Jiangxi Jemincare Group, a China-based healthcare company, has entered into a licensing agreement with fellow Chinese firm MabPharm Ltd (HKG: 2181) to obtain exclusive promotion rights to CMAB007, a prospective biosimilar of Roche/Genentech’s anti-IgE drug omalizumab, known under the trade name Xolair. The agreement encompasses rights across Greater China, including mainland China, Hong Kong, Macau, and Taiwan, with MabPharm retaining all other rights.
CMAB007 Development and Clinical Studies
CMAB007 is under development for the treatment of patients with asthma that is not adequately controlled by medium/high doses of inhaled corticosteroids plus long-acting beta-adrenoceptor agonists. The safety and efficacy of CMAB007 have been confirmed in four clinical studies involving 824 subjects. Results indicate that CMAB007 can improve asthma conditions in patients with lower doses of inhaled corticosteroids and reduce the likelihood of acute asthma episodes.
Xolair’s Market Approval and Expiration of Patents
Xolair (omalizumab), originally developed by Tanox, was first approved in China in August 2017 for the treatment of moderate to severe allergic asthma in patients aged 12 and above. It was later approved for use in “adults and adolescents (12 years and older) with chronic spontaneous urticaria (CSU) with symptoms persisting after treatment with H1 antihistamines” in April of the previous year. The patents for Xolair’s bioactive ingredients expired in China in 2016 and in the US in 2018. CMAB007 is awaiting regulatory decisions in China for the treatment of allergic asthma and is expected to become the country’s first biosimilar in this class.
Future Indications for CMAB007
Beyond allergic asthma, future explorations for CMAB007 include indications such as chronic idiopathic urticaria, seasonal allergic rhinitis, and food allergies. This broadens the potential impact of the biosimilar on the treatment landscape for various allergic conditions.
Conclusion
The licensing agreement between Jiangxi Jemincare Group and MabPharm Ltd marks a significant step in expanding access to biosimilar alternatives for anti-IgE therapies in Greater China. With CMAB007 potentially becoming the first biosimilar of its kind, this partnership could offer more affordable treatment options for patients suffering from allergic asthma and related conditions.-Fineline Info & Tech
