{
  "meta": {
    "title": "分子诊断四小龙 + 发光五虎 2025-2027 要闻/战略/已落地产品",
    "window": "2025-01 至 2027-10",
    "compiled_at": "2026-10-18",
    "coverage_note": "2025全年、2026年1-10月为已披露事实；2027年（2027-01至2027-10）尚未发生，全部为 null，原因见 gaps。",
    "source_priority": "巨潮/交易所公告与年报 > 公司官网 > 权威财经媒体"
  },
  "companies": [
    {
      "name": "圣湘生物",
      "code": "688289",
      "group": "四小龙",
      "strategy": "以并购补齐诊疗一体化版图（生物药+血球POCT+HLA血液分子），主线仍是核酸检测试剂与分子POCT放量。",
      "molecular_revenue_2025": {
        "revenue": "11.55亿元",
        "share": "70.4%",
        "basis": "2025年报分行业「体外诊断行业」收入1,155,220,173.12元，由诊断试剂10.07亿+诊断仪器1.01亿+检测服务0.47亿构成；另「生物制药行业」4.61亿系收购中山海济新增。年报未单列「分子诊断」，IVD板块以核酸法为主。",
        "source": "圣湘生物2025年年度报告",
        "url": "http://file.finance.sina.com.cn/211.154.219.97:9494/MRGG/CNSESH_STOCK/2026/2026-4/2026-04-30/12288482.PDF"
      },
      "events": [
        {
          "date": "2025-01-10",
          "type": "并购",
          "fact": "拟以8.075亿元收购中山未名海济生物医药100%股权，切入生长激素等生物制药，2025年并表贡献4.61亿元收入。",
          "source": "圣湘生物关于收购股权的公告（2025-004）",
          "url": "http://money.finance.sina.com.cn/corp/view/vCB_AllBulletinDetail.php?stockid=688289&id=10705374"
        },
        {
          "date": "2025-02-26",
          "type": "并购",
          "fact": "以7560万元受让并增资取得长沙红岸基元54%股权，将AI图像法血球POCT并入感染诊断全场景布局。",
          "source": "财联社《圣湘生物2025年增收不增利》",
          "url": "https://www.cls.cn/detail/2361154"
        },
        {
          "date": "2025-03",
          "type": "合作",
          "fact": "加码真迈生物持股至15.55%，并领投其C+轮2.8亿元融资，绑定国产高通量测序上游。",
          "source": "圣湘生物官网《湖南日报｜引全球技术 聚国际人才》",
          "url": "https://www.sansure.com.cn/ptgz/info.aspx?itemid=3557"
        },
        {
          "date": "2026-01-29",
          "type": "并购",
          "fact": "完成对德国inno-train Diagnostik GmbH的控股收购，取得HLA分型与安全输血能力，切入血液分子诊断并加速出海。",
          "source": "东方财富《圣湘生物控股德国inno-train 瞄准全球市场拓展》",
          "url": "https://wap.eastmoney.com/a/202601293635504247.html"
        },
        {
          "date": "2026-03",
          "type": "并购",
          "fact": "以7471.40万元收购华斯无微生物科技100%股权，以红外荧光增强技术补自身免疫诊断灵敏度短板。",
          "source": "圣湘生物关于与关联方共同投资华斯无微的公告",
          "url": "https://vip.stock.finance.sina.com.cn/corp/view/vCB_AllBulletinDetail.php?stockid=&id=11996264"
        },
        {
          "date": "2026-04-08",
          "type": "人事",
          "fact": "戴宏杰院士领衔组建全球战略技术与科学指导专家团，与华斯无微收购形成技术闭环。",
          "source": "湖南省工信厅《院士领衔+战略收购》",
          "url": "http://gxt.hunan.gov.cn/xxgk_71033/gzdt/qyzx/202604/t20260408_33949851.html"
        },
        {
          "date": "2026-04-30",
          "type": "财报",
          "fact": "2025年营业收入16.42亿元，同比+12.58%；体外诊断11.55亿元、生物制药4.61亿元。",
          "source": "中国证券报《圣湘生物：2025年营收同比增长12.58%》",
          "url": "https://www.cs.com.cn/ssgs/01/2026/04/30/detail_2026043010008975.html"
        },
        {
          "date": "2026-07-28",
          "type": "获证",
          "fact": "首款冻干四联检（新冠/甲流/乙流/RSV，荧光PCR法）获批，国械注准20263401609，适配分子POCT最快12分钟出结果。",
          "source": "圣湘生物官网《两项首创！圣湘冻干四联检试剂获批上市》",
          "url": "https://www.sansure.com.cn/gsyw/info.aspx?itemid=3666"
        },
        {
          "date": "2026-08-27",
          "type": "财报",
          "fact": "2026年上半年营业收入8.34亿元，同比-3.95%；归母净利润0.98亿元，同比-39.76%。",
          "source": "人民网湖南《圣湘生物上半年营收8.34亿》",
          "url": "http://hn.people.com.cn/n2/2026/0827/c356884-41679397.html"
        },
        {
          "date": "2026-10-12",
          "type": "获证",
          "fact": "第二款冻干四联检（副流感/人鼻病毒/腺病毒/肺炎支原体，荧光PCR法）获批，国械注准20263402137，与首款互补覆盖8种呼吸道病原。",
          "source": "证券时报《圣湘生物：相关产品取得医疗器械注册证》",
          "url": "https://www.stcn.com/article/detail/4213226.html"
        }
      ],
      "products": [
        {
          "name": "新型冠状病毒/甲型流感病毒/乙型流感病毒/呼吸道合胞病毒多重核酸检测试剂盒（荧光PCR法，冻干）",
          "platform": "PCR",
          "approval_date": "2026-07-28",
          "reg_no": "国械注准20263401609",
          "source": "圣湘生物官网",
          "url": "https://www.sansure.com.cn/gsyw/info.aspx?itemid=3666"
        },
        {
          "name": "副流感病毒/人鼻病毒/腺病毒/肺炎支原体核酸检测试剂盒（荧光PCR法，冻干）",
