HeyGene's CD19-Directed CAR-T Therapy Najirolunse Injection Approved in China for Relapsed/Refractory B-ALL

Nov 08, 2023 16:48 CST Updated 16:48

Juventas

Innovative Cell Therapy Drug Developer

2023Year11Month8Day, China National Medical Products Administration (NMPA）Official website announcement,Juventas TargetedCD19TheCAR-TCell and Gene Therapy Drug ProductsNaciorl Injection (formerly known as:Herkylone Injection) has been approved for marketing in China, used forTreatment of Adult Relapsed or RefractoryBCellular Acute Lymphoblastic Leukemia (r/r B-ALL）, which is the first in China for this indication.CAR-TTherapy，It is also the first fully independent innovative targeted therapy approved for marketing in China.CD19 CAR-TProduct.

Source:NMPA Official Website

Naciorl Injection (CNCT19Cell Injection,Inaticabtagene Autoleucel）It is a lentivirus vector-based autologousCAR-TProduct, itsWith global uniquenessCD19 scFv（HI19a) Structure and internationally leading production and manufacturing processes, the drugSuccessively obtained three new drug clinical trial approvals from the National Medical Products Administration (IND) license, for the treatment of adult patients with relapsed or refractory acute lymphoblastic leukemia, and for the treatment of relapsed or refractory aggressiveBCellular Non-Hodgkin Lymphoma and Treatment in ChildrenAndAdolescent Relapse or RefractoryBCellular Acute Lymphoblastic Leukemia，And this year3Month Obtained in the United StatesFDANew Drug Clinical Trial (IND) License, for the treatment of adultsr/r B-ALL。

Leukemia is one of the most common hematological malignancies, with approximately6.21/10Incidence Rate of Wan, while in the United States, the annual incidence rate is approximately12.9/10Ten Thousand. Among them, acute lymphoblastic leukemia (ALL) accounts for all leukemia15%, andBCell TypeALL（B-ALL) accounted for approximatelyALLThree-quarters of, and withTCell TypeALLIn comparison, the prognosis is worse. Moreover, overall,B-ALLAdult patients have a poorer survival status compared to pediatric patients, and adultsB-ALLThe recurrence rate of patients after initial treatment is relatively high, with about three-fifths of patients eventually progressing tor/r B-ALL. For adultsr/r B-ALLThe patient, due to their extremely poor prognosis, has a median survival time of approximately3~6Months, Recently30In recent years, the survival status of Chinese patients has not significantly improved, therefore there is an urgent need for new and effective treatment methods to extend patients' survival time and improve their quality of life.。

For the treatment of acute lymphoblastic leukemia, there are currently only two globally.CAR-TThe product has been approved for marketing, one of which is specifically for pediatric and adolescent patients.Kymriah(Developed by Novartis, on2017Year8Monthly HarvestFDAApproved for marketing), the other is for adult patientsTecartus(Developed by Gilead, on2020Year7Month ObtainedFDAApproved for Marketing)However, Nakiolumab Injection, as the first treatment in China and the second globally for adult acute lymphoblastic leukemia,CAR-TThe product fills a gap in the field of cell therapy for this disease treatment in China. According to a Frost & Sullivan report, no other companies in China have ventured into this same indication.CAR-TThe product has entered the pivotal clinical trial stage, and it is expected that after the market launch of Narlakelis, there will be a relatively long period of market exclusivity.。

According to the clinical trial data previously released by Juventas, the injection of Nageoerensai has treated over100Example Chinese patients, the largest Chinese patient population to dateCD19 CAR-TClinical safety and efficacy data accumulation, demonstrating a consistently high remission rate in pivotal clinical trials, with an overall response rate reaching82.1%, and the longest duration of sustained relief for some patients has exceeded24months, and is still in continuous remission; in addition to the long-lasting high remission rate, the injection of Naciorlen showed a significant reduction inCAR-TSeverity of Treatment-Related Toxicity,3Grade and above cytokine storm (CRS) Incidence rate is10.3%；3Grade and above immune effector cell-associated neurotoxicity syndrome (ICANS) Incidence rate is7.7%, without expected targetingCD19 CAR-TTreatment-related adverse events occurred. Overall, the durable high remission rate and safety of Naciorlcel Injection are significantly superior to existing treatment methods, making it a promising therapy for adults.r/r B-ALLMajor Breakthrough。

It is reported that Juventas is steadily advancing the clinical endpoint certification of Naciaurine Injection at top hematology treatment hospitals across China, with an expected completion by...2023Will cover China by the end of the year50Home Hospital Clinical Terminals Will Cover All Top Hematological Disease Treatment Hospitals in China, for Chinese Adultsr/r B-ALLPatients Bring More Effective Treatment Options and Long-Term Survival Hope。

In addition, the injection of Naciorlens targets children and adolescents with acute lymphoblastic leukemia as well as those with recurrent or refractory aggressiveBTwo registration clinical trials of non-Hodgkin lymphoma at the cellular level are also proceeding steadily to help more patients of different age groups in the field of acute lymphoblastic leukemia.

E.N.D

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