"take the lead in food intake and open up a new life."
ShanghaiJune 27, 2022/ PR Newswire /-- June 25, 2022"take the lead in food intake and open up a new life."the biological development benefit of Junshi®(triplizumab injection) National listing meeting of indications for first-line esophageal cancerIt was held successfully. This listing will take Guangzhou as the main venue, and set up sub-venues in Beijing, Zhengzhou, Chengdu and Nanjing. Through the interaction of the five cities, we will bring together national experts in the field of digestive tract oncology to share and discuss the achievements and prospects of emerging immunotherapy in the field of esophageal cancer.®(triplizumab)Esophageal squamous cell carcinomaOS17 life systemThe official release of "!
Tuoyi (R) first-line esophageal cancer indication national listing meeting was successfully held.
Professor Xu Ruihua of Cancer Prevention and treatment Center of Sun Yat-sen University, Professor Shen Lin of Peking University Clinical Cancer Hospital and Professor Wang Greening of Shenzhen Hospital of Chinese Academy of Medical Sciences were invited to serve as chairmen. Professor Li Yin of Cancer Hospital of Chinese Academy of Medical Sciences, Professor Chen Keneng of Peking University Cancer Hospital, Professor Luo Suxia of Henan Cancer Hospital, Professor Gao she Gan of the first affiliated Hospital of Henan University of Science and Technology, Professor Han Yongtao of Sichuan Cancer Hospital, Professor Jiang Tao of Tangdu Hospital of Air Force military Medical University, Professor Cao Guochun of Jiangsu Cancer Hospital and Professor Li Zhigang of Shanghai chest Hospital served as the chairmen respectively.
"OS17 Life system leads the New pattern of esophageal Cancer treatment
Anti-PD-1 McAb independently developed by Junshi Biology, a local innovative pharmaceutical company, in May 2022.Tuoyi®(tripril) combined with paclitaxel and cisplatin (TP chemotherapy for first-line treatment of unresectable locally advanced / recurrent or distant metastatic esophageal squamous cell carcinoma (ESCC)The new indication was approved by the State Drug Administration (NMPA). This "China program" refreshes the median overall survival time of Chinese patients with advanced esophageal squamous cell carcinoma in first-line treatment, and will use super "diet" to open up a new life system for patients.
Professor Xu Ruihua, chairman of the conference"as an anti-PD-1 monoclonal antibody independently developed in China, Tuoyi®The approval of first-line indications for esophageal cancer has multiple significance, which is a new breakthrough, a new choice, and brings new hope for patients. At the same time, it is also a major contribution of the 'China Program' to the field of international immunotherapy! "
Professor Shen Lin, Chairman of the Congress"esophageal cancer is a special type of tumor, and globally, China has an absolute high incidence," he said. It is proud that Chinese innovative drug companies have caught up with developed countries in this field. I hope that more and more Chinese innovative pharmaceutical companies like Junshi Biology will continue to invest in R & D and innovation, develop more innovative drugs, and improve the survival of cancer patients in our country! "
Professor Wang greening, chairman of the conferenceSaid: "this time Tuoyi®The approval of first-line indications for esophageal cancer is a milestone worthy of celebration in the field of esophageal cancer treatment in China, marking the arrival of a new era. the treatment pattern of advanced esophageal cancer will also be completely changed, and the 17-month survival record is bound to become a benchmark in China! "
Live for a long time and gain "benefits"The "China Plan" is expected in the future.
Tuoyi®The approval of first-line esophageal cancer indications is based on a randomized, double-blind, placebo-controlled, multicenter phase III clinical trial (JUPITER-06 study), with Professor Xu Ruihua as the lead researcher. This study was carried out in 72 units in China. A total of 514 patients with advanced or metastatic ESCC who had not received systemic anti-tumor therapy for recurrent or metastatic tumors were included in this study. TP chemotherapy regimen, which is more suitable for local clinical practice, was used in combination with PD-1 inhibitor tripril monoclonal antibody developed in China, and a breakthrough was achieved.
Professor Wang Feng, Cancer Prevention and treatment Center, Sun Yat-sen UniversityInterpreting the highlights of the JUPITER-06 study, she said: "Platinum-based chemotherapy is often used in the first-line standard treatment of patients with advanced esophageal squamous cell carcinoma, but the clinical benefits are limited, and there is an urgent need for new drugs and treatments to prolong the survival of patients. JUPITER-06 research has completely broken the pattern of treatment that has been stagnant for many years in this field.
