Bio-Thera begins patient dosing in phase 1 study of BAT2606, a proposed biosimilar of Nucala

Bio-Thera Solutions, Ltd., a commercial-stage biopharmaceutical company, announced that dosing has begun in a phase I clinical study to compare the pharmacokinetics and safety of BAT2606, a proposed biosimilar of Nucala (mepolizumab), to US-sourced and EU-sourced reference product in normal healthy volunteers. The clinical study is a randomized, double-blind, parallel group, single-dose study that is expected to enroll approximately 207 healthy volunteers. Mepolizumab is an interleukin-5 (IL-5) antagonist monoclonal antibody that is administered subcutaneously with a syringe or autoinjector. Mepolizumab is currently indicated for the following conditions: 1) as an add-on maintenance treatment of adult and paediatric patients aged 6 years and older with severe asthma and with an eosinophilic phenotype, 2) as an add-on maintenance treatment of adult patients 18 years and older with chronic rhinosinusitis with nasal, 3) the treatment of adult patients with eosinophilic granulomatosis with polyangiitis, 4) the treatment of adult and paediatric patients aged 12 years and older with hypereosinophilic syndrome for =6 months without an identifiable non-hematologic secondary cause. After the conclusion of the phase 1 study Bio-Thera plans to run a global phase 3 study and request approval for all available indications at the time of filing the BLA/MAA with NMPA, FDA, EMA and other regulatory bodies around the world. Bio-Thera Solutions is developing several additional biosimilar products for the global market including biosimilar versions of Avastin, Actemra, Cosentyx, Simponi and Stelara. QLETLI, a biosimilar to Humira, and Pobevcy, a biosimilar to Avastin, are approved by the NMPA and being commercialized in China. Bio-Thera Solutions, Ltd., a leading global biotechnology company in Guangzhou, China, is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular diseases, and other serious unmet medical needs, as well as biosimilars for existing, branded biologics to treat a range of cancer and autoimmune diseases.

Optimize Your trial insights with Clival Database.

Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you.

Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets.

With Clival, you get accurate positioning of historical sales data, patent database, company profiling, safety & efficacy, and prediction of launch of new innovative molecules helping you to align your research and driving down the cost.

To add value, we further break down our analytics for you so that improving your operational effectiveness; optimizing your clinical trials; and offering you accurate and high-quality data at lowest possible prices becomes possible.

Elevate your trial success rate with the cutting-edge insights from Clival database.

Check it out today and make more informed sourcing decisions! Learn More!