Junshi Bio Semi-Annual Report: Revenue of 575 million yuan, up 86% YoY

Introduction: Clinical trials of core drugs are advancing into the field of anti-infection treatment. Shanghai Junshi Biopharmaceutical Technology Co., Ltd. announces unaudited interim results for the six months ended June 30, 2020.
results achieved unaudited revenue of RMB575 million, up 86% YoY.
's core product, Ripley Monoanti (commodity name: Toyi ®), has conducted 15 key registered clinical trials, of which 2 NDA applications for key registered clinical trials have been accepted by the National Drug Administration (NMPA) and included in the priority review process.
entered the field of anti-infection therapy, working with the Institute of Microbiology of the Chinese Academy of Sciences to develop the new coronavirus and antibody JS016, providing innovative drugs for the treatment of COVID-19.
continued to increase investment in research and development, unaudited research and development spending during the reporting period was RMB709 million, a significant increase of 92% over the same period last year.
core product Tripley single anti-adhesive layout continues to deepen Tripley mono-resistance is The first successfully listed domestic PD-1 single-resistance in China independently developed by Regeneration Bio.
On December 17, 2018, Ripley was conditionly approved by the National Drug Administration (NMPA) for the treatment of local progress or metastasis melanoma after previous standard treatment failures, and was recommended in the 2019 and 2020 editions of the China Clinical Oncology Society (CSCO) Melanoma Guidelines.
In addition to approved melanoma adaptations, Ripley Monoanti is conducting clinical trials of more than 30 single-drug and combination therapies worldwide, including 15 key registered clinical trials and one ongoing Phase IB clinical trial for multiple solid tumors in the United States.
April 2020, a new adaptive application for the treatment of relapsed/metastatic nasopharyngeal cancer (NPC) that had previously failed to receive second-line and above systemic treatment was accepted by NMPA.
is also the world's first anti-PD-1 single anti-treatment recurrence / metastatic nasopharyngeal cancer new drug application.
phase III clinical study JUPITER-02 study in patients with relapsed or metastatic nasopharyngeal cancer combined with chemotherapy as a relapsed or metastatic nasopharyngeal cancer was also completed.
May 2020, a new adaptation application for the treatment of patients with local progressive or metastatic urethrial skin cancer (UC) who had previously been treated was accepted by NMPA.
Group has entered a new phase in the layout of "sub-sectors" of adaptation to melanoma, nasopharyngeal cancer, urethra cancer, etc.
expected that the approval of Ripley single anti-urethra skin cancer adaptation, will provide more treatment options for patients with advanced urethra skin cancer, the market prospects are considerable.
phase III key registered clinically completed patients enrolled in phase III of the first-line treatment of EGFR-negative non-small cell lung cancer in combination with chemotherapy, the Group will submit an NDA listing application to NMPA as soon as clinical trials are completed.
overseas markets, in March 2020, Ripley Monoantigen's treatment of mucosal melanoma was certified as an FDA orphan drug, contributing to Theprint's follow-up research and development, registration and commercialization in the United States.
In June, the Group and Merck, the world's leading technology company, announced a clinical research cooperation agreement on targeted-immune combination therapy for head and neck tumors, exploring the efficacy and safety of the Terripri single-anti-combination target drug sytoxidoxic therapy recurrence and/or metastatic head and neck squamous cancer. during the
reporting period, the Group also launched four key registered clinical trials of the combined first-line treatment of liver cancer with Tripri single-drug and beva-pearl monoantigroup, the first-line treatment of liver cancer with lenforatinib, the joint treatment of renal cell carcinoma with acetinib, and the treatment of gastric cancer with single-drug third-line treatment.
in the clinical progress of research products steadily advancing UBP1211 for the Group and Jiangsu Taikang Biopharmaceutical Co., Ltd. to develop a recombinant human-source anti-TNF-alpha monoclonal antibody injection, for the Someile (Adamo monoanti) bio-like drugs.
Group has submitted the NDA to the NMPA for acceptance.
JS002 for the Group's own research and development of injection recombinant humanized anti-PCSK9 monoantigen, used in the treatment of cardiovascular disease.
Group is the first Chinese company in China to be approved for clinical trials of the targeted drug, and has completed Phase I clinical trials in cooperation with the Clinical Trial Center's Hospital outside the hospital to test the safety and tolerance of JS002 in volunteers.
TAB004/JS004 is the group's first clinically approved clinically approved anti-tumor recombinant humanized anti-BTLA monoclonal antibody injection for B and T lymphocyte attenuation factors (BTLA), which was approved by NMPA in January 2020.
in April 2020, the first patients were given the drug in a Phase I clinical trial in China.
, its Phase I clinical trials in the United States have completed the dose climb and entered the dose expansion phase.
, there are no other target anti-tumor products in the world that are entering the clinical stage.
JS005 is the Group's independent research and development of recombinant humanized anti-IL-17A monoclonal antibody injection, mainly for psoriasis and other autoimmune diseases, has been approved by NMPA clinical trials.
May 2020, JS005 completed the first phase I clinical trial in China, which has now been randomized.
preclinical studies, JS005 showed the same efficacy and safety as the listed anti-IL-17 monoantigen.
expanded the map into the field of anti-infection treatment in March 2020, Junshi Bio and the Institute of Microbiology of the Chinese Academy of Sciences in cooperation with the development of the new coronavirus and antibody JS016.
antibodies are widely believed by the scientific community at home and abroad to have the potential to fight the new crown outbreak.
, the Group signed a research and development cooperation and licensing agreement with Lilly Pharmaceuticals, which was granted exclusive license to conduct research and development activities, production and sales of JS016 outside Greater China.
, JS016 completed the China I clinical trial of all subjects.
JS016 is the first new coronavirus in China to enter the clinic and antibodies, research and development progress in the world's leading level, clinical trials in the United States also started in the second quarter of 2020.
Group is conducting an international multi-center clinical study of IB for patients with light/common neo-coronary pneumonia and expects to conduct a study on high-risk groups of new coronavirus as soon as possible to evaluate the preventive effects of JS016 on new coronavirus infection.
Research and development investment to increase breakthrough results significantly Junshi Bio continued to increase research and development investment, research and development investment in the reporting period of 709 million yuan, accounting for 123% of unaudited operating income, a significant increase of 92% over the same period last year, strong support for the Group's innovative drug projects research and development.
the end of the reporting period, the Group had 61 granted patents, including 51 domestic patents and 10 offshore patents.
Group had 21 products under development at the end of the reporting period, including 19 innovative drugs and 2 bioso analogopaths, covering five therapeutic areas: malignant tumors, autoimmune system diseases, chronic metabolic diseases, neurological diseases and infectious diseases.
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