Bio-Thera’s BAT1806 Biosimilar Accepted for Review by European Medicine Agency
China-based Bio-Thera Solutions Ltd (SHA: 688177) has announced that a Biologic License Application (BLA) for...
Biosimilars
Henlius Biotech’s Hanbeitai Gains NMPA Approval for Recurrent Glioblastoma
Shanghai Henlius Biotech Inc. (HKG: 2696) has announced that a supplementary Biologic License Application (sBLA)...
Henlius Biotech’s HanBeiTai Biosimilar Accepted for Review by CDE
Shanghai Henlius Biotech Inc. (HKG: 2696) has announced that a supplementary Biologic License Application (sBLA)...
Novartis to Spin Off Sandoz, Focus on Innovative Drugs
Swiss drugmaker Novartis announced plans to spin off its generic and biosimilar unit, Sandoz, to...
Healsun Biopharm Raises USD 36.7 Million in Series B Financing for Antibody CDMO Expansion
China-based Hangzhou Healsun Biopharm Co., Ltd, an antibody and recombinant Contract Development and Manufacturing Organization...
Junshi Biosciences’ JunMaiKang Biosimilar Gets NMPA Approval Filing
China-based Junshi Biosciiences (HKG: 1877, SHA: 688180) has announced that another market approval filing for...
Henlius Biotech’s HanBeiTai sBLA Accepted for HCC Treatment Review
Shanghai Henlius Biotech Inc. (HKG: 2696) announced that a supplementary Biologic License Application (sBLA) for...
Innovent Biologics’ Q2 2022 Revenues Surpass RMB 1 Billion, Seven Products Approved
Innovent Biologics Inc. (HKG: 1801) released its Q2 2022 financial report, with product revenues exceeding...
MabPharm’s CMAB015 Biosimilar Receives NMPA Approval for Clinical Study
Taizhou-based monoclonal antibody (mAb) biosimilars specialist MabPharm Ltd (HKG: 2181) announced that it has received...
Henlius Biotech’s HanBeiTai Biosimilar of Avastin Accepted for CDE Review
Shanghai Henlius Biotech Inc. (HKG: 2696) announced that the Center for Drug Evaluation (CDE) has...
Henlius Biotech’s HLX14 Biosimilar Wins TGA Approval for Global Phase III Osteoporosis Study
China-based Shanghai Henlius Biotech Inc. (HKG: 2696) received approval from Australia’s Therapeutic Goods Administration (TGA)...
Luye Pharma Initiates Phase III Study of Trulicity Biosimilar BA5101 in China
China-based Luye Pharma Group (HKG: 2186) announced the initiation of a Phase III clinical study...
Huadong Medicine’s Biosimilar Ozempic (Semaglutide) Wins NMPA Clinical Trial Approval
China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that a clinical trial filing for its...
Shanghai Henlius Partners with Organon for Global Biosimilar Commercialization
China-based Shanghai Henlius Biotech, Inc. (HKG: 2696) has entered into a licensing and supply agreement...
Innovent Biologics Receives BPOM Approval for Bevagen in Indonesia
China-based Innovent Biologics Inc. (HKG: 1801) has announced receiving indication approvals from Indonesia’s Badan Pengawas...
Huadong Medicine’s SaiYueXin Receives NMPA Approval for Pediatric Psoriasis Treatment
China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that the National Medical Products Administration (NMPA)...