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ImmuneOnco to collaborate with Sunshine Guojian in clinical study of inetetamab (CipterbinTM) in combination with IMM01

Date:2021-04-22 Views:493

ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd. . (hereinafter referred to as ImmuneOnco ) announced collaboration with Sunshine pharmaceuticals (Shanghai) co., Ltd., a subsidiary of Sunshine Pharmaceutical Group (hereinafter referred to as Sunshine Guojian) to promote HER2 monoclonal antibody inetetamab (CipterbinTM) combined with anti-CD47 fusion protein IMM01 in clinical trial and commercialization in China.

The collaboration will conduct clinical studies in patients with a variety of HER2-positive tumors to evaluate the safety, tolerability, and efficacy of inetetamab (CipterbinTM) combined with IMM01.

Dr. Tian Wenzhi, Chairman and CEO of ImmuneOnco, said, "IMM01 is the first recombinant protein drug targeting CD47 approved to enter clinical trials in China. The biggest difference between IMM01 and other drugs to the same target is that, it largely avoids binding with red blood cells and will not cause severe anemia. At the same time, due to glycosylation modification, the immunogenicity of the drugs was greatly reduced, the PK of the drugs was improved, and the bioavailability of the drugs was significantly elevated. The safety and efficacy of IMM01 were being confirmed by the preliminary results of the Phase I clinical trial. "We are pleased to collaborate with Sunshine Guojian in the clinical development of the combination therapy, and I believe the combination of these two drugs will provide better options for cancer patients."

Dr. Lou Jing, Chairman of Sunshine Guojian, said: ‘Inetetamab (CipterbinTM) is the first Fc modified, optimized manufacturing process, innovative anti-HER2 mAb with stronger ADCC effects, which, in combination with chemotherapy agents, has been shown to slow the progression of HER2-positive metastatic breast cancer and provide survival benefits. Based on its proven safety and efficacy, Sunshine Guojian is conducting a number of clinical trials, including in combination with other innovative drugs, to further explore and expand the clinical indications for Inetetamab (CipterbinTM).’We are pleased to collaborate with ImmuneOnco to explore the combination therapy of Inetetamab (CipterbinTM) and IMM01, and hope to quickly move the combination indication to market and provide more effective options for patients."

About IMM01

IMM01 for injection is a new generation of immune checkpoint inhibitor with independent intellectual property rights, which is developed based on the "MAB-TRAP" technologic platform of ImmuneOnco. Aiming at the immune regulatory CD47, it can activate the phagocytosis of macrophages on tumor cells and present the tumor antigen to T cells. Thus, it  plays powerful effects of tumor immunology. The IMM01 project faces the challenge of CD47 target drug research and development, and has been granted invention patents in China, Japan and the United States.

About Inetetamab (CipterbinTM)

Inetetamab (CipterbinTM) is the first FC-modified, optimized, innovative anti-HER2 mAb with stronger ADCC effects that has been shown to slow the progression of HER2-positive metastatic breast cancer in combination with chemotherapy agents and provide survival benefits in China. Inetetamab (CipterbinTM) was approved to the market by the NMPA in June 2020. At the end of December 2020, Inetetamab (CipterbinTM) passed the medical insurance negotiations, and for the first time was included in the National Basic Medical Insurance, Occupational Injury Insurance and Maternity Insurance Drug Catalogue (2020 Edition) (hereinafter referred to as the "National Medical Insurance Catalogue"), which will be implemented on March 1, 2021. According to the China Consensual Guidelines for Advanced Breast Cancer 2020 (CABC3) issued by the Breast Disease Research Center of China Medical Women’s Association (CMWA), Inetetamab (CipterbinTM) has become one of the best options for advanced breast cancer. According to issued Medicine Letter [2020] No. 1047 of the National Health Office, Inetetamab (CipterbinTM) has been included in the Guidelines for Clinical Application of New Antitumor Drugs (2020 Edition).

About ImmuneOnco

Founded in June 2015 in the Zhangjiang Hi-Tech Park of the China (Shanghai) Pilot Free Trade Zone, ImmuneOnco focuses on the development and research of anti-tumor immunotherapy products, including bi-specific antibodies, novel recombinant proteins, and TankTM cellular therapy. The common feature of these products is to activate the patient's own immune system to exert the anti-tumor effects, and ultimately inhibit the endless growth of tumor cells and reverse the malignant symptoms, so that the patients gradually return to healthy. So far, several new anti-tumor drugs are in clinical research stage. ImmuneOnco is recognized by authorities as one of the ‘Top 50 Start-up Enterprises with the Most Investment Potential in Shanghai’ in 2016, the "Excellent Enterprise" in the 2017 China Innovation and Entrepreneurship Competition, and the "Enterprise Excellence Award" of Shanghai Science and Technology Entrepreneurship in 2017.

About Sunshine Guojian

Founded in 2002, Sunshine Guojian is one of the first batch of innovative biomedical enterprises focusing on antibody drugs in China. Sunshine Guojian has developed into a pioneer of antibody drugs in China with capabilities of independent research and development, industrialization and commercialization. With innovative therapeutic antibody drugs as the main direction of research and development, the company provides high-quality, safe and effective clinical solutions for the treatment of autoimmune diseases, tumors and other major diseases. At present, the company has 18 at the different development stage, tumor, autoimmune and eye disease in research in the field of antibody drugs (including 8 post-clinical and clinical stage of drugs, 10 in the preclinical phase of drugs), most of these drugs in development are in the category of biological products type-1, some of the drugs in development are carried out in both China and USA. Please visit: for more information.

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