sNDA accepted for Toripalimab Combined with Bevacizumab for the 1L Treatment of Advanced HCC

“I’m delighted to see the successful submission of the sNDA for toripalimab’s 11th indication,” General Manager and CEO of Junshi Biosciences, Dr. Jianjun ZOU, said. “Since receiving marketing approval in 2018 as the first domestically developed anti-PD-1 monoclonal antibody, toripalimab has targeted the unmet needs of cancer patients in China and even internationally. As of now, it has been approved for 10 indications in 7 cancer types, many of which are exclusive indications. This sNDA is toripalimab’s first indication in liver cancer, and once again, toripalimab is demonstrating its ‘broad-spectrum’ when battling cancer. Going forward, we will actively communicate with regulatory authorities to speed up the approval of this indication, so that more advanced liver cancer patients can benefit from our innovative therapy.”
Share:
More News
Pnina Fishman, CSO & Chairperson of Can-Fite BioPharma, commented: “We are pleased to offer this compassionate use program with Namodenoson for eligible patient in the US to address the unmet medical needs for pancreatic cancer. Initiating this program is another milestone achieved for Namodenoson, and concurrently to our ongoing Phase
“We are deeply disappointed by these results from our Phase 1 trial. Despite continuing to demonstrate differentiated safety as a more combinable ADC, updated efficacy data suggest that treatment with EO-3021 does not meet our bar for success and is insufficient to provide patients a competitive benefit-risk profile compared to
Søren Bregenholt, CEO of Alligator, commented: “The FDA’s recognition of HLX22/AC101’s potential with Orphan Drug Designation is a notable recognition. While Alligator’s is not directly involved in the development of HLX22/AC101, we continue to follow its progress as it potentially represents future income to Alligator.”
“At Servier, we are dedicated to transforming patient care in areas with significant unmet needs. Our partnership to develop BDTX-4933 is an important opportunity in targeted cancer therapies, as we believe we can serve more people by helping the right patients find the right treatment, at the right time,” said