CASI Pharmaceuticals, Inc. (CASI): Marketing Mix Analysis [Dec-2025 Updated]

You're trying to make sense of CASI Pharmaceuticals, Inc. right now, and the truth is, the old playbook is out; the company is executing a sharp, necessary pivot away from its China commercial base toward a U.S.-centric, R&D-driven future centered on CID-103. This shift comes as the China business shows strain, evidenced by Q3 2025 revenue hitting only $3.1 million, a steep 60% decrease year-over-year, mostly from EVOMELA returns. With new leadership under CEO David Cory starting in July 2025, the critical question is how this strategic re-focus-selling off the commercial assets while doubling down on the pipeline-redefines the four pillars of their market approach. Stick with me, and we'll map out the Product, Place, Promotion, and Price strategies for CASI Pharmaceuticals, Inc. that reflect this new reality.

CASI Pharmaceuticals, Inc. (CASI) - Marketing Mix: Product

The product element for CASI Pharmaceuticals, Inc. centers on its clinical-stage pipeline, specifically the lead asset CID-103, while managing the transition away from its established commercial products in China.

Lead Asset: CID-103

The lead asset is CID-103, a fully human IgG1, anti-CD38 monoclonal antibody, which CASI Pharmaceuticals, Inc. owns exclusive global rights to. This product targets a unique epitope on CD38, aiming to be a best-in-class therapy for organ transplant rejection and autoimmune diseases. The company is actively advancing its development across multiple indications.

• Indication: Renal Allograft Antibody-Mediated Rejection (AMR) for kidney transplant patients.
• US Regulatory Status: FDA clearance received for IND application for a Phase 1 study, with first patient in planned for the first quarter of 2026.
• China Regulatory Status: Regulatory submission for a proposed Phase 1/2 study accepted and under review.
• Indication: Chronic Immune Thrombocytopenia (ITP).
• Clinical Status: Phase 1 dose-escalation study ongoing, with dosing reaching the highest cohort of 900 mg.
• Future Development: Assessing multiple technologies toward a subcutaneous (SQ) delivery formulation for registration trials.

Commercial Portfolio Context and Strategic Pivot

CASI Pharmaceuticals, Inc.'s commercial portfolio, historically driven by hematology/oncology products, is being managed through a strategic divestiture of its China business, targeting completion by the second quarter of 2026. This action underscores the shift in resource allocation toward CID-103 development. The company expects to retain rights related to EVOMELA®, FOLOTYN®, CNCT19, and CB-5339 post-transaction, alongside CID-103 rights in Japan and non-Asian regions. The third quarter of 2025 revenue was $3.1 million, a 60% decrease compared to the $7.8 million reported in the third quarter of 2024, primarily due to an estimation of goods return for EVOMELA®.

The following table summarizes key product-related financial and operational data as of the third quarter of 2025 (3Q25) and Trailing Twelve Months (TTM) data:

Retained Pipeline Assets

Beyond the lead asset, CASI Pharmaceuticals, Inc. retains rights to other developmental and commercial assets following the strategic transaction involving its China subsidiaries. The company's R&D expenses for the second quarter of 2025 were $1.7 million, up 31% year-over-year, primarily for CID-103 development.

• EVOMELA® (melphalan): Retained rights; noted as the primary revenue driver for multiple myeloma treatment historically.
• FOLOTYN® (pralatrexate): Retained rights; proprietary to Acrotech Biopharma Inc. and its affiliates.
• CNCT19 (CAR-T): Retained rights; New Drug Application (NDA) accepted by National Medical Products Administration (NMPA) in China in December 2022.
• CB-5339: Retained global rights; an oral, second-generation, small molecule VCP/p97 inhibitor.

CASI Pharmaceuticals, Inc. (CASI) - Marketing Mix: Place

The Place strategy for CASI Pharmaceuticals, Inc. has undergone a significant, near-term geographic realignment, effectively contracting its commercial footprint to focus on its global research and development base. This shift is directly tied to the definitive Equity and Assets Transfer Agreement announced on May 12, 2025, for the divestiture of its China operations.

