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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.
CASI Pharmaceuticals (NASDAQ: CASI) announced the filing of its annual report on Form 20-F for the fiscal year ending December 31, 2022, with the U.S. Securities and Exchange Commission on April 26, 2023. The report highlights the company's ongoing commitment to developing innovative therapeutics in hematology oncology and other unmet medical needs. Shareholders can request a free hard copy of the audited consolidated financial statements. The company aims to establish a strong presence in the Greater China market, leveraging its regulatory and commercial competencies alongside its global drug development expertise. More details are available on the company's investor relations website.
CASI Pharmaceuticals, a biopharmaceutical firm, reported a $43.1 million revenue for 2022, marking a 26.7% year-on-year growth. The fourth quarter alone accounted for $10.2 million in revenues from EVOMELA®. Despite challenges due to COVID-19 in China, the company treated nearly 10,000 patients with EVOMELA. The company achieved key milestones, including the acceptance of the CNCT-19 NDA by the NMPA in December 2022 and the initiation of the BI-1206 phase I trial. CASI's net loss increased to $40.3 million compared to $35.8 million in 2021. As of December 31, 2022, the firm had $47.1 million in cash and equivalents, up from $38.7 million in 2021. The company plans to enhance its commercial portfolio in 2023 and beyond.
CASI Pharmaceuticals, Inc. (NASDAQ: CASI) has successfully completed a redomiciliation merger, transitioning the company to be incorporated in the Cayman Islands. As part of this move, each share of CASI's common stock will convert into an ordinary share of CASI Cayman, which will continue to trade under the same NASDAQ symbol 'CASI'. This strategic decision aims to leverage regulatory and commercial competencies in China and enhance its position in the biopharmaceutical market, focusing on hematology oncology and unmet medical needs globally.
CASI Pharmaceuticals has received approval from the NMPA for its Clinical Trial Application for CB-5339, a VCP/p97 inhibitor, targeting Multiple Myeloma. The Phase 1 trial aims to assess the safety, pharmacokinetics, and preliminary efficacy of CB-5339 as a single agent in China, with enrollment expected to start in 2023. This development aligns with CASI's strategy to enhance its oncology portfolio and leverage its regulatory expertise in the Greater China market.
CASI Pharmaceuticals announced that the China National Medical Products Administration has accepted the new drug application for CNCT19, an investigational CAR-T therapy targeting relapsed/refractory B-Cell Acute Lymphoblastic Leukemia (r/r B-ALL). This marks CNCT19 as the first CAR-T therapy for B-ALL submitted for NDA and the potential first domestically developed CD19-directed CAR-T therapy in China. The registrational trial showed a 100% drug production success rate and promising efficacy results with an 82.1% overall response rate.
CASI Pharmaceuticals reported a 26% increase in third-quarter revenue, reaching $10.2 million from $8.1 million year-over-year, attributed mainly to EVOMELA sales. During this period, research and development expenses rose to $3.9 million, reflecting ongoing clinical projects like BI-1206 and CID-103. Notably, costs of revenues increased to $4.2 million, while general and administrative expenses decreased to $4.8 million. Despite strong performance in sales, the ongoing COVID-related restrictions in China may impact future revenue.
CASI Pharmaceuticals, Inc. (NASDAQ: CASI) announced an agreement to transfer its 12.0098% equity interest in Juventas Biotechnology to Shenzhen Jiadao Gongcheng for RMB 240.87 million (USD 34.03 million). The transaction will be executed in two installments, aiding CASI's cash flow until at least the end of 2023. CEO Wei-Wu He expressed confidence in CNCT-19, a CAR-T therapy targeting CD19, which Juventas will submit for NDA to the NMPA in 2022. This strategic move is expected to enhance CASI's balance sheet and support the development of its pipeline projects.
CASI Pharmaceuticals has initiated the first patient enrollment in a Phase 1 study of BI-1206 in China, targeting relapsed/refractory Non-Hodgkin's Lymphoma (NHL). This monoclonal antibody has shown promising early efficacy and tolerable safety in previous trials. The study aims to assess safety and clinical activity, potentially addressing unmet medical needs in NHL treatment. CASI's partnership with BioInvent marks a significant milestone, with expectations for valuable data generation to enhance treatment options.
CASI Pharmaceuticals reported financial results for Q2 2022, showcasing $8.6 million in EVOMELA® sales, a 19% increase from the previous year. The company's total revenues rose due to resilient sales strategies adapting to COVID-19 challenges.
Research and development expenses rose to $3.9 million from $2.3 million year-over-year, driven by CID-103 expenses. The company maintains $18.9 million in cash as of June 30, 2022, while focusing on the upcoming launch of CNCT19 in China and progressing BI-1206's regulatory framework.
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