Heyuan Bio Announces Pricing of Its Innovative CAR-T Therapy Inaticabtagene Autoleucel at RMB 999,000 per Dose Following NMPA Approval for r/r B-ALL

Nov 28, 2023 07:39 CST Updated 07:39

Juventas

Innovative Cell Therapy Drug Developer

Recently, according to a report by Tianjin Radio and Television, the first CAR-T therapy for leukemia treatment approved for marketing in China, Narlarsen Injection, has been prescribed for the first time at the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences. It is reported that the domestic pricing of Narlarsen Injection has been revealed, at 999,000 yuan per vial.

Not long ago,Juventas TargetedCD19TheCAR-TCell Therapy Drug ProductsNaciorl Injection (formerly known as:Herkylone Injection) 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 globally uniqueCD19 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, whereas in the United States, the annual incidence rate is approximately12.9/10Ten ThousandAmong them, acute lymphoblastic leukemia (ALL) accounts for all leukemia15%, andBCell TypeALL（B-ALL) Account 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 after the 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, Near30In recent years, the survival status of Chinese patients has not significantly improved, thus there is an urgent need for new and effective treatment methods to prolong patient survival and enhance 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 China's cell therapy field for the treatment of this disease. According to a Frost & Sullivan report, domestically, no other companies have...CAR-TThe product has entered the pivotal clinical trial stage, and it is expected that after the market launch of Naciaurcel, there will be a relatively long period of market exclusivity.。

According to the clinical trial data previously released by Juventas, the injection of Naciaurelase has treated over100Example: Chinese patients, the largest-scale Chinese patient population to date.CD19 CAR-TClinical safety and efficacy data accumulation, demonstrating a durable 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; apart from the lasting high remission rate, the injection of Naciorlen showed a significantly reducedCAR-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 Naciorl 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 Naciaurlec Injection at top hematology treatment hospitals across China, with expectations to...2023Will cover China by the end of the year50Home hospitals and clinical terminals will cover all top hematology treatment hospitals in China, serving 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 relapsed or refractory aggressiveBTwo registration clinical trials for 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.

Source: Official Account "Cell Gene Therapy", Juventas,NMPA Official Website, STAR Market Daily,Tianjin Radio and Television Station, China Times, etc.

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