Ori-C101 Receives NMPA Clearance for Confirmatory Ph 2 Trial in Late-Line Advanced HCC
OriCell co-founder, Chairman and Chief Executive Officer Dr. Yang Huanfeng commented: “We are deeply grateful to the NMPA Centre for Drug Evaluation and relevant government authorities for their strong support of innovative drug development, and to Academician Fan, Professor Qin and their teams for their trust and active participation. This approval validates the scientific soundness and feasibility of our technology platform and marks a new stage of growth for OriCell. With a clear regulatory pathway now in place, we will push forward with Ori-C101’s confirmatory clinical development, with the aim of bringing a genuinely new treatment option to patients as quickly as we can. We believe this progress will also underpin China’s strategy for taking innovative medicines global and competing actively in international markets.”
Share:
More News
“The initial efficacy data from the Part C studies are consistent with the encouraging efficacy signals we previously reported for Parts A and B of THIO-101, including an 88% disease control rate in third-line NSCLC patients. This measure of efficacy is close to triple the reported outcome for standard-of-care chemotherapy
“Patients with non-muscle invasive bladder cancer continue to face a significant risk of disease recurrence despite available treatment options,” said Mark Schoenberg, M.D., Chief Medical Officer of UroGen. “UGN-501 is an investigational next-generation oncolytic virus designed to selectively destroy tumor cells while generating an anti-tumor immune response. FDA clearance of
“Whitehawk has established strong expertise in ADC technology and oncology drug development,” said Dr. Yuelei Shen, President and CEO of Biocytogen. “This collaboration further expands the application of Biocytogen’s fully human bispecific antibodies in ADC development. We look forward to supporting the efficient advancement of multiple programs by contributing high-quality
Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said: “The AZUR-1 results support the potential for dostarlimab to transform treatment for dMMR/MSI-H locally advanced rectal cancer. For many patients today, rectal cancer treatment comes with the tolerability burden and lasting impacts from chemotherapy, radiation and surgery. These data