Geographic Contraction and China Divestiture

The primary commercial market, which was Greater China, is now being divested, signaling a major contraction in CASI Pharmaceuticals, Inc.'s distribution network. The proposed sale to Kaixin Pharmaceuticals Inc., an entity wholly-owned by the CEO, Dr. Wei-Wu He, was for an aggregate purchase price of $20.0 million, which includes the assumption of approximately $20.0 million of the Company's indebtedness. This transaction effectively removes the entire business operations in China and all license-in/distribution rights in Asia (excluding Japan) for key pipeline products like CID-103, BI-1206, and Thiotepa. This move signals a pivot away from direct commercialization in the Greater China region.

The former China commercial structure, which CASI Pharmaceuticals, Inc. intended to lead, leveraged a significant local presence. While the outline suggests a team size of 100+ people, the most recent concrete figure found for the China commercial and medical marketing team was over 70 hematology and oncology sales and marketing specialists, as of late 2020. This previous scale highlights the magnitude of the distribution infrastructure being exited.

Focus on U.S. and Global R&D Base

The post-divestiture focus is squarely on the U.S. and non-Asian regions for the development and future commercialization of its lead program, CID-103. Following the transaction, CASI Pharmaceuticals, Inc. expects to retain the rights related to CID-103 in Japan and non-Asian regions, alongside EVOMELA®, FOLOTYN®, CNCT19, and CB-5339. The immediate distribution strategy for CID-103 is centered on clinical trial execution in the U.S., with plans to initiate a Phase 1 study for renal allograft antibody-mediated rejection (AMR) in the third quarter of 2025, following FDA IND clearance. The company is also actively recruiting and dosing patients in a Phase 1/2 study for chronic immune thrombocytopenia (ITP).

Distribution Channels for Oncology Products

For the oncology injectable portfolio that CASI Pharmaceuticals, Inc. previously managed, and for its future oncology/transplant pipeline products like CID-103 (an anti-CD38 monoclonal antibody), distribution relies heavily on specialized healthcare settings. This aligns with the broader market dynamics for oncology drugs, where administration often requires specialized handling and dispensing capabilities. The market data for 2025 shows a clear preference for institutional channels for complex treatments.

The anticipated distribution channel breakdown for the overall Oncology Drugs Market in 2025 is as follows:

Hospital pharmacists possess the necessary resources to manage and dispense intricate regimens, such as the immunotherapies and targeted treatments that characterize the pipeline focus of CASI Pharmaceuticals, Inc..

Manufacturing Footprint

The company maintains a critical manufacturing asset through its wholly-owned subsidiary, CASI Pharmaceuticals (Wuxi) Co., Ltd. This facility, designed to global cGMP (current Good Manufacturing Practice) requirements, began its production activities in June 2025. The commencement of production at the Wuxi site means that certain costs, amounting to $0.9 million in relation to the GMP facilities, were recorded into inventory starting in the second quarter of 2025, rather than being expensed immediately as general and administrative costs. This internal capacity supports the supply chain for any products retained or developed outside the divested China territories.

The key distribution and operational shifts are summarized below:

• China commercial team scale (pre-sale context): over 70 specialists (as of 2020).
• China business divestiture value: $20.0 million aggregate purchase price.
• Debt assumption in divestiture: Up to $20.0 million.
• Wuxi manufacturing start date: June 2025.
• Oncology distribution channel leader (Market Proxy): Hospital Pharmacies at 39.4% share in 2025.
• CID-103 retained rights geography: Japan and non-Asian regions.

CASI Pharmaceuticals, Inc. (CASI) - Marketing Mix: Promotion

For CASI Pharmaceuticals, Inc. (CASI), promotion centers heavily on scientific exchange and building credibility within the medical community, particularly in China.

The core of the promotional strategy involves direct engagement with healthcare professionals. This is not broad consumer advertising; rather, it's targeted communication aimed at adoption and recommendation.

• Marketing efforts focus on physician education.
• Engagement with Key Opinion Leaders (KOL) in China is a critical component.

