石 藥 集 團 有 限 公 司（「 本 公 司 」， 連 同 其 附 屬 公 司 統 稱「 本 集 團 」）董 事 會（「 董 事 會 」）欣 然 宣 佈，本集團開發的SYS 6036注射液（「該產品」）已獲中華人民共和國國家藥品監督管理局批 准，可在中國開展臨床試驗。 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，並明確表示概不就因本公告全部或任何部份內容而產生 或因倚賴該等內容而引致的任何損失承擔任何責任。 CSPC PHARMACEUTICAL GROUP LIMITED 石 藥 集 團 有 限 公 司 （股份代號：1093） （於香港註冊成立之有限公司） 自願公告 SYS 6036注射液在中國獲臨床試驗批准 該產品是一款腫瘤免疫治療的人源化單克隆抗體藥物，按照治療用生物製品3.3類申報，預 計將適用於治療黑色素瘤、非小細胞肺癌、食管癌、頭頸部鱗狀細胞癌等多種腫瘤。 該產品的研發遵循生物類似藥相關研究指南。藥學及非臨床研究結果顯示，該產品與原研 參照藥在質量、安全性和有效性方面高度相似，支持開展後續臨床研究。 承董事會命 石藥集團有限公司 ...

Core Viewpoint - XinNuoWei (300765) announced that its subsidiary, Shiyao Group Jushi Biopharmaceutical Co., Ltd., received approval from the National Medical Products Administration for the clinical trial of SYS6036 injection, a humanized monoclonal antibody drug for tumor immunotherapy [1] Group 1 - SYS6036 injection is classified as a Class 3.3 therapeutic biological product [1] - The drug is expected to be used for the treatment of multiple cancers, including melanoma, non-small cell lung cancer, esophageal cancer, and head and neck squamous cell carcinoma [1]

Group 1 - The core point of the article is that XinNuoWei's subsidiary, Shiyao Group Jushi Biopharmaceutical Co., has received approval from the National Medical Products Administration for the clinical trial of SYS6036 injection, a humanized monoclonal antibody for tumor immunotherapy [1] - SYS6036 injection is classified under Category 3.3 of therapeutic biological products and is expected to be used for treating various tumors including melanoma, non-small cell lung cancer, esophageal cancer, and head and neck squamous cell carcinoma [1]

Group 1 - The core point of the article is that XinNuoWei (300765.SZ) announced that its subsidiary, Giant Stone Biopharmaceutical Co., Ltd., received approval from the National Medical Products Administration for the clinical trial of SYS6036 injection [1] - SYS6036 is a humanized monoclonal antibody drug for tumor immunotherapy, expected to be used for treating melanoma, non-small cell lung cancer, esophageal cancer, and head and neck squamous cell carcinoma [1] - The product's development follows the guidelines for biosimilar drug research, and the pharmaceutical and non-clinical research results indicate high similarity in quality, safety, and efficacy compared to the reference drug, supporting further clinical research [1]

Core Viewpoint - Suzhou Zelgen Biopharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for clinical trials of injectable ZG005, ZGGS18, and JAK inhibitor Jika Xini tablets in combination for advanced solid tumors [2][3]. Group 1: Drug Information - Injectable ZG005 is a recombinant humanized anti-PD-1/TIGIT bispecific antibody, classified as a Class 1 innovative tumor immunotherapy product, with potential applications for various solid tumors. It is one of the first drugs globally to enter clinical research targeting the same mechanism [3][4]. - Injectable ZGGS18 is a recombinant humanized bispecific antibody fusion protein targeting VEGF and TGF-β, also classified as a Class 1 therapeutic biological product, expected to be an innovative treatment for solid tumors [4][5]. - JAK inhibitor Jika Xini tablets, developed by the company, are a new Class 1 drug with independent intellectual property rights. They have received NDA approval for treating high-risk myelofibrosis and are undergoing clinical trials for other indications [5][6]. Group 2: Clinical Trial Approval Impact - The approval for the clinical trial of the combination therapy is not expected to have a significant impact on the company's recent performance due to the lengthy and uncertain nature of drug development and approval processes [2][7]. - The company will actively promote the research projects in accordance with national regulations and fulfill information disclosure obligations regarding subsequent project developments [7][8].

