Ascentage Pharma Announces Clinical Collaboration with Junshi Biosciences to Evaluate IAP Inhibitor APG-1387 in Combination with Anti-PD-1 Monoclonal Antibody Toripalimab

April 8, 2019—Ascentage Pharma, a clinical-stage biopharmaceutical company dedicated to developing innovative drugs in the fields of oncology, hepatitis B, and age-related diseases, announced that it has entered into a strategic collaboration agreement with Shanghai Junshi Biosciences Co., Ltd. (“Junshi Biosciences”). The two parties will conduct clinical exploration in mainland China on the combination therapy of Ascentage Pharma’s proprietary inhibitor of apoptosis protein (IAP) inhibitor APG-1387 and Junshi Biosciences’ anti-PD-1 monoclonal antibody toripalimab, for the treatment of cancers (solid tumors and hematologic malignancies), particularly refractory tumors, drug-resistant tumors, and other indications to be mutually determined by both parties.

APG-1387, an investigational drug developed by Ascentage Pharma, is a next-generation, highly potent and specific inhibitor of Inhibitor of Apoptosis Proteins (IAPs). It primarily induces and accelerates apoptosis by mimicking endogenous Smac molecules to degrade IAPs, and is being developed for the treatment of advanced solid tumors and chronic hepatitis B virus (HBV) infection. APG-1387 is the first IAP-targeted therapy to enter clinical trials in China. As a monotherapy, APG-1387 has completed Phase I dose-escalation trials in patients with solid tumors in China and Australia, and is currently undergoing a Phase Ib trial in the United States evaluating its combination with PD-1 antibodies for the treatment of advanced solid tumors. Preclinical studies have demonstrated that the combination of APG-1387 and PD-1 antibodies exhibits robust anti-tumor activity and may enhance the efficacy of PD-1 blockade therapy, warranting further clinical investigation.

Toripalimab (brand name: Tuoyi, product code: JS001), independently developed by Junshi Biosciences, is the first domestically produced anti-PD-1 monoclonal antibody approved for marketing in China, indicated for the treatment of unresectable or metastatic melanoma in patients who have failed prior systemic therapy.

Dr. Yang Dajun, Chairman of Ascentage Pharma, stated, “We are pleased to enter into this collaboration with Junshi Biosciences. APG-1387, as a monotherapy, has completed Phase I clinical trials in China and Australia, initially demonstrating its potential for clinical safety and efficacy. Based on our preclinical studies and the ongoing immuno-oncology combination clinical trials in the United States, the combination of APG-1387 with toripalimab is expected to yield favorable synergistic effects. We look forward to working closely with Junshi Biosciences to conduct in-depth research on the combination therapy of these two agents, thereby providing more treatment options for patients in China.”

APG-1387 is a novel small-molecule inhibitor of inhibitor of apoptosis proteins (IAPs) designed and developed by Ascentage Pharma. The Company is developing APG-1387 globally; it has completed the Phase I dose-escalation trial in patients with solid tumors in China and Australia, and is currently conducting a Phase Ib trial of APG-1387 in the United States. Clinical studies of APG-1387 for the treatment of hepatitis B are also underway.

Tuoyi (Toripalimab Injection), the first domestically produced monoclonal antibody drug targeting PD-1 approved for marketing in China, has received support from the National Science and Technology Major Project. Clinical development of this product commenced in early 2016, and to date, more than twenty clinical trials are ongoing, including those conducted concurrently in the United States. In March 2018, the National Medical Products Administration (NMPA) formally accepted its marketing application and included it in the priority review and approval program to expedite the evaluation process. Clinical trial results demonstrated that among patients with unresectable or metastatic melanoma who had failed prior systemic therapies, the objective response rate was 17.3%, the disease control rate was 57.5%, and the one-year survival rate was 69.3%. The approval of Tuoyi holds positive significance for expanding clinical treatment options for cancer patients in China.

Ascentage Pharma is a clinical-stage, China-based global biopharmaceutical company dedicated to developing innovative drugs in the therapeutic areas of oncology, hepatitis B, and aging-related diseases. The company possesses a proprietary protein-protein interaction (PPI) targeted drug design platform. Ascentage Pharma’s R&D pipeline primarily focuses on inhibitors of key proteins in the apoptosis pathway, such as BCL-2, IAP, and MDM2-p53, to reactivate apoptotic programs in tumor cells; it also includes second- and third-generation inhibitors targeting kinase mutants that emerge during cancer treatment. Currently, eight of the company’s novel drug candidates have entered Phase I-II clinical development in China, the United States, and Australia.

Junshi Biosciences was founded in December 2012 by a team of graduates from prestigious universities in China and the United States, with extensive experience in cross-border technology transfer and industrialization. The company focuses primarily on the development of therapeutic antibodies, specializing in the research, development, and commercialization of innovative monoclonal antibody drugs and other therapeutic protein drugs. It currently boasts a robust pipeline of products under development, including 16 innovative drugs and one biosimilar. Junshi Biosciences is the first Chinese company to receive marketing approval from the National Medical Products Administration (NMPA) for an anti-PD-1 monoclonal antibody, and the first domestic company to obtain NMPA approval for Investigational New Drug (IND) applications for anti-PCSK9 and anti-BLyS monoclonal antibodies. The company employs over 700 people worldwide, with offices in San Francisco and Maryland in the United States, and Shanghai, Suzhou, and Beijing in China.