CASI Pharmaceuticals, Inc. has planned to submit an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) for CID-103 for the treatment of antibody-mediated rejection (AMR) in kidney transplant recipients by the end of 2024.

CID-103 is a fully human IgG1 anti-CD38 monoclonal antibody recognizing a unique epitope that has demonstrated an encouraging preclinical efficacy and safety profile compared to other anti-CD38 monoclonal antibodies.

The company believes that with the proceeds from the previously announced private placement financing, together with its existing cash and cash equivalents, it will have sufficient capital to complete the Phase II clinical trial for AMR.

CASI also announced that its board of directors received a preliminary non-binding proposal letter, from Dr. Wei-Wu He, Chairman of the Board and CEO of the Company, to acquire the entire business operations of the Company in China and all license-in, distribution and related rights in Asia (excluding Japan) related to all of the company's pipeline products, including but not limited to EVOMELA, FOLOTYN, CNCT19, BI-1206, CB-5339, CID-103 and Thiotepa, for an aggregate purchase price of USD 40 million, which shall include assumption of up to USD 20 million of indebtedness of the company.

On June 25, the Board formed a special committee comprised solely of incumbent independent directors to evaluate the transaction contemplated under the Proposal Letter and such other strategic and business alternatives available to the Company in respect of the Company's business operations in China.

The Board and the Special Committee caution the company's shareholders and others considering trading the company's securities that no decisions have been made with respect to the Proposed Transaction or any alternative strategic option that the company may pursue.