Studies have shown that more patients with advanced esophageal squamous cell carcinoma have better survival benefits than chemotherapy alone.Median overall survival (MOS) extended significantly to 17 monthsCompared with the control group, the chemotherapy alone was prolonged for 6 months.Reduced risk of disease progression or death42%And no matter what the expression of PD-L1 is, the patients can benefit. In terms of safety, no new safety signals were found when triplizumab was added to chemotherapy. "
It is worth mentioning that JUPITER-06 's research results have also been recognized by the international academic community for many times, including published by the international top oncology journal Cancer Cell (impact factor: 31.743), and presented at the annual meeting of the European Society of Internal Oncology (ESMO 2021) and the Society of Cancer Immunotherapy (SITC 2021) in the form of oral report, which is another wonderful presentation of the "China Program" in the international academic arena.
In addition, based on the JUPITER-06 study, the therapy of "triplatin + cisplatin + paclitaxel" was recommended by the 2022 Chinese Society of Clinical Oncology (CSCO) guidelines for esophageal Cancer diagnosis and treatment and the 2022 CSCO immune checkpoint inhibitor Clinical Application Guide "double", which will bring better survival benefits for Chinese patients with advanced esophageal squamous cell carcinoma.
Do not forget the initial ideals and aspirations of patients driven by the need to move forward
In the past, the development of immune checkpoint inhibitors represented by anti-PD-1 monoclonal antibody mainly focused on the mainstream diseases in Europe and the United States, while the development of new drugs with high incidence of tumors in Asia, such as esophageal cancer, was relatively slow. As a local innovative pharmaceutical company, Junshi Bio actively works with Chinese experts and scholars to boldly explore and innovate, and constantly expand the application of immunotherapy in the new indications of local high incidence tumor species, in order to meet the long-term unmet clinical needs of Chinese patients.
Mr. Li Cong, Co-CEO of Junshi BiologySaid: "We are very pleased with Tuoyi.®New indications have been approved in the field of first-line treatment of advanced esophageal squamous cell carcinoma, bringing our tumor immunotherapy to a wider range of patients, including patients with low PD-L1 expression tumors with limited efficacy for immune checkpoint inhibitors in the past. About Tuoyi®The innovation is still being written. We have prospectively laid out a wide range of research and exploration to make Tuoyi®The clinical exploration in esophageal cancer has been further moved forward, and it is one of the earliest domestic anti-PD-1 McAbs for neoadjuvant therapy for esophageal cancer, which is expected to bring more benefits to patients with esophageal cancer in China and even around the world. "
In overseas markets, the use of triplizumab in the treatment of esophageal cancer has been approved by the US Food and Drug Administration (FDA) for Orphan Drug qualification (Orphan-drug Designation), helping to accelerate the progress of clinical trials and registration of the drug in the United States.
Dr. Zou Jianjun, President of Global Research and Development of Junshi BiologyJun Shi Bio continues to pay attention to the types of tumors that have a high incidence in Chinese and are in urgent need of clinical treatment. In addition to triplet, the company is simultaneously developing nearly 40 new antineoplastic drugs based on new platforms and new targets, and strives to create a research and development pipeline with synergistic and complementary effects. We look forward to continuing to work with Chinese experts to provide patients with more effective and cost-effective treatment options, as well as contributing 'Chinese answers' and 'Chinese solutions' to the global oncology field. "
About esophageal cancer
Esophageal cancer is one of the most common malignant tumors in digestive tract. According to statistics, in 2020, the number of new cases of esophageal cancer in China reached 320000, and the number of deaths reached 300000, accounting for more than half of the world's total. The morbidity and mortality ranked fifth and fourth among all malignant tumors in the country, respectively.[1][2]. Esophageal squamous cell carcinoma and adenocarcinoma are the two main histological subtypes of esophageal cancer. Esophageal squamous cell carcinoma is the main subtype in Chinese patients, accounting for about 90% of the total incidence.[3]. For patients with advanced esophageal squamous cell carcinoma, platinum-based chemotherapy is often used in the current first-line standard treatment, but the clinical benefit is limited, and the 5-year overall survival rate is less than 20%. There is an urgent need for new drugs and treatments to prolong the survival time of patients.[4]。
About Tripril Monoclonal injection (Tuoyi®）
