证券研究报告：医药生物 | 公司点评报告 研究所 分析师:盛丽华 SAC 登记编号:S1340525060001 Email:shenglihua@cnpsec.com 研究助理:徐智敏 SAC 登记编号:S1340125080012 Email: xuzhimin@cnpsec.com 智翔金泰(688443) 感染类双产品牵手康哲，聚焦研发质效与自免商业 化 发布时间：2025-10-09 股票投资评级 增持|首次覆盖 个股表现 -21% -16% -11% -6% -1% 4% 9% 14% 19% 24% 2024-10 2024-12 2025-02 2025-05 2025-07 2025-09 智翔金泰 医药生物 资料来源：聚源，中邮证券研究所 公司基本情况 | 最新收盘价（元） | 30.55 | | --- | --- | | 总股本/流通股本（亿股）3.67 / 1.17 | | | 总市值/流通市值（亿元）112 / 36 | | | 52 周内最高/最低价 | 37.02 / 22.86 | | 资产负债率(%) | 32.4% | | 市盈率 | -14.08 | | 第一大股东 | ...

中国经济网北京9月29日讯智翔金泰(688443.SH)今日收报30.90元，跌幅2.22%。 智翔金泰首次公开发行股票募集资金总额347,283.84万元；扣除发行费用后，募集资金净额为329,140.14 万元。智翔金泰实际募资净额比原拟募集资金金额少68,859.86万元。智翔金泰于2023年6月15日披露的 招股说明书显示，该公司拟募集资金398,000.00万元，用于抗体产业化基地项目一期改扩建、抗体产业 化基地项目二期、抗体药物研发项目、补充流动资金。 智翔金泰首次公开发行股票的发行费用合计18,143.70万元(不含税)，其中，保荐承销费16,495.98万元。 智翔金泰已连亏4年，2021年至2024年，智翔金泰归属于上市公司股东的净利润分别为-3.22亿元、-5.76 亿元、-8.01亿元、-7.97亿元；归属于上市公司股东的扣非净利润分别为-3.34亿元、-6.45亿元、-8.13亿 元、-8.04亿元。 智翔金泰于2023年6月20日在上交所科创板上市，公开发行新股9,168.0000万股，发行价格为37.88元/ 股，保荐机构(主承销商)为海通证券股份有限公司(现名"国泰海通证券股份有 ...

资料显示，重庆智翔金泰生物制药股份有限公司位于重庆市巴南区麻柳大道699号2号楼A区，成立日期 2015年10月20日，上市日期2023年6月20日，公司主营业务涉及抗体药物的研发、生产与销售。主营业 务收入构成为：销售药品99.96%，其他0.04%。 截至6月30日，智翔金泰股东户数1.17万，较上期增加27.44%；人均流通股9946股，较上期减少 19.91%。2025年1月-6月，智翔金泰实现营业收入4539.18万元，同比增长358429.65%；归母净利润-2.89 亿元，同比增长20.07%。 机构持仓方面，截止2025年6月30日，智翔金泰十大流通股东中，工银前沿医疗股票A（001717）位居 第一大流通股东，持股666.00万股，相比上期增加166.00万股。鹏华医药科技股票A（001230）位居第 六大流通股东，持股314.77万股，持股数量较上期不变。东方红医疗升级股票发起A（015052）位居第 七大流通股东，持股245.12万股，相比上期减少9.27万股。工银医药健康股票A（006002）位居第九大 流通股东，持股169.30万股，相比上期减少24.30万股。中欧医疗健康混合A（0 ...

