Biosimilars

Company Drug

Henlius and Organon Canada Launch Denosumab Biosimilars BILDYOS and TUZEMTY – Expanding Access to Bone-Targeted Therapies Across All Canadian Indications

Shanghai Henlius Biotech, Inc. (HKG: 2696) and Organon Canada announced the official commercial launch of...

Policy / Regulatory

Anhui Province Launches National Alliance for Monoclonal Antibody Biologics Volume-Based Procurement

Fineline Cube Jun 23, 2026

The Anhui Provincial Healthcare Security Administration has formally invited other provinces to participate in a...

Company Drug

CSPC Pharmaceutical’s Cosentyx Biosimilar Accepted for NMPA Review in China’s Competitive IL-17A Market

Fineline Cube Jun 22, 2026

CSPC Pharmaceutical Group (HKG: 1093) announced that China’s National Medical Products Administration (NMPA) has accepted...

Company Drug

Bio-Thera Solutions Secures Singapore Approval for BAT2206, Biosimilar to J&J’s Stelara, Expanding Access Across Multiple Autoimmune Indications

Fineline Cube Jun 11, 2026

Bio-Thera Solutions Ltd. (SHA: 688177) announced it has received marketing approval from Singapore’s Health Sciences...

Company Deals Drug

Shandong Buchang Pharmaceuticals Partners with Vietnamese MKT for Exclusive Adalimumab Biosimilar Distribution in Vietnam

Fineline Cube Jun 9, 2026

Shandong Buchang Pharmaceuticals Co., Ltd. (SHA: 603858) announced today plans to sign a “Distribution, Marketing...

Company Deals

Shandong Boan Biotech Licenses BA5101 Dulaglutide Biosimilar for US Market – First Global Copycat of Trulicity

Fineline Cube Jun 4, 2026

Shandong Boan Biotechnology Co., Ltd. (HKG: 6955) announced a licensing agreement with an undisclosed pharmaceutical...

Company Drug

Shandong Boan Submits Dual Denosumab Biosimilar BLAs to FDA for Osteoporosis and Oncology Indications

Fineline Cube Jun 1, 2026

Shandong Boan Biotechnology Co., Ltd. (HKG: 6955) announced the submission of Biologics License Applications (BLAs)...

Company Drug

Henlius Biotech’s Perjeta Biosimilar HLX11 (Poherdy) Secures NMPA Approval for HER2-Positive Breast Cancer in China

Fineline Cube Jun 1, 2026

Shanghai Henlius Biotech Inc. (HKG: 2696) announced that the National Medical Products Administration (NMPA) has...

Company Drug

Shanghai Henlius Biotech Doses First Patient in China for Global Phase I Study of Daratumumab Biosimilar HLX15-SC in Multiple Myeloma

Fineline Cube May 27, 2026

Shanghai Henlius Biotech Inc. (HKG: 2696) announced the dosing of the first patient in China...

Company Drug

Qyuns Therapeutics and Huadong Medicine Secure NMPA Approval for Stelara Biosimilar HDM3001-2/QX001S in Crohn’s Disease

Fineline Cube May 24, 2026

Qyuns Therapeutics (HKG: 2509) announced that HDM3001-2/QX001S, a biosimilar to Johnson & Johnson’s autoimmune therapy...

Company Drug

Mabwell Bioscience Secures Second NMPA Approval for Denosu Biosimilar, Expanding Indication to Bone Metastases and Multiple Myeloma

Fineline Cube May 21, 2026

Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) announced it has received a second indication approval...

Company Drug

Bio-Thera Solutions Secures FDA Approval for Golimumab Biosimilars Immgolis and Immgolis Intri

Fineline Cube May 19, 2026

Bio-Thera Solutions (SHA: 688177) announced it has received marketing approval from the U.S. Food and...

Company Drug

Henlius Biotech Receives FDA Clearance for Phase I Trial of HLX05-N Cetuximab Biosimilar in Metastatic Colorectal Cancer

Fineline Cube May 11, 2026

Shanghai Henlius Biotech Inc. (HKG: 2696) announced it has received Investigational New Drug (IND) clearance...

Company Drug

Henlius Biotech Secures European Commission Approval for Poherdy Biosimilar to Roche’s Perjeta

Fineline Cube Apr 29, 2026

Shanghai Henlius Biotech, Inc. (HKG: 2696) announced it has received marketing authorization from the European...

Company Drug

Shandong Boan Biotech Advances First-in-China Anti-CD25 Antibody BA1106 into Phase II NSCLC Trial in Combination with Nivolumab Biosimilar BA1104

Fineline Cube Apr 27, 2026

Shandong Boan Biotechnology Co., Ltd. (HKG: 6955) announced that the Center for Drug Evaluation (CDE)...

Company

Roche Q1 Sales Rise 6% Driven by Innovative Medicines as China Expansion and Diagnostics Recovery Offset Currency Headwinds

Fineline Cube Apr 24, 2026

Roche AG (SWX: ROP, OTCMKTS: RHHBY) reported first-quarter 2026 group sales of CHF 14.7 billion...

