{
  "slug": "o-glycosidase-feasibility-2026",
  "topic": "评估对标 NEB 的 Enterococcus faecalis 和默克的 Streptococcus pneumoniae 两种 O-糖苷酶，自主开发的可行性、实施方案与差异化创新点",
  "subtitle": "面向糖蛋白分析与生物药去糖基化工艺的 O-糖苷酶自主研发立项可行性研究",
  "author": "Deep Research 系统",
  "date": "2026-04-20",
  "type": "研究",
  "target_words": 35000,
  "min_words": 30000,
  "audience": "混合（公司管理层 + 研发负责人为主，兼顾投资/BD 视角）",
  "time_range": "近 5 年（2021-2026），机制与历史部分可追溯更早文献",
  "geography": "全球为主，含中国国产替代视角",
  "core_questions": [
    "Q1: NEB (E. faecalis, P0733) 与 Merck (S. pneumoniae, O2024) 两款 O-糖苷酶在酶学本质（底物特异性、活性、稳定性、表达体系）上的差异，以及各自的市场定位与份额",
    "Q2: 自主开发是否存在专利壁垒？FTO 分析结论与绕开路径有哪些？",
    "Q3: 重组表达技术路线选型（E. coli / Pichia pastoris / CHO / Bacillus），哪种最优？关键难点在哪？",
    "Q4: 现有产品的核心痛点（价格、活性、底物范围、稳定性、批次一致性）及可切入的差异化机会",
    "Q6: 从克隆到上市的典型研发时间表、预算估算、关键里程碑与风险点",
    "Q8: 下一代 O-糖苷酶（可处理唾液酸化、岩藻糖化、硫酸化等复杂 O-聚糖底物的工程酶，如 Roche OpeRATOR、IMPa 等）的技术前沿与差异化机会"
  ],
  "comparison_targets": [
    {
      "name": "NEB O-Glycosidase (Enterococcus faecalis)",
      "catalog": "P0733",
      "source": "New England Biolabs",
      "note": "重组表达，主要切除 Core 1 / Core 3 未修饰 O-聚糖"
    },
    {
      "name": "Merck/Sigma O-Glycosidase (Streptococcus pneumoniae)",
      "catalog": "O2024 / 36405",
      "source": "Merck/Sigma-Aldrich",
      "note": "天然或重组来源，经典 O-糖苷酶"
    },
    {
      "name": "Roche/Genovis OpeRATOR",
      "catalog": "参照对象（下一代）",
      "source": "Genovis AB",
      "note": "可切除唾液酸化 O-聚糖，作为差异化方向的参照系"
    }
  ],
  "exclusions": [
    "不深入专利撰写层面的实操细节，只做 FTO 判断与绕开思路",
    "不做具体的财务估值模型（DCF/NPV 详细计算），但保留预算量级估算"
  ],
  "data_sources_required": [
    "PubMed / Google Scholar（机制与酶学文献）",
    "USPTO / EPO / CNIPA / Google Patents（FTO 分析）",
    "NEB / Merck / Roche / Genovis 官网产品手册与技术资料",
    "ClinicalTrials.gov（如涉及临床级应用）",
    "上市公司披露（NEB 母公司、Merck、Bio-Techne、华大智造、诺唯赞、近岸蛋白等）",
    "EvaluatePharma 替代公开源：Frost & Sullivan 公开摘要、Grand View Research 报告摘要"
  ],
  "version": "0.1",
  "disclaimer": "本报告基于公开信息与 AI 辅助研究生成，仅供参考，不构成投资或医疗建议。",
  "phase1": {
    "status": "approved",
    "approved": true,
    "approved_at": "2026-04-20T23:10:00+08:00",
    "framework_path": "projects/o-glycosidase-feasibility-2026/phase1/framework.md",
    "initial_scan_path": "projects/o-glycosidase-feasibility-2026/phase1/initial-scan.md",
    "chapter_count": 12,
    "active_framework": "C",
    "framework_name": "决策驱动（Decision-Driven）",
    "central_thesis": "对标 NEB 和 Merck 单纯复制经典 O-糖苷酶是一条技术可行但商业价值有限的红海赛道；真正的立项机会在于以国产化价格优势快速切入传统产品、同时投入下一代唾液酸耐受 O-糖肽酶构建 IP 壁垒，形成'短期替代收入 + 中期工程酶毛利 + 长期治疗化前瞻'的三段式双轨战略。",
    "chapter_quotas": [
      {
        "index": 1,
        "title": "立项背景：O-糖苷酶从\"小众试剂\"到\"糖分析工作流关键组分\"的角色跃迁，与三个待决核心问题",
        "quota": 2450,
        "priority": "intro"
      },
      {
        "index": 2,
        "title": "决策 1（技术门槛）：要不要做传统 O-糖苷酶？GH101 的技术门槛是真门槛还是\"竞品构筑的纸老虎\"？",
        "quota": 4200,
        "priority": "P0"
      },
      {
        "index": 3,
        "title": "决策 2（IP 路径）：要不要直接跳到下一代工程酶？专利/IP 到底卡不卡人？",
        "quota": 3850,
        "priority": "P0"
      },
      {
        "index": 4,
        "title": "决策 3（宿主工艺）：用什么宿主？E. coli 是不是唯一选项？B. subtilis 的 60% 工业酶市场能不能复用？",
        "quota": 3150,
        "priority": "P1"
      },
      {
        "index": 5,
        "title": "决策 4（客户切入）：卖给谁？CMC 客户真的会切换供应商吗？CRO/科研/诊断谁是第一桶金？",
        "quota": 3150,
        "priority": "P1"
      },
      {
        "index": 6,
        "title": "决策 5（定价博弈）：定价怎么打？30–50% 折扣策略的可持续性和触发 NEB 反击的临界点？",
        "quota": 2450,
        "priority": "P1"
      },
      {
        "index": 7,
        "title": "决策 6（SKU 范围）：做多宽的 SKU？单酶、组合试剂盒、工作流套装的 FTO 与毛利取舍？",
        "quota": 2800,
        "priority": "P1"
      },
      {
        "index": 8,
        "title": "决策 7（组织模式）：自建还是 CDMO 代工？国内金斯瑞/百斯杰能力能不能承接？",
        "quota": 2450,
        "priority": "P1"
      },
      {
        "index": 9,
        "title": "决策 8（时间与风险）：18 个月能不能见收入？风险矩阵、兜底策略与关键里程碑",
        "quota": 2800,
        "priority": "P1"
      },
      {
        "index": 10,
        "title": "前瞻：下一代工程酶与 mucinase 治疗化——OpeRATOR/IMPa/SmE/eStcE 的红利窗口还有 3–5 年",
