Group 1 - The core point of the news is that Sihuan Pharmaceutical Holdings Group Ltd. has received acceptance from the National Medical Products Administration (NMPA) for the regular approval of Envita (generic name: Envafolimab injection) as a domestically produced drug supplement application [1][2] - The application was submitted by Sichuan Sihuan Kangrui Pharmaceutical Co., Ltd., a subsidiary of the company, and the acceptance number is CYSB2600056, with the application specification being 200mg (1.0ml) per bottle [1] - The application materials were completed and accepted for review 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 independently by Kanglong Chemical and its subsidiaries, in collaboration with the company since 2016 [2] - A cooperation agreement was signed on March 30, 2020, between Jiangsu Kanglong Chemical, Sihuan Pharmaceutical, and Jiangsu Xiansheng Pharmaceutical, granting Jiangsu Xiansheng exclusive marketing rights for Envita in mainland China for oncology indications [2] - In January 2024, the company entered into a licensing agreement with Kanglong Chemical and Glenmark Specialty S.A., granting Glenmark exclusive licensing and sublicensing rights for Envita in oncology indications across various regions, including India, the Asia-Pacific region (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]

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 - Corning Jereh Pharmaceutical-B (09966.HK) has announced that the National Medical Products Administration of China has officially accepted the New Drug Application (NDA) for KN035 (Envafolimab injection) in combination with GEMOX for the 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), which is a randomized, parallel-controlled, multi-center study designed for advanced first-line BTC patients in China [1] - The trial aims to evaluate the efficacy and safety of KN035 in combination with the GEMOX regimen compared to the GEMOX regimen alone [1] Group 2 - KN035 (Envafolimab injection) is a recombinant humanized anti-PD-L1 single-domain antibody Fc fusion protein, developed independently by the company in collaboration with Suzhou Innovent Biologics since 2016 [2] - In March 2020, a cooperation agreement was established between the company's wholly-owned subsidiary Jiangsu Corning Jereh Biopharmaceutical Co., Ltd., Jiangsu Xiansheng Pharmaceutical Co., Ltd., and Suzhou Innovent Biologics, granting Jiangsu Xiansheng exclusive marketing rights for KN035 in oncology indications in mainland China [2] - In January 2024, a licensing agreement was signed with Suzhou Innovent Biologics and Glenmark Specialty S.A., granting Glenmark exclusive licensing and sublicensing rights for KN035 in oncology indications across various regions including India, the Asia-Pacific (excluding Singapore, Thailand, and Malaysia), the Middle East and Africa, Russia, CIS countries, and Latin America [2] Group 3 - KN035 is the world's first subcutaneous PD-L1 inhibitor, which was approved by the National Medical Products Administration 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]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部分內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 本公告乃由思路迪医药股份有限公司（「本公司」，連同其附屬公司統稱為「本集 團」）自願作出。 本公司董事會（「董事會」）欣然宣佈，國家藥品監督管理局(NMPA)已正式受理 本公司商業化產品恩維達® （通用名：恩沃利單抗注射液，原研代號：KN035）聯 合吉西他濱和奧沙利鉑(GEMOX)方案，用於一線治療不可切除或轉移性膽道癌 (BTC)的新藥上市申請(NDA)。 此次受理基於III期臨床試驗(KN035-CN-005)的臨床研究結果，這是一項針對中國 晚期一線膽道癌患者設計的隨機、平行對照、多中心III期臨床試驗，旨在評估恩 維達®(KN035)聯合GEMOX方案對比單純GEMOX方案的療效與安全性。 關於恩維達® （通用名：恩沃利單抗注射液，原研代號：KN035） 3D Medicines Inc. 思路迪医药股份有限公司 （於開曼群島註冊成立的有限公司） （股份代號：1244） 自願公告 恩維達®一線 ...

Core Viewpoint - The article discusses the development of a hydrogel-fiber composite device (HFCD) aimed at enhancing the efficacy of immune checkpoint blockade (ICB) therapy for recurrent glioblastoma (GBM) by activating cytotoxic T lymphocytes (CTL) in the postoperative tumor microenvironment (pTME) [2][3][5]. Group 1: Background on Glioblastoma and ICB Therapy - Glioblastoma (GBM) is the most common and aggressive brain tumor, accounting for approximately 57% of all gliomas, with a recurrence rate exceeding 90% due to its invasive nature [5]. - The postoperative tumor microenvironment (pTME) is characterized by immune suppression, including CTL exhaustion and infiltration of immunosuppressive cells, which reduces the clinical benefits of ICB therapy [5][6]. - There is a need to reshape the immune landscape within the pTME to enhance the response and durability of ICB therapy against GBM recurrence [5][6]. Group 2: Development of HFCD - The HFCD is designed to locally activate CTLs and modulate the acidic pTME, creating a favorable niche for CTLs [3][8]. - The device releases chemokine CXCL10 and PD-L1 inhibitors in a timed manner, enhancing CTL infiltration and maintaining their cytotoxic function [3][8]. - In an in situ GBM resection model, HFCD treatment achieved a 40% rate of complete recurrence inhibition and significantly extended the median survival to 49 days [9][10]. Group 3: Mechanism of Action - HFCD consists of quaternized chitosan hydrogel and electrospun fibers, which neutralize the acidic pTME and release CXCL10 to recruit CTLs [8]. - The sustained release of PD-L1 inhibitors from the PLGA matrix maintains PD-L1 blockade, enhancing CTL recognition and cytotoxic activity against residual GBM cells [8][10]. - This strategy alleviates immune suppression in the GBM pTME and enhances the protective effect of ICB against GBM recurrence [8][10].