Leading star news section " Breaking News" weekly high-frequency updates, including domestic and foreign new tumor drug approval status, clinical trial progress, industry 12strong, etc. It only takes 1 minute a day to master first-hand news easily.
domestic new drug approved
strong 10 new indications in China
On the 30th, the NMPA official website showed that Bristol-Myers Squibb PD-1 inhibitor nivolumab injection received the drug approval number. According to industry news, this approved indication is the first-line treatment for advanced or metastatic gastric cancer, gastroesophageal junction cancer or esophageal adenocarcinoma. (NMPA)
[Multiple cancers] Eli Lilly’s RET inhibitor Selpercatinib capsules are planned to be included in the priority review
span 5,span 5The latest announcement on the CDE official website shows that Eli Lilly’s RET inhibitor Selpercatinib capsules are planned to be included in the priority review and are suitable for transfected rearranged gene fusion-positive patients with locally advanced or metastatic non-small cell lung cancer, and advanced RET mutations that require systemic treatment. Or metastatic medullary thyroid cancer adults and children 12 years and older, as well as RET gene fusion-positive advanced or metastatic thyroid cancer adults and children 12 years and older who are refractory to systemic therapy and radioiodine therapy. (CDE)
[ neuroblastoma ] The new drug application for GD2 antibody introduced by Saisheng Pharmaceutical will be included in the priority review on 26 days Public announcements show that the marketing application for nactuomab injection declared by Saisheng Pharmaceutical has been included in the proposed priority review, and it is planned to be developed for the treatment of patients with relapsed or refractory high-risk neuroblastoma. (CDE)
Foreign new drug approved
2spanspan5 span5 strong span_5 The plan was approved in Japan
Recently,Ono Pharmaceuticals and Takeda Pharmaceuticals jointly announced that Japanese regulatory agencies have approved the anti-PD-1 therapy Opdivo combined with the targeted anticancer drug Cabometyx as the first-line treatment for adult patients with unresectable or metastatic renal cell carcinoma. (Bio Valley)
【Multiple cancers】Japan approved Merck’s Keytruda to treat breast cancer and colorectal cancer _spanspan 5 span _span 5 span _span 5 span _span 5 span 5 span 5 span 5 span 5 span strong 7strong span 5 span Two more regulatory victories were won in Japan, namely breast cancer and colorectal cancer. The therapy currently approved in Japan for indications has reached 9 tumor types. (Sina Pharmaceutical News)
[Bile duct cancer] Oral IDH1 inhibitors have been approved by the FDA for targeted treatment of cholangiocarcinoma _spanspan5 span5 span5 span _span10 p2p The FDA approved Tibsovo to expand its indications for the treatment of treated adult patients with locally advanced or metastatic cholangiocarcinoma with IDH1 mutations. ( WuXi AppTec)
clinical trial progress
p5span strongspan strongspan strongspan 5span p5span strongspan_strongspan_span5 Positive results for cancerA few days ago,TILT Biotherapeutics announced that the oncolytic virus TILT-452 expressing the IL-2 variant developed using the company’s oncolytic virus immunotherapy platform has achieved positive results in preclinical trials. In the hamster model of pancreatic cancer, TILT-452 significantly reduces the tumor volume and prolongs the survival time of the animal. At the same time, histological studies show that TILT-452 can change the tumor microenvironment. (Wuxi AppTec)
[Cervical cancer] Agenus anti-PD-1 monoclonal antibody treatment of refractory cervical cancer phase 2 results positive s
p0span span The PD-1 monoclonal antibody batilimumab, a single-agent treatment of recurrent/metastatic cervical cancer phase 2 clinical trial results were published online in the international peer-reviewed journal Gynecologic Oncology. (WuXi AppTec)[ solid tumor ] Shanghai Pharmaceuticals SPH6516 tablets obtained clinical trial implied approval
pan5, span5, span10span _span50 SPH6516, a new class 1 drug of span10span, has been approved by clinical trials and is intended to be used for the treatment of advanced malignant solid tumors. (CDE)
[urothelial cancer] Genting New Yaogosartuzumab global phase 3 clinical trial completed the first patient administration in China _5span2p 26 days ,Genting Sunshine announced that the global phase 3 clinical trial of gosartuzumab for the treatment of metastatic urothelial cancer, TROPiCS-04, completed the first patient administration in China, aimed at platinum chemotherapy and PD-1 /PD-L1 antibody In patients with metastatic or locally advanced unresectable urothelial cancer who still have disease progression after treatment, evaluate and compare gosartuzumab and doctors to choose treatment. (PR Newswire)
[Prostate cancer] Hengrui Pharmaceuticals AR antagonist SHR3680 is planned to be included in the breakthrough treatment variety _span10pspan _span5 _span5, the latest on 26th, CSP Swiss Medicine's AR antagonist SHR3680 is included in the proposed breakthrough treatment product, and it is planned to be developed for the treatment of metastatic hormone-sensitive prostate cancer patients with high tumor burden. (CDE)
Industry dynamics
Inhibitors of intestinal microbial response in the intestinal spheroids: revealing the mechanism of anti-intestinal microbial response in the intestinal spheroids_strong10.
Recently, in a study published on Science,Researchers from the Rockefeller University and the Scripps Research Institute in the United States have found that members of the Enterococcus genus in the gut microbiome can improve the response of mouse tumor models to immune checkpoint inhibitors, and have a special peptide polymer. Sugar remodeling active gut microbial species and treatment methods based on cell wall peptides can enhance cancer immunotherapy. (Bio Valley)
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