(Yicai) Oct. 10 -- Chinese biotechnology company CARsgen Therapeutics Holdings has applied to US regulators to resume the clinical trials for its chimeric antigen receptor T-cell immunotherapy in the country after passing the latest reinspection.

CARsgen's production facility in Durham, North Carolina, passed a reinspection from the US Food and Drug Administration with zero deficiencies, the Shanghai-based company announced yesterday, adding that it applied to resume clinical trials for its three CAR-T cell therapies, with the response expected to come out within 30 calendar days.

Last December, the FDA forced CARsgen to suspend the clinical trials for three new drugs -- CT053, CT041, and CT071 -- pending the conclusion of an inspection at its facility in Durham.

After the suspension of clinical trials last year, CARsgen rebuilt its US management team, including appointing a new head of product quality, Li Zhonghai, the company's founder, chairman, and chief executive officer, told Yicai yesterday in an exclusive interview.

"The FDA usually conducts manufacturing inspections just before product launch," Li noted. "Inspections at the drug development stage are relatively rare and may cause short-term delays, but passing them early brings significant long-term value for the quality of clinical trials."

In fact, early inspections can help companies perfect their quality systems early, thus reducing risks of setbacks right before the drugs' formal launch, Li pointed out.

"Our US team then put tremendous efforts to meet regulatory requirements this time," Li said about passing the FDA reinspection.

CARsgen develops innovative CAR-T cell therapies for hematologic malignancies and solid tumors. Its production facility in Durham manufactures autologous CAR-T cell products that are able to satisfy the needs of 700 patients per year. It supports clinical research and early commercialization production in the US, Canada, and Europe.

The National Medical Products Administration of China approved the New Drug Application of CT053 in March, making it the fifth CAR-T cell therapy to get greenlit in the country. Marketed under the brand name zevorcabtagene autoleucel, CT053 is indicated for adult patients with relapsed or refractory multiple myeloma who have progressed after at least three prior lines of therapy.

Editors: Tang Shihua, Futura Costaglione