BOCOM INTL: SIMCERE PHARMA(02096) successfully authorized the self-developed blood tumor/self-immunization three anti-bodies on the TCE platform of ABBVIE for the first time with the endorsement of MNC.

BOCOM INTL released a research report stating that SIMCERE PHARMA (02096) has announced a licensing option agreement with AbbVie (ABBV.US/Not Rated) for SIM0500 (BCMA x GPRC5D x CD3 triple-specific antibody). According to the agreement, AbbVie will have the licensing option rights for SIM0500 and will make an upfront payment to Simcere, as well as up to $1.055 billion in licensing option and milestone payments. After the product is approved for market, Simcere will also receive additional sales royalties outside of Greater China, while AbbVie will have the rights to receive sales royalties in Greater China. This is the second and largest licensing out-licensing transaction in Simcere's history (the first one was reached in September 2022, licensing IL-2muFc SIM0278 to Almirall). BOCOM INTL's main points are as follows: Huge market potential for SIM0500 in potential indications: SIM0500 is currently in Phase I clinical dose escalation stage in China and the United States, used for the treatment of relapsed/refractory multiple myeloma (MM). According to the company, the global annual numbers of new MM cases and deaths are 188,000 and 121,000 respectively; the global MM treatment market size is expected to reach approximately $26.7 billion in 2024, making it the largest single subtype market in hematologic malignancies. In addition, the BCMA and GPRC5D targets are also expressed on B cells in some autoimmune diseases, so SIM0500 also has the potential to eliminate pathogenic B cells. Other agents targeting BCMA have shown preliminary efficacy in autoimmune diseases such as Sjogren's syndrome, NMOSD, systemic sclerosis, and rheumatoid arthritis. In the future, the company will actively explore the development potential of SIM0500 in the field of autoimmunity with AbbVie. Differentiated triple-specific molecules validate the strength of the TCE platform, three more molecules are about to enter clinical trials: The bank believes that reaching an authorization transaction with a multinational pharmaceutical company is an important validation of the company's TCE development platform. As a potential best candidate with the same target, SIM0500 has shown superior antitumor effects in multiple preclinical models compared to competitors such as BCMA x CD3 bispecific + GPRC5D x CD3 bispecific from United Therapeutics Corporation, and other investigational triple-specific targeting the same targets. At the same time, low-affinity targeting of CD3 and subcutaneous injection formulation are expected to reduce the risk of CRS and improve administration convenience. In the short term, three new molecules generated on the TCE platform are expected to enter clinical trials, including a triple-specific for AML, a triple-specific for CLL and DLBCL, and a triple-specific for solid tumors, all three of which also have considerable BD and out-licensing potential.