Sunday, 14 August 2022

Chinese Bio-pharma firm to authorize recombinant arthritis biosimilar drug in Singapore

27 August 2021 | News

Shanghai-based Mabwell inks agreement with Singapore based FEGO to produce and commercialize "recombinant human anti-TNF-α monoclonal antibody" viz, 'Humira' a biosimilar of Adalimumab

Photo Credit: Mabwell

Photo Credit: Mabwell

Mabwell (Shanghai) Bioscience Co. Ltd and Singapore's FEGO Biotech Pte Ltd have jointly entered into a cooperation agreement to commercialize Mabwell's 9MW0113, a proposed biosimilar of Adalimumab (Humira®) for Singapore Market.

The partnership includes supply of drug substance with drug product technology. FEGO shall produce the Drug Product and bring it to market by obtaining the necessary regulatory approvals in the country where FEGO holds the commercialization rights of 9MW0113.

9MW0113 is a recombinant human anti-TNF-α monoclonal antibody, which is used for reducing pain and swelling due to certain types of arthritis (such as rheumatoid arthritis). Biosimilars are shown to be similar in safety, efficacy and immunogenicity to the innovator's approved product with the advantage of offering to lower the healthcare expenditure of government and patients.

Under the terms of the agreement, both companies aim to achieve over $60 million in sales upon obtaining market authorization by 2030. 

Dr LIM Kah Meng, CEO and principal founder of FEGO Biotech commented that "We are excited to work with Mabwell in long-term collaboration to expand FEGO's footprint into the Biopharma sector. Mabwell team is committed to make all necessary steps to complete the regulatory process of 9MW0113".

Dr. Datao Liu, CEO and principal founder of Mabwell commented, "We are keen to work with FEGO to bring affordable biosimilar medicines to patients in SouthEast Asian region and we are also equally excited to work with FEGO on any possible collaborations on their local fill-finish in Singapore by supporting on uninterrupted supplies of Drug substances of this biosimilar and several other future biologics". 

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