Here are 1-2 brief analogies for CASI Pharmaceuticals:

• A 'Jazz Pharmaceuticals for China'
• A 'specialized Eli Lilly for the Chinese market'

• EVOMELA (melphalan hydrochloride for injection): A chemotherapy agent used as a conditioning treatment before hematopoietic stem cell transplantation for multiple myeloma.
• Glucarpidase (Voraxaze): An enzyme used to rapidly reduce toxic methotrexate levels in patients with delayed methotrexate elimination.
• CNPC-19 (CD19 CAR-T): An investigational CAR-T cell therapy being developed for the treatment of B-cell malignancies.

For CASI Pharmaceuticals (symbol: CASI), the company primarily sells its pharmaceutical products to other companies within the healthcare supply chain rather than directly to individuals.

Its major customers are:

• Pharmaceutical Wholesalers and Distributors: These companies are responsible for purchasing CASI's products (such as oncology drugs EVOMELA and Zepzelca) and then distributing them throughout the healthcare system to pharmacies, hospitals, and clinics across China.
• Hospitals and Other Healthcare Providers: CASI also engages in direct sales to hospitals and larger healthcare institutions, particularly for its specialized oncology products that are administered in clinical settings.

CASI Pharmaceuticals focuses its commercialization and sales efforts predominantly in China. While they sell to numerous entities within the aforementioned categories, the company has publicly stated in its filings (e.g., 10-K reports) that it does not believe it is substantially dependent on any single customer or a small group of customers. Consequently, specific names of major customer companies, particularly public ones that account for a significant portion of their revenue, are not disclosed.

• Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. (SSE: 603707)
• Pharmadax Pharmaceutical (Suzhou) Co., Ltd.

David Cory, Chief Executive Officer

Mr. Cory was appointed Chief Executive Officer of CASI Pharmaceuticals on July 21, 2025. He brings over 30 years of operational management experience in the biopharmaceutical industry, having held executive positions in both private and public companies, including emerging biotechnology firms and large pharmaceutical organizations. Mr. Cory is recognized for his ability to build and lead high-performing clinical and regulatory teams, successfully overseeing the commercial launch of 20 approved drugs across various therapeutic areas. His capital markets experience includes leading fundraising efforts totaling over $1 billion and overseeing multiple company acquisitions and exits.

Deanna Qian, Chief Financial Officer

Ms. Qian assumed the role of Chief Financial Officer for CASI Pharmaceuticals on May 14, 2025, while continuing her responsibilities as Global Controller. She possesses 17 years of experience in global financial operations and financial management for companies listed on both U.S. and Hong Kong stock exchanges. Her career includes leadership roles at PwC (China & Singapore), where she guided audit and consulting for various listed enterprises, and at Weichai Power (a Hong Kong-listed company), where she managed the financial operations for over ten overseas subsidiaries. As Chief Accounting Officer at Wanda Sports Group (a U.S.-listed company), Ms. Qian played a key role in its successful listing on Nasdaq. She also served as Financial Director at Guazi.com, where she managed group-wide financial affairs and was deeply involved in the company's Hong Kong IPO.

Wei-Wu He, Executive Chairman

Dr. He serves as the Executive Chairman of the Board of Directors for CASI Pharmaceuticals. He previously held the position of Chief Executive Officer from 2019 until July 2025. Dr. He is a scientist, inventor, investor, entrepreneur, and venture capitalist. He is the founder and General Partner of Emerging Technology Partners, LLC (ETP), a venture firm focused on incubating innovative life sciences companies, which has funded approximately 70 biotech companies. Dr. He also founded OriGene Technologies, Inc. in 1995, where he served as Chairman and CEO. He has been involved in the funding and founding of over 100 global biotechnology companies and was an early scientist at Human Genome Sciences, Inc. Currently, he also chairs Human Longevity Inc.

Larry Zhang, Senior Vice President

Mr. Zhang was appointed Senior Vice President in September 2024, after serving as President of CASI's global operations since September 2019 and President of CASI Pharmaceuticals (Beijing) Co., Ltd. since September 2018. He has over 20 years of executive experience in commercial operations, regulatory affairs, sales and marketing, and business development across the U.S., Asia Pacific, and China within the healthcare and biopharmaceutical industries. Prior to joining CASI, Mr. Zhang was Vice President, Head of Public Affairs and Corporate Responsibility at Novartis Group (China) and served as Chief Executive Officer of Sandoz (China) Pharmaceutical Co. Ltd, a Novartis Company, where he successfully launched six new products. His experience also includes executive leadership roles at Bayer Healthcare and Baxter International Corporation.

Alexander A. Zukiwski, Chief Medical Officer

Dr. Zukiwski has been the Chief Medical Officer of CASI Pharmaceuticals since April 2017. Before joining CASI, he served as Chief Executive Officer and Chief Medical Officer at Arno Therapeutics, where he was responsible for leading clinical development and regulatory affairs. Prior to his time at Arno, Dr. Zukiwski held the position of Executive Vice President and Chief Medical Officer at MedImmune.

The key risks to CASI Pharmaceuticals' business are primarily centered around its immediate financial stability, revenue generation, and the inherent challenges of drug development.