          "platform": "PCR",
          "approval_date": "2026-10-12",
          "reg_no": "国械注准20263402137",
          "source": "证券时报",
          "url": "https://www.stcn.com/article/detail/4213226.html"
        },
        {
          "name": "分子诊断一体机（分子POCT，2025年全年装机超200台，2026Q1新增70余套）",
          "platform": "POCT",
          "approval_date": "2025年（年报披露装机数据）",
          "reg_no": null,
          "source": "中国证券报",
          "url": "https://www.cs.com.cn/ssgs/01/2026/04/30/detail_2026043010008975.html"
        },
        {
          "name": "血球POCT（红岸基元AI图像法，2025年2月控股并表）",
          "platform": "POCT",
          "approval_date": "2025-02",
          "reg_no": null,
          "source": "财联社",
          "url": "https://www.cls.cn/detail/2361154"
        }
      ]
    },
    {
      "name": "达安基因",
      "code": "002030",
      "group": "四小龙",
      "strategy": "以核酸首证守住分子基本盘，引入广药控股纾困，同时向自有测序仪与化学发光延伸第二平台。",
      "molecular_revenue_2025": {
        "revenue": "7.27亿元",
        "share": "95.96%",
        "basis": "2025年报分行业「生物制品业」727,082,424.37元（分子诊断试剂与仪器为主），金融服务0.31亿占4.04%。年报未单列「分子诊断」，生物制品业含少量生化/免疫产品。",
        "source": "达安基因2025年年度报告",
        "url": "http://file.finance.sina.com.cn/211.154.219.97:9494/MRGG/CNSESZ_STOCK/2026/2026-4/2026-04-28/12234867.PDF"
      },
      "events": [
        {
          "date": "2025-09-05",
          "type": "获证",
          "fact": "人类免疫缺陷病毒1型（HIV-1）DNA检测试剂盒（PCR-荧光探针法）获批，国械注准20253401805，成为国内唯一具备HIV DNA/RNA/耐药全套方案的厂家。",
          "source": "新浪财经《达安基因HIV-1 DNA检测试剂盒取得注册证》",
          "url": "https://cj.sina.cn/articles/view/5835524730/15bd30a7a0200205ry"
        },
        {
          "date": "2025-09-25",
          "type": "获证",
          "fact": "基孔肯雅病毒核酸检测试剂盒（荧光PCR法）获批，国械注准20253401955，国内首证，从受理到获批不足1个月。",
          "source": "达安基因官网《国内首证！基孔肯雅病毒核酸检测产品正式获批》",
          "url": "https://www.daangene.com/news/index165.html"
        },
        {
          "date": "2025-06-10",
          "type": "获证",
          "fact": "六项呼吸道病原体核酸检测试剂盒（PCR-荧光探针法）获批，有效期至2030-06-05，同期推出呼吸道「6+2」产品方案。",
          "source": "达安基因官网《呼吸道六联检产品获批上市！》",
          "url": "https://www.daangene.com/news/index156.html"
        },
        {
          "date": "2026-01-26",
          "type": "获证",
          "fact": "国产小型快速基因测序仪DAseq-60获三类证，国械注准20263220149，为时隔10年的第二款自有测序仪。",
          "source": "达安基因官网",
          "url": "https://www.daangene.com"
        },
        {
          "date": "2026-03-31",
          "type": "获证",
          "fact": "控股子公司达瑞生物HIV抗原抗体检测试剂盒（化学发光免疫分析法）获批，国械注准20263400639。",
          "source": "财联社",
          "url": "https://www.cls.cn/detail/2330501"
        },
        {
          "date": "2026-04-28",
          "type": "财报",
          "fact": "2025年营业收入7.58亿元，同比-11.18%；归母净利润亏损，主因减值计提增加与毛利率下降。",
          "source": "达安基因2025年年度报告摘要（巨潮）",
          "url": "https://static.cninfo.com.cn/finalpage/2026-04-28/1225220188.PDF"
        },
        {
          "date": "2026-05-18",
          "type": "并购",
          "fact": "广药集团以现金24.18亿元受让广永科技100%股权并协议受让股份，成为达安基因间接控股股东。",
          "source": "中国食品药品网《现金支付超24亿元！广药集团将成为达安基因间接控股股东》",
          "url": "https://m.cnpharm.com/c/2026-05-18/1097531.shtml"
        },
        {
          "date": "2026-09-24",
          "type": "获证",
          "fact": "子公司达泰生物游离PSA（国械注准20263402036）与甲胎蛋白（国械注准20263401671）两项化学发光试剂获批，补齐肿瘤标志物发光菜单。",
          "source": "上海证券报（达安基因公告2026-045）",
          "url": "https://www.sohu.com/a/1081529773_122014422"
        },
        {
          "date": "2026-10-08",
          "type": "中标",
          "fact": "中标长春市中心血站全自动核酸提取设备采购，金额97.6万元。",
          "source": "搜狐财经《达安基因中标：全自动核酸提取设备中标结果公告》",
          "url": "https://m.sohu.com/a/1085951665_121319643"
        }
      ],
      "products": [
        {
          "name": "基孔肯雅病毒核酸检测试剂盒（荧光PCR法）",
          "platform": "PCR",
          "approval_date": "2025-09-25",
          "reg_no": "国械注准20253401955",
          "source": "达安基因官网",
          "url": "https://www.daangene.com/news/index165.html"
        },
        {
          "name": "人类免疫缺陷病毒1型（HIV-1）DNA检测试剂盒（PCR-荧光探针法）",
          "platform": "PCR",
