恩维达 (通用名：恩沃利单抗注射液，原研代号：KN035)是重组人源化抗程序性死亡配体1(PD-L1)单域 抗体Fc融合蛋白。恩维达由康宁杰瑞生物制药(09966)的获豁免有限公司及其附属公司(均为独立第三 方))自主研发， 2016年起与公司合作开发。于2020年3月30日，江苏康宁杰瑞生物制药有限公司(为康宁 杰瑞的全资附属公司)、思路迪医药及江苏先声药业有限公司(为先声药业集团有限公司的附属公司)订立 一份合作协议。根据该协议，江苏先声获授予恩维达于中国大陆内的肿瘤适应症的独家市场推广权及对 外许可或转让下的优先受让权。于2024年1月，公司已与康宁杰瑞及Glenmark Specialty S.A.(Glenmark) 订立许可协议，据此思路迪医药与康宁杰瑞同意向Glenmark授予恩维达肿瘤适应症的独家许可及再授 权，以(其中包括)在印度、亚太区(新加坡、泰国及马来西亚除外)、中东及非洲、俄罗斯、独联体国家 及拉丁美洲在肿瘤所有使用领域开发及商业化恩维达。此外，其作为全球首个皮下注射PD-L1抑制剂， 已于2021年11月获得国家药监局批准上市用于不可切除或转移性微卫星高度不稳定(MSI-H)或错配 ...

Group 1 - The core point of the news is that Sihuan Pharmaceutical (01244) has received acceptance from the National Medical Products Administration (NMPA) for the regular approval of Envita (generic name: Envafolimab injection), which was previously conditionally approved [1] - The application was submitted by Sichuan Sihuan Kangrui Pharmaceutical Co., Ltd., and the submission materials were completed and accepted on February 2, 2026 [1] Group 2 - Envita (generic name: Envafolimab injection) is a recombinant humanized anti-PD-L1 single-domain antibody Fc fusion protein developed by Kangning Jereh Biopharmaceutical (09966) and its subsidiaries, in collaboration with Sihuan Pharmaceutical since 2016 [2] - A cooperation agreement was signed on March 30, 2020, granting Jiangsu Xiansheng exclusive marketing rights for Envita in mainland China for oncology indications [2] - In January 2024, Sihuan Pharmaceutical entered into a licensing agreement with Kangning Jereh and Glenmark Specialty S.A., granting exclusive licensing rights for Envita in oncology indications across various regions including India, the Asia-Pacific (excluding Singapore, Thailand, and Malaysia), the Middle East, Africa, Russia, CIS countries, and Latin America [2] - Envita is the world's first subcutaneous PD-L1 inhibitor, which was approved by the NMPA in November 2021 for the treatment of adult patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) advanced solid tumors [2]

Core Viewpoint - The company has received conditional approval for its drug Envita (generic name: Enviroli monoclonal antibody injection) to transition to regular approval, with the application officially accepted by the National Medical Products Administration (NMPA) of China [1] Group 1 - The application for Envita was submitted by Sichuan Silu Kangrui Pharmaceutical Co., Ltd., a subsidiary of the company, and the submission materials were completed and accepted on February 2, 2026 [1] - Envita is a recombinant humanized anti-PD-L1 single-domain antibody Fc fusion protein, developed by CanSino Biologics and has been in collaboration with the company since 2016 [2] - A cooperation agreement was established in March 2020 between Jiangsu CanSino Biologics, the company, and Jiangsu Xiansheng Pharmaceutical, granting exclusive marketing rights for Envita in mainland China for oncology indications to Jiangsu Xiansheng [2] Group 2 - In January 2024, the company entered into a licensing agreement with CanSino and Glenmark Specialty S.A., granting exclusive licensing and re-licensing rights for Envita in oncology indications across various regions including India, the Asia-Pacific (excluding Singapore, Thailand, and Malaysia), the Middle East, Africa, Russia, CIS countries, and Latin America [3] - Envita is the world's first subcutaneous PD-L1 inhibitor, which received approval from the NMPA in November 2021 for the treatment of adult patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) advanced solid tumors [3]

Core Viewpoint - The company has received acceptance from the National Medical Products Administration (NMPA) for the regular approval of its drug, Envita (generic name: Envolimab injection), which was previously conditionally approved [1] Group 1 - The drug Envita is now transitioning from conditional approval to regular approval in the domestic market [1] - The application for regular approval was submitted by Sichuan Silu Kangrui Pharmaceutical Co., Ltd., a subsidiary of the company [1] - The acceptance number for the application is CYSB2600056, with the application specification being 200mg (1.0ml) per bottle [1]

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]