1. Nasdaq Delisting and Going Concern Risk: CASI Pharmaceuticals faces an immediate and critical risk of delisting from the Nasdaq Capital Market. The company received a deficiency notice in November 2025, and previously in May 2025, for failing to maintain the minimum Market Value of Listed Securities (MVLS) of $35 million. While the company is appealing the latest delisting determination, regaining compliance is a critical near-term hurdle. This delisting threat is compounded by the company's precarious financial position, characterized by a significant cash crunch, a low cash balance of $4.7 million as of September 30, 2025, and a high burn rate. The company's ability to continue as a going concern is explicitly stated as being dependent on its capacity to raise sufficient capital for operational needs.
2. Revenue Volatility and Dependence on a Single Product/Market: The business is highly vulnerable to fluctuations in the sales of its primary revenue driver, EVOMELA® (Melphalan for Injection). The third quarter of 2025 saw a substantial 60% decline in revenue to $3.1 million, largely due to estimated returns of EVOMELA®. This indicates a significant reliance on a single product and market (China), making the company susceptible to market shifts, competitive pressures, or regulatory changes in that region. The company is also facing a looming divestiture of its China business by Q2 2026, adding further uncertainty to its revenue stream.
3. Clinical Development and Regulatory Risks: As a biopharmaceutical company, CASI Pharmaceuticals' long-term success hinges on the successful development and regulatory approval of its pipeline products. Key risks include the inability to predict the timing or likelihood of regulatory approval for its product candidates by authorities like the U.S. Food and Drug Administration (FDA) and China's National Medical Products Administration (NMPA). There are inherent uncertainties and potential for delays in preclinical and clinical trials, and there is no guarantee of success in the clinical development of any of its products. The company's strategic viability is particularly reliant on the clinical success of its lead asset, CID-103.

• Intensifying Competition in the Chinese Oncology Market: The rapid growth and increasing sophistication of domestic Chinese biopharmaceutical companies, coupled with the expanded presence of global pharmaceutical giants, are leading to a highly competitive landscape in oncology. These competitors are actively developing and launching novel cancer therapies, including advanced treatments like CAR-T cell therapies, bispecific antibodies, and antibody-drug conjugates (ADCs). This surge in innovation and market entry poses a direct threat to CASI's existing product portfolio and its pipeline candidates, such as CNCT19 (CD19 CAR-T), by introducing potentially superior, more cost-effective, or more widely accessible alternatives.
• Escalating Government-Led Pricing Pressure and Market Access Challenges in China: The Chinese government's aggressive policies aimed at controlling healthcare costs, primarily through centralized drug procurement (CDP) and frequent negotiations for inclusion on the National Reimbursement Drug List (NRDL), continue to intensify. These initiatives consistently lead to significant price reductions for drugs to gain market access and widespread adoption. This environment puts substantial pressure on the profitability of CASI's commercialized products and creates significant hurdles for the successful commercialization of future pipeline assets, forcing companies to accept lower margins for market penetration.

CASI Pharmaceuticals (NASDAQ: CASI) is focusing its strategic efforts on several key areas to drive future revenue growth over the next two to three years, primarily centered around its lead drug candidate, CID-103, and the commercialization of existing products in specific markets.

• Advancement and Commercialization of CID-103 for Immune Thrombocytopenia (ITP): CASI Pharmaceuticals is actively pursuing the development of CID-103, a potential best-in-class anti-CD38 monoclonal antibody, for the treatment of immune thrombocytopenia. The company received FDA IND clearance in May 2024 and NMPA approval in October 2024, with the first patient dosed in a Phase 1/2 study in January 2025. Data from this ongoing Phase 1 study in adult patients with ITP is anticipated to be presented at the 67th American Society of Hematology Annual Meeting in December 2025. Successful clinical development and eventual commercialization of CID-103 for ITP are expected to be a significant revenue driver.
• Development of CID-103 for Renal Allograft Antibody-Mediated Rejection (AMR): Another key focus for CID-103 is its development for organ transplant rejection, specifically renal allograft antibody-mediated rejection (AMR). CASI received FDA IND clearance for a Phase 1 study in this indication and plans to initiate the study in the first quarter of 2026 in the U.S. Advancing this program through clinical trials and toward potential market approval represents a substantial opportunity for future revenue.
• Commercialization of Retained Products in Designated Regions: Following the divestiture of its China operations, CASI Pharmaceuticals retains rights to several other products, including EVOMELA®, FOLOTYN®, CNCT19, and CB-5339, in Japan and non-Asian regions. While some of these products face competition (e.g., EVOMELA®), continued commercialization efforts and potential market penetration in these designated territories are expected to contribute to revenue. For instance, FOLOTYN® saw its first patient dosing in China in February 2024.
• Strategic Focus and Debt Reduction from China Divestiture: Although not a direct revenue generator, the divestiture of its Chinese subsidiaries and certain product rights to Kaixin Pharmaceuticals for $20 million allows CASI to sharpen its strategic focus on core priorities, primarily the development of CID-103. This transaction also helps to eliminate $20 million of existing debt, improving the company's financial position and enabling it to allocate resources more effectively towards its high-potential pipeline, which could indirectly support future revenue growth.

Share Repurchases

• In December 2021, CASI Pharmaceuticals' board of directors approved a stock repurchase program authorizing the repurchase of up to $10 million of the company's common stock.

Share Issuance

• CASI Pharmaceuticals completed a private placement in July 2024, issuing 1.02 million ordinary shares at a price of $5.00 per share, resulting in gross proceeds of approximately $15.0 million.

Inbound Investments

• In July 2024, CASI completed a $15.0 million private placement financing with investors, including Venrock Healthcare Capital Partners, Foresite Capital, Panacea Venture, and CEO Wei-Wu He and his family trust.

Capital Expenditures

• CASI Pharmaceuticals (Wuxi) Co., Ltd., a subsidiary, entered into a fifty-year lease agreement in November 2019 for state-owned land in China to construct a GMP manufacturing facility, indicating a long-term capital expenditure focus.