SHANGHAI – Astrazeneca plc, of London, is betting that a "made-in-China" label will shave years off the usual CFDA review and approval timelines that imported drugs face and will get its pipeline of therapeutics to Chinese patients much faster.

Getting a step closer to local status, Astrazeneca signed an exclusive service and manufacturing agreement with Wuxi Apptec to produce a line-up of biologics for China, covering all of the big pharma's strategic therapeutic areas, including respiratory, inflammation and autoimmunity, cardiovascular and metabolic diseases, and oncology.

Astrazeneca has also optioned to buy a Wuxi Apptec biologic facility for $100 million and has committed to invest a further $50 million in Astrazeneca's existing small-molecule manufacturing facility also located in Wuxi.

For some time, the writing has been on the wall that importing drugs into China following initial approval elsewhere is no longer a viable option for big pharma in a race where time to market matters most. Regulatory reforms that got under way in the summer have made it increasingly favorable for international companies to manufacture in China locally. (See BioWorld Today, Oct. 28, 2015, and Nov. 11, 2015.)

"Candidates that would have come in with an imported drug license [IDL] are now able to come on the market through the domestic pathway – this is a game-changer," Chris Chen, vice president and chief technology officer of biologic services at Wuxi Apptec, told BioWorld Asia. "We can expedite global biologics to come to market in China. This is the first time a large pharma seeks to file almost their entire portfolio for China using a local pathway."

With the regulatory door now open, how to execute locally – especially for hard-to-manufacture biologics – becomes an issue for multinational corporations. Developing a biologics manufacturing team from scratch is not an easy proposition, while finding the right manufacturing partner in China can be almost as challenging.

Three years ago, Medimmune, Astrazeneca's biologics arm, experimented with a way to gain local market access with the establishment of a joint venture (JV) with Wuxi Apptec to develop and commercialize MEDI5117, an anti-IL-6 biologic for autoimmune and inflammatory diseases in China.

The CFDA accepted the application for MEDI5117 in March, signaling that innovative structures such as the JV partnership would be accepted by the authorities under the domestic pathway. That further spurred big pharma to find suitable local partners, either in licensing deals seeking out local biotechs with track records of success in meeting pharma's quality expectations, or more recently in more wide-ranging, flexible, strategic partnerships based on trust. That has been the case with Innovent Biologics Inc. and Eli Lilly and Co., Wuxi and Lilly and now in this most recent partnership between Wuxi and Astrazeneca/Medimmune. (See BioWorld Today, Oct. 12, 2015, and Nov. 16, 2015.)

China a new global hub?

Under the current agreement, Wuxi will be the exclusive service provider in China for the chemistry, manufacturing process, process development and manufacturing for Astrazeneca's biologic therapies intended for the China market. The number of assets covered was not disclosed. Globally, Medimmune has 40 biologic products in clinical development.

Chen, who has been managing the JV from the Wuxi side, points to the high degree of trust that has been created between the two parties to get to this stage of signing a strategic manufacturing deal, along with months of due diligence efforts on the part of Astrazeneca/Medimmune to ensure that handing the assets over would be wise. "Thus far, we are the only company in China working with a large pharma in biologics on development in manufacturing. We are the only company that is up to that standard," Chen said.

Wuxi is also the first Chinese firm to receive FDA approval for a China-made biologic used in U.S. investigational new drug trials. The biologic is an HIV therapy, ibalizumab (TMB-355), which it manufactures for Taiwan Taimed Biologics Inc., of Taipei, Taiwan. (See BioWorld Today, May 14, 2014.)

The Astrazeneca deal's exclusivity extends to biologics only for the China market. For drugs Astrazeneca plans to market globally, Wuxi will have to compete with other big manufacturing firms such as Boehringer Ingelheim GmbH. Boehringer's China plant, located in Zhangjiang, Shanghai, is expected to come online in the first quarter of 2017.

Should Astrazeneca exercise its option to purchase one of Wuxi's biologics manufacturing facilities in the next few years, having budgeted $100 million to do so, it would make the big pharma a local biologics manufacturer overnight; it would be eligible for the domestic drug pathway and expedited review times.

Chen clarified the biologics plant that Astrazeneca has optioned to purchase is not Wuxi's large facility currently under construction and expected to be the biggest in China. It's slated to be operational in January 2017 as well. (See BioWorld Today, May 5, 2015.)

Not stopping there, there are also plans to make China a new global hub for pharmaceutical development – alongside existing hubs in the U.K. and Sweden – that will require up to 50 scientists in Wuxi and Shanghai. Also in the works is the establishment of a late-stage medicine development organization in China to coordinate biologics and small-molecule development.

According to Mark Mallon, Astrazeneca executive vice president, international, "these initiatives will allow us to better integrate the needs of this important market into our global portfolio decisions and make us the first multinational biopharmaceutical company to create a dedicated R&D platform and manufacturing capabilities in China for local development from research through to commercialization."

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