ZAIMING and MSD Enter Clinical Collaboration to Evaluate SIM0235 in Combination with KEYTRUDA® for Advanced Solid Tumors and CTCL

On March 14, 2023, ZAIMING, an innovative drug company under Simcere (2096.HK) focusing on the field of oncology, announced that it had reached a clinical development collaboration with MSD (MSD is the corporate name of Merck & Co., Inc., located in Rahway, New Jersey, USA). The collaboration aims to explore the combination of ZAIMING’s Tumor Necrosis Factor Receptor 2 (TNFR2) monoclonal antibody SIM0235 and MSD’s PD-1 antibody drug KEYTRUDA® (pembrolizumab) for the treatment of advanced solid tumors and Cutaneous T-cell Lymphoma (CTCL).

This Phase I clinical trial (SIM1811-03-TNFR2-102) will evaluate the safety, efficacy, pharmacokinetic/pharmacodynamic characteristics, and immunogenicity of SIM0235 as a monotherapy and in combination with KEYTRUDA for the treatment of advanced cancers.

TNFR2 is a member of the tumor necrosis factor receptor superfamily, primarily expressed on the surface of tumor cells and inhibitory immune cells in the tumor microenvironment, leading to tumor immune escape and proliferation.

ZAIMING Chief Medical Officer Bijoyesh Mookerjee, M.D., said:

SIM0235 is a TNFR2 antibody immunotherapy with Best-in-Class (BIC) potential. In preclinical studies, this molecule has demonstrated promising effects when used in combination with KEYTRUDA, offering potential clinical benefits for cancer patients.

According to the agreement between both parties, MSD will provide KEYTRUDA for research purposes. ZAIMING will retain the global commercialization rights for SIM0235.

KEYTRUDA® is a registered trademark owned by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. located in Rahway, New Jersey, USA.

About SIM0235

SIM0235 (original code SIM1811-03) is a humanized immunoglobulin G1 (IgG1) monoclonal antibody targeting TNFR2. It can block the activation of TNFR2 by endogenous tumor necrosis factor (TNF), thereby reducing TNFR2-induced immunosuppression and tumor proliferation, and enhancing anti-tumor immune response. In addition, this molecule can kill immunosuppressive cells expressing TNFR2 through antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), including regulatory T cells and myeloid-derived suppressor cells. This investigational drug has entered Phase I clinical trials in both China and the United States (SIM1811-03-TNFR2-101, SIM1811-03-TNFR2-102) for the treatment of patients with advanced solid tumors and cutaneous T-cell lymphoma (CTCL).

About ZAIMING

ZAIMING, a biopharmaceutical company under the Simcere Group, is dedicated to the research, development, production, and commercialization of innovative oncology drugs. Operating independently since 2023, ZAIMING aims to address significant unmet clinical needs in oncology across China and globally through breakthrough therapies. The company has established a high-value innovative R&D pipeline, with its marketed portfolio including three globally innovative drugs: Cosela®, Endostar®, and Envikine®. These products are driving rapid revenue growth. Through collaborative innovation with global partners, ZAIMING provides more effective treatment options for clinical use, offering hope for survival to more cancer patients. Media contact: pr@zaiming.com

About Simcere

Simcere (2096.HK) is an innovation- and R&D-driven pharmaceutical company that owns the "State Key Laboratory of Translational Medicine and Innovative Drugs." The company focuses on oncology, neurology, autoimmune diseases, and anti-infective fields, while proactively making forward-looking investments in disease areas with significant future clinical needs, striving to provide patients with more effective drugs sooner. With dual drivers of independent R&D and collaborative innovation, Simcere has established strategic partnerships with multiple innovative enterprises and research institutions. For more information, please visit: www.simcere.com