CAR001 / Ever Supreme Bio Tech - LARVOL DELTA

National Innovation Award helps biomedical innovation CAR001 key technology obtain clinical license in Taiwan and the United States [Google translation] (Yahoo News) - "The 21st National Innovation Award ceremony was held today (12/26). A total of 196 winning teams were selected this year. Among the award-winning teams in Taiwan, the key technology of Changsheng Biotechnology's 'CAR001 Cell Therapy' has successfully obtained Phase I and IIa clinical trial execution licenses in Taiwan and the United States."

New P1 trial • New P2a trial • Solid Tumor

CAR001: A Safety and Efficacy Study of Allogeneic CAR Gamma-Delta T Cells in Subjects with Relapsed/Refractory Solid Tumors (clinicaltrials.gov) - P1/2 | N=60 | Recruiting | Sponsor: Ever Supreme Bio Technology Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • Glioblastoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Changsheng’s revenue in September hit a new monthly high after growing for nine months in a row [Google translation] (stock.yahoo) - "Changsheng...benefited from CDMO services and cooperation with 19 medical institutions across Taiwan. Its revenue in September reached 90.02 million yuan...In addition to continued revenue growth, Changsheng’s new allogeneic immune cell drug CAR001 also won the Taipei Biotechnology Awards Silver Award for Innovation Technology...Entered Phase I/IIa clinical trials, and the clinical trials are currently underway smoothly....CAR001 has been successfully administered to the first patient with metastatic colorectal cancer. After the patient failed two lines of standard chemotherapy and targeted therapy, he was successfully discharged from the hospital after being administered CAR001 and successfully completed the safety observation period., no adverse reactions occurred."

Commercial • Trial status • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Changsheng’s allogeneic CAR-T I/IIa clinical trial for solid tumors will enroll the first patient next month [Google translation] (stock.yahoo) - "Liu Zhuqi, chairman of the regenerative medical company Changsheng International Biotechnology (6712), said today (26th) that Changsheng is one of the fourth companies in the world to develop allogeneic CAR-T therapy for the treatment of solid tumors. One industry, the CAR001 Phase I/IIa clinical trial using HLA-G target to treat solid cancer....After a one-year review by the TFDA in Taiwan, the first patient is expected to be admitted next month."

Enrollment status • Oncology • Solid Tumor

Changsheng's July revenue continues to be 7%, US joint venture to attack 90 billion stem cell market [Google translation] (stock.yahoo) - "Changsheng will hold the first Elderly Health Industry Expo on August 2 to showcase the breakthrough regenerative medical technology of allogeneic CAR001 (CAR-T) for the treatment of solid tumors. This technology is regarded as the most potential technology to solve the urgent medical needs of cancer in the future."

Clinical • Oncology • Solid Tumor

Changsheng Allogeneic CAR001 launches Phase I/IIa clinical trial for the treatment of solid tumors [Google translation] (stock.yahoo) - "Changsheng...announced on the 25th that its immune allogeneic CAR001 (CAR-T) has started recruiting patients for Phase I/IIa clinical trials of four major cancers, including colorectal cancer, malignant brain cancer, breast cancer and lung cancer. In addition to providing guidance on index cases of the Center for Drug Examination (CDE), it also actively negotiates authorization with international pharmaceutical companies to expand the global market for CAR001."

Enrollment open • Brain Cancer • Breast Cancer • CNS Tumor • Gastrointestinal Cancer • Lung Cancer • Oncology • Solid Tumor

Changsheng's new CAR-T drug was approved by TFDA to enter Phase I/IIa clinical trials [Google translation] (China Times) - "Changsheng (6712) announced on the 10th that its allogeneic CAR001 (CAR-T) Phase I/IIa clinical trial, which uses AI to screen HLA-G targets for the treatment of solid cancers, has been approved by Taiwan's TFDA. The new drug has also received indicator case guidance from the Center for Drug Evaluation (CDE), which will accelerate the advancement of new drug clinical trials to drug marketing."

New P1/2 trial • Oncology • Solid Tumor

Changsheng: Product and technology transfer revenue will boost operations in the first quarter, which will be better than the same period last year [Google translation] (stock.yahoo) - "...Changsheng also mentioned that the new drug CAR001 (CAR-T) has been approved by the U.S. Food and Drug Administration (FDA) for Phase I/IIa clinical trials and is currently under review by the Food and Drug Administration (TFDA) of the Ministry of Health and Welfare."

Non-US regulatory • Oncology • Solid Tumor

China Medical University Hospital's Breakthrough Drug of 'Allogenic mRNA CAR-T' & Its GenAI 'gHi' Standing Out in Healthcare+ Expo (Taiwan) 2023 (PRNewswire) - Taiwan's biggest bio-tech annual event, Healthcare+ Expo (Taiwan) 2023, was held in Taipei from November through early December...Among them, China Medical University Hospital (CMUH, Taiwan) was attracted most attention in the exposition. The 'Allogenic mRNA CAR-T' immune cell treatment, which has been approved human clinical trials phase I & II by U.S. FDA since last September, targets globally prevalent cancers such as lung, breast, and colorectal cancers....CMUH had examined clinical data on severe diseases and hard-to-treat cancers with leveraging AI smart healthcare and innovative scientific knowledge, and that resulted in leading to many unexpected breakthroughs and innovations in the global medical community. One of significant findings was the identification of critical tumor targets of human leukocyte antigen-G (HLA-G) of the 'Allogeneic Non-viral Gene-Edited Multi-targeted Nanoantibody-CAR.BiTE-γδT Immune Cells' therapy."

Clinical data • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Oncology • Solid Tumor

’Biomedical Stocks’ Changsheng Allogeneic CAR-T HLA-G has been approved by the United States to enter Phase I/IIa clinical trials [Google translation] (China Times) - "Changsheng...has made a major breakthrough in the field of cell therapy. The U.S. Food and Drug Administration (FDA) recently officially approved its new drug CAR001 (CAR-T) to conduct Phase I/IIa clinical trials, becoming the world's first allogeneic drug approved to enter human clinical trials."

IND • New P1/2 trial • Oncology