Huadong Medicine (000963.SZ): The registration of Sometribove injection has been accepted.

Huadong Medicine (000963.SZ) announced that on March 10, 2025, its wholly-owned subsidiary Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. (hereinafter referred to as "Zhongmei Huadong") received the "Acceptance Notification" issued by the National Medical Products Administration (NMPA). The supplemental application for the conversion of the conditional approval to regular approval of the Somic Single Chain Antibody Injection (Erlahe/ELAHERE) applied by Zhongmei Huadong was accepted. This product is suitable for adult patients with platinum-resistant epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have previously received 1-3 lines of systemic therapy and are positive for folate receptor (FR). The announcement stated that platinum-resistant ovarian cancer is resistant to platinum-based chemotherapy, has a short survival period, and presents a serious unmet clinical need. Somic Single Chain Antibody Injection has already received full approval for this indication in the United States and is preferred in FR-positive PROC patients according to the NCCN Guidelines (2024 Version 3). The acceptance of the supplemental application for the conversion of the Somic Single Chain Antibody Injection from conditional approval to regular approval in China marks another important milestone in the development process of this product.