With plans to bring surufatinib stateside, Chi-Med vastly scales up manufacturing with new Chinese plant
Hutchison China MediTech, or Chi-Med, is attempting to break new ground by bringing its internally developed oncology candidate surufatinib to US shores—which would make it just the second Chinese-developed drug to do so. With that goal in mind, the firm is vastly scaling up its manufacturing operations for a planned global push.
Chi-Med is building out a new large-scale manufacturing facility in Zhangjiang, Shanghai, that will total 592,000 square feet of floor space and boost the company’s production capacity by more than 600% past its current operations in Suzhou.
The build out will come in two phases: first, the company will expand its production capacity to churn out around 250 million tablets and 550 million capsules of small-molecule candidates per year; then, the drugmaker will add capacity to enlarge its large-molecule production.
No details were provided on when the two phases would be completed, how much the project will cost, or when operations are expected to begin in a news release Tuesday. A Chi-Med spokesperson could not be reached for comment by press time.
Chi-Med has been planning since June to file an NDA for surufatinib, a drug for treating cancer patients with advanced neuroendocrine tumors. The company said Tuesday it still plans to do so by the end of 2020— if approved, surufatinib would become the second cancer drug developed in China to be approved in the U.S. after BeiGene’s Brukinsa.
Chi-Med CEO Christian Hogg said in a statement that the new facility will “significantly increase Chi-Med’s production capacity to bring our home-grown Chinese innovations to more patients in China and around the world.”
Representatives from AstraZeneca and Eli Lilly attended a groundbreaking ceremony at the site Tuesday in addition to officials from the Shanghai municipal government, Shanghai Free-Trade Zone, Zhangjiang Management Committee and Zhangjiang Group.
Chi-Med’s Suzhou site has supplied numerous drug candidates the space for clinical trials, including the production and commercialization of in-house-developed Elunate, a colorectal cancer drug for patients who have failed at least two other treatment methods. Chi-Med has nine other cancer drugs currently in various clinical trial stages.