CStone Pharmaceuticals, a leading biopharmaceutical company focused on research, development, and commercialization of innovative immuno-oncology therapies and precision medicines, and Pfizer Inc. announced that the National Medical Products Administration (NMPA) of China has approved sugemalimab (Cejemly®) for the treatment of patients with unresectable stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent or sequential platinum-based chemoradiotherapy. Together with the previous approval of the treatment for first-line stage IV NSCLC patients, sugemalimab is now the only anti- PD-1/PD-L1 monoclonal antibody for both stage III and stage IV NSCLC patients.
Dr. Frank Jiang, CEO of CStone, said, “We appreciate the NMPA for granting the new approval which is an important milestone in our journey to lead the treatment of lung cancer as China steps up efforts to support innovative therapies and address unmet needs. As a leading biopharma company in fostering precision medicines and immuno-oncology therapies, CStone has been spearheading multiple medical breakthroughs. With this approval, it will provide a new treatment option for stage III NSCLC patients, while demonstrating our prowess in advancing lung cancer treatments and bringing forward transformative drugs to the market. Partnerships are crucial to meet massive clinical needs of cancer patients. We will continue to work closely with Pfizer to deliver cutting-edge oncology therapies and improve the health of cancer patients in China.”
Jean-Christophe Pointeau, China President of Pfizer Biopharmaceutical Group, says, “Committed to delivering ‘breakthroughs that change patients’ lives’, Pfizer has achieved a series of important breakthroughs in the field of immuno-oncology. After the approval of Stage IV NSCLC indication a few months ago, Cejemly® achieved immediate commercialization across China, offering hopes to Chinese NSCLC patients with improved diagnosis and treatment solutions. We firmly believe that the approval of the new indication will allow more patients to benefit from this drug, bridge the gap and fulfill the unmet needs, especially the needs of unresectable Stage III NSCLC patients for immune consolidation therapy after sequential chemoradiotherapy. Cejemly® is Pfizer’s strategic asset in immuno-oncology, and a paradigm for innovative strategic partnership with local biotech companies, like CStone guided by the slogan of “Science Will Win, Conquer Cancer Together”. Starting from here, Pfizer will continue the exploration in this field, promote the upgrades and advances in immunodiagnostics and immunotherapy, offer more tailor-made, globally innovative solutions to Chinese cancer patients, and help to achieve the grand goal of “Healthy China 2030”.