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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, Inc. (Nasdaq: CASI) reported preliminary unaudited revenues of approximately $9.12 million for Q4 2021 and $30 million for the full year, exceeding its projected $27 million guidance and marking a significant 100% increase from 2020's $15 million. The company anticipates more than 30% growth in EVOMELA revenue for 2022. Key developments include ongoing clinical trials for pipeline products, with a focus on the commercialization of CNCT-19 and approvals for CB-5339 and BI-1206 expected this year.
CASI Pharmaceuticals, Inc. (Nasdaq: CASI) announced that the FDA granted Orphan Drug Designation (ODD) to its partner BioInvent International AB for BI-1206, an investigational antibody targeting follicular lymphoma (FL). This designation supports the ongoing clinical trials for BI-1206, which is being studied in combination with rituximab and Keytruda for treating various lymphomas and solid tumors. Dr. Wei-Wu He highlighted the significance of this designation, noting the potential for innovative cancer therapies and ongoing preparations for clinical studies in China.
CASI Pharmaceuticals announced that the U.S. FDA has granted Orphan Drug Designation to its partner, Juventas Cell Therapy, for CNCT19, a CD-19 directed CAR-T therapy aimed at treating Acute Lymphoblastic Leukemia (ALL). This designation supports the ongoing Phase II trials of CNCT19, which is already approved in China for relapsed/refractory B-ALL and B-NHL. CASI holds worldwide co-commercial rights and plans to commence global commercialization as regulatory advancements occur.
CASI Pharmaceuticals, Inc. (Nasdaq: CASI) received a deficiency letter from Nasdaq on December 30, 2021, indicating its stock had closed below the $1.00 minimum bid price for 30 consecutive business days. CASI has until June 28, 2022, to regain compliance by maintaining a bid price of $1.00 or more for 10 consecutive days. If compliance isn't achieved, CASI may seek a second 180-day compliance period or face potential delisting. The company is considering options, including a reverse stock split, and will actively monitor its stock price.
CASI Pharmaceuticals (NASDAQ: CASI) has announced a stock repurchase program allowing for the buyback of up to USD 10 million worth of its shares, equating to no more than 12,500,000 shares. This initiative, approved by the board, reflects CASI's confidence in its business model and aims to enhance shareholder value. The buyback will occur through open market purchases, subject to market conditions and regulations. Funding will be sourced from corporate funds, including cash on hand.
BioInvent International announced that the Center for Drug Evaluation of China's NMPA approved a Clinical Trial Application (CTA) for CASI Pharmaceuticals to initiate two clinical trials of BI-1206 in patients with non-Hodgkin's Lymphoma (NHL). BI-1206, BioInvent's lead drug candidate, is currently in Phase 1/2 trials using anti-PD1 therapy and other combinations. CASI's Phase 1 trials aim to assess safety and early efficacy. The companies' agreement includes potential milestone payments of up to $83 million and royalties on sales. Trials are expected to begin in H1 2022.
CASI Pharmaceuticals (NASDAQ: CASI) has received approval from the China National Medical Products Administration (NMPA) for its Clinical Trial Application (CTA) regarding BI-1206, a first-in-class fully human monoclonal antibody targeting FcγRIIB. Planned Phase 1 trials will assess BI-1206 as a standalone treatment and in combination with rituximab for various forms of non-Hodgkin's lymphoma (NHL). These trials are set to commence in the first half of 2022, aimed at evaluating safety and early efficacy. This milestone is vital for CASI's development strategy in Greater China.
CASI Pharmaceuticals, a U.S. biopharmaceutical company, will have President Larry Zhang present at the upcoming Jefferies London Healthcare Conference on November 18 and 19. The presentation will be held virtually and available on-demand. This event highlights CASI's commitment to developing innovative therapeutics targeted at unmet medical needs in hematology oncology and other areas.
The company leverages its expertise in the global drug market, focusing on China as a key area for expansion.
CASI Pharmaceuticals reported Q3 2021 revenues of $8.1 million from EVOMELA, a 93% increase year-over-year. The company anticipates full-year revenue growth exceeding 80% compared to 2020. CASI highlighted positive interim data from its partner BioInvent's BI-1206 clinical trial, showing a 50% objective response rate in patients with B-cell non-Hodgkin's lymphoma. Net loss narrowed to $10 million from $16.7 million in Q3 2020. Cash reserves stood at $53.1 million as of September 30, 2021.
CASI Pharmaceuticals, Inc. announced that its partner BioInvent International has released positive interim data from the Phase 1/2a trial of BI-1206, an anti-FcγRIIB antibody combined with rituximab for treating non-Hodgkin's lymphoma. The study reported a 50% objective response rate among 12 patients, with long-lasting complete responses observed. The promising safety profile suggests potential for broader application across various cancers. CASI is responsible for the commercialization of BI-1206 in Greater China and anticipates further developments from BioInvent at the upcoming ASH 2021 meeting.
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