Anti-CD38 antibody - Pipeline Insight, 2025

DelveInsight's, "Anti-CD38 antibody - Pipeline Insight, 2025" report provides comprehensive insights about 10+ companies and 12+ pipeline drugs in Anti-CD38 antibody pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered:

• Global coverage

Anti-CD38 antibody: Understanding

Anti-CD38 antibody: Overview

CD38 is a membrane-bound protein first identified by monoclonal antibody typing of lymphocytes and thus thought of as a lymphocyte-specific antigen. CD38 was discovered in 1980 by E.L Reinherz and S. Schlossman, and is a type II transmembrane glycoprotein. CD38 plays a role in regulation of migration, receptor-mediated adhesion by interaction with CD31 or hyaluronic acid, and signaling events. Consistently, its expression in lymphocytes shows stage-related variations and ligation by agonistic antibodies against CD38 can trigger a wide range of responses in various types of blood cells. It is present not only on cell surfaces but also in various intracellular organelles, including the nucleus. The unexpected discovery that CD38 is homologous to ADP-ribosyl cyclase has brought in a new perspective on the cellular function of CD38 and ushered in a new field of investigation. Indeed, it has now been established that CD38 is a multi-functional enzyme catalyzing the metabolism of two distinct Ca2+ messengers, cyclic ADP-ribose (cADPR) and nicotinic acid adenine dinucleotide phosphate (NAADP). The former is a novel cyclic nucleotide that modulates the ryanodine receptor and mobilizes the endoplasmic Ca2+ stores. NAADP is structurally distinct from cADPR and targets separate Ca2+ stores, acidic organelles like lysosomes.

The human CD38 antigen is a 46 kilodalton (kDa) type II transmembrane glycoprotein with a short N-terminal cytoplasmic tail and a long extracellular domain.CD38 can be internalized and shed and it also exists in a 39 kDa soluble form in biological fluids. The gene encoding CD38 is on Chromosome. It is present in hematopoietic cells (its distribution seems to depend on the activation and differentiation of the cell) and can be expressed also in various tissues. It is also expressed on regulatory T cells, regulatory B cells, and myeloid-derived suppressor cells with a high surface expression associated with compromised immune surveillance for malignancies. CD38 is present in most of the circulating T- and B-cells are CD38-, and activated B- and T-cells, it is also present on monocytes, natural killer cells, dendritic cells, and plasma cells.

The ability of anti-CD38 antibodies to induce cell death is at least partially dependent on CD38 expression on the MM cell surface. Thus, maintenance of CD38 expression is likely important for continued responsiveness of MM cells to anti-CD38 therapy. Continuous exposure of various MM cell lines to effective concentrations of isatuximab induces internalization of CD38, but not its significant release from the surface of MM cells. On the other hand, CD38 ligation by daratumumab leads to aggregation of protein: antibody complexes, formation of distinct polar aggregates, and subsequent release of microvesicles (MVs). Prior to eventual internalization by distant immune cells, the formation of MVs, which also contain important immune-cell receptors and inhibitory complement receptors, may contribute to an immune or tolerogenic microenvironment for MM cells in the bone marrow (BM) niche.

"Anti-CD38 antibody- Pipeline Insight, 2025" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Anti-CD38 antibody pipeline landscape is provided which includes the disease overview and Anti-CD38 antibody treatment guidelines. The assessment part of the report embraces, in depth Anti-CD38 antibody commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Anti-CD38 antibody collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights:

• The companies and academics are working to assess challenges and seek opportunities that could influence Anti-CD38 antibody R&D. The therapies under development are focused on novel approaches to treat/improve Anti-CD38 antibody.

Anti-CD38 antibody Emerging Drugs Chapters

This segment of the Anti-CD38 antibody report encloses its detailed analysis of various drugs in different stages of clinical development, including Phase III, II, I, Preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Anti-CD38 antibody Emerging Drugs

• TAK-079: Takeda

TAK-079 is a high-affinity antibody against a specific molecule called CD38, which is found in abundance on the surface of malignant myeloma cells and at low levels on the surface of normal immune cells, including activated natural killer (NK) cells, T- and B-cells, among others. TAK-079 binds with great affinity to myeloma cells in the bone marrow and other organs. Therapy with mezagitamab is designed to deliver rapid and sustained improvement in platelet response and generally rapidly restores platelet counts to functional levels. Currently, the drug is in the Phase III stage of its development for the treatment of Immune Thrombocytopenic Purpura.

• HLX15: Shanghai Henlius Biotech

HLX15 is a fully human anti-CD38 IgG1κ monoclonal antibody independently developed by Henlius. The indication to be developed for HLX15 is multiple myeloma (MM), which is an incurable clonal plasma cell dysplasia, the second most hematological malignancy which mainly develops in elderly population. In February 2025, Shanghai Henlius Biotech, Inc. announced it had entered into a license agreement with Dr. Reddy's Laboratories. Under the terms of the agreement, Henlius will be responsible for development, manufacturing and commercial supply. Dr. Reddy's will gain exclusive rights to commercialize both subcutaneous and intravenous formulation of HLX15 in a total of 43 countries and regions, comprising 42 European countries and regions and the United States. Currently, the drug is in the Phase III stage of its development for the treatment of Multiple myeloma.

• CID-103: CASI Pharmaceuticals

CID-103 is a fully human IgG1 anti-CD38 monoclonal antibody that recognizes a unique epitope on CD38. It was engineered to have strong activity against CD38 malignant cells and to reduce certain safety issues observed with existing treatments. Preclinical data of CID-103 demonstrates enhanced activity against a broad array of malignancies which express CD38 and demonstrates a better preclinical safety profile when compared to other CD38 mAbs. These attributes offer the potential for accelerated development and regulatory review, including rapid advancement into earlier lines of therapy. Currently, the drug is in the Phase I stage of its development for the treatment of patients with multiple myeloma.

Anti-CD38 antibody: Therapeutic Assessment

This segment of the report provides insights about the different Anti-CD38 antibody drugs segregated based on following parameters that define the scope of the report, such as:

• Major Players in Anti-CD38 antibody
• There are approx. 10+ key companies which are developing the therapies for Anti-CD38 antibody. The companies which have their Anti-CD38 antibody drug candidates in the most advanced stage, i.e. Phase III include, Takeda and Shanghai Henlius Biotech.
• Phases

DelveInsight's report covers around 12+ 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
• Route of Administration

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

• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical
• Molecule Type

Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy
• Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Anti-CD38 antibody: Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, II, I, preclinical and discovery stage. It also analyses Anti-CD38 antibody therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Anti-CD38 antibody drugs.

Anti-CD38 antibody Report Insights

• Anti-CD38 antibody Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Anti-CD38 antibody Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions:

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Anti-CD38 antibody drugs?
• How many Anti-CD38 antibody drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Anti-CD38 antibody?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Anti-CD38 antibody therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Anti-CD38 antibody and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• I-MAB Biopharma
• Takeda
• HLX15
• Ancora Biotech
• CASI Pharmaceuticals

Key Products

• Felzartamab
• TAK-079
• Shanghai Henlius Biotech
• TNB 738
• CID-103