CASI Pharmaceuticals

What CASI Pharmaceuticals does

CASI Pharmaceuticals (NASDAQ: CASI) is a clinical-stage biopharmaceutical company developing CID-103, an investigational anti-CD38 monoclonal antibody that targets B memory cells, plasmablasts, and plasma cells. Its lead indication is antibody-mediated rejection (AMR) in kidney transplant patients—an area with no FDA-approved treatment—where approximately 12% of recipients (over 30,000 people in the United States alone) experience acute or chronic AMR. The company is also extending CID-103 into immune thrombocytopenia (ITP). The asset uses a proprietary R78 epitope-binding approach designed to reduce red blood cell binding while maintaining strong antibody-dependent cellular cytotoxicity (ADCC) and phagocytosis (ADCP) activity with reduced complement-dependent cytotoxicity (CDC), and the company is developing a subcutaneous formulation for patient convenience.

The company historically generated revenue through commercial sales of EVOMELA (melphalan), FOLOTYN (pralatrexate), and Zimberelimab in China, distributed through its Beijing headquarters and Wuxi manufacturing/R&D center. CASI is now pursuing divestiture of these China commercial assets to refocus on CID-103 development in both the United States and China, where the asset received FDA Phase 1 clearance in December 2025 and NMPA clinical trial approval for kidney rejection in January 2026. Recent capital raises include a $15 million private placement in June 2024 and a $20 million convertible note in December 2025.

CASI faces significant financial and operational headwinds: a 91.13% share-price decline over twelve months, market capitalization of approximately $2.55 million, a Nasdaq delisting determination in February 2026, and a planned CEO transition at the end of March 2026. The company employs 101-250 staff across US (Rockville, South San Francisco) and China operations, and markets through healthcare industry conferences, analyst coverage, and SEC-registered investor communications.

Name

CASI Pharmaceuticals

Legal name

CASI Pharmaceuticals, Inc.

Website

https://casipharmaceuticals.com

Company type

Public

Founded year

1991

Operating status

Operating

Headcount range

101–250 employees

Short description

CASI Pharmaceuticals is a clinical-stage biopharmaceutical company developing CID-103, an anti-CD38 monoclonal antibody targeting antibody-mediated rejection in kidney transplant patients and immune thrombocytopenia, while winding down its China commercial product franchise.

Ownership category

akta.pro rank

Product category

Clinical-stage biopharmaceuticals

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Pharmaceutical Preparation Manufacturing (325412), Drugs and Druggists' Sundries Merchant Wholesalers (424210)

SIC

Pharmaceutical Preparations (2834), Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Transplant & Immunosuppression Specialty Pharmaceuticals (HLAIACAJ)

akta.pro secondary industries

Immunology & Autoimmune Specialty Pharmaceuticals (HLAIACAB), Hematology Specialty Pharmaceuticals (Non-malignant) (HLAIACAI)

Keywords

• Clinical-stage biopharmaceuticals
• Monoclonal antibody therapeutics
• Organ transplant rejection treatment
• Autoimmune disease therapies
• Pharmaceutical product distribution

Headquarters

HQ city

Rockville

HQ country

United States

HQ region

North America

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Supply Chain, Marketing or Sales

Revenue model

1. Pharmaceutical Product Sales (China): CASI generates revenue from commercial pharmaceutical products sold in China, including EVOMELA® (melphalan) for injection and Zimberelimab. The company reports quarterly revenue from these product sales.
2. Financing/Convertible Notes: The company has secured $20 million in funding through a convertible note purchase agreement and $15 million through a private placement financing to support clinical development and operations.

Go-to-market motion2 records

Distribution channels2 records

Marketing channels4 records

Core offering

CASI Pharmaceuticals is a clinical-stage biopharmaceutical company developing CID-103, an investigational anti-CD38 monoclonal antibody that targets B memory cells, plasmablasts, and plasma cells for the treatment of antibody-mediated rejection (AMR) in organ transplant recipients and autoimmune diseases such as immune thrombocytopenia (ITP). In parallel, the company commercializes a portfolio of pharmaceutical products in China including EVOMELA® (melphalan for injection), FOLOTYN® (pralatrexate injection), and Zimberelimab.

Product overview

CASI Pharmaceuticals is an innovative biopharmaceutical company developing CID-103, an anti-CD38 monoclonal antibody treatment, as its core investigational product for organ transplant rejection and autoimmune diseases. The company also has a portfolio of commercial pharmaceutical products in China including EVOMELA (melphalan), FOLOTYN (pralatrexate injection), and Zimberelimab. The company is developing subcutaneous formulations of CID-103 to enhance patient convenience and treatment adherence, particularly for kidney transplant patients.

