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(Yicai) Oct. 10 -- Chinese regulators have started reviewing an application by JW Cayman Therapeutics to substitute imported viral vectors for one of its CAR-T therapies with its own lentiviral vector, a change that could lower the cancer drug’s high price.
The National Medical Products Administration has accepted JW Therapeutics' post-marketing supplemental filing to use its in-house lentiviral vector, JWLV011, in manufacturing relmacabtagene autoleucel, which is called Carteyva in China, the Shanghai-based firm announced yesterday.
Chimeric antigen receptor T-cell therapies are targeted and efficient cancer treatments, but their high price limits their accessibility. China has approved seven such drugs, all priced at over CNY1 million (USD140,000), which has prevented them from being added to the National Reimbursement Drug List, thereby limiting patient access and constraining commercial uptake.
Carteyva, JW Therapeutics first product, was approved in China in 2021. It is used for treating three types of blood cancer, and costs CNY1.3 million (USD182,500) per injection.
Lentiviral vectors, the vehicles that deliver CAR genes into patient T-cells, are among the most expensive and key raw materials in making Carteyva, JW Therapeutics noted, adding that reliance on foreign suppliers has created cost and supply issues that impinge on the drug’s commercial production and clinical development.
To address those constraints, the company developed JWLV011 and integrated it into the production of Carteyva, while also optimizing the viral production process and strengthening quality controls to ensure consistent supply and lower per-dose costs, it pointed out.
"Localizing the production of lentiviral vectors holds significant strategic importance for us," said Liu Min, chairman and chief executive of JW Therapeutics. “Upon successful substitution with domestically produced viral vectors, we will achieve a more stable supply both for our commercial products and clinical development, along with a substantial reduction in product costs.”
"Lower costs will enable us to better navigate commercial competition and insurance negotiations, creating an opportunity to significantly enhance the commercial value of Carteyva," Liu added.
JW Therapeutics was jointly set up in 2026 by US biopharmaceutical firm Juno Therapeutics and WuXi AppTec, a Chinese provider of pharmaceutical research and development services.
Editors: Dou Shicong, Martin Kadiev