Group 1 - Qianyu Medical's shareholder QM5 LIMITED plans to transfer approximately 6.6693 million shares, accounting for 2% of the company's total share capital [1] - Guizhou Platinum Industry intends to raise no more than 1.291 billion yuan for technological innovation platform construction, industrial transformation, and working capital [1] - Guangdong Construction has won a bid for the Guangzhou Financial City East District project with a contract value of 1.924 billion yuan [1] Group 2 - Sanfu New Science plans to repurchase shares with a total amount not less than 10 million yuan and not exceeding 15 million yuan [3] - Baiyun Mountain's subsidiary has entered the II phase of clinical trials for children's Xiao Chai Hu granules, aimed at treating pediatric gastrointestinal colds [4] - Lepu Medical has signed a strategic cooperation agreement with Hanhai Information for market promotion and operation rights in mainland China [5] Group 3 - Daotong Technology plans to transfer 46% of its stake in Saifang Technology for a total consideration of 109 million yuan [7] - Rizhao Port's shareholder Shandong Energy Group intends to reduce its stake by up to 3% [8] - Saiwei Electronics reports that the National Integrated Circuit Fund has reduced its stake by 6.3481 million shares, representing 0.87% of the total share capital [10] Group 4 - Changji Logistics proposes a cash dividend of 0.31 yuan per share for the 2025 interim period [11] - Xuelong Group's shareholder plans to reduce its stake by up to 1.95% [13] - Lianxiang Co. plans to reduce its stake by a total of 3.74% [15] Group 5 - Yingfeite's actual controller plans to reduce its stake by up to 2.82% [16] - Baolong Technology's director plans to reduce his stake by up to 0.11% [17] - China Electric Research's shareholder plans to transfer 2% of the company's shares through an inquiry transfer [18] Group 6 - Oriental Pearl plans to participate in establishing an investment fund with a total fundraising scale of 714 million yuan [19] - Tianqin Equipment's shareholder plans to reduce its stake by up to 1% [21] - Crystal Optoelectronics' shareholder plans to reduce its stake by up to 0.99% [22] Group 7 - Changchun Technology expects a net profit increase of 131.39% to 145.38% for the first three quarters of 2025 [22] - Jinhai Tong's shareholder plans to reduce its stake by up to 1% [24] - Zhongdian Electric's shareholder plans to reduce its stake by up to 3% [26] Group 8 - Zhixiang Jintai has signed exclusive cooperation agreements for two monoclonal antibody injections [27] - Chuangli Group's director plans to reduce his stake by up to 0.7% [28] - Henghui Security's shareholders plan to reduce their stake by a total of 2.34% [29] Group 9 - Tianci Materials' subsidiary has signed a supply cooperation agreement for no less than 800,000 tons of electrolyte products [29] - Tianci Materials has submitted an application for H-share listing on the Hong Kong Stock Exchange [30] - Zhongke Haixun has signed a strategic cooperation agreement with Beibu Gulf Port Group [30] Group 10 - China CNR has elected Sun Yongcai as the chairman of the board [31] - Baiwei Storage plans to issue H-shares and list on the Hong Kong Stock Exchange [32] - Shengxin Lithium Energy plans to acquire a 21% stake in Qicheng Mining for 1.456 billion yuan [33] Group 11 - Zhongjing Electronics plans to raise no more than 700 million yuan for various projects [35] - Dingxin Communications clarifies that its technology authorization from Pingtouge is unrelated to AI intelligent reasoning chips [37] - Rihai Intelligent's major shareholder plans to reduce its stake by up to 2.77% [38] Group 12 - Rihai Optical's actual controller plans to reduce his stake by up to 3% [39] - Xilong Science's actual controllers plan to reduce their stake by a total of 3% [40] - Honggong Technology plans to sign a project contract with a maximum investment of 450 million yuan [41] Group 13 - Mankang Pharmaceutical has signed a strategic cooperation agreement with Nanjing Haijing Pharmaceutical [42] - Mankang Pharmaceutical plans to raise no more than 1.033 billion yuan through a private placement [42] - Kaidi Co.'s shareholder plans to reduce its stake by up to 38,030 shares [43] Group 14 - Hesheng Co. has launched a stock option and restricted stock incentive plan totaling 3.6 million shares [44] - ST Yigou's shareholder plans to reduce its stake by up to 2.85% [46] - Jinziham's subsidiary plans to invest up to 300 million yuan in Zhongzheng Microelectronics [49]

智翔金泰(688443)旗下产品商业化获实质性进展。 9月23日，智翔金泰发布公告，该上市公司已与康哲药业之附属公司西藏康哲药业发展有限公司（以下 简称"西藏康哲"）和RXILIENT MEDICAL PTE. LTD.（以下简称"RXILIENT"）就唯康度塔单抗注射液 （GR2001注射液）以及斯乐韦米单抗注射液（GR1801注射液）分别签订独家合作协议。 根据协议，智翔金泰将获得首付款、里程碑付款并获得其商业化推广等服务，西藏康哲将获得上述两款 产品在中国内地的独家商业化权，RXILIENT将获得上述两款产品除中国内地之外的亚太地区及中东、 北非的独家许可权。 需要指出的是，唯康度塔单抗注射液是一款智翔金泰自主研发的重组人源化抗破伤风毒素（TeNT）的 单克隆抗体，注册分类为治疗用生物制品1类。该产品可通过特异性结合TeNT-Hc，阻断其进入神经元 细胞，起到被动免疫作用。2024年5月，唯康度塔单抗注射液被国家药品监督管理局（NMPA）药品审 评中心（CDE）纳入突破性治疗品种名单，其新药上市申请（NDA）已于2025年5月获得CDE受理。 此外，智翔金泰自主研发的斯乐韦米单抗注射液则是一款重组全人源 ...

