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CASI Pharmaceuticals, Inc. (symbol: CASI) is a biopharmaceutical company dedicated to the development and commercialization of innovative therapeutic and pharmaceutical products in China, the United States, and globally. The company's core focus is on hematology-oncology, tackling unmet medical needs through advanced treatments and collaborative efforts.
CASI’s product pipeline includes:
- EVOMELA®: Melphalan hydrochloride for injection, used as a high-dose conditioning treatment prior to hematopoietic progenitor cell transplantation in patients with multiple myeloma. It is a significant contributor to CASI’s revenue.
- CNCT19: An autologous CD19 CAR-T cell therapy product designed for patients with B-cell acute lymphoblastic leukemia (B-ALL) and B-cell non-Hodgkin lymphoma. This product, developed in collaboration with Juventas, has recently received market approval in China, marking a critical milestone in cell therapy.
- CID-103: An anti-CD38 monoclonal antibody for the treatment of multiple myeloma. CID-103 has shown promising preclinical efficacy and safety profiles.
- FOLOTYN®: Pralatrexate injection, a treatment for relapsed or refractory peripheral T-cell lymphoma in China, demonstrating a significant impact in addressing critical medical needs.
- BI-1206: A first-in-class FcγRIIB monoclonal antibody under development for relapsed/refractory non-Hodgkin lymphoma in combination with rituximab.
- CB-5339: An oral novel VCP/p97 inhibitor for the treatment of hematological malignancies and solid tumors, currently preparing for clinical trials in China.
CASI's recent achievements include the successful commercialization of FOLOTYN® in China and receiving regulatory approval for CNCT19. Despite competitive pressures, EVOMELA continues to play a critical role in the treatment of multiple myeloma in China, with nearly 10,000 patients treated in 2023.
The company faced challenges such as decreased revenues due to competition and restructuring but remains committed to advancing its pipeline. CASI is also actively involved in arbitration with Juventas over the commercialization rights of CNCT19, asserting its legal rights vigorously.
CASI's forward-looking strategy involves leveraging its regulatory and commercial competencies in China, combined with its global drug development expertise, to launch innovative therapies and maintain market leadership in hematology-oncology.
For more detailed information, visit www.casipharmaceuticals.com.
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CASI Pharmaceuticals, Inc. reports a material development in its dispute with Juventas, disclosed in a Form 6-K filing. The company focuses on developing and commercializing innovative therapeutics and pharmaceutical products.
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CASI Pharmaceuticals, Inc. reported fourth quarter 2023 revenue of $6.9 million, 33% lower than 2022, with full-year revenue of $34 million, an 11% decrease. Key highlights include the approval of Inaticabtagene Autoleucel and advancements in pipeline development. Despite positive developments, revenue decline and ongoing arbitration proceedings with Juventas pose challenges for CASI.
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CASI Pharmaceuticals and BioInvent International announce positive preliminary efficacy data for BI-1206 in combination with rituximab for patients with relapsed/refractory indolent Non-Hodgkin's Lymphoma in China.
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CASI Pharmaceuticals administers first dose of FOLOTYN to a patient in China, a significant step in addressing peripheral T-cell lymphoma. Pralatrexate shows promising results with an overall response rate of 52% and a median progression-free survival of 4.8 months in Chinese study. CEO Dr. Wei-Wu He expresses enthusiasm for advancing patient care.
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CASI Pharmaceuticals, Inc. (Nasdaq: CASI) reported Q3 2023 financial results, including a 13.5% decrease in sales revenue. The company's partner Juventas received approval for Inaticabtagene Autoleucel in China, marking the first commercialized cell therapy for B-ALL in the country.
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CASI Pharmaceuticals Inc. (Nasdaq: CASI) announces market approval for Juventas Cell Therapy Ltd.'s Inaticabtagene Autoleucel (CNCT 19) by China's NMPA for treating r/r B-ALL. The CD19 CAR-T cell therapy product has shown high efficacy and safety in clinical studies.
