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CASI 
CASI Pharmaceuticals Inc (CASI)
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Upturn Advisory Summary
12/18/2025: CASI (1-star) is currently NOT-A-BUY. Pass it for now.
Upturn Star Rating
Not Recommended Performance
These Stocks/ETFs, based on Upturn Advisory, consistently fall short of market performance, signaling caution before investing.
Number of Analysts
1 Analysts rated it
Very few follow this stock; limited insights, higher-risk early investing.
1 Year Target Price $4
1 Year Target Price $4
| 0 | Strong Buy |
| 1 | Buy |
| 0 | Hold |
| 0 | Sell |
| 0 | Strong Sell |
Analysis of Past Performance
Type Stock | Historic Profit 16.21% | Avg. Invested days 35 | Today’s Advisory PASS |
Upturn Star Rating | Upturn Advisory Performance  3.0 | Stock Returns Performance  2.0 |
| Profits based on simulation | Last Close 12/18/2025 |
Key Highlights
Company Size Small-Cap Stock | Market Capitalization 12.88M USD | Price to earnings Ratio - | 1Y Target Price 4 |
Price to earnings Ratio - | 1Y Target Price 4 | ||
Volume (30-day avg) 1 | Beta 0.85 | 52 Weeks Range 0.80 - 3.47 | Updated Date 12/19/2025 |
52 Weeks Range 0.80 - 3.47 | Updated Date 12/19/2025 | ||
Dividends yield (FY) - | Basic EPS (TTM) -3.02 |
Analyzing Revenue: Products, Geography and Growth
Revenue by Products
Earnings Date
Report Date - | When - | Estimate - | Actual - |
Profitability
Profit Margin -183.96% | Operating Margin (TTM) -333.14% |
Management Effectiveness
Return on Assets (TTM) -61.8% | Return on Equity (TTM) -1094.5% |
Valuation
Trailing PE - | Forward PE - | Enterprise Value 31440823 | Price to Sales(TTM) 0.48 |
Enterprise Value 31440823 | Price to Sales(TTM) 0.48 | ||
Enterprise Value to Revenue 1.17 | Enterprise Value to EBITDA 0.07 | Shares Outstanding 15492781 | Shares Floating 10066188 |
Shares Outstanding 15492781 | Shares Floating 10066188 | ||
Percent Insiders 54.76 | Percent Institutions 17.15 |
Upturn AI SWOT
CASI Pharmaceuticals Inc
Company Overview
History and Background
CASI Pharmaceuticals Inc. (formerly CASI Pharmaceuticals, Inc.) was founded in 1990. The company has undergone several transformations, shifting its focus over the years. Originally involved in various life sciences and biotechnology ventures, it has strategically repositioned itself to focus on the development and commercialization of innovative biopharmaceutical products for oncology and autoimmune diseases, particularly within China.
Core Business Areas
- Oncology and Autoimmune Disease Drug Development: CASI Pharmaceuticals is primarily focused on the research, development, and commercialization of novel therapies for the treatment of cancer and autoimmune diseases. This involves identifying promising drug candidates, conducting clinical trials, and seeking regulatory approval for market entry, with a significant emphasis on the Chinese market.
- Commercialization and Partnerships: The company aims to build a robust pipeline through internal R&D, strategic collaborations, and licensing agreements. It also focuses on establishing commercialization channels and partnerships to bring its developed drugs to market, especially in China.
Leadership and Structure
CASI Pharmaceuticals Inc. has a management team led by a CEO, CFO, and other key executives responsible for its strategic direction, operations, and financial management. The organizational structure is designed to support its drug development and commercialization efforts, with dedicated teams for R&D, clinical affairs, regulatory affairs, and business development.
Top Products and Market Share
Key Offerings
- CNCT19 (Erlotinib): Erlotinib is a tyrosine kinase inhibitor used for the treatment of non-small cell lung cancer (NSLC) and pancreatic cancer. CASI Pharmaceuticals has rights to develop and commercialize it in China. Competitors include generic erlotinib manufacturers and other EGFR inhibitors like Gefitinib and Afatinib.
- Imrecatinib (MB07133): Imrecatinib is a novel small molecule tyrosine kinase inhibitor being developed for the treatment of advanced solid tumors, including colorectal cancer, non-small cell lung cancer, and gastrointestinal stromal tumors. Its development is ongoing, and its market share is yet to be established. Competitors in this space are broad, encompassing various targeted therapies and chemotherapies for these indications.
- Zoptarel (Paliperidone Palmitate Extended-Release): An extended-release injectable antipsychotic medication for the treatment of schizophrenia. CASI has rights for China. Competitors include other long-acting injectable antipsychotics and oral atypical antipsychotics.
Market Dynamics
Industry Overview
The biopharmaceutical industry, particularly in oncology and autoimmune diseases, is characterized by high R&D costs, lengthy development cycles, stringent regulatory processes, and intense competition. The market is driven by unmet medical needs, advancements in scientific research, and growing healthcare expenditure globally. The Chinese pharmaceutical market, specifically, is experiencing rapid growth due to an aging population, increasing prevalence of chronic diseases, and government initiatives to foster innovation.
Positioning
CASI Pharmaceuticals positions itself as a biopharmaceutical company focused on developing and commercializing innovative therapies for critical unmet medical needs in oncology and autoimmune diseases, with a strategic emphasis on the Chinese market. Its competitive advantages lie in its localized approach to the Chinese market, potential partnerships, and its pipeline of promising drug candidates. However, it faces significant competition from both multinational pharmaceutical giants and emerging local players.