智翔金泰于2023年6月20日在上交所科创板上市，公开发行新股9,168.0000万股，发行价格为 37.88元/股，保荐机构（主承销商）为海通证券股份有限公司（现名"国泰海通证券股份有限公司"）， 保荐代表人为王永杰、刘丹。 智翔金泰首次公开发行股票募集资金总额347,283.84万元；扣除发行费用后，募集资金净额为 329,140.14万元。智翔金泰实际募资净额比原拟募集资金金额少68,859.86万元。智翔金泰于2023年6 月15日披露的招股说明书显示，该公司拟募集资金398,000.00万元，用于抗体产业化基地项目一期改 扩建、抗体产业化基地项目二期、抗体药物研发项目、补充流动资金。 中国经济网北京9月23日讯 智翔金泰(688443.SH)今日收报32.93元，跌幅2.55%。 智翔金泰2025年半年度报告显示，上半年公司实现营业收入4539.18万元，上年同期为1.27万元； 归属于上市公司股东的净利润为-2.89亿元，上年同期为-3.62亿元；归属于上市公司股东的扣非净利润 为-3.17亿元，上年同期为-3.64亿元；经营活动产生的现金流量净额为-1.16亿元，上年同期为-2.64亿 元。 智 ...

本报讯(记者李雯珊)9月22日，康哲药业控股有限公司(以下简称"康哲药业")与重庆智翔金泰生物制药股 份有限公司(以下简称"智翔金泰")签订独家合作协议，获得两款1类治疗用生物制品唯康度塔单抗 (GR2001)注射液和斯乐韦米单抗(GR1801)注射液在中国大陆的独家商业化权与除中国大陆之外的亚太 地区及中东、北非的独家许可权。 唯康度塔单抗是一款安全性佳，且优效于破伤风人免疫球蛋白(HTIG)，可为患者提供快速且持久保护 的破伤风被动免疫制剂。产品中国Ⅲ期临床试验达到了主要疗效终点。2024年5月，产品被国家药品监 督管理局(NMPA)药品审评中心(CDE)纳入突破性治疗品种名单，其新药上市申请(NDA)已于2025年5月 获得CDE受理，有望成为中国第二个获批的破伤风被动免疫单抗。 斯乐韦米单抗是全球首款针对狂犬病毒糖蛋白表位Ⅰ和/或Ⅲ的重组全人源抗狂犬病病毒(RABV)双特异 性抗体，符合世界卫生组织(WHO)建议开发的针对不同抗原位点的"鸡尾酒式"疗法，可大规模标准化稳 定生产，并且中和谱广、免疫原性低、对疫苗主动免疫干扰小、成本可控。2025年1月14日，其用于成 人疑似狂犬病病毒暴露后的被动免疫适 ...

Core Viewpoint - China Medical System Holdings Limited (CMS) has entered into exclusive collaboration agreements with Chongqing Genrix Biopharmaceutical Co., Ltd. for two Class 1 therapeutic biological products, Vecantoxatug and Silevimig, aimed at passive immunization against tetanus and rabies, respectively. The agreements grant CMS exclusive commercialization rights in mainland China and licensing rights in the Asia-Pacific region, the Middle East, and North Africa, with a term extending up to ten years post-marketing approval [1][4]. Group 1: Vecantoxatug - Vecantoxatug is a passive immunization agent that has shown superior protection compared to human tetanus immunoglobulin (HTIG) and has successfully met its primary efficacy endpoint in Phase III clinical trials [2][4]. - The product was designated as a Breakthrough Therapy by the Center for Drug Evaluation (CDE) in May 2024, and its New Drug Application (NDA) was accepted on May 22, 2025 [2]. - Vecantoxatug is a recombinant humanized monoclonal antibody that effectively blocks tetanus neurotoxin entry into neurons, providing a safer and more effective option for passive immunization [5][7]. Group 2: Silevimig - Silevimig is the world's first recombinant, fully human bispecific antibody against rabies virus, developed to target specific antigenic sites as recommended by the World Health Organization (WHO) [3][9]. - The NDA for Silevimig was accepted by the CDE on January 14, 2025, and a clinical trial application for use in children and adolescents was approved in July 2025 [3][10]. - In Phase III clinical trials, Silevimig demonstrated non-inferior protective efficacy compared to human rabies immunoglobulin (HRIG), providing immediate protection without compromising the active immune response from vaccination [10][12]. Group 3: Market Context and Clinical Need - The market for passive immunization against tetanus and rabies is significant, with existing products facing safety and accessibility issues, highlighting the need for innovative solutions like Vecantoxatug and Silevimig [4][11]. - Tetanus has a high global mortality rate, with 500,000 to 1,000,000 cases reported annually, while rabies has a near 100% case-fatality rate once symptoms appear, emphasizing the urgent need for effective preventive measures [6][11]. - Current passive immunization options in China, such as HRIG and equine rabies antiserum, have limitations including high costs and potential adverse reactions, creating a market opportunity for the new products [12].

