(Yicai) Jan. 10 -- China has given the green light to French pharmaceutical giant Sanofi's CD38 monoclonal antibody isatuximab injection for the treatment of hematological cancer.

Isatuximab, which is sold under the name Sarclisa, was approved by China's National Medical Product Administration to treat adult patients with multiple myeloma who have received at least one line of therapy, in combination with pomalidomide and dexamethasone, Sanofi announced yesterday.

Sarclisa is a CD38 monoclonal antibody that binds to a specific epitope on the CD38 receptor on MM cells, inducing distinct antitumor activity, according to Sanofi. It is designed to work through multiple mechanisms of action, including programmed tumor cell death and immunomodulatory activity.

"The approval of this innovative drug provides a new weapon to treat Chinese patients with MM during the critical window period of the first recurrence," said Wu Depei, director of the Hematology Department at the First Affiliated Hospital of Soochow University.

Sarclisa was the first hematological tumor drug to be approved in China based on a real-world study as key evidence, the Paris-based firm added.

The branch in Hainan province of Ruijin Hospital, which is affiliated with the School of Medicine of Shanghai Jiao Tong University, carried out Sarclisa’s IsaFiRsT real-world study within 238 days, making progress for China's drug and equipment review and approval system, said Zhao Weili, vice president of Ruijin Hospital.

In recent years, the NMPA has been actively exploring the use of real-world data during the review and approval of drugs and medical devices to facilitate the quick entry of advanced international products into China for the benefit of Chinese patients.

The NMPA has approved several innovative drugs developed by international pharmaceutical giants this year, including the poly adenosine diphosphate ribose polymerase inhibitor developed by AstraZeneca and Merck to treat adult patients with early high-risk breast cancer and programmed death-1 inhibitor pembrolizumab developed by Merck for the treatment of adult patients with advanced or metastatic urothelial cancer.

Editors: Tang Shihua, Futura Costaglione