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CASI Pharmaceuticals, Inc. has announced an Assignment Agreement with Mundipharma International Corporation Limited, Mundipharma Medical Company, and Acrotech Biopharma Inc. for the commercialization of FOLOTYN® in China. FOLOTYN® is a drug approved for the treatment of relapsed or refractory peripheral T-cell lymphoma. CASI will assume the rights and obligations for the commercialization of FOLOTYN® in China.
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CASI Pharmaceuticals has acquired global rights to CB-5339, a clinical-stage VCP/p97 inhibitor, while Eikon Therapeutics has acquired Cleave Therapeutics' pre-clinical assets. CB-5339 has shown promise in a Phase 1 clinical trial for acute myeloid leukemia and myelodysplastic syndrome. CASI plans to develop CB-5339 for multiple myeloma in China, while Eikon aims to leverage Cleave's preclinical assets to address novel targets.
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CASI Pharmaceuticals, Inc. (Nasdaq: CASI) announced the execution of an Assignment Agreement with Cleave Therapeutics, Inc. to obtain all rights and global intellectual property related to CB-5339, a novel VCP/p97 inhibitor. The company will also assume responsibility for the US CB-5339 Investigational New Drug application. CB-5339 is an oral, second-generation, small molecule valosin-containing protein (VCP)/p97 inhibitor, designed to disrupt protein homeostasis, DNA damage response, and other cellular stress pathways. In a Phase 1 clinical trial, the drug was well tolerated in 55 patients and demonstrated signs of clinical activity. Two patients remain on CB-5339 under compassionate use protocols at two leading US cancer centers.
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FAQ
What is the current stock price of CASI Pharmaceuticals Ordinary Shares (CASI)?
The current stock price of CASI Pharmaceuticals Ordinary Shares (CASI) is $5.33 as of November 15, 2024.
What is the market cap of CASI Pharmaceuticals Ordinary Shares (CASI)?
The market cap of CASI Pharmaceuticals Ordinary Shares (CASI) is approximately 89.2M.
What is CASI Pharmaceuticals' main focus?
CASI Pharmaceuticals focuses on developing and commercializing innovative hematology-oncology therapeutics and pharmaceutical products in China, the United States, and globally.
What are the key products in CASI Pharmaceuticals' pipeline?
CASI's key products include EVOMELA®, CNCT19, CID-103, FOLOTYN®, BI-1206, and CB-5339, targeting various hematological and oncological conditions.
What recent achievements has CASI Pharmaceuticals made?
Recent achievements include the approval of CNCT19 in China, the first dose administration of FOLOTYN® in China, and significant progress in the clinical development of BI-1206 and CB-5339.
How does CASI Pharmaceuticals plan to address competition?
CASI plans to strengthen its commercial and medical marketing strategies, focusing on market leadership for existing products while progressing its innovative pipeline to meet unmet medical needs.
What challenges has CASI Pharmaceuticals faced recently?
CASI faced revenue decline due to generic competition and experienced operational challenges, including restructuring and inventory management issues.
How does CASI Pharmaceuticals leverage its regulatory competencies?
CASI leverages its China-based regulatory and commercial expertise to launch new medicines and drive market adoption, particularly in the Greater China market.
What is the significance of CNCT19's approval in China?
The approval of CNCT19 is a milestone for CASI, representing a significant advancement in cell therapy and providing a novel treatment for relapsed/refractory B-cell acute lymphoblastic leukemia.
What are CASI Pharmaceuticals' plans for CID-103?
CASI plans to advance CID-103 into clinical trials for multiple myeloma in China and has received FDA approval to proceed with trials for autoimmune indications in the US.
What collaborations does CASI Pharmaceuticals engage in?
CASI collaborates with companies like Juventas for cell therapy products and BioInvent for developing novel antibodies, aiming to enhance its product pipeline and market reach.
Where can more information about CASI Pharmaceuticals be found?
More detailed information can be found on the company's official website at www.casipharmaceuticals.com.
CASI Pharmaceuticals, Inc. Ordinary Shares