Japan’s PMDA clears CTN for Ph 3 MRCT of Serplulimab Combo in patients with 1L mCRC
“Shanghai Henlius Biotech announced that the clinical trial notification (CTN) for phase 3 international multicenter clinical study (ASTRUM-015) of Henlius’ self-developed anti-PD-1 monoclonal antibody (mAb) HANSIZHUANG (serplulimab) in combination with bevacizumab and chemotherapy in patients with metastatic colorectal cancer (mCRC) has been permitted by Japan’s Pharmaceuticals and Medical Devices Agency. The study has previously completed dosing of the first subject in China, and the regulatory registration and clinical development is advancing efficiently in more countries and regions around the world.”
Share:
More News
Thomas Guérinier, CEO and Co-founder of Inside Therapeutics: “The collaboration with OSE and MiNT provides us with a fantastic opportunity to demonstrate the uniqueness of our technology for the development of mRNA therapies from early development through to clinical trials and GMP production. The HexARN project fits perfectly with our
Thomas Mehrling, MD, PhD, CEO and Director of Helix, said “As co-founder of the Laevoroc companies, I’ve had the privilege of seeing LEUMUNA and GEMCEDA evolve from early scientific concepts into differentiated, first-in-class therapeutic candidates with real potential to transform cancer care. Their integration into Helix marks a strategic consolidation
“At Boundless, we’re committed to delivering innovative therapies for patients with oncogene-amplified cancers through disciplined execution,” said Zachary Hornby, President and Chief Executive Officer of Boundless Bio. “By prioritizing the novel combination of BBI-355 and BBI-825, along with our exciting Kinesin program, BBI-940, we’re concentrating our resources where we see