          "approval_date": "2025-09-05",
          "reg_no": "国械注准20253401805",
          "source": "新浪财经",
          "url": "https://cj.sina.cn/articles/view/5835524730/15bd30a7a0200205ry"
        },
        {
          "name": "DAseq-60 基因测序仪",
          "platform": "测序",
          "approval_date": "2026-01-26",
          "reg_no": "国械注准20263220149",
          "source": "达安基因官网",
          "url": "https://www.daangene.com"
        },
        {
          "name": "游离前列腺特异性抗原测定试剂盒（化学发光免疫分析法）",
          "platform": "发光",
          "approval_date": "2026-09-24",
          "reg_no": "国械注准20263402036",
          "source": "上海证券报（公告2026-045）",
          "url": "https://www.sohu.com/a/1081529773_122014422"
        },
        {
          "name": "甲胎蛋白测定试剂盒（化学发光法）",
          "platform": "发光",
          "approval_date": "2026-09",
          "reg_no": "国械注准20263401671",
          "source": "达安基因官网",
          "url": "https://www.daangene.com/news/index_p14.html"
        },
        {
          "name": "人类免疫缺陷病毒抗原抗体检测试剂盒（化学发光免疫分析法）",
          "platform": "发光",
          "approval_date": "2026-03-31",
          "reg_no": "国械注准20263400639",
          "source": "财联社",
          "url": "https://www.cls.cn/detail/2330501"
        }
      ]
    },
    {
      "name": "凯普生物",
      "code": "300639",
      "group": "四小龙",
      "strategy": "守住宫颈癌筛查分子主业，靠甲基化、生殖道与虫媒新品扩菜单，并投资赛陆医疗补测序上游。",
      "molecular_revenue_2025": {
        "revenue": "4.47亿元",
        "share": "66.69%",
        "basis": "2025年报分行业「分子诊断行业」446,553,356.35元，同比-21.44%，毛利率69.10%；另有医学检验服务1.96亿（29.21%）、医疗服务0.27亿（4.10%）。",
        "source": "凯普生物2025年年度报告",
        "url": "http://file.finance.sina.com.cn/211.154.219.97:9494/MRGG/CNSESZ_STOCK/2026/2026-4/2026-04-29/12246655.PDF"
      },
      "events": [
        {
          "date": "2025-09-10",
          "type": "获证",
          "fact": "联合艾米森研发的SOX1和PAX1基因甲基化检测试剂盒（PCR-荧光探针法）获批，切入宫颈癌早筛。",
          "source": "财联社《凯普生物：全资子公司产品取得医疗器械注册证书》",
          "url": "https://www.cls.cn/detail/1794729"
        },
        {
          "date": "2026-04-29",
          "type": "财报",
          "fact": "2025年营业收入6.70亿元，同比-17.89%；归母净利润-1.31亿元，由盈转亏。",
          "source": "凯普生物2025年年度报告摘要",
          "url": "http://news.10jqka.com.cn/field/sn/20260429/57764873.shtml"
        },
        {
          "date": "2026-08-14",
          "type": "财报",
          "fact": "2026年上半年营业收入3.00亿元，同比-4.74%；归母净利润3126.21万元，同比扭亏为盈。",
          "source": "东方财富《凯普生物2026年半年度报告摘要》",
          "url": "https://finance.eastmoney.com/a/202608143841921518.html"
        },
        {
          "date": "2026-08-31",
          "type": "获证",
          "fact": "子公司潮州凯普基孔肯雅病毒/登革病毒核酸检测试剂盒（荧光PCR法）获批，国械注准20263401806。",
          "source": "东方财富《凯普生物：子公司基孔肯雅/登革病毒核酸检测试剂盒获批》",
          "url": "https://wap.eastmoney.com/a/202608313860140869.html"
        },
        {
          "date": "2026-08",
          "type": "并购",
          "fact": "以5500万元投资深圳赛陆医疗（首期3500万元、8月追加2000万元），布局自主可控测序仪、空间组学与固相基因芯片。",
          "source": "凯普生物2026年半年度报告摘要（巨潮）",
          "url": "https://money.finance.sina.com.cn/corp/view/vCB_AllBulletinDetail.php?stockid=300639&id=12494207"
        },
        {
          "date": "2026-10-09",
          "type": "获证",
          "fact": "阴道微生物核酸检测试剂盒（PCR-荧光探针法）获批，国械注准20263402138，覆盖阴道毛滴虫/加德纳菌/白色念珠菌。",
          "source": "东方财富《凯普生物全资子公司获医疗器械注册证》",
          "url": "https://finance.eastmoney.com/a/202610113892072065.html"
        }
      ],
      "products": [
        {
          "name": "SOX1和PAX1基因甲基化检测试剂盒（PCR-荧光探针法）",
          "platform": "PCR",
          "approval_date": "2025-09-10",
          "reg_no": null,
          "source": "财联社",
          "url": "https://www.cls.cn/detail/1794729"
        },
        {
          "name": "基孔肯雅病毒/登革病毒核酸检测试剂盒（荧光PCR法）",
          "platform": "PCR",
          "approval_date": "2026-08-31",
          "reg_no": "国械注准20263401806",
          "source": "东方财富",
          "url": "https://wap.eastmoney.com/a/202608313860140869.html"
        },
        {
          "name": "阴道微生物核酸检测试剂盒（PCR-荧光探针法）",
          "platform": "PCR",
