CASI Pharmaceuticals, Inc. (CASI): 5 FORCES Analysis [Nov-2025 Updated]

You're looking at CASI Pharmaceuticals right now, and honestly, the picture is one of high-stakes transformation. This isn't just a minor strategy tweak; CASI Pharmaceuticals is making a massive pivot, moving away from its legacy China hematology/oncology business to focus squarely on developing CID-103 globally. That shift fundamentally rewrites the rules of the game across all five competitive forces. With Q3 2025 showing a razor-thin cash position of just $4.7 million and a net loss hitting $10.9 million, while revenue dropped a staggering 60% due to issues with EVOMELA, you need to know exactly where the pressure points are. We need to see how supplier leverage, customer demands, rivalry, substitutes, and new entrants look now, because the survival of this new strategy depends on it; dig into the forces below to see the immediate risks and potential upside.

CASI Pharmaceuticals, Inc. (CASI) - Porter's Five Forces: Bargaining power of suppliers

You're assessing the supplier landscape for CASI Pharmaceuticals, and frankly, the picture shows significant leverage held by a few key partners, which is a major near-term risk given the company's current financial footing.

The bargaining power of suppliers is elevated because CASI Pharmaceuticals' commercial success and pipeline advancement are tied to a small number of critical third parties. For its established revenue stream, CASI Pharmaceuticals has a high reliance on external licensors for key commercial products. For instance, EVOMELA® is proprietary to Acrotech Biopharma Inc. and its affiliates, and FOLOTYN® commercialization in China involves agreements with Acrotech Biopharma Inc., Mundipharma International Corporation Limited, and Mundipharma Medical Company. This concentration means these entities can exert considerable influence over terms, especially when disputes arise.

Dependence on Juventas Cell Therapy Ltd. for the development and potential co-marketing of CNCT19 further concentrates supplier power. CASI Pharmaceuticals' initial commitment included an investment of RMB 80 million (approximately $11.6 million) in Juventas in lieu of an upfront payment for the license. This deep initial tie-in, coupled with the ongoing arbitration proceedings related to the CNCT-19 Agreements, highlights a supplier relationship under strain but still critical to a pipeline asset.

The existence of these conflicts directly translates to financial pressure. Specifically, legal fees related to the current arbitration with Juventas and the dispute with Acrotech were a primary driver for the 60% increase in General and administrative expenses to $7.7 million in the first quarter of 2025, compared to $4.8 million in the same period last year. This shows that supplier disputes carry a tangible, immediate cost.

The table below summarizes the core dependencies that define the supplier power dynamic for CASI Pharmaceuticals as of late 2025:

The company's precarious cash position significantly weakens its negotiating stance against these suppliers. As of September 30, 2025, CASI Pharmaceuticals reported cash and cash equivalents of only $4.7 million. This low liquidity, especially following a Q3 2025 net loss of $10.9 million, means the company has limited financial flexibility to absorb supply chain disruptions or fund costly transitions away from an incumbent supplier.

The supplier power is further amplified by the nature of the assets:

• - High reliance on third-party licensors for key commercial products like EVOMELA® and FOLOTYN®.
• - Dependence on Juventas for CNCT19 clinical development and co-marketing in China.
• - Legal disputes with Acrotech and Juventas increase supplier-side risk and leverage.
• - Suppliers of specialized API for biologics like CID-103 face high barriers to entry for replacement, given the complexity of monoclonal antibody manufacturing.
• - CASI's cash position of only $4.7 million (Q3 2025) severely limits negotiation power.

Honestly, when your cash on hand is less than one quarter of your last reported quarterly loss, you don't dictate terms to your licensors; you accept them. Finance: draft 13-week cash view by Friday.

CASI Pharmaceuticals, Inc. (CASI) - Porter's Five Forces: Bargaining power of customers

You're looking at a situation where the buyers-the hospitals, the payers, and the ultimate patients-hold considerable sway over CASI Pharmaceuticals, Inc. (CASI) in the Chinese market, especially concerning its key product, EVOMELA. This power dynamic is not theoretical; we saw its immediate, sharp impact in the third quarter of 2025.

The most concrete evidence of this power is the financial fallout. CASI Pharmaceuticals reported third-quarter 2025 revenue of just $3.1 million, which represented a steep year-over-year drop of 60% compared to the $7.8 million generated in the third quarter of 2024. Management explicitly attributed this massive revenue decline to estimated goods returns for EVOMELA and competitive pressures. That kind of sudden reversal signals that the purchasing side-whether through contractual terms or market substitution-can dictate terms very quickly.

