Cornerstone pharmaceutical semiannual report: 2019 will be a transformative year

August 15, 2019 - cornerstone pharmaceutical, a leading biopharmaceutical company focusing on the development and commercialization of innovative tumor immunotherapy and molecular targeted drugs for cancer treatment, announced its business highlights and financial performance in the first half of 2019 on August 15 "In the first half of 2019, our team continued to make significant progress in all aspects," said Dr Jiang Ningjun, chairman and CEO of cornerstone pharmaceutical Our successful listing on the main board of the stock exchange of Hong Kong Limited on February 26, 2019 marks a significant milestone in the development of our company We continue to build strategic partnerships, including a global partnership with Bayer healthcare LLC ("Bayer") to explore the potential of our leading product, PD-L1 monoclonal antibody cs1001 in combination with regofinib, in a variety of cancer types, and numab therapeutics Authorization transaction between Ag ("numab") on a potential to be the best of its kind next generation backbone We have carried out 5 registration trials of cs1001 for multiple indications, and more than 650 patients have been given drugs We will promote all the imported licensed products from Agios pharmaceuticals and blueprint medicines, including ivosedenib, avapritinib, fisogatinib (cs3008) and pralsettinib (cs3009), to the stage of registered clinical or potential registration As a first step towards commercialization, we submitted the new drug listing application of ivosidenib in Taiwan in May 2019 " "Looking forward to the future, we will present the key data of our PD-L1 monoclonal antibody in esophageal cancer, gastric cancer, cholangiocarcinoma, high microsatellite instability and nktl, as well as the phase I clinical data of PD-1 (cs1003) and CTLA-4 (cs1002) monoclonal antibodies at the upcoming annual meeting of the Chinese society of clinical oncology, the European Society of oncology and the American Society of Hematology in the second half of 2019 We will continue to promote the entry of several candidate drugs, including our PD-L1 and PD-1 monoclonal antibodies, into new joint trials and registration studies for large indications With the continuous construction of business, R & D and production capacity, 2019 will be a transformative year for cornerstone pharmaceutical industry, and will lay the foundation for the company to become a globally recognized leading Chinese Biomedical Company, so as to bring innovative therapies for cancer patients in China and the world " Business summary review financial summary non IFRS measurement: After deducting the impact of changes in the fair value of preferred stock conversion characteristics and share based payment expenses, the total loss and comprehensive expenses decreased by RMB 162.6 million from RMB 439.3 million for the six months ended June 30, 2018 to RMB 276.7 million for the six months ended June 30, 2019, mainly due to the decrease in license fees compared with the same period in 2018 IFRSs figures: other income increased by 24.6 million yuan from 4.0 million yuan in the six months ended June 30, 2018 to 28.6 million yuan in the six months ended June 30, 2019 This is mainly due to the increase of interest on bank deposits and time deposits and the change of fair value of money market funds Other gains and losses increased by rmb493.0 million from rmb202.2 million in the six months ended June 30, 2018 to rmb695.2 million in the six months ended June 30, 2019 The increase of other losses is mainly due to the increase of fair value loss of derivative financial liabilities (non cash, one-off adjustment after listing in accordance with international financial reporting standards) R & D expenditure decreased by RMB 125.1 million from RMB 508.7 million for the six months ended June 30, 2018 to RMB 383.6 million for the six months ended June 30, 2019 This was mainly due to a decrease in licensing fees compared to the same period in 2018, which was partially offset by an increase in third-party contract costs due to more trials Administrative expenses increased by 130.5 million yuan from 37.3 million yuan for the six months ended June 30, 2018 to 167.8 million yuan for the six months ended June 30, 2019 This is mainly due to the increase in the number of employees and the one-time share based payment expenses related to the IPO Due to the above factors, the loss in the current period increased by RMB 491.5 million from RMB 744.3 million for the six months ended June 30, 2018 to RMB 1235.8 million for the six months ended June 30, 2019 In the first half of 2019, our product pipeline and business operation have made significant progress: we actively participate in the cooperation with multinational pharmaceutical companies In June 2019, we entered into a global clinical partnership with Bayer focusing on China to evaluate the safety, tolerance, pharmacokinetic characteristics and antitumor activity of our PD-L1 monoclonal antibody cs1001 combined with Bayer's oral multi kinase inhibitor regofinib in the treatment of multiple cancers including gastric cancer This is also the first global proof of concept clinical study jointly carried out by both parties In May 2019, we reached a regional exclusive license agreement with numab, which will allow us to potentially acquire the unique multi-specific antibody technology platform created by numab The protocol is specifically for the development and commercialization of nd021, a monovalent Trispecific antibody fragment for PD-L1, 4-1BB and HSA We have the exclusive right to develop and commercialize nd021 in Greater China (including Mainland China, Hong Kong, Macao and Taiwan), South Korea and Singapore We have made significant progress in advancing our product pipeline: PD-L1 antibody (cs1001) - in April 2019, we launched a phase III clinical trial of cs1001 for gastric cancer patients in China In June 2019, we were approved to start clinical trials of cs1001 combined with fisogatinib (cs3008) in patients with locally advanced or metastatic HCC in China We are currently carrying out 5 Registration tests of cs1001 Ivosidenib (cs3010) - expanded beyond mainland China, in May 2019, we submitted a new drug application to Taiwan's food and drug administration, tibsovo (ivosidenib), which is the first to be approved treatment for adult patients with relapse or refractory acute myeloid leukemia (R / R AML) with IDH1 mutations In July 2019, we obtained the approval of the State Drug Administration to carry out the bridging test of ivosedenib for idh1m R / R AML in China, and achieved the first Chinese subject administration in the global phase III agile test in the same month Avapritinib (cs3007) - in January 2019, we obtained the clinical trial approval of the National Drug Administration ("nmpa") to join a global critical phase III study comparing avapritinib with regofinib as a three-line treatment for unresectable or metastatic gastrointestinal stromal tumor (GIST), and in July 2019, we achieved the first Chinese trial administration In April 2019, we obtained the clinical trial approval of China drug administration to carry out a Chinese bridging study of avapritinib for the treatment of non resectable or metastatic GIST Fisogatinib (cs3008) - in May 2019, we delivered the first Chinese trial in the global phase I clinical study of FGFR4 inhibitor fisogatinib for the treatment of advanced HCC Pralsettinib (cs3009) - in March 2019, nmpa approved us to launch a clinical trial application for the use of pralsettinib, a RET inhibitor, in the phase I / II trial of RET mutant non-small cell lung cancer, medullary thyroid cancer and other advanced solid tumors in China We have since achieved the first patient administration in China in August 2019 We employ four internationally renowned oncologists, Paul A Bunn, Dr Jr., Dr Elizabeth M Jaffee, Dr Zou Weiping and Dr Richard S Finn, as members of our scientific advisory board (SAB) We believe that the participation of these four experts will greatly enhance the company's public image in the field of cancer and provide valuable insights for our clinical progress In August 2019, we signed an agreement with a state-owned enterprise affiliated to Suzhou Industrial Park to build a R & D and production base of about 100000 square meters in Suzhou Industrial Park for the development and commercial production of large and small molecular drugs We expect to start construction of the base in early 2020 About cornerstone pharmaceutical, cornerstone pharmaceutical is a biopharmaceutical company focusing 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 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.