Bio-Thera Solutions is a global biopharmaceutical company based in Guangzhou, China, focused on developing innovative therapeutics and biosimilars for major unmet medical needs including cancer and autoimmune disease. It operates both approved products and a broader pipeline across multiple disease areas.
Recent biosimilar and biologic developments included Health Canada approval of denosumab biosimilars, FDA review actions, and new licensing and commercialisation agreements. Other updates covered court, trial and reimbursement agenda decisions.
Bio-Thera Solutions expands its partnership with Intas Pharmaceuticals for BAT2506, a golimumab biosimilar, through an exclusive commercialization agreement for India. The India biosimilars market is projected to grow from $184 million to $1.02 billion by 2035, driven by patent expirations and strategic partnerships.
Over 10 companies are developing 12+ pipeline therapies for Neuromyelitis Optica Spectrum Disorder, including Roche's satralizumab Phase III pediatric trial and multiple anti-CD20 monoclonal antibody candidates.
The European Commission has approved Gotenfia (golimumab), a biosimilar to Simponi developed by Bio-Thera and marketed by STADA, for chronic inflammatory autoimmune diseases across the EU and EEA.
The European Commission has granted marketing authorization for Gotenfia, a golimumab biosimilar to Simponi, developed by Bio-Thera and to be commercialized by STADA across the EU, EEA, UK, Switzerland and selected other countries.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07515079 |
Efficacy Evaluation Study of BAT5906 and Lucentis® in Patients With Diabetic Macular Edema |
RECRUITING | PHASE3 |
| NCT07499700 |
A Clinical Study of BAT4406F Injection in Patients With Minimal Change Disease/Focal Segmental Glomerulosclerosis |
RECRUITING | PHASE2/PHASE3 |
| NCT07180862 |
A Study Evaluating BAT3306 Compared With Keytruda® in NSCLC Cancer Participants |
RECRUITING | PHASE1 |
| NCT06545617 |
A Clinical Study to Observe How Well That BAT8006 Works on Patients With Platinum Resistance Ovarian Cancer |
WITHDRAWN | PHASE1/PHASE2 |
| NCT06376136 |
A Multicenter Open Clinical Study of Safety, Tolerability, Pharmacokinetic Profile, and Initial Clinical Efficacy of BAT 8010 for Injection Combined With BAT 1006 in the Treatment of Locally Advanced or Metastatic Tumors |
RECRUITING | PHASE1/PHASE2 |
| NCT06341114 |
A Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of the Combination of BAT8008 With BAT1308 in Patients With Advanced Solid Tumors |
ACTIVE_NOT_RECRUITING | PHASE1/PHASE2 |
| NCT06321068 |
BAT1308 in Combination With Platinum-containing Chemotherapy is Used for the First-line Treatment of Advanced or Recurrent dMMR Endometrial Cancer |
TERMINATED | PHASE2/PHASE3 |
| NCT06280196 |
A Study to Evaluate PK, Efficacy, and Safety of BAT3306 Plus Chemo and Compare With Keytruda®(EU/US) in Participants With IV nqNSCLC |
TERMINATED | PHASE3 |
| NCT06139536 |
Assessment of Safety, Tolerability and Pharmacokinetics With BAT4706 and BAT1308 in Advanced Solid Tumors Patients |
RECRUITING | PHASE1 |
| NCT06123884 |
BAT1308 Combined with Platinum-Based Chemotherapy± Bevacizumab for PDL1-Positive (CPS ≥1) Cervical Cancer |
RECRUITING | PHASE2/PHASE3 |