          "approval_date": "2026-10-09",
          "reg_no": "国械注准20263402138",
          "source": "东方财富",
          "url": "https://finance.eastmoney.com/a/202610113892072065.html"
        },
        {
          "name": "宫颈癌HPV12+2检测试剂（国内首款明确用于初筛/联合筛查/ASC-US分流）",
          "platform": "PCR",
          "approval_date": "2025年前已上市（年报口径）",
          "reg_no": null,
          "source": "南方日报《凯普生物 用科技创新守护亿万群众健康》",
          "url": "https://epaper.nfnews.com/m/ipaper/nfrb/html/202511/27/content_10154584.html"
        }
      ]
    },
    {
      "name": "硕世生物",
      "code": "688399",
      "group": "四小龙",
      "strategy": "以呼吸道与HPV核酸检测为基本盘，多条注册证扩菜单并加码海外（2025年境外收入同比+13.08%）。",
      "molecular_revenue_2025": null,
      "events": [
        {
          "date": "2025-09-29",
          "type": "获证",
          "fact": "同批取得两项三类证：腺病毒抗原检测试剂盒（胶体金法）与七项呼吸道病原体核酸检测试剂盒（荧光PCR法），有效期至2030-09-28。",
          "source": "雷达财经《硕世生物获得两项医疗器械注册证》",
          "url": "https://www.leidacj.com/article/111542"
        },
        {
          "date": "2026-04-23",
          "type": "财报",
          "fact": "2025年报披露：境外收入同比增长13.08%，产品覆盖全球100多个国家和地区；新冠甲乙流RSV四联检列入WHO应急使用清单。",
          "source": "硕世生物2025年度「提质增效」专项公告（巨潮）",
          "url": "https://static.cninfo.com.cn/finalpage/2026-04-23/1225153710.PDF"
        },
        {
          "date": "2025-12-26",
          "type": "合作",
          "fact": "召开2026年战略合作伙伴交流大会，发布呼吸道病原等五大创新成果，并启动「门、急呼吸道实验室能力建设项目」。",
          "source": "CACLP《硕世生物五大创新成果重磅发布》",
          "url": "https://www.caclp.com/article?detail_13966.html="
        },
        {
          "date": "2026-04-22",
          "type": "财报",
          "fact": "2025年营业收入3.39亿元，同比-3.02%；归母净利润-4108万元，亏损扩大。",
          "source": "硕世生物2025年年度报告（巨潮）",
          "url": "https://static.cninfo.com.cn/finalpage/2026-04-23/1225153757.PDF"
        },
        {
          "date": "2026-09-24",
          "type": "获证",
          "fact": "丙型肝炎病毒核酸检测试剂盒（国械注准20263402040）与基孔肯雅病毒核酸检测试剂盒（国械注准20263402045）双证获批。",
          "source": "证券时报《硕世生物：两款产品取得医疗器械注册证》",
          "url": "https://www.stcn.com/article/detail/4198603.html"
        },
        {
          "date": "2026-10-12",
          "type": "获证",
          "fact": "人乳头瘤病毒核酸分型检测试剂盒（PCR熔解曲线法）获国家药监局注册证。",
          "source": "每日经济新闻《硕世生物：产品取得注册证》",
          "url": "https://www.nbd.com.cn/articles/2026-10-12/4602191.html"
        },
        {
          "date": "2026-09-07",
          "type": "中标",
          "fact": "中标上海市嘉定区疾病预防控制中心2026年试剂耗材采购项目，金额241.30万元。",
          "source": "证券之星《硕世生物中标：2026年试剂耗材采购项目的合同》",
          "url": "https://mt.sohu.com/a/1074280570_121319643"
        }
      ],
      "products": [
        {
          "name": "七项呼吸道病原体核酸检测试剂盒（荧光PCR法）",
          "platform": "PCR",
          "approval_date": "2025-09-29",
          "reg_no": null,
          "source": "雷达财经",
          "url": "https://www.leidacj.com/article/111542"
        },
        {
          "name": "腺病毒抗原检测试剂盒（胶体金法）",
          "platform": "POCT",
          "approval_date": "2025-09-29",
          "reg_no": null,
          "source": "雷达财经",
          "url": "https://www.leidacj.com/article/111542"
        },
        {
          "name": "丙型肝炎病毒核酸检测试剂盒（荧光PCR法）",
          "platform": "PCR",
          "approval_date": "2026-09-24",
          "reg_no": "国械注准20263402040",
          "source": "证券时报",
          "url": "https://www.stcn.com/article/detail/4198603.html"
        },
        {
          "name": "基孔肯雅病毒核酸检测试剂盒（荧光PCR法）",
          "platform": "PCR",
          "approval_date": "2026-09-24",
          "reg_no": "国械注准20263402045",
          "source": "证券时报",
          "url": "https://www.stcn.com/article/detail/4198603.html"
        },
        {
          "name": "人乳头瘤病毒核酸分型检测试剂盒（PCR熔解曲线法）",
          "platform": "PCR",
          "approval_date": "2026-10-12",
          "reg_no": null,
          "source": "每日经济新闻",
          "url": "https://www.nbd.com.cn/articles/2026-10-12/4602191.html"
        }
      ]
    },
    {
      "name": "迈瑞医疗",
      "code": "300760",
      "group": "发光五虎",
      "strategy": "IVD承压下以化学发光试剂与智慧流水线补短板，同步推进H股上市与全球本地化。",
