The partnership between AstraZeneca’s global biologics R&D arm and WuXi commenced in September 2012 with a focus on the development of the former’s candidate MEDI5117, a monoclonal antibody initially investigated for autoimmune and inflammatory diseases in China.
A month after, the Chinese CDMO opened a fully single-use GMP biologics manufacturing facility in WuXi – about 50km west of Shanghai – which, according to an announcement today, MedImmune has the option to acquire through an investment of around $100m (€92m).
The AstraZeneca offshoot said the option forms part of an expanded joint venture which will look to address unmet patient needs in China across a range of therapeutic areas, including respiratory, inflammation and autoimmunity; cardiovascular and metabolic diseases, and oncology.
MedImmune’s EVP Bahija Jallal said she was “delighted” to broaden the collaboration with WuXi.
“This strategic alliance, alongside our accelerated investments will create a sustainable and strategic innovation platform in China and strengthen our leadership in developing next-generation biologics for both local needs and patients around the world.”
MEDI5117 was originally being investigated for osteoarthritic pain, but last year the firm dropped the programme and concentrated on developing the anti-IL6 mAb in rheumatoid arthritis (RA).
In March this year, the China Food and Drug Administration (CFDA) accepted the candidate for review. WuXi completed all CMC (chemistry, manufacturing and control), nonclinical, and clinical sections of the dossier, while the wholly owned subsidiary of the joint venture filed an IND for it with the Jiangsu provincial FDA as a Class 1 therapeutic biologic in December 2014.
Small molecule investment
The expanded alliance will also see the firms invest $50m into a new plant on the WuXi site to aid the development and manufacturing of innovative small molecule drug candidates.
AstraZeneca’s EVP Mark Mallon said the increased investment would further help bring medicines to Chinese patients while also making the firm “the first multinational biopharmaceutical company to create a dedicated R&D platform and manufacturing capabilities in China for local development.”