(Yicai) Oct. 10 -- Chinese biotech firm CARsgen Therapeutics Holdings has applied to US regulators to restart clinical trials halted last year for its chimeric antigen receptor T-cell immunotherapy after its production facility passed reinspection.

The facility in Durham, North Carolina passed reinspection by the US Food and Drug Administration with zero deficiencies, the Shanghai-based firm said yesterday. CARsgen has applied to resume clinical testing of its three CAR-T cell therapies, with a response expected within 30 calendar days, it added.

Last December, the FDA forced CARsgen to halt clinical trials of three new drugs -- CT053, CT041, and CT071 -- pending the conclusion of an inspection at the Durham facility. After the suspension, CARsgen rebuilt its US management team, including appointing a new head of product quality, Li Zhonghai, the company's founder, chairman, and chief executive, told Yicai yesterday.

“The FDA usually conducts manufacturing inspections just before product launch,” Dr. Li said. “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.”

These early inspections help companies perfect their quality systems early on, reducing the risk of setbacks before a drugs' market launch, Li pointed out.

“Our US team has made great efforts to meet regulatory requirements,” Li said about passing the FDA reinspection. “FDA inspections are not notified in advance.”

Shares of CARsgen [HKG: 2171] closed 5.6 percent higher at HKD4.75 (61 US cents) each in Hong Kong today. The benchmark Hang Seng Index gained 3 percent.

CARsgen develops innovative CAR-T cell therapies for hematologic malignancies and solid tumors. Its Durham facility makes autologous CAR-T cell products that meet the needs of 700 patients a year and supports clinical research and early-stage commercial production in the US, Canada, and Europe.

The National Medical Products Administration of China approved CT053’s new drug application in March, making it the fifth CAR-T cell therapy to be 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