      "molecular_revenue_2025": null,
      "events": [
        {
          "date": "2025-10-14",
          "type": "资本运作",
          "fact": "董事会通过发行H股并在港交所主板上市的议案，拟打造国际化资本运作平台。",
          "source": "证券时报《迈瑞医疗正式启动港股IPO》",
          "url": "https://www.stcn.com/article/detail/3382049.html"
        },
        {
          "date": "2025-11-10",
          "type": "资本运作",
          "fact": "首次向港交所递交H股上市申请。",
          "source": "新浪财经《迈瑞医疗，再次递表港交所》",
          "url": "https://finance.sina.com.cn/wm/2026-05-12/doc-inhxqzkr8416455.shtml"
        },
        {
          "date": "2026-03-11",
          "type": "合作",
          "fact": "与中国同辐续签战略合作框架协议，深化核医学与IVD国际业务协同。",
          "source": "迈瑞医疗官网《迈瑞与中国同辐续签战略合作协议》",
          "url": "https://www.mindray.com/cn/media-center/news/mindray-renews-strategic-cooperation-agreement-with-china-national-nuclear-corporation-cnnc-isotope"
        },
        {
          "date": "2026-03-31",
          "type": "财报",
          "fact": "2025年营业收入332.82亿元，同比-9.38%；归母净利润81.36亿元，同比-30.28%；体外诊断类产品122.41亿元（占36.78%，-9.41%）。",
          "source": "迈瑞医疗2025年年度报告",
          "url": "https://www.cnpharm.com/upload/resources/file/2026/04/01/186982.pdf"
        },
        {
          "date": "2026-05-11",
          "type": "资本运作",
          "fact": "按港交所要求更新H股发行申请及公司信息，二次递表。",
          "source": "新浪财经《迈瑞医疗，再次递表港交所》",
          "url": "https://finance.sina.com.cn/wm/2026-05-12/doc-inhxqzkr8416455.shtml"
        },
        {
          "date": "2026-07-30",
          "type": "产品",
          "fact": "ADLM2026全球首发智能流水线MT 7000，FA-N微生物培养系统成为唯一获奖的中国自研设备，22项临床研究成果获国际会议认证。",
          "source": "迈瑞医疗官网《智慧生态，学术破局：迈瑞医疗在ADLM2026》",
          "url": "https://www.mindray.com/cn/media-center/news/mindray-medical-at-adlm2026"
        }
      ],
      "products": [
        {
          "name": "MT 7000 智能流水线（ADLM 2026 全球首发）",
          "platform": "发光",
          "approval_date": "2026-07-30（首发，非注册证日期）",
          "reg_no": null,
          "source": "迈瑞医疗官网",
          "url": "https://www.mindray.com/cn/media-center/news/mindray-medical-at-adlm2026"
        },
        {
          "name": "化学发光试剂新品8项（2025年上半年获批上市）",
          "platform": "发光",
          "approval_date": "2025年上半年",
          "reg_no": null,
          "source": "医药魔方《营收、利润再双跌，医疗器械一哥迈瑞价值重估》",
          "url": "https://www.pharmcube.com/newsLibrary/detail?id=9a243d445ad29b41181efa1ec78a16a5"
        }
      ]
    },
    {
      "name": "安图生物",
      "code": "603658",
      "group": "发光五虎",
      "strategy": "以免疫为主做全平台扩菜单：补分子（HIV核酸）、凝血与流式，并通过外延投资切入基因测序。",
      "molecular_revenue_2025": null,
      "events": [
        {
          "date": "2026-02-09",
          "type": "并购",
          "fact": "通过新增对外投资成为厦门飞朔生物技术有限公司大股东，持股39.76%，切入基因测序/肿瘤分子检测。",
          "source": "经济观察网《安图生物获医疗器械注册证并投资基因测序公司》",
          "url": "http://www.eeo.com.cn/2026/0214/796077.shtml"
        },
        {
          "date": "2026-02-12",
          "type": "获证",
          "fact": "公司及子公司获河南省药监局多款注册证：霉酚酸、皮质醇、丙戊酸检测试剂盒及流式细胞仪AutoFCM3600。",
          "source": "经济观察网",
          "url": "http://www.eeo.com.cn/2026/0214/796077.shtml"
        },
        {
          "date": "2026-04-22",
          "type": "财报",
          "fact": "2025年营业收入42.26亿元，归母净利润10.68亿元；研发投入7.68亿元，占营收18.16%。",
          "source": "安图生物2025年年度报告摘要（巨潮）",
          "url": "https://static.cninfo.com.cn/finalpage/2026-04-23/1225149051.PDF"
        },
        {
          "date": "2026-08-24",
          "type": "财报",
          "fact": "2026年上半年营业收入20.58亿元，同比-0.12%；归母净利润4.97亿元，同比-12.94%；研发投入4.01亿元占19.50%。",
          "source": "网易财经《安图生物2026年上半年营收20.58亿元》",
          "url": "https://www.163.com/dy/article/L58MLFF00519QIKK.html"
        },
        {
          "date": "2026-08-30",
          "type": "合作",
          "fact": "与科曼医疗签署战略合作协议，围绕体外诊断、智慧检验与生命支持、超声影像打造诊疗一体化方案。",
          "source": "安图生物官网《强强联合！安图生物与科曼医疗达成战略合作》",
          "url": "https://www.autobio.com.cn/news"
        },
        {
          "date": "2026-09-04",
          "type": "产能",
          "fact": "临时股东会审议募投项目：体外诊断产品产能扩大项目累计投入6.81亿元（进度47.87%）、研发中心项目投入4.56亿元（55.28%）。",
