Hello! Welcome to the official website of Betta Pharmaceuticals!
Service Hotline:0571-86130357     Add to Favorites | Online Feedback 中文
新闻中心 / News Center
Betta Pharmaceuticals’ new drug Project Initiating the First Exploratory Research on the Application of ALK Inhibitor in Melanoma Treatment
Form: Planning and Propaganda Department   Date: 2017-12-20

    Betta Pharmaceuticals stepped another important step on the way of new drug R&D! On December 19th, 2017 US Time, Xcovery Holding Company LLC, a holding subsidiary, declared to initiate the Phase II clinical trial of ALK inhibitor Ensartinib based on its independent R&D. This trial was applied by the famous MSKCC to FDA (IND 137434) and approved to conduct Phase II study of Ensartinib (X-396) on patients suffering advanced malignant melanoma with ALK mutation; and the trial was led by researcher of MSKCC and MD Alexander Shoushtari in the field of melanoma and immunotherapy. This clinical study is the first exploratory research on the application of ALK inhibitor on melanoma in the world. The trial will be based on case study of small sample size before the further expansion of clinical study based on concrete research data. 


MSKCC is a private cancer center with the most profound history and largest scale in the world. 


    Ensartinib is a new-generation ALK inhibitor developed by Xcovery targeted at lung cancer and it is to be applied in the treatment of patients suffering ALK-positive NSCLC. At present, MRCT Phase III clinical trial comparing Ensartinib and Crizotinib treatment for patients suffering ALK-positive NSCLC has made smooth progress. Meanwhile, Phase II clinical study conducted in China to evaluate the curative effect and safety of Ensartinib and Crizotinib treatment for patients suffering ALK-positive NSCLC has been propelling successfully. 


A Cooperation Agreement Concluded by and between Betta and Xcovery 


    Melanoma is a category of malignant tumor originated from melanocytes, common in the skin, and mucous membrane and tunicae rhagoides as well, acting as one of the malignant tumors with the highest morbidity in recent years. Ensartinib is a new type of ALK TKI that can specifically target on melanoma with ALK mutation. 


    The newly initiated research is targeted at Ensartinib’s CBR. CBR is defined to evaluate any confirmed objective response in RECIST 1.1 or disease control until the end of 24-week evaluation. This research is an open and single-arm Phase II clinical trial, which recruits patients suffering from melanoma who have received or are receiving PD-1 drug therapy or BRAF treatment for BRAF V600 mutation. This research is divided into 2 phases: the screening phase and treatment phase. In the screening phase, patients’ archived tumor tissues will be applied in ALK-ATI mutation test conducted by MSKCC based on Nanostring’s RNA determination, tumor patients with ALK-ATI mutation can enter into the treatment phase. 


    “Despite the remarkable clinical progress achieved in the treatment of advanced malignant melanoma, there are still 30-40% of patients with no response to the immunotherapy or resistance to treatment. We believe that this is the first detection method to identify the epigenetic regulation of tumor’s growth mechanism based on RNA and it is expected to conduct further research. It will be a key new treatment choice for patients with not so many choices at present,” said Dr. Alexander Shoushtari.


    For this issue, Dr. Ding Lieming, Chairman of Betta Pharmaceuticals and Xcovery, expressed that Betta Pharmaceuticals was very honored to cooperate with the outstanding scientists and researchers of MSKCC, who had discovered the ALK mutation of melanoma patients in the world for the first time. Betta Pharmaceuticals expects to provide more accurate and effective treatment for patients suffering this type of diseases through this project, to enable human beings to better enjoy the achievements of pharmaceutical scientific and technological innovation. 

Prev: None
Next: Betta Pharmaceuticals Winning the Title of Top Hundred National Hi-tech Enterprises for Innovation Capability of Zhejiang Province and Top 10 Enterprises of Hi-tech Industry of Zhejiang Province