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中国渐冻症细胞疗法全球首获FDA正式批准开展注册临床实验|Healthcare View
红杉汇· 2025-02-27 14:27
Group 1: Shizai Bio - Shizai Bio's iPSC-derived cell therapy for ALS has received FDA approval for clinical trials, marking it as the first globally and the first from China to gain Orphan Drug Designation [2] Group 2: Burning Stone Medical - Burning Stone Medical has partnered with BGI Genomics to enhance global tumor precision diagnosis, leveraging BGI's sequencing technology and Burning Stone's extensive product portfolio [3][4] Group 3: Jingtai Technology - Jingtai Technology and Guangdong Hengjian Investment announced a project in the Greater Bay Area to develop AI infrastructure, aiming to drive a billion-level AI pharmaceutical materials industry [5][6] Group 4: Tongxin Medical - Tongxin Medical's BrioVAD system has completed its first clinical enrollment in the US, entering a multi-center clinical trial for advanced heart failure [7][8] Group 5: WuXi XDC - WuXi XDC and LigaChem have deepened their collaboration in ADC development, aiming to accelerate the transition of ADC candidates from early research to commercialization [9][10] Group 6: Huayi Lekang - Huayi Lekang's GS1191-0445 injection has entered Phase III clinical trials, marking it as China's first gene therapy for Hemophilia A [12][13] Group 7: Ruike Bio - Ruike Bio's new adjuvanted nine-valent HPV vaccine REC604c has had its clinical trial application accepted, targeting the male market and reducing the required doses from three to two [15] Group 8: Angkuo Pharmaceutical - Angkuo Pharmaceutical's CUSP06 has received FDA Fast Track designation for treating platinum-resistant ovarian cancer, showing promising early clinical results [16] Group 9: Phanes Therapeutics - Phanes Therapeutics has completed the first patient dosing of its dual antibody drug PT217 in combination with chemotherapy for small cell lung cancer [18] Group 10: Jiayue Pharmaceutical - Jiayue Pharmaceutical's JYP0015 has received clinical trial approval for treating RAS-mutant cancers, showing significant efficacy compared to similar drugs [20][22]