Differentiator

Problem solved

Functional benefit

Brands

• CID-103: Anti-CD38 monoclonal antibody investigational drug candidate for organ transplant rejection and autoimmune diseases

Products and services

• CID-103 Investigational anti-CD38 monoclonal antibody targeting B memory cells, plasmablasts, and plasma cells. Developed for the treatment of antibody-mediated rejection (AMR) in organ transplant patients and autoimmune diseases such as immune thrombocytopenia (ITP). Binds to a distinct R78 epitope on CD38 to reduce red blood cell binding while maintaining ADCC/ADCP activity.
• EVOMELA® (Melphalan) Melphalan for injection product commercially launched in China by CASI Pharmaceuticals. Registered trademark held by CASI. Used in oncology treatment settings.
• Zimberelimab Injection product commercially offered by CASI Pharmaceuticals in China under the Zimberelimab brand name.
• FOLOTYN® (Pralatrexate Injection) Pralatrexate injection product commercially launched in China by CASI Pharmaceuticals for the treatment of relapsed or refractory peripheral T-cell lymphoma. Registered trademark held by CASI.

Quantifiable outcome

• Approximately 12% of kidney transplant patients experience acute or chronic AMR
• +1 more outcomes

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Scale indicators6 records

Recent moves8 records

Expansion highlights5 records

Direct peers

• Sanofi: Markets isatuximab (Sarclisa), the second approved anti-CD38 monoclonal antibody. As a class competitor to CID-103 in plasma-cell-depleting therapy, Sanofi is a direct peer in anti-CD38 mechanism, with potential read-through to CID-103's positioning in transplant and autoimmune indications.
• Eledon Pharmaceuticals: Clinical-stage biotech developing tegoprubart, a CD40L antagonist for prevention of organ transplant rejection including AMR. Eledon is a direct competitor in the kidney transplant rejection space that CASI is targeting with CID-103, and serves as a useful valuation and clinical-readout comparable for a small-cap transplant biotech.
• Janssen Biotech (Johnson & Johnson): Developer of daratumumab (Darzalex/Darzalex Faspro), the leading approved anti-CD38 monoclonal antibody. Janssen is the most directly comparable competitor to CASI's CID-103, with active investigator and company-sponsored work evaluating daratumumab in antibody-mediated rejection (AMR) — the same indication CASI is pursuing.
• Veloxis Pharmaceuticals (Asahi Kasei): Specialty transplant company commercializing Envarsus XR (tacrolimus extended-release) for organ transplant patients. Comparable to CASI as a focused transplant-focused therapeutics company with both immunosuppression expertise and experience navigating transplant regulatory and commercial pathways.

Regional players

• Hansoh Pharmaceutical Group: Leading Chinese biopharmaceutical company with a portfolio of innovative drugs and a strong domestic China commercial footprint. Comparable to CASI's legacy China business (EVOMELA, Zimberelimab, FOLOTYN distribution) and a relevant regional peer for understanding Chinese pharma market dynamics during CASI's planned divestiture.
• Innovent Biologics: Chinese biopharmaceutical company developing and commercializing innovative biologics including monoclonal antibodies. Comparable to CASI as a developer of mAb-based therapeutics with China regulatory and commercial infrastructure, relevant to CASI's dual US/China development strategy for CID-103.
• BeiGene: Global oncology-focused biotech with major operations in China and the US, developing innovative biologics including monoclonal antibodies. BeiGene is a regional peer relevant to CASI's mAb development strategy and as a benchmark for dual US/China biotech execution.

Broad incumbents

• Astellas Pharma: Markets Prograf (tacrolimus), the leading calcineurin inhibitor in transplant immunosuppression, and has a dedicated transplant franchise. Astellas is a broad incumbent against whom any new transplant/AMR therapy (including CID-103) would compete for share of treatment protocols.
• Bristol Myers Squibb: Markets Nulojix (belatacept) for kidney transplant rejection prophylaxis and has a broad immunology/immunosuppression portfolio. BMS is a broad incumbent in transplant therapeutics and a relevant comparator for AMR market dynamics and pricing benchmarks.
• Takeda Pharmaceutical: Global biopharma with a significant transplant franchise (including products like Adcetris used in post-transplant lymphoproliferative disorders) and oncology biologics portfolio. Takeda is a broad incumbent relevant to AMR treatment landscapes and potential strategic-acquirer profile for a small transplant biotech.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/casi-pharmaceuticals-inc.

Revenue estimate

Valuation estimate

Number of profiles

Profiles14 records

Subsidiaries2 records

Funding overview

Funding rounds11 records

Investors10 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A1 record

Investments3 records

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about CASI Pharmaceuticals