Synermore’s anti-asthma biosimilar drug SYN008 has been approved by CFDA for human clinical trial phase I
Synermore’s SYN008 IND application was approved by China National Food and Drug Administration (CFDA) in September 13, 2016 for the clinical phase I trial study. This clinical trial will evaluate the comparability of SYN008 and Xolair (Omalizumab) in pharmacokinetics, pharmacodynamics, and safety in healthy volunteers.
Founded in December 2013, Synermore Biologics Co. Ltd. has established a large number of the state-of-the-art technologies and platforms necessary for the development and production of therapeutic monoclonal antibodies, focusing on innovative biologics and high commercial potential biosimilars. The company is committed to providing effective medicines for the unmet medical need therefore contributing to human health and the economic development of Great China.
The traditional drugs for asthma are antihistamine, steroid, bronchodilator, leukotriene antagonist, but these anti allergic drugs not only have limited therapeutic effect, also need to be taken every day. Patients with moderate to severe asthma need a long-term use of high doses of corticosteroids to relieve symptoms, resulting in severe side effects such as immune system damage. Immunoglobulin IgE has been proved to be the main cause of asthma and allergy. At present, the only biological drug, anti IgE antibody Xolair (Omalizumab), has been successfully developed and currently is on market to overcome the disadvantage of traditional medicines for asthma and allergy.
SYN008 has the same mechanism as Xolair. It can neutralize IgE which causes allergic reactions. SYN008 has the same indications as Xolair, targeting on moderate to severe allergic asthma, chronic urticaria and allergic diseases. Synermore has mastered the key technology and process to develop Xolair biosimilar. The company has received approval from Australia Therapeutic Goods Administration (TGA) in early 2016 for the clinical phase I trial. It has been planned to manufacture and sell it in China in near future. Referring to Xolair's sales in 2015, the global market for anti-allergy drugs exceeds $2 billion. Therefore, when Synermore successfully completes the clinical trials and launches the authorized product on global markets, it is expected to collaborate with big pharmaceuticals for realizing its full market potential, which will create considerable revenue for the company.