Cornerstone pharmaceutical and Bayer have reached a global clinical cooperation to jointly evaluate the combination of PD-L1 McAb cs1001 and regofinib

Cornerstone Pharmaceutical (Suzhou) Co., Ltd announced today that it has reached a global clinical cooperation with Bayer health care LLC (hereinafter referred to as "Bayer") focusing on China The two sides will jointly evaluate the safety, tolerance, pharmacokinetics (PK) and antitumor efficacy of PD-L1 McAb cs1001 combined with oral administration of multi kinase inhibitor regofinib (targeting VEGFR, FGFR, csf1r, etc.) in the treatment of multiple cancers including gastric cancer This is also the first global proof of concept clinical study jointly conducted by both parties The cornerstone pharmaceutical industry is the initiator of this research Bayer will provide regofinib for the experiment Professor Shen Lin, vice president of Cancer Hospital of Peking University, said: "at present, there is no safe and effective treatment plan for patients with advanced gastric cancer The preclinical and clinical evidences show that the combination of multi kinase inhibitors targeting VEGFR and PD-1 / PD-L1 antibody can produce significant synergistic antitumor effect We hope that this combination therapy can provide a new treatment option for patients with gastric cancer and other serious cancers " Cs1001 is one of the cytoskeleton products of cancer immunotherapy in cornerstone pharmaceutical industry, which has been proved to have good tolerance, and has been found to have good antitumor activity in clinical research of multiple cancer species At present, cs1001 is carrying out 7 clinical trials, 5 of which are registered trials Regofinib has been approved in more than 90 countries for the treatment of metastatic colorectal cancer (mCRC) and gastrointestinal stromal tumor (GIST), and in more than 80 countries for the second-line treatment of advanced liver cell carcinoma (HCC) Dr Jiang Ningjun, chairman and CEO of cornerstone pharmaceutical, said: "we are very pleased that Bayer has chosen cornerstone pharmaceutical as a partner and recognized the potential of cs1001 We hope that this combination treatment program can supplement the product pipeline of the two companies, so that we can develop better tumor treatment programs for patients In addition, once we get positive data, this cooperation will be a big step forward for cornerstone pharmaceutical's global strategy " Dr Scott Z fields, senior vice president of Bayer's prescription medicine business division and head of tumor development, said: "in order to find new solutions and fill the clinical needs that are still unmet, the combination of multi kinase inhibitors such as regofinib and checkpoint inhibitors is a development trend of cancer treatment Cornerstone pharmaceutical is an innovative biopharmaceutical company We are looking forward to this cooperation and hope that through this global clinical cooperation, we can explore the potential of regofinib combined with cs1001 in the treatment of multiple types of tumors " Cs1001 cs1001 is a monoclonal antibody against PD-L1 developed by cornerstone pharmaceutical Cs1001 is produced by OMT transgenic animal platform authorized by ligand company of the United States, which can realize one-stop production of all human antibody As a full-length human anti-PD-L1 monoclonal antibody, cs1001 is a natural immunoglobulin-4 (IgG4) monoclonal antibody that is closest to human body Compared with similar drugs, cs1001 has a lower risk of immunogenicity and related toxicity in patients, which makes cs1001 have a potential unique advantage in safety Cs1001 has completed phase I clinical study dose escalation in China In the phase ia study, cs1001 showed good antitumor activity and tolerance Currently, cs1001 is undergoing a number of clinical trials, including a US bridging phase I trial In China, cs1001 is carrying out a multi arm IB phase test, two registered phase II tests and three phase III tests for multiple cancer species At present, cs1001 has not been approved for listing in any market in the world As for baivango (regofinib), regofinib is an oral multi kinase inhibitor, which can block a variety of protein kinases related to tumor angiogenesis (VEGFR1, - 2, - 3, Tie2), tumor proliferation (kit, RET, Raf-1, BRAF), tumor metastasis (VEGFR3, PDGFR, FGFR) and tumor immunity (csf1r) At present, regofinib has been approved in more than 90 countries for the treatment of metastatic colorectal cancer (mCRC) and gastrointestinal stromal tumor (GIST) The drug is approved under the trade name of baivango ® (stivarga ®), and approved by the United States, European Union countries, China and Japan In addition, the product has also been approved in more than 80 countries for second-line treatment of advanced liver cancer (HCC), including the United States, Japan, European Union countries and China Regofinib is a compound developed by Bayer In 2011, Bayer reached an agreement with Onyx, a biotech pharmaceutical company Under the agreement, Onyx will receive royalties based on regofinib's global net sales in the field of cancer About cornerstone Pharmaceutical (HKEx: 2616), a biopharmaceutical company, focuses on the development and commercialization of innovative tumor immunotherapy and precision treatment drugs to meet the keen medical needs of cancer patients in China and around the world Founded at the end of 2015, cornerstone pharmaceutical has assembled a world-class management team with rich experience in new drug research and development, clinical research and commercialization Based on the combination therapy, the company has established a powerful tumor drug pipeline consisting of 15 tumor candidate drugs At present, five late candidate drugs are in or near critical trials With an experienced team, rich pipelines, strong clinical development driven business model and abundant funds, cornerstone pharmaceutical's vision is to become a world-renowned leading Chinese biopharmaceutical company by bringing innovative cancer therapy to cancer patients around the world.