QureBio's First Bispecific Antibody Q-1802 Combination Clinical Trial (phase I/II) Was Approved

April. 12, 2022

QureBio announced today that its self-developed bispecific antibody Q-1802 was approved by National Medical Products Administration on April 2, 2022 for the phase I / II clinical trial of preliminary efficacy, safety and tolerance of combined standard treatment regimen in patients with gastrointestinal tumors.

Previously, the IND application of Q-1802 has been successfully approved in both China and the United States, and the Phase I clinical study of single drug safety and efficacy has been successfully advanced. Partial Phase I safety study results will be presented at ASCO meeting in June 2022.

The clinical research of Q-1802 combined drug therapy will continue to be promoted by QureBio and Shen Lin, President of Peking University Cancer Hospital. President Shen Lin is a well-known expert in the field of digestive cancer in China. She serves as the chairman of several national academic organizations. Previously, she has been responsible for the clinical phase I research of single drug of the project.

About Q-1802

Q-1802 is the world's first CLDN18.2/PD-L1 bispecific antibody to enter the clinic, and has the characteristics that are different from other monoclonal antibody products. It is a bispecific antibody with independent intellectual property rights and developed by QureBio using its antibody engineering technology platform. It can target PD-L1 and claudin18.2 at the same time. Q-1802 has excellent performance in preclinical aspects. In terms of CMC, Q-1802 has good physical and chemical properties such as high expression cell line (more than 4 g/L after process optimization), high purity, and good stability. The results of the single-agent phase I clinical study suggest that the safety is good, and the adverse reaction data is better than those of competing products with the same target, and it showed positive antitumor activity in the treatment of patients with advanced malignant solid tumors who have failed standard therapy.

About QureBio

QureBio is an international company focusing on the research and development of innovative macromolecular biological drugs, dedicated to solving clinical urgent and unmet needs such as intractable cancers, autoimmune diseases. The company was founded by a senior scientist returning to China. The management team has many years of experience in R&D and management in the field of biomedicine. Since its establishment, the company has built a number of core technology platforms and efficiently deployed more than a dozen innovative, competitive and clinically valuable R&D pipelines. The R&D progress of bispecific antibodies, such as Q-1802 and Q-1801, is in the forefront at home and abroad.

QureBio's technology in antibody engineering and screening is widely recognized in the industry. The company has strong self-research capabilities and has established several innovative platforms, including phage display technology platform, hybridoma antibody humanization platform, single domain antibody platform and antibody engineering, etc. Among them, the hybridoma antibody humanization platform can overcome immune tolerance, and successfully completed several multi-transmembrane region antigen projects. The phage display platform is a synthetic human library platform for screening of common light chain libraries for bispecific antibody. Using Qurebio's own technology platform, QureBio has successively reached a series of cooperation with well-known biotechnology companies in the industry, including BRL Medicine, BioMap, Hengrui Pharma, and Precision Scientific. These collaborations fully reflect QureBio's industry status in the field of innovative macromolecular biopharmaceuticals.

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