Report card of zaiding pharmaceutical H1: net income in the first half of the year was 3.4 million US dollars, and the revenue of optune, a heavyweight tumor product, was significantly higher than expected, reaching 1.5 million US dollars

On September 3, 2019, zaiding pharmaceutical announced its financial report and business progress for the first half of June 30, 2019: Dr Du Ying, founder and chief executive officer of zaiding pharmaceutical, said: "in the first half of 2019, zaiding pharmaceutical continues to make solid progress towards becoming a fully integrated global biomedical company At present, our product pipeline includes 10 innovative drugs and therapies, 9 of which are in the late clinical stage, covering more than 20 indications Our leading anti-tumor product zele has been launched in Hong Kong and Macao, China, and the tumor electric field treatment product optune ® has also been launched in Hong Kong, China At the same time, we have submitted the listing application of these two products in mainland China and established a complete business team We will continue to work with strategic partners to advance the clinical development progress of other late clinical candidate drugs, including margeuximab, ripretinib, bemarituzumab, omadacycline and sulbactam durlobactam, and achieve important milestones We will continue to look for innovative clinical projects with the best potential of the same kind, improve our pipeline in key indications, and solve the unmet clinical needs of Chinese patients Since this year, we have reached two cooperation agreements, one is to cooperate with deciphera company to develop an advanced clinical stage candidate drug ripretinib for gastrointestinal stromal tumors, the other is to cooperate with Incyte company to develop a globally competitive anti-PD-1 anti-body incmga0012 In the future, it will have the potential to cooperate with multiple existing tumor candidates of zaiding medicine Use With the expansion of the company's product pipeline and the promotion of commercialization, zaiding pharmaceutical has established its international reputation as a pioneer in China's biotechnology industry As an integrated biopharmaceutical company, zaiding currently has nearly 600 employees in six offices in Greater China and the United States Moreover, with our rich experience in clinical development, registration and business development at home and abroad, we hope to further demonstrate our commercial and internal R & D capabilities in the near future As the company's business continues to grow, the recently completed financing will assist in the implementation of all our important projects We are actively preparing for the approval of zele and optune in mainland China, and look forward to the important development of zene pharmaceutical in the next few months, and to a new level " In recent years, the pipeline and product highlights in the field of cancer, zelaparil is an efficient and selective daily oral small molecule poly (ADP ribose) PARP 1 / 2 inhibitor In August 2019, zaiding pharmaceutical announced that it published "the results of the open label study on the pharmacokinetics (PK) characteristics of Chinese herbal medicines for Chinese ovarian cancer patients" in the oncologist magazine, which proved that the pharmacokinetics (PK) characteristics of nilapari in Chinese patients were similar to those of GSK's global PK study In July 2019, GSK, a partner of zaiding pharmaceutical, announced the positive results of Prima, a phase III clinical study of nilaparil as a first-line maintenance treatment for ovarian cancer The primary end point of the study was a statistically significant improvement in patients' progression free survival (PFS) regardless of their biomarker status In June 2019, zaiding pharmaceutical partner GSK announced that, based on the research results of Quadra, the US Food and Drug Administration (FDA) accepted the application of new drug supplement (SNDA) for the treatment of advanced ovarian cancer by nilaparil, and granted its priority review qualification FDA plans to make preliminary review comments before October 24, 2019 In June 2019, zaiding pharmaceutical announced that nirapali had been approved for marketing in Macao, China, for the treatment of patients with recurrent ovarian cancer In January 2019, zaiding pharmaceutical announced that the drug review center of the State Drug Administration has accepted zele as a new drug for maintenance treatment of adult patients with recurrent epithelial ovarian cancer, salpingocarcinoma or primary peritoneal ovarian cancer who have been completely or partially relieved by platinum chemotherapy into the priority review In December 2018, the State Drug Administration announced the acceptance of zele's new drug listing application, more than a year ahead of schedule In January 2019, zaiding pharmaceutical announced the inclusion of patients who completed the key clinical study of nilaparil in the second-line maintenance treatment of patients with recurrent platinum sensitive ovarian cancer Optune ®, tumor electric field treatment, is a new tumor treatment method that uses specific electric field frequency to interfere with cell division, inhibit tumor growth and cause cancer cells affected by electric field to die In August 2019, the National Drug Administration awarded the qualification of optune innovative medical devices, a tumor electric field treatment product, which will have an opportunity to accelerate the approval process of optune In May 2019, novocure, a pharmaceutical partner of zaiding, announced that the US FDA approved novottf-100l Gamma Systemic combined chemotherapy is used for the first-line treatment of unresectable locally advanced or metastatic malignant pleural mesothelioma (MPM) Novottf-100l is a non-invasive and anti mitotic cancer therapy, which can apply electric field to the tumor area for treatment It is the first new therapy approved by FDA in the United States for more than 15 years to treat MPM In March 2019, novocure, a partner of zaiding pharmaceutical, launched phase III clinical study of tumor electric field treatment in patients with recurrent ovarian cancer Novocure's tumor electric field therapy is currently in the late stage of clinical development in four solid tumor indications, including non-small cell lung cancer, brain metastasis, pancreatic cancer and ovarian cancer In February 2019, optune was launched in Hong Kong, China for the