Dinutuximab beta is a Monoclonal Antibody owned by Recordati, and is involved in 16 clinical trials, of which 7 were completed, 8 are ongoing, and 1 is planned.

APN311 is an unconjugated anti-GD2 antibody. The ch14.18 monoclonal antibody binds to GD2. The antibody specifically targets the antigen GD2, a feature on the surface of neuroblastoma cells and thereby initiates an immune reaction against these cells. GD2 is a specific glycolipid on neuroblastoma cells that inhibits immune system cells from killing the cancer cells. The monoclonal antibody provokes an attack by different types of immune cells against the cancer cells. Ganglioside GD2 is a cell surface antigen. GD2 is richly expressed at the cell surfaces of human neuroblastomas. The drug candidate acts by inhibiting GD2, thereby exhibiting therapeutic intervention in the treatment of the disease.

The revenue for Dinutuximab beta is expected to reach a total of $1.3bn through 2038. This change impacts the valuation of this asset and is an important factor to understand the current value of the drug in a clinical process. View the complete picture with the Dinutuximab beta NPV Report.

Dinutuximab beta was originated by Children’s Cancer Research Institute and is currently owned by Recordati.

Dinutuximab beta Overview

Dinutuximab beta (APN-311, Isqette, Qarziba) is a chimeric monoclonal antibody. It is produced in Chinese hamster ovary (CHO) cells. It is formulated as concentrate solution for intravenous route of administration. It is indicated for the treatment of high-risk neuroblastoma in patients aged 12 months and above, who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and stem cell transplantation, as well as patients with history of relapsed or refractory neuroblastoma, with or without residual disease. Dinutuximab beta Apeiron should be combined with interleukin-2 (IL-2) in patients with a history of relapsed/refractory disease and in patients who have not achieved a complete response after first line therapy.

Dinutuximab beta is under development for the treatment of leiomyosarcoma. It was under development for neuroblastoma in the U.S, Japan and other countries and also for other GD2 indications.

Recordati Overview

Recordati, a subsidiary of Fimei SpA, is a pharmaceutical company that researches, develops, manufactures and markets pharmaceuticals. The company offers pharmaceuticals for cardiovascular diseases, central nervous system disorders, dermatology, musculoskeletal disorders and analgesia, and urology diseases. It also offers cosmetics, dietary supplements, pregnancy test products, over-the-counter (OTC) and non-prescription pharmaceuticals, anti-infectives and others. It manufactures pharmaceutical chemicals such as active pharmaceutical ingredients (APIs) and intermediates. The company sells its pharmaceuticals directly in the countries of its operations and through licensees in other places. Recordati is headquartered in Milan, Italy.

The company reported revenues of (Euro) EUR1,580.1 million for the fiscal year ended December 2021 (FY2021), an increase of 9.1% over FY2020. In FY2021, the company’s operating margin was 31%, compared to an operating margin of 32.4% in FY2020. In FY2021, the company recorded a net margin of 24.4%, compared to a net margin of 24.5% in FY2020. The company reported revenues of EUR485.1 million for the third quarter ended September 2022, an increase of 2.5% over the previous quarter.

Quick View – Dinutuximab beta

Report Segments
  • Innovator (NME)
Drug Name
  • Dinutuximab beta
Administration Pathway
  • Intravenous
  • Parenteral
Therapeutic Areas
  • Oncology
Key Companies
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

To create this model, GlobalData takes into account factors including patent law, known and projected regulatory approval processes, cash flows, potential applicable patients, drug margins, company expenses, and pricing estimates. Combining these data points with GlobalData’s world class analysis creates high value models that companies can use to help in evaluation processes for each drug or company.

The rNPV method integrates the probability of a drug reaching a clinical stage into the cash flow at that time, which provides a more accurate rNPV, as it considers the probability that the drug never makes it through the clinical pathway to commercialization. GlobalData’s rNPV model uses proprietary likelihood of approval (LoA)and phase transition success rate(PTSR) data for the indication in the highest development stage, which can be found on GlobalData’s Pharmaceutical Intelligence Center.