          "source": "安图生物2026年第一次临时股东会会议材料（巨潮）",
          "url": "https://static.cninfo.com.cn/finalpage/2026-09-04/1225546545.PDF"
        },
        {
          "date": "2026-10-12",
          "type": "获证",
          "fact": "公司及子公司8项产品获证，含HIV-1核酸检测试剂盒（PCR-荧光探针法）、EB病毒核抗原IgG、全自动凝血分析仪AutoCimo C6000等。",
          "source": "安图生物公告2026-046",
          "url": "https://stockmc.xueqiu.com/202610/603658_20261013_03QY.pdf"
        }
      ],
      "products": [
        {
          "name": "人类免疫缺陷病毒1型（HIV-1）核酸检测试剂盒（PCR-荧光探针法）",
          "platform": "PCR",
          "approval_date": "2026-10-12",
          "reg_no": "国械注准20263401948",
          "source": "安图生物公告2026-046",
          "url": "https://stockmc.xueqiu.com/202610/603658_20261013_03QY.pdf"
        },
        {
          "name": "EB病毒核抗原IgG抗体检测试剂盒（磁微粒化学发光法）",
          "platform": "发光",
          "approval_date": "2026-10-12",
          "reg_no": "国械注准20263402121",
          "source": "安图生物公告2026-046",
          "url": "https://stockmc.xueqiu.com/202610/603658_20261013_03QY.pdf"
        },
        {
          "name": "抗磷脂酶A2受体抗体IgG检测试剂盒（磁微粒化学发光法）",
          "platform": "发光",
          "approval_date": "2026-10-12",
          "reg_no": "豫械注准20262400570",
          "source": "安图生物公告2026-046",
          "url": "https://stockmc.xueqiu.com/202610/603658_20261013_03QY.pdf"
        },
        {
          "name": "全自动凝血分析仪 AutoCimo C6000",
          "platform": "发光",
          "approval_date": "2026-10-12",
          "reg_no": "豫械注准20262220615",
          "source": "安图生物公告2026-046",
          "url": "https://stockmc.xueqiu.com/202610/603658_20261013_03QY.pdf"
        },
        {
          "name": "流式细胞仪 AutoFCM3600",
          "platform": "发光",
          "approval_date": "2026-02-12",
          "reg_no": null,
          "source": "经济观察网",
          "url": "http://www.eeo.com.cn/2026/0214/796077.shtml"
        }
      ]
    },
    {
      "name": "新产业",
      "code": "300832",
      "group": "发光五虎",
      "strategy": "纯发光路线受国内集采压制，靠海外装机与X10高端机守增长，2026年起自建分子PCR平台。",
      "molecular_revenue_2025": null,
      "events": [
        {
          "date": "2025-06",
          "type": "获证",
          "fact": "高端旗舰全自动化学发光免疫分析仪MAGLUMI X10取得国内产品注册证。",
          "source": "新产业2026年半年度报告（巨潮）",
          "url": "http://static.cninfo.com.cn/finalpage/2026-08-14/1225471102.PDF"
        },
        {
          "date": "2025-07",
          "type": "获证",
          "fact": "全自动生化分析仪Biossays C10取得国内产品注册证，补齐中大型终端生化能力。",
          "source": "新产业2026年半年度报告（巨潮）",
          "url": "http://static.cninfo.com.cn/finalpage/2026-08-14/1225471102.PDF"
        },
        {
          "date": "2026-04-28",
          "type": "财报",
          "fact": "2025年营业收入45.77亿元，归母净利润16.2亿元；国内收入25.64亿元同比-9.82%，化学发光试剂销量仍逆势增长3.2%。",
          "source": "医药魔方《年报发布，IVD企业的悲欢各不同》",
          "url": "https://www.pharmcube.com/newsLibrary/detail?id=db897a64015c1444aed3b69be744708b"
        },
        {
          "date": "2026-07-06",
          "type": "人事",
          "fact": "公司收到实控人翁先定家属通知，其被监察委员会实施留置，公司称经营正常。",
          "source": "东方财富《新产业：实控人翁先定被实施留置》",
          "url": "https://wap.eastmoney.com/a/202607063795372768.html"
        },
        {
          "date": "2026-08-14",
          "type": "财报",
          "fact": "2026年上半年营业收入24.20亿元，同比+10.78%；归母净利润8.68亿元，同比+12.53%；试剂收入18.19亿元同比+19.59%。",
          "source": "新浪财经《体外诊断：化学发光迎来修复？出海才定高度！》",
          "url": "https://finance.sina.cn/stock/jdts/2026-10-13/detail-inivasea0506237.d.html"
        },
        {
          "date": "2026-09-14",
          "type": "获证",
          "fact": "全自动核酸检测分析系统MolecisionR8获三类证，国械注准20263221949，公司正式切入分子诊断（实时荧光PCR）赛道。",
          "source": "新产业关于获得医疗器械注册证的公告（2026-082）",
          "url": "https://money.finance.sina.com.cn/corp/view/vCB_AllBulletinDetail.php?stockid=300832&id=12606413"
        }
      ],
      "products": [
        {
          "name": "MAGLUMI X10 全自动化学发光免疫分析仪",
          "platform": "发光",
          "approval_date": "2025-06",
          "reg_no": null,
          "source": "新产业2026年半年度报告",