        "quota": 3850,
        "priority": "P0"
      },
      {
        "index": 11,
        "title": "差异化创新点整合：唾液酸耐受突变 + 国产供应链 + 诊断/治疗延伸三条差异化轴",
        "quota": 2100,
        "priority": "P2"
      },
      {
        "index": 12,
        "title": "立项决议草案：Go 条件、首期 3,000 万预算分配、90 天行动清单、Kill Criteria",
        "quota": 3500,
        "priority": "conclusion"
      }
    ],
    "total_quota": 36800,
    "alternative_frameworks": [
      {
        "name": "A",
        "theme": "技术–竞争–实施三段式",
        "audience_fit": "混合受众均衡"
      },
      {
        "name": "B",
        "theme": "按技术成熟度金字塔（自下而上）",
        "audience_fit": "研发为主"
      }
    ],
    "framework_switch_log": [
      {
        "from": "A",
        "to": "C",
        "at": "2026-04-20",
        "reason": "用户主动要求换成决策驱动版"
      }
    ]
  },
  "phase2": {
    "status": "completed",
    "started_at": "2026-04-20T23:30:00+08:00",
    "resumed_at": "2026-04-21T06:47:00+08:00",
    "completed_at": "2026-04-21T08:10:00+08:00",
    "current_batch": 4,
    "batches": [
      {
        "batch": 1,
        "chapters": [
          1,
          2,
          3
        ],
        "note": "引言章 + 2 个 P0 核心章（技术门槛 + IP 路径）",
        "status": "completed"
      },
      {
        "batch": 2,
        "chapters": [
          4,
          5,
          6
        ],
        "note": "宿主工艺 + 客户切入 + 定价博弈",
        "status": "completed"
      },
      {
        "batch": 3,
        "chapters": [
          7,
          8,
          9
        ],
        "note": "SKU 范围 + 组织模式 + 时间风险",
        "status": "completed"
      },
      {
        "batch": 4,
        "chapters": [
          10,
          11,
          12
        ],
        "note": "前瞻（P0）+ 差异化整合 + 结论章",
        "status": "completed"
      }
    ],
    "chapters": [
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        "quota": 2450,
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        "completion_pct": 208.7,
        "completed_at": "2026-04-21"
      },
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        "index": 2,
        "title": "决策1 技术门槛",
        "quota": 4200,
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        "completion_pct": 106.6,
        "completed_at": "2026-04-21"
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        "index": 3,
        "title": "决策2 IP路径",
        "quota": 3850,
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        "actual_chars": 6764,
        "draft_path": "projects/o-glycosidase-feasibility-2026/phase2/drafts/ch03.md",
        "evidence_path": "projects/o-glycosidase-feasibility-2026/phase2/evidence/ch03-evidence.md",
        "completion_pct": 175.7,
        "completed_at": "2026-04-21"
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        "index": 4,
        "title": "决策3 宿主工艺",
        "quota": 3150,
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        "actual_chars": 3022,
        "draft_path": "projects/o-glycosidase-feasibility-2026/phase2/drafts/ch04.md",
        "evidence_path": "projects/o-glycosidase-feasibility-2026/phase2/evidence/ch04-evidence.md",
        "completion_pct": 95.9,
        "completed_at": "2026-04-21"
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        "index": 5,
        "title": "决策4 客户切入",
        "quota": 3150,
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        "actual_chars": 3132,
        "draft_path": "projects/o-glycosidase-feasibility-2026/phase2/drafts/ch05.md",
        "evidence_path": "projects/o-glycosidase-feasibility-2026/phase2/evidence/ch05-evidence.md",
        "completion_pct": 99.4,
        "completed_at": "2026-04-21"
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        "completion_pct": 100.0,
        "completed_at": "2026-04-21"
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        "index": 7,
        "title": "决策6 SKU范围",
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        "completed_at": "2026-04-21"
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}