The structure of the distribution relationship itself concentrates buyer power:

• - The sole distributor for EVOMELA in China is China Resources Pharmaceutical Commercial Group International Trading Co., Ltd. (CRPCGIT).
• - This exclusive arrangement means CRPCGIT acts as the primary gatekeeper between CASI Pharmaceuticals and the end-users, giving it significant leverage in negotiations over volume, pricing, and inventory management, as evidenced by the goods returns.

The broader regulatory environment in China amplifies this customer power significantly. While EVOMELA was initially the only approved melphalan injection upon its August 2019 launch, the threat of substitution is constant due to government-led cost-control initiatives. You have to factor in the known pressure from the country's procurement system:

The CVBP heavily favors domestic generics by making price the primary bidding factor, often leading to cuts over 50% for winning products. This creates an environment where any local generic melphalan product, even if slightly less differentiated than EVOMELA (which avoids propylene glycol), can exert immense downward price pressure on CASI Pharmaceuticals, making switching easy for the ultimate payer. If onboarding takes 14+ days, churn risk rises.

The leverage of the sole distributor, CRPCGIT, combined with the known price sensitivity enforced by the centralized procurement mechanism, means CASI Pharmaceuticals has limited ability to dictate terms to the customer base. The 60% revenue drop in Q3 2025 is the bottom-line result of this high bargaining power.

CASI Pharmaceuticals, Inc. (CASI) - Porter's Five Forces: Competitive rivalry

You're looking at a competitive landscape for CASI Pharmaceuticals, Inc. (CASI) that is intensely shaped by its ongoing strategic pivot. The rivalry force here is multifaceted, involving entrenched local players in its legacy market and large, well-capitalized biopharma firms in its core therapeutic areas.

The legacy China market presents a very high rivalry hurdle, particularly concerning generic melphalan products. For instance, in the second quarter of 2025, CASI Pharmaceuticals noted that increased selling and marketing expenses were a direct response to intensified competition from local melphalan generic products. This pressure on legacy commercial assets underscores the difficulty of maintaining ground against local manufacturers who often have lower cost structures.

Strategically, CASI Pharmaceuticals is actively reducing its future exposure to this high-rivalry environment. The company is targeting completion of the divestiture of its China business in Q2 2026. This move is a clear attempt to shift focus away from that highly competitive regional market and concentrate resources on its pipeline assets, like CID-103, primarily in the U.S. and Asia.

However, the current financial strain directly impacts its capacity to compete effectively against established players. CASI Pharmaceuticals competes with large biopharma firms such as BeiGene and Jazz Pharmaceuticals, which generally possess significantly deeper pockets for R&D, clinical trials, and market access. The latest figures show this strain clearly:

The third quarter of 2025 resulted in a net loss of $10.9 million, a widening from the $8.4 million net loss reported in the third quarter of 2024. This deterioration in profitability, set against a revenue drop of 60% year-over-year to just $3.1 million in Q3 2025, definitely weakens CASI Pharmaceuticals' competitive investment capacity. You have to wonder how long the current cash position can sustain this burn rate.

Here's a quick look at the financial context as of the end of Q3 2025, which frames the competitive pressure:

The competitive dynamics are further illustrated by the operational context surrounding the company's pivot:

• Rivalry in China is high due to local generic melphalan manufacturers.
• The company is actively divesting its China business, targeting Q2 2026 completion.
• CASI Pharmaceuticals is ranked 58th among 3,122 active competitors in its sector as of late 2025.
• The Q3 2025 net loss of $10.9 million compares to a $10.8 million net loss in Q1 2025.
• Selling and marketing expenses for Q3 2025 were $4.6 million.

Finance: draft 13-week cash view by Friday.

CASI Pharmaceuticals, Inc. (CASI) - Porter's Five Forces: Threat of substitutes

The threat of substitutes for CASI Pharmaceuticals, Inc. (CASI) is significant, particularly concerning its legacy revenue stream and the competitive landscape for its pipeline asset, CID-103.

High threat from generic melphalan, directly substituting the key revenue driver EVOMELA.

The primary revenue driver, EVOMELA, faces direct substitution pressure from generic melphalan formulations. This pressure is evident in CASI Pharmaceuticals' financial performance, with third quarter 2025 revenues falling to $3.1 million, a 60% decrease compared to the third quarter of 2024, largely attributed to anticipated goods returns for EVOMELA. The broader Melphalan market, which was valued at approximately $1.2 billion in 2023, is projected to reach $1.75 billion by 2032. Competition from local melphalan generics was cited as a reason for increased selling and marketing expenses in the second quarter of 2025. Studies indicate that generic melphalan formulations are comparable to the innovator formulation (EVOMELA, a propylene glycol-free formulation) in terms of pharmacokinetics and efficacy for autologous stem cell transplantation conditioning in multiple myeloma.

CID-103 targets unmet needs but faces competition from off-label or existing therapies.

