Shanghai Pharmaceuticals Holding (02607): Paclitaxel Injection Approved for Production

Shanghai Pharmaceuticals Holding (02607) has announced that recently, Shanghai Jinyihe Biopharmaceutical Co., Ltd. ("Shanghai Jinyihe Biopharmaceutical"), a subsidiary of Shanghai Pharmaceuticals Holding Group Co., Ltd. (the "Company"), received a Drug Registration Certificate (Certificate No.: 2026S03433) issued by the National Medical Products Administration (the "NMPA") for Paclitaxel Injection (the "Drug"), and the Drug has been approved for production. Paclitaxel Injection is indicated for: 1. first-line and subsequent treatment of advanced ovarian cancer; 2. adjuvant treatment of lymph node-positive breast cancer patients after combination chemotherapy with a standard doxorubicin-containing regimen; 3. breast cancer patients with metastatic breast cancer who have failed combination chemotherapy or who have relapsed within 6 months of adjuvant chemotherapy; 4. first-line treatment of patients with non-small cell lung cancer; 5. second-line treatment of AIDS-related Kaposi's sarcoma. Paclitaxel Injection was developed by Bristol-Myers Squibb S.R.L. of the United States and was approved for marketing by the U.S. Food and Drug Administration (FDA) in December 1992. In January 2025, Shanghai Jinyihe Biopharmaceutical submitted a registration and marketing application to the NMPA for the Drug, which was accepted. As of the date of this announcement, the Company has invested approximately RMB 4.51 million in research and development expenses for the Drug. As of the date of the announcement, manufacturers of the Drug within China include Sichuan Huiyu Pharmaceutical Co., Ltd., Yangzijiang Pharmaceutical Group Co., Ltd., Wuxi Taxus Pharmaceutical Co., Ltd., Beijing Sl Pharmaceutical Co., Ltd., and Shanghai Chuangnuo Pharmaceutical Co., Ltd., among others. According to the IQVIA database, the amount of hospital procurement of Paclitaxel Injection in mainland China in 2025 was RMB 361 million.