Triplet monoclonal antibody injection (Tuoyi®As the first domestic monoclonal antibody drug with PD-1 as the target, it has won the support of the major national science and technology project, and won the highest award in the national patent field, "China Patent Gold Award". The first indication approved for this product is for the treatment of unresectable or metastatic melanoma that has previously failed systemic treatment. In December 2020, triplizumab passed the national health insurance negotiation for the first time, and three indications have been included in the 2021 Drug catalogue. In February 2021, triplizumab was approved by the State Drug Administration (NMPA) for the treatment of patients with recurrent / metastatic nasopharyngeal carcinoma who had previously failed to receive second-line or more systematic treatment. In April 2021, triplet was approved by NMPA for locally advanced or metastatic urothelial cancer that failed to receive platinum-containing chemotherapy, including neoadjuvant or adjuvant chemotherapy within 12 months. In November 2021, new indications for first-line treatment of locally recurrent or metastatic nasopharyngeal carcinoma patients with terriprizumab combined with cisplatin and gemcitabine were approved by NMPA. In May 2022, new indications for first-line treatment of unresectable locally advanced / recurrent or distant metastatic esophageal squamous cell carcinoma patients with terriprizumab combined with paclitaxel and cisplatin were approved by NMPA. In addition, triplizumab was recommended by the Chinese Society of Clinical Oncology (CSCO) guidelines for the diagnosis and treatment of melanoma, CSCO guidelines for the diagnosis and treatment of head and neck tumors, CSCO guidelines for the diagnosis and treatment of nasopharyngeal carcinoma, CSCO guidelines for the diagnosis and treatment of urothelial cancer, CSCO guidelines for the diagnosis and treatment of esophageal cancer, and guidelines for clinical application of CSCO immune checkpoint inhibitors.
In March 2021, the first-line treatment of advanced mucosal melanoma with triplizumab was incorporated into the breakthrough drug program by NMPA. In December 2021, the application for new indications for untreated, driver-negative advanced non-small cell lung cancer (NSCLC) combined with standard first-line chemotherapy was accepted by NMPA. In terms of international layout, triplizumab has been awarded by FDA in mucosal melanoma, nasopharyngeal carcinoma, soft tissue sarcoma, esophageal cancer and small cell lung cancer. 2 breakthrough therapy identification, 1 fast track identification, 1 priority review identification and 5 orphan drug qualification.
Since its clinical research and development in early 2016, more than 30 clinical studies covering more than 15 indications have been carried out around the world. actively explore the efficacy and safety of triplizumab in melanoma, nasopharyngeal carcinoma, urothelial cancer, lung cancer, gastric cancer, esophageal cancer, liver cancer, cholangiocarcinoma, breast cancer, kidney cancer and other indications. Cooperation with leading innovative drug companies at home and abroad is also under way. Look forward to giving more patients in China and other countries access to the international advanced level of tumor immunotherapy.
About Junshi creature
Founded in December 2012, Junshi Bio (688180.SHPower1877.HK) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies. The company has a rich R & D pipeline of more than 50 products under research, covering five major treatment areas, including malignant tumors, autoimmune diseases, chronic metabolic diseases, nervous system diseases and infectious diseases.
With the core platform technology of protein engineering, Junshi Bio is at the forefront of international macromolecular drug research and development, and has obtained the first domestic anti-PD-1 monoclonal antibody NMPA marketing approval, domestic anti-PCSK9 monoclonal antibody NMPA clinical application approval, and the world's first clinical application approval for tumor anti-BTLA blocking antibody in NMPA in China and FDA in the United States. Phase Ib/II clinical trials are being carried out in China and the United States.
Since the beginning of the epidemic outbreak in 2020, Junshi Bio has responded quickly, joined hands with domestic and foreign scientific research institutions and enterprises to fight the epidemic, made use of technology accumulation to rapidly develop a variety of innovative drugs for the treatment of COVID-19, and actively assumed the social responsibility of Chinese pharmaceutical companies. These include: novel coronavirus neutralizing antibody JS016, the first neutralizing antibody in China to enter the clinical stage and participate in the global anti-epidemic, was granted emergency use authorization in more than 15 countries and regions in 2021, the new oral nucleoside anti-novel coronavirus drug VV116 (JT001) has entered the international multicenter phase III registered clinical research phase, and many other types of drugs continue to contribute China's efforts to the global fight against epidemic.
At present, Junshi has more than 2800 employees worldwide, including Shanghai, Suzhou, Beijing and Guangzhou in China, as well as San Francisco and Maryland in the United States.
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[3]Abnet, C.C., Arnold, M., and Wei, W.Q. (2018). Epidemiology of Esophageal Squamous Cell Carcinoma. Gastroenterology 154,360-373.
[4]Wang et al., Toripalimab plus chemotherapy in treatment-naive, advanced esophageal squamous cell carcinoma (JUPITER-06): a multi-center phase 3 trial, Cancer Cell. 2022.