达雷妥尤单抗注射液是一种靶向ADP-核糖基环化酶(CD38)的重组全人源IgG1单克隆抗体，为原研药兆 珂的生物类似药，按照治疗用生物制品3.3类申报，适用于治疗多发性骨髓瘤成年患者。该产品研发遵 循生物类似药相关研究指导原则，药学及非临床研究结果显示，该产品与原研参照药在质量、安全性和 有效性方面高度相似，支持开展后续临床研究。 新诺威（300765）(300765.SZ)发布公告，公司的控股子公司石药集团巨石生物制药有限公司(以下简 称"巨石生物")于近日收到国家药品监督管理局核准签发的关于达雷妥尤单抗注射液的《药物临床试验 批准通知书》，将于近期开展临床试验。 ...

Core Viewpoint - The announcement indicates that the company’s subsidiary, Jushi Biopharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial of Daratumumab injection, a biosimilar to the original drug, targeting multiple myeloma patients [1] Group 1 - The clinical trial approval is for Daratumumab injection, a recombinant fully human IgG1 monoclonal antibody targeting ADP-ribosyl cyclase (CD38) [1] - The product is classified as a biosimilar to the original drug, known as Zhaoke®, and is submitted under the category of biological products for therapeutic use [1] - The research results indicate that the biosimilar shows high similarity in quality, safety, and efficacy compared to the reference drug, supporting the initiation of subsequent clinical studies [1]

Core Viewpoint - The company XinNuoWei (300765.SZ) announced that its subsidiary, JuShi Bio, has received approval from the National Medical Products Administration for the clinical trial of Daratumumab injection, a biosimilar to the original drug, which is intended for the treatment of adult patients with multiple myeloma [1] Group 1 - The clinical trial approval notification allows the company to proceed with clinical trials for the drug [1] - Daratumumab is a biosimilar of the original drug, known as Zhaoke® [1] - The drug is specifically aimed at treating adult patients diagnosed with multiple myeloma [1] Group 2 - Following the approval, the drug must undergo clinical trials and receive further approval from regulatory authorities before it can be marketed and sold [1] - There are inherent risks associated with the clinical trial process, including the possibility of trial results not meeting expectations, failure to obtain necessary approvals, delays in market entry, or lower-than-expected sales post-launch [1]

Core Viewpoint - The announcement indicates that the subsidiary of XinNuoWei, Shiyao Group Jushi Biopharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial of Daratumumab injection, a biosimilar to the original drug, which is intended for the treatment of adult patients with multiple myeloma [1] Group 1 - The clinical trial approval notification for Daratumumab injection has been issued, allowing the company to commence clinical trials shortly [1] - Daratumumab injection is a recombinant fully human IgG1 monoclonal antibody targeting ADP-ribosylation factor (CD38) [1] - The drug is a biosimilar to the original drug, Zhaoke®, which is used for treating multiple myeloma [1]

人民财讯12月23日电，新诺威（300765）12月23日公告，控股子公司石药集团巨石生物制药有限公司近 日收到国家药监局核准签发的关于达雷妥尤单抗注射液的《药物临床试验批准通知书》，将于近期开展 临床试验。该药品适用于治疗多发性骨髓瘤成年患者。 ...

石药创新制药股份有限公司 证券代码：300765 证券简称：新诺威 公告编号：2025-101 关于控股子公司达雷妥尤单抗注射液 三、药物的其他相关情况 达雷妥尤单抗注射液是一种靶向 ADP-核糖基环化酶（CD38）的重组全人源 IgG1 单克隆抗体，为原研药兆珂®的生物类似药，按照治疗用生物制品 3.3 类申 报，适用于治疗多发性骨髓瘤成年患者。该产品研发遵循生物类似药相关研究指 1 剂 型：注射剂 注册分类：治疗用生物制品 3.3 类 申请事项：临床试验 受 理 号：CXSL2500876 申请人：石药集团巨石生物制药有限公司 获得药物临床试验批准通知书的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚假 记载、误导性陈述或重大遗漏。 一、概述 石药创新制药股份有限公司（以下简称"公司"）的控股子公司石药集团巨石 生物制药有限公司（以下简称"巨石生物"）于近日收到国家药品监督管理局核 准签发的关于达雷妥尤单抗注射液的《药物临床试验批准通知书》，将于近期开 展临床试验。现将相关情况公告如下： 二、药物的基本信息 药物名称：达雷妥尤单抗注射液 审批结论：根据《中华人民共和国药品管理法》及 ...

证券日报网讯 12月22日，新诺威发布公告称，公司第六届董事会第二十九次会议审议通过《关于与关 联方共同投资设立合资公司暨关联交易的议案》。 （文章来源：证券日报） ...

