WuXi Eyes Growing Biologics Business With New Integrated Center
This article was originally published in PharmAsia News
Executive Summary
An integrated biologics solution center is China's largest CRO WuXi AppTec's first investment completes its going private move. Aiming to provide full range of services to clients developing antibody drugs, WuXi plans more investment within the next 12 months.
SHANGHAI – WuXi AppTec Inc. is not resting on its laurels as the largest contract research organization (CRO) in China, and has announced a plan to build a new integrated biologics development center in Shanghai.
With a total of $120m in investment, the solutions center will be facilitated through a collaboration with Open Monoclonal Technology Inc. (OMT), a US-based leader in the genetic engineering of animals for discovery of human therapeutic antibodies, for the use of its proprietary OmniRat platform.
OmniRat is the first human monoclonal antibody (mAb) platform based on rats. With its complete immune system and diverse antibody repertoire, the system is able to generate antibodies with human idiotypes, according to OMT.
The platform is integrated from discovery, development to clinical manufacturing of conventional and bi-specific mAbs and antibody drug conjugates (ADCs), combining OmniRat and in-house proprietary phage display libraries and Chinese hamster ovary cell lines.
“The center will provide integrated discovery, development and manufacturing of biologics for our clients, not a piecemeal service. It is to provide a solution,” Chris Chen, SVP and chief technology officer, Biologics Services at WuXi, told PharmAsia News.
Currently under construction, the center is expected to be operational in 2017 and will house 800 scientists, with a production capability of three 2,000L fed-batch and two 500L perfusion bioreactors.
“The center will further expand the capacity of WuXi Biologics and will significantly reduce project timelines and expedite biologics development,” Chen declared.
Chen noted that the new center is only for client projects. WuXi Biologics does not develop its own drugs and is building the center to support the ambitious plans of its clients, he explained.
WuXi Funding Moves
WuXi PharmaTech entered into a definitive merger agreement with New Wuxi Life Science Limited and its subsidiary Wuxi Merger Limited in August 2015. The company completed a going private cash transaction in December, which was valued at approximately $3.3bn (Also see "WuXi Bids Farewell To US Listing As It Vows To ‘Revolutionize R&D’" - Scrip, 14 Dec, 2015.).
When asked whether WuXi plans on raising any further capital within the next 12 months, Chen said the company will use its own funds and is still planning more investments.
Back in May 2015, WuXi Biologics began the construction of a new $150m biologics manufacturing facility in Wuxi city. The new plant is going to be the world’s largest mammalian cell culture production plant using disposable bioreactors.
To be completed by January 2017, the facility will house 14 2,000L disposable bioreactors for fed-batch cell culture and two 1,000L bioreactors for perfusion runs. It will also be built to run advanced continuous or semi-continuous manufacturing processes in addition to traditional fed-batch and perfusion modes.
String Of Partners
WuXi has had a string of recent partnerships with international firms in the biologics area.
Under a strategic agreement formed last December with MedImmune LLC, the global biologics research and development arm of AstraZeneca PLC, WuXi Biologics remains the exclusive partner for R&D manufacturing for MedImmune's innovative biologics in China, including in the respiratory, inflammation and autoimmunity, cardiovascular and metabolic diseases and oncology areas. AstraZeneca has the option to acquire the biologics manufacturing facility in Wuxi city.
In November, WuXi and Eli Lilly & Co. built on a long history of collaboration by entering into a new partnership for the development in China of an experimental drug that addresses cardiovascular risk in patients with dyslipidemia, a huge unmet medical need in the country (Also see "New WuXi/Lilly Deal Builds On Long Partnership" - Scrip, 12 Nov, 2015.).
WuXi CEO Ge Li had disclosed Wuxi’s client contribution during an earnings call: “I think right now, international versus domestic is about 80-20. The biotech versus large pharma, I would say right now about 50-50.”
In May 2015, Shanghai Stock Exchange-listed Gloria Pharmaceutical Co. Ltd and Wuxi also signed a risk-sharing joint development agreement to co-develop a selected biologic oncology drug and four Class 1.1 small molecule drugs for lung diseases, including lung cancer and respiratory indications.
Its partner TaiMed Biologics Co. received breakthrough therapy designation from the US FDA for ibalizumab (TMB355) in February 2015. Ibalizumab is a humanized monoclonal antibody and a member of an emerging class of HIV therapies known as viral entry inhibitors.
Clinical trial supplies of ibalizumab were manufactured at WuXi's biologics manufacturing facilities. WuXi will work closely with TaiMed in additional clinical supply manufacture and process validation to assist TaiMed's anticipated submission of a rolling biologics licensing application in the US.
If approved, ibalizumab would become the first biologic product manufactured in China to be launched in the US market.