          "url": "http://static.cninfo.com.cn/finalpage/2026-08-14/1225471102.PDF"
        },
        {
          "name": "全自动核酸检测分析系统 Molecision R8",
          "platform": "PCR",
          "approval_date": "2026-09-14",
          "reg_no": "国械注准20263221949",
          "source": "新产业公告2026-082",
          "url": "https://money.finance.sina.com.cn/corp/view/vCB_AllBulletinDetail.php?stockid=300832&id=12606413"
        }
      ]
    },
    {
      "name": "迈克生物",
      "code": "300463",
      "group": "发光五虎",
      "strategy": "从去代理化转向智慧化实验室，联合华为、唯公建生态，海外与骨代谢发光新品补增量。",
      "molecular_revenue_2025": null,
      "events": [
        {
          "date": "2025-03-21",
          "type": "战略",
          "fact": "以「ALL IN」为主题召开新品发布暨经销商大会，600余家经销商到场，正式转向医学实验室智慧化整体方案。",
          "source": "凤凰网《迈克生物丨智慧化实验室先锋》",
          "url": "https://baby.ifeng.com/c/8i2f1R1rvHu"
        },
        {
          "date": "2025-12-22",
          "type": "获证",
          "fact": "血气生化分析仪（Q600）等多项产品获注册证，有效期自2025-12-22起；同批新增M100全自动细胞形态学分析仪、全自动血细胞分析仪系列国内注册证。",
          "source": "东方财富《迈克生物及子公司获多项医疗器械注册证》",
          "url": "https://wap.eastmoney.com/a/202512243600814385.html"
        },
        {
          "date": "2026-04-28",
          "type": "财报",
          "fact": "2025年营业收入21.7亿元，同比-14.84%；归母净利润-0.36亿元，上市以来首次年度亏损；海外收入2.23亿元同比+37.69%。",
          "source": "迈克生物2025年年度报告摘要",
          "url": "https://pdf.dfcfw.com/pdf/H2_AN202604281821683185_1.pdf"
        },
        {
          "date": "2026-05-27",
          "type": "合作",
          "fact": "与深圳唯公科技签署《智慧化实验室生态融合战略合作协议》，共建智慧检验生态。",
          "source": "CACLP《迈克生物&唯公科技达成战略合作》",
          "url": "https://www.caclp.com/m/article.asp?id=14230"
        },
        {
          "date": "2026-07-08",
          "type": "合作",
          "fact": "与华为签署合作协议，围绕智慧化实验室、集团全球一朵云、智能制造平台及鸿蒙+IVD设备联合创新展开。",
          "source": "证券时报《迈克生物：三款新产品取得医疗器械注册证》",
          "url": "https://www.stcn.com/article/detail/4198502.html"
        },
        {
          "date": "2026-09-24",
          "type": "获证",
          "fact": "总Ⅰ型胶原氨基端延长肽、β-胶原特殊序列、骨钙素三项骨代谢标志物（直接化学发光法）获四川省药监局注册证。",
          "source": "证券时报《迈克生物：三款新产品取得医疗器械注册证》",
          "url": "https://www.stcn.com/article/detail/4198502.html"
        }
      ],
      "products": [
        {
          "name": "总Ⅰ型胶原氨基端延长肽测定试剂盒（直接化学发光法）",
          "platform": "发光",
          "approval_date": "2026-09-24",
          "reg_no": null,
          "source": "证券时报",
          "url": "https://www.stcn.com/article/detail/4198502.html"
        },
        {
          "name": "β-胶原特殊序列测定试剂盒（直接化学发光法）",
          "platform": "发光",
          "approval_date": "2026-09-24",
          "reg_no": null,
          "source": "证券时报",
          "url": "https://www.stcn.com/article/detail/4198502.html"
        },
        {
          "name": "骨钙素测定试剂盒（直接化学发光法）",
          "platform": "发光",
          "approval_date": "2026-09-24",
          "reg_no": null,
          "source": "证券时报",
          "url": "https://www.stcn.com/article/detail/4198502.html"
        },
        {
          "name": "Q600 血气生化分析仪（公司首款血气产品）",
          "platform": "POCT",
          "approval_date": "2025-12-22",
          "reg_no": null,
          "source": "东方财富",
          "url": "https://wap.eastmoney.com/a/202512243600814385.html"
        },
        {
          "name": "交叉配血质控品",
          "platform": "发光",
          "approval_date": "2026-01-08",
          "reg_no": null,
          "source": "中国食品药品网《迈克生物交叉配血质控品取得产品注册证书》",
          "url": "https://www.cnpharm.com/c/2026-01-08/1088256.shtml"
        }
      ]
    },
    {
      "name": "亚辉龙",
      "code": "688575",
      "group": "发光五虎",
      "strategy": "发光主业靠自产试剂与微流控平台支撑，但2026年因脑机接口信披违规被罚，治理与内控承压。",
      "molecular_revenue_2025": null,
      "events": [
        {
          "date": "2025-12-23",
          "type": "获证",
          "fact": "涎液化糖链抗原KL-6与抗黑色素瘤分化相关基因5（MDA5）IgG两项化学发光试剂分别获广东省药监局、湖南省药监局注册证。",
          "source": "凤凰财经《亚辉龙：两款产品取得医疗器械注册证》",
          "url": "https://finance.ifeng.com/c/8pK2TqA05en"
        },
        {
          "date": "2025-02-21",
          "type": "产品",