This targeted approach requires significant financial commitment. Looking at the second quarter of 2025, the Selling and marketing expenses totaled $5.0 million. That represented a year-over-year increase of 14% when compared to the same period in the prior year. This increased spending isn't arbitrary; it's a direct response to market dynamics.

The primary catalyst for this heightened promotional spend is the intensified competition from local generic melphalan products. You have to spend more to ensure your message cuts through when the market gets crowded. To give you a more current snapshot, Q3 2025 selling and marketing expenses were $4.6 million, which was a 6% decrease compared to the $4.9 million spent in the third quarter of 2024.

The financial commitment to promotion can be tracked over the recent quarters:

Beyond the commercial side, investor relations acts as a key promotional arm, shaping the narrative around the company's pipeline assets. The primary focus here is the CID-103 program. Investor messaging consistently frames CID-103 as a potentially best-in-class, high-value asset, especially given its mechanism of action as an anti-CD38 monoclonal antibody for organ transplant rejection and autoimmune diseases.

A recent, significant event is being leveraged promotionally to signal a renewed, focused direction for the U.S. operations. The appointment of CEO David Cory in July 2025 is a key message point. This leadership change, succeeding Dr. Wei-Wu He who transitioned to Executive Chairman, is promoted as bringing over 30 years of operational experience and a track record of raising over $1B+ in capital markets to drive the CID-103 advancement.

Key elements of the leadership transition narrative include:

• New CEO David Cory appointed on July 21, 2025.
• Focus is explicitly on maximizing the potential of the CID-103 program.
• Former CEO Wei-Wu He remains as Executive Chairman.
• The move is positioned to concentrate resources on the U.S. business.

CASI Pharmaceuticals, Inc. (CASI) - Marketing Mix: Price

You're looking at the pricing reality for CASI Pharmaceuticals, Inc. (CASI) as of late 2025, and the numbers tell a story of significant pressure on realized price and revenue.

The most recent top-line figure shows a severe impact: CASI Pharmaceuticals, Inc. (CASI) reported that third quarter 2025 revenue was $3.1 million, which represents a sharp 60% decrease year-over-year from the $7.8 million reported in Q3 2024. This steep decline was mainly attributable to the Company's estimation of goods return for EVOMELA^®, following a modified distribution agreement entered into in June 2025 that allows the distributor to return goods close to expiration dates.

To see the trend leading into this, second quarter 2025 revenue was $4.2 million, which showed a modest 5% increase compared to the $4.0 million in the same period last year, before the significant Q3 drop.

The cost side reflects this volume change. Cost of revenue for Q3 2025 was $2.4 million, a 35% decrease compared to $3.7 million in Q3 2024, which is in line with the lower sales volume and a decrease in royalty costs for EVOMELA^®. For comparison, Q2 2025 cost of revenue was $2.1 million.

Here's a quick look at the recent revenue and cost structure:

The pricing environment for EVOMELA^® in China has been challenging. The launch of an undifferentiated generic formulation of melphalan for injection by a Chinese domestic manufacturer in 2024 already presented challenges, resulting in a decline of EVOMELA^® sales and creating downward pressure on pricing. This competitive dynamic is a key external factor influencing the realized price and revenue recognition for that product line.

Strategically, CASI Pharmaceuticals, Inc. (CASI) is de-risking its exposure to this pricing environment by executing a major strategic transaction. The agreement to sell its China assets is valued at an aggregate purchase price of $20.0 million, which includes the assumption of up to $20.0 million of indebtedness of the Company. This transaction, targeting completion by Q2 2026, effectively sets a floor for the valuation of that business unit, removing future revenue streams subject to that specific market's pricing competition.

The impact of pricing and sales volume on the P&L is clear when you look at the bottom line:

• Q3 2025 Net Loss was $10.9 million, compared to $8.4 million in Q3 2024.
• The company raised approximately $5.7 million (after commissions) from its at-the-market (ATM) facility during 3Q 2025, indicating a need for external capital to offset operational shortfalls.
• Selling and marketing expenses for Q3 2025 were $4.6 million, a 6% decrease year-over-year, reflecting a reduced focus on promoting the product line being divested.

Finance: draft 13-week cash view by Friday.