Core Viewpoint - Zai Jian Pharmaceutical has received approval from the National Medical Products Administration for clinical trials of its innovative cancer immunotherapy products, ZG005 and ZGGS18, in combination with JAK and ACVR1 dual inhibitor, JAK inhibitor [1] Group 1 - ZG005 is a recombinant humanized anti-PD-1/TIGIT bispecific antibody classified as a Class 1 innovative tumor immunotherapy biological product, expected to treat various solid tumors [1] - ZG005 is one of the first drugs globally to enter clinical research targeting the same mechanism, with no similar mechanism drugs approved for market worldwide [1] - ZGGS18 is a recombinant humanized bispecific antibody fusion protein targeting VEGF/TGF-β, classified as a Class 1 therapeutic biological product, anticipated to be an innovative treatment for solid tumors [1] Group 2 - JAK inhibitor, also known as JAK and ACVR1 dual inhibitor, is a new Class 1 drug independently developed by the company, which holds the intellectual property rights for this product [1]

Core Viewpoint - ZaiJing Pharmaceutical (688266.SH) has received approval from the National Medical Products Administration for clinical trials of its innovative cancer immunotherapy products, ZG005 and ZGGS18, in combination with a specific drug for advanced solid tumors [1] Company Summary - ZG005 is a recombinant humanized bispecific antibody targeting PD-1/TIGIT, classified as a Class 1 innovative biopharmaceutical, with potential applications in treating various solid tumors [1] - ZG005 is one of the first drugs globally to enter clinical research targeting the same mechanism, with no similar mechanism drugs approved for market worldwide [1]

Group 1 - The company Zai Lab (688266.SH) has received approval from the National Medical Products Administration for clinical trials of ZG005 and ZGGS18 in combination with JAK inhibitor for advanced solid tumors [1] - ZG005 is a recombinant humanized anti-PD-1/TIGIT bispecific antibody, classified as a Class 1 innovative tumor immunotherapy product, and is among the first in the world to enter clinical research for this target [1] - ZGGS18 is a recombinant humanized bispecific antibody fusion protein targeting VEGF/TGF-β, also classified as a Class 1 therapeutic biological product, with potential as an innovative treatment for solid tumors [1] Group 2 - The JAK inhibitor, previously known as JAK inhibitor, is a novel dual inhibitor of JAK and ACVR1 developed by the company, classified as a Class 1 new drug, with the company holding independent intellectual property rights for this product [1]

Core Viewpoint - The company has received approval from the National Medical Products Administration for clinical trials of its innovative cancer immunotherapy products, ZG005 and ZGGS18, in combination with a specific drug for advanced solid tumors [1] Group 1: Product Information - ZG005 is a recombinant humanized anti-PD-1/TIGIT bispecific antibody classified as a Class 1 innovative tumor immunotherapy biological product [1] - ZG005 is among the first drugs globally to enter clinical research targeting the same mechanism, with no similar mechanism drugs approved for market worldwide [1] Group 2: Clinical Trial Approval - The clinical trial approval includes the use of ZG005 and ZGGS18 in conjunction with hydrochloride gicaxetine tablets for advanced solid tumors [1]

Core Viewpoint - Suzhou Zelgen Biopharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for clinical trials of injectable ZG005 combined with JAK inhibitor and chemotherapy for advanced solid tumors [2][5]. Group 1: Drug Information - Injectable ZG005 is a recombinant humanized dual-specificity antibody targeting PD-1 and TIGIT, classified as a Category 1 innovative tumor immunotherapy product, with potential applications for various solid tumors. It is one of the first drugs globally to enter clinical research targeting the same mechanism [3]. - ZG005 works by blocking both PD-1 and TIGIT pathways, enhancing T-cell activation and proliferation, thereby improving the immune system's ability to kill tumor cells [3]. - Hydrochloride JAK inhibitor (previously known as JAK inhibitor) is a new dual inhibitor developed by the company, classified as a Category 1 new drug, with independent intellectual property rights. It is the first domestic JAK inhibitor approved for treating myelofibrosis [4]. Group 2: Clinical Trial and Market Impact - The approval for the clinical trial of injectable ZG005 and JAK inhibitor combined with chemotherapy is not expected to have a significant impact on the company's recent performance due to the lengthy and uncertain nature of drug development [2][5]. - The JAK inhibitor is also undergoing multiple key clinical studies for other immune-inflammatory diseases, including atopic dermatitis and ankylosing spondylitis, and has received support from national major new drug creation projects [4].