          "fact": "自研首条iTLA Max全场景智慧生态流水线落户四川大学华西医院锦江院区，该方案同年获德国iF设计奖。",
          "source": "亚辉龙官网《iTLA Max流水线落户华西医院最大分院》",
          "url": "https://www.szyhlo.com/newscenter/1737033457608069120-96-8.html"
        },
        {
          "date": "2026-02-06",
          "type": "监管",
          "fact": "因涉嫌信息披露违法违规被中国证监会立案调查（涉脑机接口相关产品进展与订单的误导性陈述）。",
          "source": "新华网《证监会对亚辉龙公告涉嫌误导性陈述立案调查》",
          "url": "https://www.news.cn/fortune/20260206/876e6e0742b54c469bcced4fa2235093/c.html"
        },
        {
          "date": "2026-03-17",
          "type": "监管",
          "fact": "收到深圳证监局《行政处罚决定书》：公司罚400万元、董事长胡鹍辉罚200万元、董秘王鸣阳罚150万元，合计750万元。",
          "source": "东方财富《亚辉龙处罚落地：信披违法违规构成误导性陈述》",
          "url": "https://wap.eastmoney.com/a/202603173674726182.html"
        },
        {
          "date": "2026-05-07",
          "type": "财报",
          "fact": "2025年营业收入18.11亿元，同比-9.99%；归母净利润2401.90万元，同比-92.03%。",
          "source": "东方财富《亚辉龙2025年净利暴跌92%》",
          "url": "https://wap.eastmoney.com/a/202605073730042683.html"
        },
        {
          "date": "2026-07",
          "type": "获证",
          "fact": "广东省药监局签发6项微流控化学发光法检测试剂注册证，含高敏肌钙蛋白I、NT-proBNP、肌酸激酶同工酶、肌红蛋白、BNP、D-二聚体。",
          "source": "亚辉龙关于自愿披露取得医疗器械注册证的公告（巨潮）",
          "url": "http://file.finance.sina.com.cn/211.154.219.97:9494/MRGG/CNSESH_STOCK/2026/2026-8/2026-08-18/12498771.PDF"
        },
        {
          "date": "2026-08-17",
          "type": "获证",
          "fact": "2款微流控化学发光法检测仪器获注册证，系「十四五」国家重点研发计划专项成果，可适配7月获证的6项微流控试剂。",
          "source": "东方财富《亚辉龙：2款微流控化学发光法检测仪器获医疗器械注册证》",
          "url": "https://finance.eastmoney.com/a/202608173843292978.html"
        },
        {
          "date": "2026-08-26",
          "type": "财报",
          "fact": "2026年上半年营业收入8.88亿元，同比+9.84%；归母净利润0.70亿元；自产产品收入7.67亿元同比+14.33%，自产化学发光6.8亿元。",
          "source": "雪球《亚辉龙2026年半年度报告》",
          "url": "https://xueqiu.com/S/SH688575"
        }
      ],
      "products": [
        {
          "name": "高敏肌钙蛋白I测定试剂盒（微流控化学发光法）",
          "platform": "发光",
          "approval_date": "2026-07",
          "reg_no": null,
          "source": "亚辉龙公告（巨潮）",
          "url": "http://file.finance.sina.com.cn/211.154.219.97:9494/MRGG/CNSESH_STOCK/2026/2026-8/2026-08-18/12498771.PDF"
        },
        {
          "name": "N末端B型利钠肽前体（NT-proBNP）测定试剂盒（微流控化学发光法）",
          "platform": "发光",
          "approval_date": "2026-07",
          "reg_no": null,
          "source": "亚辉龙公告（巨潮）",
          "url": "http://file.finance.sina.com.cn/211.154.219.97:9494/MRGG/CNSESH_STOCK/2026/2026-8/2026-08-18/12498771.PDF"
        },
        {
          "name": "微流控化学发光法检测仪器（2款）",
          "platform": "发光",
          "approval_date": "2026-08-17",
          "reg_no": null,
          "source": "东方财富",
          "url": "https://finance.eastmoney.com/a/202608173843292978.html"
        },
        {
          "name": "涎液化糖链抗原（KL-6）测定试剂盒（化学发光法）",
          "platform": "发光",
          "approval_date": "2025-12-23",
          "reg_no": null,
          "source": "凤凰财经",
          "url": "https://finance.ifeng.com/c/8pK2TqA05en"
        },
        {
          "name": "抗MDA5 IgG抗体测定试剂盒（化学发光法）",
          "platform": "发光",
          "approval_date": "2025-12-23",
          "reg_no": null,
          "source": "凤凰财经",
          "url": "https://finance.ifeng.com/c/8pK2TqA05en"
        }
      ]
    }
  ],
  "gaps": [
    "2027年（2027-01至2027-10）全部为空：编制日为2026-10-18，2026年年报尚未披露，2027年尚未发生，故2027年无任何可核验要闻与获证信息，一律不填、不推测。",
    "分子诊断营收：硕世生物2025年报仅按诊断试剂2.93亿/诊断仪器0.14亿/检测服务0.06亿拆分，未按技术平台单列分子诊断，记为null。",
    "分子诊断营收：迈瑞医疗2025年报仅披露「体外诊断类产品」122.41亿元（占36.78%），未单列分子诊断，记为null。",
    "分子诊断营收：安图生物2025年报按试剂36.13亿/仪器5.21亿拆分，未单列分子诊断，记为null。",
    "分子诊断营收：新产业2025年几乎全部收入来自化学发光与生化，分子诊断未单独披露（2026年9月才获PCR系统注册证），记为null。",
    "分子诊断营收：迈克生物2025年报按自主产品/代理产品拆分，分子诊断未单列，记为null。",
    "分子诊断营收：亚辉龙为化学发光/免疫平台企业，无分子诊断业务板块，记为null。",
    "注册证号：凯普SOX1/PAX1甲基化、硕世七项呼吸道与腺病毒抗原、HPV分型、圣湘一体机、迈克骨代谢三项、亚辉龙微流控6项试剂及2款仪器，公开报道未列证号，记为null（非「无证」）。",
    "2026年三季报（2026Q1-Q3）截至2026-10-18尚未披露，2026全年数据缺失。",
    "达安基因2025年「六项呼吸道病原体核酸检测试剂盒」仅有年报文字表述，未检索到单独获证公告日期，日期记为「2025年内」。"
  ]
}