Zejyme (Sugemalimab) Becomes First PD-L1 Inhibitor Approved for Gastric Cancer as Fifth Indication

China Finance and Economics News, March 15: Pfizer, Inc. announced today that Zhejie Stone (Sugemalimab Injection), an innovative tumor immunotherapy drug, has been approved by the National Medical Products Administration (NMPA) for first-line treatment in combination with fluorouracil- and platinum-based chemotherapy for locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma (G/GEJ) that cannot be surgically removed and expresses PD-L1 (Combined Positive Score [CPS] ≥5). It has become the world's first PD-L1 monoclonal antibody approved for the indication of gastric/gastroesophageal junction adenocarcinoma.

This is the second indication approved recently in the field of upper gastrointestinal tumors for Zhejie Stone, following esophageal squamous cell carcinoma, and also the fifth indication approved for Zhejie Stone since 2021.

Jean-Christophe Pointeau, Senior Vice President of Pfizer Global, President of Pfizer China, Chairman of the RDPAC Executive Committee, and Vice President of the China Association of Enterprises with Foreign Investment, stated that the consecutive approvals of Zejia in a short period for two upper gastrointestinal tumor indications—esophageal squamous cell carcinoma and gastric adenocarcinoma—not only expand Pfizer's presence in the field of cancer immunotherapy but also provide more clinical solutions for the highly prevalent gastrointestinal cancers in China.

Data show that gastric cancer is a malignant tumor originating from the epithelial cells of the gastric mucosa and is also one of the most common cancers in China.

"China is one of the countries with the heaviest global burden of gastric cancer. Clinically, most patients with gastric adenocarcinoma are already at an advanced stage at the time of initial diagnosis, making surgical resection impossible. Moreover, the prognosis for patients with advanced or metastatic gastric cancer is generally poor, indicating a significant unmet medical need." Professor Lin Shen from Peking University Cancer Hospital, the principal investigator of the GEMSTONE-303 study for Zejula, stated that Zejula is the first approved PD-L1 monoclonal antibody with a clear biomarker for gastric cancer, which will undoubtedly provide more options for the precise treatment of G/GEJ patients. "We hope Zejula can be quickly applied in clinical practice to bring new hope to more patients with gastric cancer."

To date, Zejia Stone has been successively approved for five indications in China, including Stage IV and Stage III non-small cell lung cancer (NSCLC), relapsed or refractory extranodal NK/T-cell lymphoma (R/R ENKTL), unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma, and locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma. Among these, in the highly prevalent tumor areas in China such as Stage IV NSCLC, gastric cancer, and esophageal squamous cell carcinoma, all are first-line therapies.