Dr. Jianmin Fang, CEO of RemeGen, commented, "Cancer is the common enemy of mankind, and at RemeGen we feel a strong sense of responsibility and mission to continue to provide more effective and safer treatment options for cancer patients around the world through our cutting-edge innovation and research. On World Cancer Day 2024, we are proud to announce more advances in cancer drug research through drug discovery and collaboration with our partners. We are celebrating the progress of scientific research and working for a more just and healthier future. Our time is now, and our mission is clear. Let's act together for a world without cancers."

RemeGen's three major recent developments

On January 12, RemeGen announced that it enrolled its first patient on a Phase II study of Disitamab Vedotin combined with Zimberelimab to treat cervical cancer patients who have failed at least one first-line platinum-containing standard treatment. Preliminary data show that Disitamab Vedotin can significantly improve treatment efficiency and its safety is controllable. Zimberelimab, compared with the data of PD-1/PD-L1 single drugs approved for this indication (not head-to-head), displayed excellent long-term efficacy with a higher objective response rate (ORR) of 27.8%, a median progression-free survival (mPFS) of 3.7 months, a median overall survival (mOS) of 16.8 months, and a 2-year duration of response (DoR) rate of 55%. This study is a new combination treatment strategy that is expected to provide better options for cervical cancer patients and bring new hope.

On January 15, RemeGen announced its RC88 combined with Sintilimab injection to treat advanced malignant entities in cooperation with Innovent Biologics was approved by the State Food and Drug Administration's for Center for Drug Evaluation (CDE). The Phase I/IIa clinical study in tumor patients approved by the CDE is an open, multi-center Phase I/IIa clinical study in patients with advanced malignant solid tumors expressing mesothelin (MSLN). It includes, but is not limited to, pleural mesothelioma, peritoneal mesothelioma, ovarian cancer, pancreatic cancer, and lung adenocarcinoma, gastric adenocarcinoma, triple-negative breast cancer, among other cancer types that may benefit to evaluate the efficacy, safety, tolerability, PK characteristics, immunogenicity, and preliminary results of RC88 combined with Sintilimab injection administered every three weeks.

Also recently, a national multi-center clinical study of RemeGen's Disitamab Vedotin (RC48) combined with monoclonal antibody, Toripalimab, in the treatment of HER2-expressing advanced gastric cancer and other solid tumors, led by Professor Shen Lin from Peking University Cancer Hospital, was published in The Lancet sub-journal eClinicalMedicine. This study is the first to explore the safety and efficacy of antibody drug conjugates (ADC) combined with immunotherapy in patients with HER2-positive and HER2-low-expressing gastric cancer. The study results show that Disitamab Vedotin combined with Toripalimab has a controllable safety profile and is effective in patients with HER2-positive and HER2-low-expressing gastric cancer or gastroesophageal junction (G/GEJ) cancer, displaying encouraging efficacy.