CTLA-4 monoclonal antibody cs1002 independently developed by cornerstone Pharmaceutical Co., Ltd. has been approved for clinical use

August 28, 2018 / Meitong news agency / -- Cornerstone Pharmaceutical (Suzhou) Co., Ltd (hereinafter referred to as "cornerstone pharmaceutical") today announced that the clinical trial of its independently developed anti cytotoxic T lymphocyte associated antigen 4 (CTLA-4) all human monoclonal antibody cs1002 has been approved by the State Drug Administration ("SFDA") "We are very pleased to welcome the third Chinese clinical approval document of independently developed products this year Cs1002 has carried out phase I clinical trials in Australia and completed the first patient administration in May this year " Dr Jiang Ningjun, chairman and chief executive officer of cornerstone Pharmaceutical Co., Ltd., said, "the approval of CS1002 in clinical practice also marks that cornerstone Pharmaceutical Co., Ltd has become the only company in China that has three core products of tumor immunity in clinical phase, namely, anti PD-L1, PD-1 and CTLA-4." Dr Li Jingrong, senior vice president of product development and production of cornerstone pharmaceutical, said: "previous research results have shown that cs1002 has a high degree of selectivity, specificity and strong affinity A large number of international clinical trials have confirmed that CTLA-4 mAb combined with PD-1 mAb has an ideal therapeutic effect in the treatment of multiple cancer species We will actively explore the combination therapy of cs1002 and other drugs in the company's product line, and strive to benefit patients in China and even in the world as soon as possible " At present, there are 14 anti-tumor products in the pipeline of cornerstone pharmaceutical products, eight of which are in the clinical stage, and three of which have been registered for clinical trials at home and abroad Cs1001, the first natural full-length, all human anti-PD-L1 monoclonal antibody drug independently developed by cornerstone pharmaceutical, has entered the critical phase II clinical research and is expected to become the first domestic PD-L1 anti-cancer drug to be listed in China In June 2018, cornerstone pharmaceutical entered into an exclusive cooperation and authorization agreement with blueprint medicine and Agios, introducing four products to complete the clinical concept verification, including ivosidenib, which has been approved for marketing in the United States, and avapritinib, which has entered the phase III clinical trial in the United States CTLA-4, also known as CD152, is a transmembrane protein encoded by CTLA-4 gene CTLA-4 can inhibit the activation of T cells by binding to its ligand B7, which can protect tumor cells from the attack of T lymphocytes Therefore, blocking the immune effect of CTLA-4 can stimulate the proliferation of immune cells and induce or enhance the anti-tumor immune response CTLA-4 provides a new method for immunotherapy of many diseases including tumor At present, irilimumab of Bristol Myers Squibb is the only CTLA-4 inhibitor listed in the world, and yet yervoy has not been listed in China The bioassay results show that cs1002 has a strong affinity for human CTLA-4, and the effect is similar to yevoy About cornerstone pharmaceutical, cornerstone pharmaceutical is a biopharmaceutical company driven by the research and development of innovative drugs It is committed to the development of anti-cancer drugs and the research of tumor immune combination drugs, and has a rich product line Cornerstone pharmaceutical management team members are senior executives from top international pharmaceutical companies, and have successfully built a team with clinical research and development and transformation medicine as the core competitiveness In July 2016 and may 2018, the company has completed 150 million US dollars (about 975 million RMB) round a financing and 260 million US dollars (about 1.65 billion RMB) round B financing invested by well-known VC / PE funds The unique advantages in management team, product line, R & D mode and capital will make cornerstone pharmaceutical become the best partner for multinational pharmaceutical companies and international biopharmaceutical companies to jointly develop products in China and the Asia Pacific region.