Group 1 - Rongchang Biotech plans to repurchase shares worth between 20 million and 40 million yuan, with a maximum price of 95 yuan per share, aiming to buy back approximately 21,050 to 42,110 shares, representing about 0.04% to 0.07% of total share capital [1] - Nanya New Materials intends to raise no more than 900 million yuan through a private placement for AI computing power-based high-frequency high-speed copper-clad laminate R&D and working capital [2] - Xiechuang Data has signed a strategic cooperation agreement with Ping An Financial Leasing, aiming for a cooperation scale of 2 billion yuan over three years [3] Group 2 - Chuangshi Technology's controlling shareholder is under investigation and has been placed under detention, having resigned from all positions in the company [4] - Deep Kangjia A has reported overdue shareholder loans to Yikang Technology and Chuzhou Kangxin, totaling approximately 233 million yuan and 395 million yuan respectively, due to repayment issues [5] - Ningbo Yuanyang announced the resignation of two directors due to work adjustments [6] Group 3 - China Merchants Energy has delivered the world's first methanol dual-fuel VLCC oil tanker, with 15 oil tanker orders in hand [7] - Tianyu Co., Ltd. has received a drug registration certificate for hydrochloride trazodone tablets, which are used for treating depression [8] - Haizheng Pharmaceutical has received FDA approval for clinical trials of HS387 tablets for treating advanced solid tumors [9] Group 4 - Warner Pharmaceuticals has obtained a drug registration certificate for isoproterenol hydrochloride injection, used for treating shock and complete atrioventricular block [10] - Hekang New Energy's subsidiary received a government subsidy of 1.5 million yuan, which accounts for 14.57% of the company's latest audited net profit [11] - Duku Culture is planning a change in company control, with stock suspension expected for no more than two trading days [12] Group 5 - Haisco has received acceptance for an IND application for HSK46575 tablets for prostate cancer treatment [13] - *ST Xinyan is executing a capital reserve transfer to increase share capital, resulting in a stock suspension [14] - Nanjing Public Utilities is transferring a 45% stake in a subsidiary for 23.6443 million yuan [15] Group 6 - Action Education plans to repurchase shares worth between 20 million and 25 million yuan, with a maximum price of 45 yuan per share [16] - Bai'ao Tai has received government subsidies totaling 29 million yuan [18] - Weisi Medical intends to sell assets worth 119 million yuan, expecting a profit impact of approximately 10 million yuan [19] Group 7 - Tongyu Communications plans to increase capital by 10 million yuan to introduce investment from Wuchuang Institute [20] - Dongtu Technology's subsidiary is introducing strategic investor Guofeng Investment Fund with a capital increase of 11 million yuan [21] - China General Nuclear Power Technology's shareholder is facing a judicial auction of 2.91% of the company's shares [22] Group 8 - Nanshan Aluminum plans to repurchase shares worth between 300 million and 600 million yuan, with a maximum price of 7.52 yuan per share [23] - Yipin Hong's controlling shareholder has committed to transferring 9.07% equity in Arthrosi without compensation [24] - Sanli Pharmaceutical has signed a technology transfer contract worth 200 million yuan with Hainan University [25] Group 9 - Xin Nuo Wei plans to jointly invest 450 million yuan with Zhongqi Pharmaceutical to establish a joint venture focusing on innovative metabolic drugs [26] - Li Qun Co. has been approved to issue 1 billion yuan in medium-term notes to optimize debt structure and supplement working capital [27] - Dongfang Ocean's subsidiary has received a medical device registration certificate for a procalcitonin test kit [28] Group 10 - Tibet Mining's chairman has resigned due to work adjustments [29] - Wantai Biological's subsidiary has been shortlisted for a national immunization program vaccine procurement project, with a bid price of 27.5 yuan [30] - Xingfu Blue Sea has appointed Zhang Chen as the new deputy general manager [31] Group 11 - Changyuan Donggu has elected Li Yixuan as the vice chairman of the board [32] - Ningbo Huaxiang's subsidiary has signed a strategic cooperation agreement with Dahuang Robotics for collaboration in humanoid robot development [33] - Yongda Co. has been pre-selected for a procurement project worth approximately 350 million yuan [34] Group 12 - Fuan Pharmaceutical's subsidiary has received a drug registration certificate for hydrochloride trazodone tablets [35] - Nanjing Food reported a 71.03% year-on-year decrease in net profit for November due to rising raw material costs [36] - Changqing Technology's special polymer monomer project has commenced production [37]

Core Viewpoint - The announcement reveals that XinNuoWei plans to establish a joint venture with Zhongqi Pharmaceutical, focusing on the development and commercialization of innovative metabolic drugs, particularly targeting GLP-1 related products [1] Group 1: Joint Venture Details - XinNuoWei will invest 157.5 million yuan, holding a 35% stake in the joint venture, while Zhongqi Pharmaceutical will contribute 292.5 million yuan for a 65% stake [1] - The total investment for the joint venture is set at 450 million yuan [1] Group 2: Business Focus - The joint venture will primarily focus on the research, industrialization, and commercialization of innovative metabolic drugs, targeting areas such as overweight/obesity and type 2 diabetes [1] - The company plans to develop new drug formulations and expand indications continuously [1] Group 3: Product Pipeline - The joint venture will take over all GLP-1 related product pipelines from Shijiazhuang Pharmaceutical Group, including those in preclinical research, clinical stages, and those submitted for market approval [1] - The company aims to enhance its product matrix through various methods, including independent development, rights acquisition, and pipeline introduction [1]

Core Viewpoint - The company plans to establish a joint venture with Zhongqi Pharmaceutical Technology Co., Ltd. with a total investment of 450 million RMB, focusing on the development and commercialization of innovative metabolic drugs targeting GLP-1 [1] Group 1: Joint Venture Details - The company will contribute 157 million RMB, representing 35% of the registered capital [1] - Zhongqi Pharmaceutical will invest 292 million RMB, holding 65% of the registered capital [1] - The joint venture will primarily focus on the research, industrialization, and commercialization of innovative metabolic drugs [1] Group 2: Transaction Classification - This transaction is classified as a related party transaction and does not constitute a major asset reorganization [1]