Total Addressable Market (TAM)
The TAM for oncology and autoimmune disease treatments in China is substantial and rapidly growing. Estimates vary, but the Chinese oncology drug market alone is projected to reach tens of billions of dollars in the coming years, driven by rising cancer incidence and improved access to advanced therapies. CASI Pharmaceuticals is positioned to capture a share of this market through its targeted product pipeline and commercialization strategy for China.
Upturn SWOT Analysis
Strengths
- Strategic focus on the large and growing Chinese pharmaceutical market.
- Pipeline of drug candidates in key therapeutic areas (oncology and autoimmune diseases).
- Potential for strategic partnerships and collaborations.
- Experienced management team with expertise in drug development and commercialization.
Weaknesses
- Relatively early-stage pipeline with significant development and regulatory hurdles.
- Limited revenue generation from current products.
- Dependence on external funding for R&D and operations.
- Intense competition in the biopharmaceutical sector.
Opportunities
- Growing demand for innovative therapies in China.
- Government support for biopharmaceutical innovation in China.
- Potential for licensing and co-development agreements.
- Expansion into other emerging markets.
- Advancements in precision medicine and targeted therapies.
Threats
- Failure of drug candidates in clinical trials.
- Regulatory delays or rejections in China.
- Intensifying competition from established and emerging players.
- Pricing pressures and reimbursement challenges.
- Economic downturns affecting healthcare spending.
Competitors and Market Share
Key Competitors
- BeiGene, Ltd. (BGNE)
- Innovent Biologics, Inc. (1801.HK)
- Shanghai Junshi Biosciences Co., Ltd. (1877.HK)
- Hutchmed Limited (1352.HK)
- Gilead Sciences, Inc. (GILD)
Competitive Landscape
CASI Pharmaceuticals operates in a highly competitive landscape dominated by larger, well-established pharmaceutical companies and rapidly growing Chinese biotechs. Its advantages include a strategic focus on the Chinese market and specific therapeutic niches. However, it faces disadvantages in terms of scale, R&D resources, and market presence compared to its larger competitors. Success hinges on differentiated products, efficient clinical development, and effective market access strategies in China.
Growth Trajectory and Initiatives
Historical Growth: CASI Pharmaceuticals' historical growth has been characterized by strategic shifts in its business focus and pipeline development. The company has transitioned through various stages of R&D and commercialization planning. Financial growth has been characterized by significant investment in R&D, with revenue generation being a future objective for its advanced pipeline candidates.
Future Projections: Future growth projections for CASI Pharmaceuticals are contingent on the successful development and commercialization of its drug candidates, particularly in the large Chinese market. Analyst estimates would focus on potential peak sales of approved drugs, market penetration rates, and the impact of new pipeline additions. Key drivers include regulatory approvals, successful market launches, and the expansion of its therapeutic offerings.
Recent Initiatives: Recent initiatives likely involve advancing its lead drug candidates through clinical trials, seeking regulatory approvals in China, forming strategic partnerships for co-development or commercialization, and potentially securing new funding to support its ongoing operations and R&D activities.
Summary
CASI Pharmaceuticals Inc. is a biopharmaceutical company focused on oncology and autoimmune diseases, with a strategic emphasis on the Chinese market. Its strengths lie in its targeted approach and pipeline, while weaknesses include its early-stage development and reliance on funding. The company has significant opportunities in China's growing healthcare sector but faces threats from intense competition and development risks. Careful execution of its development and commercialization strategies is crucial for its success.
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Sources and Disclaimers
Data Sources:
- Company SEC Filings (10-K, 10-Q)
- Financial News Websites (e.g., Bloomberg, Reuters, Yahoo Finance)
- Biopharmaceutical Industry Analysis Reports
- Market Research Databases
Disclaimers:
This information is for informational purposes only and does not constitute financial advice. Data may be subject to change and may not be exhaustive. Investors should conduct their own due diligence before making any investment decisions.
AI Summarization is directionally correct and might not be accurate.
Summarized information shown could be a few years old and not current.
Fundamental Rating based on AI could be based on old data.
AI-generated summaries may have inaccuracies (hallucinations). Please verify the information before taking action.
About CASI Pharmaceuticals Inc
Exchange NASDAQ | Headquaters - | ||
IPO Launch date 1996-06-11 | CEO & Director Mr. David A. Cory M.B.A., R.Ph. | ||
Sector Healthcare | Industry Biotechnology | Full time employees 233 | |
Full time employees 233 | |||
CASI Pharmaceuticals, Inc., a biopharmaceutical company, develops and commercializes therapeutics and pharmaceutical products in the People's Republic of China, the United States, and internationally. It offers EVOMELA, an intravenous formulation of melphalan for use as a conditioning treatment prior to stem cell transplantation and as a palliative treatment for patients with multiple myeloma. The company's hematology/oncology assets in pipeline include CNCT19, an autologous CD19 CAR-T investigative product; BI-1206, an novel anti-Fc"RIIB antibody for the treatment of solid tumors and relapsed/refractory non-hodgkin lymphoma; CB-5339, a novel VCP/p97 inhibitor that focuses on valosin-containing protein (VCP)/p97 as a novel target in protein homeostasis, DNA damage response, and other cellular stress pathways for therapeutic use in the treatment of patients with various malignancies; CID-103, a human IgG1 anti-CD38 monoclonal antibody; and Thiotepa, a chemotherapeutic agent, which has various indications, including use as a conditioning treatment for use prior to certain allogeneic haemopoietic stem cell transplants. It has licensing agreements with Juventas Cell Therapy Ltd.; BioInvent International AB; Black Belt Therapeutics Limited; Cleave Therapeutics, Inc.; and Acrotech Biopharma L.L.C. to develop and commercialize its commercial product EVOMELA. CASI Pharmaceuticals, Inc. was incorporated in 1991 and is based in Beijing, the People's Republic of China.
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