced breast cancer (ABC) treated with endocrine therapies for recurrence or progression Chidamide (CS055/HBI-8000/tucidinostat) is an orally available low-nanomolar inhibitor of cancer-associated histone deacetylase (HDAC) enzymes targeting subtype […]Read More

Merck’s Keytruda (pembrolizumab) + CT Receives NMPA’s approval as 1L

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 sq. NSCLC and data from the extension of the global study in Chinese patients The P-III KEYNOTE-407 study results: improvement in OS and PFS; 36% reduction in risk of death; 44% reduction […]Read More

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

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) including clinical/nonclinical, PK/PD data The approval of QLETLI marks the first approval in a regulated market from Bio Thera’s biosimilar portfolio and is the second biosimilar to be approved by NMPA QLETLI […]Read More