Anti-CD38 antibody Clinical, Companies, Therapeutic Assessment, Therapies, Treatment Algorithm, Pipeline Analysis | I-MAB Biopharma, Takeda, HLX15, Ancora Biotech, CASI Pharmaceuticals

Anti-CD38 antibody Pipeline constitutes 10+ key companies continuously working towards developing 12+ Anti-CD38 antibody treatment therapies, analyzes DelveInsight.

Anti-CD38 antibody Overview:

CD38 is a membrane-bound protein initially identified through monoclonal antibody analysis of lymphocytes, leading to its early classification as a lymphocyte-specific marker. Discovered in 1980 by E.L. Reinherz and S. Schlossman, CD38 is a type II transmembrane glycoprotein. It plays important roles in cell migration regulation, receptor-mediated adhesion (via interactions with CD31 or hyaluronic acid), and various signaling pathways. Its expression in lymphocytes varies depending on the developmental stage, and stimulation with agonistic CD38 antibodies can elicit diverse responses in different blood cell types. CD38 is found not only on cell surfaces but also within intracellular compartments, including the nucleus.

A significant discovery was its structural similarity to ADP-ribosyl cyclase, which expanded the understanding of CD38's functions. CD38 is now known to be a multifunctional enzyme involved in the metabolism of two key calcium signaling molecules: cyclic ADP-ribose (cADPR) and nicotinic acid adenine dinucleotide phosphate (NAADP). cADPR modulates ryanodine receptors to release calcium from the endoplasmic reticulum, while NAADP targets calcium stores in acidic organelles such as lysosomes.

The human CD38 protein is a 46 kDa type II transmembrane glycoprotein, featuring a short cytoplasmic N-terminal segment and a large extracellular domain. It can be internalized, shed, and also exists in a soluble 39 kDa form detectable in bodily fluids. The CD38 gene is located on a human chromosome and is expressed in various hematopoietic cells, with expression levels influenced by cell activation and differentiation. CD38 is also found in several tissues and is expressed by regulatory T cells, regulatory B cells, and myeloid-derived suppressor cells-where high expression may impair immune responses to cancer. Although many circulating T and B cells are CD38-negative, the protein is found on activated T and B cells, monocytes, natural killer (NK) cells, dendritic cells, and plasma cells.

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"Anti-CD38 antibody Pipeline Insight 2025" report by DelveInsight provides a comprehensive analysis of the ongoing clinical development activities and growth prospects across the Anti-CD38 antibody Therapeutics Market.

Key Takeaways from the Anti-CD38 antibody Pipeline Report

DelveInsight's Anti-CD38 antibody pipeline report depicts a robust space with 10+ active players working to develop 12+ pipeline therapies for Anti-CD38 antibody treatment.
FDA granted accelerated approval on July 2, 2025 for relapsed/refractory multiple myeloma in adults who've had ≥4 prior therapies, including anti‐CD38 mAbs.
Key Anti-CD38 antibody companies such as I-MAB Biopharma, Takeda, HLX15, Ancora Biotech, CASI Pharmaceuticals, and others are evaluating new drugs for Anti-CD38 antibodies to improve the treatment landscape.
Promising Anti-CD38 antibody pipeline therapies in various stages of development include TAK-079, HLX15, CID-103, and others.

Anti-CD38 antibody Pipeline Analysis
The report provides insights into:
The report provides detailed insights into the key companies that are developing therapies in the Anti-CD38 antibody Market.
The report also evaluates different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Anti-CD38 antibody treatment.
It analyzes the key companies involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
It navigates the emerging drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement, and financing details for future advancement of the Anti-CD38 antibody market.

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Anti-CD38 antibody Emerging Drugs

TAK-079 - Takeda

TAK-079 (mezagitamab) is a high-affinity monoclonal antibody that targets CD38-a molecule highly expressed on malignant myeloma cells and present in lower amounts on normal immune cells, including activated NK cells, T cells, and B cells. TAK-079 binds strongly to myeloma cells in the bone marrow and other tissues. The therapy aims to provide a fast and sustained increase in platelet counts, quickly restoring them to functional levels. It is currently in Phase III clinical development for treating Immune Thrombocytopenic Purpura (ITP).
HLX15 - Shanghai Henlius Biotech

HLX15 is a fully human IgG1κ monoclonal antibody directed against CD38, developed independently by Shanghai Henlius Biotech. It is being investigated for the treatment of multiple myeloma (MM)-a serious, currently incurable malignancy of clonal plasma cells and the second most common blood cancer, typically affecting older adults. In February 2025, Henlius entered into a licensing agreement with Dr. Reddy's Laboratories, granting Dr. Reddy's exclusive commercialization rights for both subcutaneous and intravenous formulations of HLX15 across 43 countries, including the U.S. and 42 European territories. The drug is currently in Phase III clinical trials for multiple myeloma.

Anti-CD38 antibody Companies

Approximately 10 or more leading companies are actively developing therapies targeting the Anti-CD38 antibody. Among them, Takeda and Shanghai Henlius Biotech have the most advanced drug candidates, both currently in Phase III clinical trials.

DelveInsight's report covers around 75+ products under different phases of clinical development like

Late stage products (Phase III)
Mid-stage products (Phase II)
Early-stage product (Phase I) along with the details of
Pre-clinical and Discovery stage candidates
Discontinued & Inactive candidates

Anti-CD38 antibody pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

Intravenous
Subcutaneous
Oral
Intramuscular

Anti-CD38 antibody Products have been categorized under various Molecule types such as

Monoclonal antibody
Small molecule
Peptide

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Anti-CD38 antibody Pipeline Therapeutic Assessment
• Anti-CD38 antibody Assessment by Product Type
• Anti-CD38 antibody By Stage
• Anti-CD38 antibody Assessment by Route of Administration
• Anti-CD38 antibody Assessment by Molecule Type

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Table of Content

1. Report Introduction
2. Executive Summary
3. Anti-CD38 antibody Current Treatment Patterns
4. Anti-CD38 antibody - DelveInsight's Analytical Perspective
5. Therapeutic Assessment
6. Anti-CD38 antibody Late-Stage Products (Phase-III)
7. Anti-CD38 antibody Mid-Stage Products (Phase-II)
8. Early Stage Products (Phase-I)
9. Pre-clinical Products and Discovery Stage Products
10. Inactive Products
11. Dormant Products
12. Anti-CD38 antibody Discontinued Products
13. Anti-CD38 antibody Product Profiles
14. Anti-CD38 antibody Key Companies
15. Anti-CD38 antibody Key Products
16. Dormant and Discontinued Products
17. Anti-CD38 antibody Unmet Needs
18. Anti-CD38 antibody Future Perspectives
19. Anti-CD38 antibody Analyst Review
20. Appendix
21. Report Methodology

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Contact Info:
Kritika Rehani
krehani@delveinsight.com
info@delveinsight.com
+14699457679

About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance.

This release was published on openPR.