China's first CAR-T cell therapy product was listed on the first anniversary: benefited more than 200 Chinese patients

"In 2014, I first learned about the new therapy for treating lymphoma for the first time under the guidance of the doctor. I clearly remember that the rain outside the window seemed to stop at that time, as if I saw the hope of cure cancer. Gu Hongfei, the founder of the "lymphoma House" of lymphoma patients with an online exchange community "lymphoma House" in the country.

On June 22, 2021, China ’s first CAR-T cell therapy product Yi Kaida (Aquelun Samship injection) was officially approved in China to open the first year of Chinese CAR-T cell therapy. It has also become the annual "Car-T Day" established by Fosun Kate. It is reported that on the first anniversary of the listing of Yi Kaida, more than 200 Chinese patients had benefited.

CAR-T brings hope of healing

Lymphoma is the most common blood tumor, but traditional treatment methods have poor effect on lymphoma. A summary analysis of 603 recurrence/refractory DLBCL patients show that the patient's clinical relief rate is only 26%, and the median position The total survival period is only 6.3 months. Clinically, it is urgent to innovate, high-accessible drug treatment methods. With the launch of CAR-T cell therapy products, new hope is for patients with recurrence/refractory lymphoma (LBCL).

In June last year, Yi Kai reached the first domestic CAR-T cell treatment product that was approved for listing, which was suitable for the treatment of second-tier or above systemic treatment after recurrence/refractory large B-cell lymphoma (LBCL) adult patients. The product is the CAR-T product of KITE (a company under Geely Duris), a CAR-T product of Kite, and has been authorized to target CD19 auto-CAR-T cell therapy products for localized production in China.

At present, CAR-T has shown exact clinical effects in the field of hematological tumors.

According to the results of one-arm, multi-center, and open clinical research (ZUMA-1) performed among 101 recurrence/refractory large B-cell lymphoma patients, the 5-year total survival rate of patients with Yescarta treatment was received 42.6%, and 92%of patients with 5 years of survival no longer need additional anti -cancer treatment.

After CAR-T cell therapy, these patients may have been cured clinically. At present, YESCARTA has benefited more than 7,500 patients with more recurrence/refractory large B -cell lymphoma worldwide, and Yicaida has also benefited more than 200 LBCL Chinese patients in the first anniversary of listing in China.

Professor Wang Li, chief physician of the Hematology Department of Ruijin Hospital affiliated to the School of Medicine of Shanghai Jiaotong University, said, "Last year, the approval of China's first CAR-T cell therapy products not only provided more options for our clinical treatment, but also made the original" no " Patients with medicine can be treated see the possibility of cure and get the opportunity to return to normal life. "

Professor Wang Li shared a set of clinical treatment data from Ruijin Hospital. She pointed out that as of now, Ruijin Hospital has treated more than 30 patients through commercial CAR-T products. There are 19 patients who can be evaluated during the treatment stage. Rate (ORR) is as high as 94.7%, and the complete relief rate (CR) is as high as 63.1%.

"CAR-T cell therapy products are personal customized drugs. Affected by factors such as genotypes, immune function, and disease status of patients, the treatment effect will vary from person to person. The relief rate and overall survival period of patients with hematological tumors bring the possibility of cure for patients. "Professor Li added.

Multiple measures to improve patients' accessibility

According to Huang Hai, CEO of Fosun Kate, Fosun Kate is constantly improving the availability of products in the process of commercialization of CAR-T cell therapy.

On the one hand, Fosun Kate actively promoted the implementation of the innovative payment model and reduced the economic burden of patients. As of May 25, Yicaida has been included in the benefit of the people's protection in more than 30 provinces and cities; on the other hand, Fosun Kate has actively expanded The coverage of CAR-T the treatment center, as of the end of May, Yicaida's treatment center had reached more than 80, meeting the treatment needs of the nearest treatment of patients with recurrence/refractory large B-cell lymphoma in different provinces and cities.

"We are actively expanding Yicaida's more indications, developing new targets and new technologies, and accelerating the research and development process of the physical tumor field. We hope to benefit more tumor patients." Huang Hai said.

It is reported that in June this year, Yikaida's clinical trial application (IND) for second -line therapy for large B -cell lymphoma was accepted by NMPA. In addition to the expansion of more indications, Fosun Kate's second CAR-T cell therapy products FKC889 (for treatment of previous second-line and above treatment recurrence/refractory cell lymphoma (R/R MCL) adults Patients were approved in China in March 2022 to conduct clinical trials in China.

In addition, Fosun Kate actively deployed the research and development pipeline and strengthened its independent research and development capabilities, and is accelerating the promotion of five preclinical projects for physical tumors, and is committed to making up the huge gaps in the application of physical tumors.

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