CASI Pharmaceuticals, Inc. (CASI) is pivoting resources to CID-103, an anti-CD38 monoclonal antibody, for organ transplant rejection and autoimmune diseases. For Antibody-Mediated Rejection (AMR) in kidney transplant patients, approximately 12% experience acute or chronic AMR, affecting over 30,000 people in the United States alone, and currently, there is no FDA-approved treatment. For its indication in chronic Immune Thrombocytopenia (ITP), the Phase 1 dose-escalation study was enrolling and dosing at the highest dose of 900 mg as of the third quarter of 2025.

Biologics targeting CD19 and CD20 are functional substitutes for some CID-103 indications.

CID-103's mechanism of action, targeting CD38, is explicitly positioned to address limitations in existing therapeutic classes.

• - CID-103 targets B memory, plasmablasts, and plasma cells.
• - CD19 and CD20 therapies do not deplete persistent plasma cells.
• - Plasma cells generate antibodies attacking the donor organ.

The new focus on organ transplant/autoimmune disease reduces oncology substitute risk.

The strategic emphasis on CID-103 for renal allograft AMR and ITP shifts the competitive focus away from the segment where EVOMELA faced generic erosion. The company is targeting AMR with an FDA-cleared IND, with the Phase 1 U.S. study preparation ongoing. The divestiture of the China business is targeted for completion in the second quarter of 2026, further streamlining focus.

CASI Pharmaceuticals, Inc. (CASI) - Porter's Five Forces: Threat of new entrants

You're looking at the barriers to entry for a new firm trying to compete directly with CASI Pharmaceuticals, Inc. (CASI) in the specialized biopharma space. Honestly, the hurdles are immense, built on regulatory requirements and massive capital needs.

• - High regulatory barriers (FDA/NMPA) and extensive clinical trial costs for new biologics.
• - CASI's Nasdaq delisting risk (November 2025) highlights the huge capital barrier to entry.
• - The need for specialized R&D talent and GMP manufacturing facilities is a major hurdle.
• - New entrants in the CID-103 space must overcome the first-mover advantage in clinical trials.

The sheer cost of navigating the U.S. Food and Drug Administration (FDA) and China's National Medical Products Administration (NMPA) for a novel biologic is a primary deterrent. The average cost to develop a new prescription drug, which includes the cost of failures, is estimated to be approximately $2.6 billion. This process typically spans 10 to 15 years. For a new entrant, preclinical research alone can run between $300 million and $600 million.

Clinical trial expenses stack up quickly. Phase 1 trials might cost between $1.5 million and $6 million per drug, while Phase 3 trials, which involve thousands of patients, can demand between $25 million and $100 million. If a new entrant were attempting a biosimilar pathway, the FDA application fee with clinical data for Fiscal Year 2025 is set at $4,310,002, though a Biosimilar User Fee Act (BsUFA) application fee with clinical data is lower at $1,471,118. Furthermore, avoiding a Comparative Efficacy Study (CES) for a biosimilar, which the FDA may waive, can save one to three years and $24 million in development costs.

The capital barrier is starkly illustrated by CASI Pharmaceuticals, Inc.'s (CASI) recent struggles. In November 2025, CASI received a Nasdaq delisting determination because its Market Value of Listed Securities (MVLS) fell below the required $35 million threshold. At that time, CASI's market capitalization stood at only $20.14 million. This demonstrates that even an established, albeit small, player struggles to maintain the public market capitalization necessary for visibility and capital access, a hurdle a new entrant must clear immediately.

This financial strain is reflected in CASI Pharmaceuticals, Inc.'s operational figures. For the third quarter of 2025, CASI reported a net loss of $10.9 million, with cash and cash equivalents dwindling to $4.7 million as of September 30, 2025. While CASI raised approximately $5.7 million from its at-the-market (ATM) facility in Q3 2025, this capital infusion is minor compared to the billions required for full development.

Securing the necessary human capital and infrastructure presents another significant barrier. CASI Pharmaceuticals, Inc.'s Research and Development (R&D) expenses for Q3 2025 were $1.4 million, indicating continuous, specialized spending. Moreover, the need for Good Manufacturing Practice (GMP) facilities requires substantial investment; CASI recorded $0.9 million in costs related to GMP facilities into inventory in June 2025.

For a competitor targeting CASI Pharmaceuticals, Inc.'s specific pipeline asset, CID-103, the first-mover advantage is a factor. CASI is advancing CID-103, an anti-CD38 monoclonal antibody, in two main indications.

A new entrant would need to replicate or surpass the clinical progress already made, such as the dosing up to 900 mg in the ITP trial which started on June 4, 2025. The fact that CASI Pharmaceuticals, Inc. has already secured FDA clearance for its Investigational New Drug (IND) application for the AMR indication means a new entrant must start from the very beginning of that regulatory pathway.