Group 1 - Huadong Medicine's subsidiary received FDA approval for the clinical trial of HDM2017, a new antibody-drug conjugate targeting Cadherin 17, for advanced malignant solid tumors [1] - Tianjin Pharmaceutical's subsidiary obtained approval for the new indication of Pu You Ke for thrombolytic treatment of acute ischemic stroke, making it the only approved recombinant human urokinase product in China [2] - Yabao Pharmaceutical decided to terminate the clinical trial of SY-009 and fully provision for asset impairment of 55.793 million yuan, which will reduce the company's profit for 2025 [3] Group 2 - Zhixiang Jintai signed exclusive cooperation agreements with Kangzhe Pharmaceutical for the commercialization of GR2001 and GR1801 monoclonal antibodies, with expected payments totaling approximately 510 million yuan [4] - Lepu Medical established a strategic partnership with Hanhai Information to jointly develop the medical aesthetics business, aiming to enhance sales channels and improve performance amid industry competition [5][6]

Major Events - Shengxin Lithium Energy plans to acquire 21% stake in Qicheng Mining for 1.456 billion yuan, increasing its ownership to 70% [3] - Tianpu Co. has seen its stock rise 279.73% over 14 consecutive trading days, but the acquirer Zhonghao Xinying has no asset injection plans [4] - Hangdian Co. reports losses in its optical communication business while its copper foil business is still in the early stages [5] Shareholder Activities - Tianchuang Fashion is launching a shareholder reward event, offering 30% discount coupons to shareholders [6] - Beiliang Co. is collaborating with Tonghuashun for a "Shareholder Festival" event for past investors [7] Production and Operational Changes - Xinxiang Chemical Fiber will halt its biomass cellulose filament production line for 90 days starting October 1, affecting an annual capacity of 31,200 tons and expected revenue loss of approximately 185 million yuan [8] - Baijun Precision plans to transfer 18.29% of its stake in Suzhou Linghou Robotics for 64 million yuan [9] New Contracts and Projects - Tiancheng Self-Control has received a project designation from a leading domestic new energy vehicle company for seat assembly, expected to start production in June 2026 [10] - Huazi Industrial's subsidiary plans to sell dairy farm assets for 38.5 million yuan, impacting current profits by approximately 11.7 million yuan [11] - Oriental Pearl is participating in a special fund to acquire equity in Chaoyuan Digital Technology, with a total investment of 244 million yuan [12] Financial Performance - Changchuan Technology expects a net profit increase of 131.39% to 145.38% year-on-year for the first three quarters of 2025, driven by strong demand in the semiconductor industry [17] Major Contracts - Guangdong Construction has won a construction contract worth 1.924 billion yuan for a property reconstruction project in Guangzhou [18] - Youxunda anticipates winning a procurement project from the State Grid worth approximately 107 million yuan [19] - Samsung Medical is a candidate for multiple procurement projects from the State Grid, with a total expected value of about 193 million yuan [20] Share Buybacks and Financing - Sanfu New Science plans to repurchase shares worth between 10 million and 15 million yuan for employee stock incentives [39] - Guiyan Platinum plans to raise up to 1.291 billion yuan through a private placement for industrial upgrades and working capital [40] - Zhongjing Electronics intends to raise up to 700 million yuan, with the controlling shareholder participating in the subscription [41]