Core Viewpoint - The company, Sihuan Pharmaceutical Holdings Group Ltd. (01244), has announced that the National Medical Products Administration (NMPA) has officially accepted its new drug application (NDA) for Envida (generic name: Envafolimab injection, original research code: KN035) in combination with Gemcitabine and Oxaliplatin (GEMOX) for first-line treatment of unresectable or metastatic biliary tract cancer (BTC) [1] Group 1 - The acceptance of the NDA is based on the results of a Phase III clinical trial (KN035-CN-005) [1] - The clinical trial was designed as a randomized, parallel-controlled, multi-center Phase III study targeting Chinese patients with advanced first-line biliary tract cancer [1] - The trial aims to evaluate the efficacy and safety of Envida (KN035) in combination with the GEMOX regimen compared to the GEMOX regimen alone [1]

Core Viewpoint - The company, Sihuan Pharmaceutical Holdings Group Ltd. (01244), has announced that the National Medical Products Administration (NMPA) has officially accepted the new drug application (NDA) for its commercial product Envita® (generic name: Envolimab injection, original research code: KN035) in combination with Gemcitabine and Oxaliplatin (GEMOX) for first-line treatment of unresectable or metastatic biliary tract cancer (BTC) [1] Group 1 - The acceptance of the NDA is based on the results of a Phase III clinical trial (KN035-CN-005) [1] - The clinical trial was designed as a randomized, parallel-controlled, multi-center Phase III study targeting Chinese patients with advanced first-line biliary tract cancer [1] - The trial aims to evaluate the efficacy and safety of Envita® (KN035) in combination with the GEMOX regimen compared to the GEMOX regimen alone [1]

Core Viewpoint - Sihuan Pharmaceutical Holdings Group Ltd. (01244) shares rose nearly 7%, reaching HKD 4.73 with a trading volume of HKD 911,200, following the announcement of its product Envidat receiving orphan drug designation for gastric cancer and gastroesophageal junction cancer indications [1] Group 1: Product Development - Envidat (generic name: Envafolimab injection, original research code: KN035) has officially received orphan drug status for its third indication, following approvals for cholangiocarcinoma and soft tissue sarcoma [1] - The approval is based on the results of a Phase II clinical study demonstrating significant antitumor efficacy, with an objective response rate of 60% and a disease control rate of 100% when combined with the FOLFOX regimen [1] Group 2: Safety and Tolerability - The clinical study indicated that Envidat has good safety and tolerability, with no adverse events leading to treatment discontinuation or death reported [1]

Core Viewpoint - Sidley Pharmaceuticals (01244) announced that its commercial product Envita (generic name: Envafolimab injection, original research code: KN035) has officially received orphan drug designation for the indications of gastric cancer and gastroesophageal junction cancer, marking the third orphan drug indication approval following cholangiocarcinoma and soft tissue sarcoma [1] Group 1 - The approval is based on the results of the Phase II clinical study of Envita in patients with advanced gastric/gastroesophageal junction adenocarcinoma, which demonstrated clear antitumor efficacy [1] - The objective response rate of the combination with the FOLFOX regimen reached 60%, and the disease control rate was as high as 100% [1] - The safety and tolerability of the treatment were good, with no adverse events leading to treatment discontinuation or death reported [1]