Company Drug

Mabwell Bioscience Secures Second NMPA Approval for Denosu, China’s First Xgeva Biosimilar, Expanding Indication to Bone Metastasis and Multiple Myeloma

Fineline Cube Apr 16, 2026

Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced a second indication approval from China’s...

Company Drug

Shanghai Henlius Biotech Launches Phase I Trial for HLX05-N Cetuximab Biosimilar in Metastatic Colorectal Cancer

Fineline Cube Apr 15, 2026

Shanghai Henlius Biotech, Inc. (HKG: 2696), a leading Chinese biopharmaceutical company, announced it has received...

Company Drug

Henlius Biotech Doses First Patient in Phase I Trial for HLX319, a Biosimilar to Roche’s Phesgo

Fineline Cube Apr 13, 2026

Shanghai Henlius Biotech, Inc. (HKG: 2696) has announced the dosing of the first subject in...

Company Drug

Henlius Biotech Secures Two New NMPA Approvals for Hanlikang – Expands Rituximab Biosimilar into DLBCL Combination Therapies

Fineline Cube Apr 12, 2026

Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that China’s National Medical Products Administration (NMPA) has granted...

Biosimilars

Henlius and Organon Canada Launch Denosumab Biosimilars BILDYOS and TUZEMTY – Expanding Access to Bone-Targeted Therapies Across All Canadian Indications

Anhui Province Launches National Alliance for Monoclonal Antibody Biologics Volume-Based Procurement

CSPC Pharmaceutical’s Cosentyx Biosimilar Accepted for NMPA Review in China’s Competitive IL-17A Market

Bio-Thera Solutions Secures Singapore Approval for BAT2206, Biosimilar to J&J’s Stelara, Expanding Access Across Multiple Autoimmune Indications

Shandong Buchang Pharmaceuticals Partners with Vietnamese MKT for Exclusive Adalimumab Biosimilar Distribution in Vietnam

Shandong Boan Biotech Licenses BA5101 Dulaglutide Biosimilar for US Market – First Global Copycat of Trulicity

Shandong Boan Submits Dual Denosumab Biosimilar BLAs to FDA for Osteoporosis and Oncology Indications

Henlius Biotech’s Perjeta Biosimilar HLX11 (Poherdy) Secures NMPA Approval for HER2-Positive Breast Cancer in China

Shanghai Henlius Biotech Doses First Patient in China for Global Phase I Study of Daratumumab Biosimilar HLX15-SC in Multiple Myeloma

Qyuns Therapeutics and Huadong Medicine Secure NMPA Approval for Stelara Biosimilar HDM3001-2/QX001S in Crohn’s Disease

Mabwell Bioscience Secures Second NMPA Approval for Denosu Biosimilar, Expanding Indication to Bone Metastases and Multiple Myeloma

Bio-Thera Solutions Secures FDA Approval for Golimumab Biosimilars Immgolis and Immgolis Intri

Henlius Biotech Receives FDA Clearance for Phase I Trial of HLX05-N Cetuximab Biosimilar in Metastatic Colorectal Cancer

Henlius Biotech Secures European Commission Approval for Poherdy Biosimilar to Roche’s Perjeta

Shandong Boan Biotech Advances First-in-China Anti-CD25 Antibody BA1106 into Phase II NSCLC Trial in Combination with Nivolumab Biosimilar BA1104

Roche Q1 Sales Rise 6% Driven by Innovative Medicines as China Expansion and Diagnostics Recovery Offset Currency Headwinds

Mabwell Bioscience Secures Second NMPA Approval for Denosu, China’s First Xgeva Biosimilar, Expanding Indication to Bone Metastasis and Multiple Myeloma

Shanghai Henlius Biotech Launches Phase I Trial for HLX05-N Cetuximab Biosimilar in Metastatic Colorectal Cancer

Henlius Biotech Doses First Patient in Phase I Trial for HLX319, a Biosimilar to Roche’s Phesgo

Henlius Biotech Secures Two New NMPA Approvals for Hanlikang – Expands Rituximab Biosimilar into DLBCL Combination Therapies

You Missed

Gilead’s Trodelvy (Sacituzumab Govitecan) Secures European Commission Approval for First-Line Metastatic TNBC – Expanding ADC Access to Treatment-Naïve Patients

Henlius and Organon Canada Launch Denosumab Biosimilars BILDYOS and TUZEMTY – Expanding Access to Bone-Targeted Therapies Across All Canadian Indications

AbbVie’s SKYRIZI (Risankizumab) Secures European Commission Approval for Pediatric Plaque Psoriasis – First IL-23 Inhibitor Authorized for Children as Young as Six

YHLO Biotech and Jingyi Bio Forge Strategic Alliance to Advance Neuroimmunology Diagnostics – Expanding Autoimmune Testing into Neurological Disorders