HISUN(SH:600267) Ge Long Hui A P P·2025-12-12 09:02Core Viewpoint - Haizheng Pharmaceutical (600267.SH) has received the Certificate of Suitability (CEP) from the European Directorate for the Quality of Medicines & HealthCare (EDQM) for the active pharmaceutical ingredient Everolimus, indicating compliance with European Pharmacopoeia standards [1]. Group 1 - Haizheng Pharmaceutical's subsidiary, Haizheng Pharmaceutical Hangzhou Co., Ltd., is the entity that received the CEP certificate [1]. - The CEP certification is crucial for the marketing and distribution of Everolimus in Europe, enhancing the company's competitive position in the pharmaceutical market [1]. Group 2 - Everolimus is primarily indicated for adult patients with advanced renal cell carcinoma who have failed prior treatment with Sunitinib or Sorafenib [2]. - The drug is also applicable for adults with unresectable, locally advanced, or metastatic well-differentiated neuroendocrine tumors of the pancreas, gastrointestinal tract, or lung [2]. - Additionally, Everolimus is used in the treatment of subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC) in both adults and children, as well as for the prevention of organ transplant rejection [2].