treatment of glioblastoma (GBM) patients Margetuximab is an anti HER2 monoclonal antibody optimized for Fc fragment in clinical research stage In February 2019, macrogenics, a partner of zaiding pharmaceutical, announced that the phase III clinical study Sophia of margetuximab, a cancer drug under research, aimed at HER2 positive metastatic breast cancer, achieved positive results At the annual meeting of the American Society of Clinical Oncology (ASCO) in June 2019, macrogenomics released the preliminary analysis report One of the main end points of the study was that patients receiving margeuximab combined chemotherapy improved their PFS compared with patients receiving trastuzumab combined chemotherapy In January 2019, macrogenics, a partner of zaiding pharmaceutical, announced the clinical data of margeuximab combined with pabolizumab in the 2019 ASCO gastrointestinal cancer symposium Based on the results of relevant positive data, macrogenomics and zaiding pharmaceutical plan to carry out margetuximab combined immunocheckpoint inhibitors in 2019, including incmga0012 (anti-PD-1 monoclonal antibody) and mgd013 (anti-PD-1 and LAG-3 bispecific antibody), for the first-line treatment of HER2 positive gastric cancer and gastroesophageal junction cancer Ripretinib is a kit / PDGFR α - kinase switch regulatory inhibitor in clinical research, which is used to treat Kit / PDGFR α - driven gastrointestinal stromal tumors (GIST), systemic mastocytosis and other cancers In August 2019, deciphera, a partner of zaidin pharmaceutical, announced the positive results of the critical phase III clinical study Invictus used by ripretinib to treat GIST patients with four or more lines The Invictus study reached the primary end point for improving median progression free survival (MPFs) in patients Compared with placebo, riprotinib significantly reduced the risk of disease progression or death by 85% In June 2019, zaiding pharmaceutical and deciphera reached an exclusive licensing cooperation agreement, and zaiding pharmaceutical obtained the exclusive development and commercialization rights of ripretinib in Greater China Incmga0012 is an anti-PD-1 monoclonal antibody in the stage of clinical research At present, it is in the process of clinical research for the single drug treatment of high microsatellite instability endometrial cancer, Merkel cell cancer and anal cancer for the purpose of registration In July 2019, zaiding pharmaceutical announced to enter into an exclusive cooperation and licensing agreement with Incyte, and zaiding pharmaceutical will obtain the exclusive development and commercialization rights of incmga0012 in Greater China This cooperation will enable zaiding to rapidly explore the potential of a competitive anti-PD-1 drug as a single drug and combination therapy, and fully release the potential of zaiding's existing product pipeline Bemarituzumab is one of the best homologous isomer selective monoclonal antibodies It can directly kill tumor cells by enhancing the antibody dependent cell-mediated cytotoxicity (ADCC), as a targeted immunotherapy for fgfr2b overexpression of tumor Because the positive rate of fgfr2b biomarkers remained stable at more than 30%, the enrollment progress of the key clinical research (light Research) in patients with fgfr2b overexpressed gastric cancer and gastroesophageal junction cancer was ahead of schedule Five prime therapeutics, a partner of zaiding pharmaceutical, plans to suspend patient enrollment in the fourth quarter of 2019 and conduct an early ineffectiveness analysis of the light study in the first half of 2020 Nuzyra ® (omadacycline) is a new type of tetracycline It has two dosage forms, oral and intravenous It is used once a day to treat community-acquired bacterial pneumonia (CaBP) and acute bacterial skin and skin structural infection (absssi) In July 2019, the China bridging test required by the drug evaluation center of the State Drug Administration was completed in advance Bioequivalence, pharmacokinetics and microbiology studies were also completed on time Sulbactam durlobactam is a new broad-spectrum a, C and D β - lactamase inhibitor, which is used to treat all kinds of infections caused by carbapenem resistant Acinetobacter baumannii In May 2019, the National Drug Administration accepted the clinical research application (CTA) submitted by zaiding pharmaceutical, which was used to start the phase III clinical research on the treatment of carbapenem resistant Acinetobacter baumannii infection The attack study is a global phase III clinical study that will recruit about 300 patients from 18 countries Zaiding will be responsible for the enrollment of Chinese patients, and may provide early enrollment for patients in the Asia Pacific region Entasis therapeutics will be responsible for the inclusion of patients in the United States and Europe Recent progress of the company: in July 2019, Dr Alex a Adjei joined zaiding Medical Science Advisory Committee Dr Alex a Adjei is a world-renowned clinical scientist from Mayo Clinic, with rich experience in drug development, tumor pharmacology and early clinical research He will provide suggestions for clinical research of several innovative molecular drugs in the expanding tumor pipeline of zaiding pharmaceutical In June 2019, zaiding pharmaceutical appointed Dr Valeria Fantin as chief scientific officer to further strengthen the company's internal R & D strength and influence in the United States Dr Fantin will be responsible for the global internal R & D of zaiding pharmaceutical and report to Dr Du Ying directly In May 2019, zaiding pharmaceutical raised $216.2 million after deducting underwriting fees through the public issuance of American Depository shares (ads), each of which represents one common share In February 2019, Professor Chen Liping, a pioneer of tumor immunotherapy, joined zaiding medicine as a member of the Scientific Advisory Committee Professor Chen will provide suggestions for the expanding independent research and development of cancer pipeline of zaiding pharmaceutical Zaiding continues to expand its influence in the United States to improve its internal drug development capabilities As of July 31, 2019, the R & D center of zaiding pharmaceutical in the bay area of San Francisco has about 10 employees, and the team is still growing The R & D and business teams of zaiding are growing As of July 31, 2019, zaiding pharmaceutical has 577 full-time employees engaged in research