397 lines
14 KiB
JSON
397 lines
14 KiB
JSON
{
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"slug": "o-glycosidase-feasibility-2026",
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"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",
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"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",
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"author": "Deep Research 系统",
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"date": "2026-04-20",
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"type": "研究",
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"target_words": 35000,
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"min_words": 30000,
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"audience": "混合（公司管理层 + 研发负责人为主，兼顾投资/BD 视角）",
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"time_range": "近 5 年（2021-2026），机制与历史部分可追溯更早文献",
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"geography": "全球为主，含中国国产替代视角",
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"core_questions": [
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"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",
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"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？",
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"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？",
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"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",
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"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",
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"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"
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],
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"comparison_targets": [
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{
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"name": "NEB O-Glycosidase (Enterococcus faecalis)",
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"catalog": "P0733",
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"source": "New England Biolabs",
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"note": "重组表达，主要切除 Core 1 / Core 3 未修饰 O-聚糖"
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},
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{
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"name": "Merck/Sigma O-Glycosidase (Streptococcus pneumoniae)",
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"catalog": "O2024 / 36405",
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"source": "Merck/Sigma-Aldrich",
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"note": "天然或重组来源，经典 O-糖苷酶"
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},
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{
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"name": "Roche/Genovis OpeRATOR",
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"catalog": "参照对象（下一代）",
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"source": "Genovis AB",
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"note": "可切除唾液酸化 O-聚糖，作为差异化方向的参照系"
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}
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],
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"exclusions": [
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"不深入专利撰写层面的实操细节，只做 FTO 判断与绕开思路",
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"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"
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],
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"data_sources_required": [
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"PubMed / Google Scholar（机制与酶学文献）",
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"USPTO / EPO / CNIPA / Google Patents（FTO 分析）",
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"NEB / Merck / Roche / Genovis 官网产品手册与技术资料",
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"ClinicalTrials.gov（如涉及临床级应用）",
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"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）",
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"EvaluatePharma 替代公开源：Frost & Sullivan 公开摘要、Grand View Research 报告摘要"
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],
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"version": "0.1",
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"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。",
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"phase1": {
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"status": "approved",
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"approved": true,
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"approved_at": "2026-04-20T23:10:00+08:00",
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"framework_path": "projects/o-glycosidase-feasibility-2026/phase1/framework.md",
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"initial_scan_path": "projects/o-glycosidase-feasibility-2026/phase1/initial-scan.md",
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"chapter_count": 12,
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"active_framework": "C",
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"framework_name": "决策驱动（Decision-Driven）",
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"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。",
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"chapter_quotas": [
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{
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"index": 1,
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"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",
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"quota": 2450,
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"priority": "intro"
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},
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{
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"index": 2,
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"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\"？",
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"quota": 4200,
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"priority": "P0"
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},
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{
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"index": 3,
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"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？",
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"quota": 3850,
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"priority": "P0"
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},
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{
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"index": 4,
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"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？",
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"quota": 3150,
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"priority": "P1"
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},
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{
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"index": 5,
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"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？",
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"quota": 3150,
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"priority": "P1"
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},
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{
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"index": 6,
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"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？",
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"quota": 2450,
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"priority": "P1"
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},
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{
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"index": 7,
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"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？",
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"quota": 2800,
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"priority": "P1"
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},
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{
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"index": 8,
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"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？",
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"quota": 2450,
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"priority": "P1"
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},
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{
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"index": 9,
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"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",
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"quota": 2800,
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"priority": "P1"
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},
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{
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"index": 10,
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"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",
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"quota": 3850,
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"priority": "P0"
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},
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{
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"index": 11,
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"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",
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"quota": 2100,
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"priority": "P2"
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},
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{
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"index": 12,
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"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",
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"quota": 3500,
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"priority": "conclusion"
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}
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],
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"total_quota": 36800,
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"alternative_frameworks": [
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{
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"name": "A",
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"theme": "技术–竞争–实施三段式",
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"audience_fit": "混合受众均衡"
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},
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{
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"name": "B",
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"theme": "按技术成熟度金字塔（自下而上）",
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"audience_fit": "研发为主"
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}
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],
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"framework_switch_log": [
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{
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"from": "A",
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"to": "C",
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"at": "2026-04-20",
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"reason": "用户主动要求换成决策驱动版"
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}
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]
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},
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"phase2": {
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"status": "completed",
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"started_at": "2026-04-20T23:30:00+08:00",
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"resumed_at": "2026-04-21T06:47:00+08:00",
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"completed_at": "2026-04-21T08:10:00+08:00",
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1,
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2,
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3
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],
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"note": "引言章 + 2 个 P0 核心章（技术门槛 + IP 路径）",
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"status": "completed"
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},
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{
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"batch": 2,
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"chapters": [
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4,
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5,
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6
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],
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"note": "宿主工艺 + 客户切入 + 定价博弈",
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"status": "completed"
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},
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{
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"batch": 3,
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"chapters": [
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7,
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8,
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9
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"note": "SKU 范围 + 组织模式 + 时间风险",
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"status": "completed"
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},
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{
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"batch": 4,
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"chapters": [
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10,
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11,
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12
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],
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"note": "前瞻（P0）+ 差异化整合 + 结论章",
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"status": "completed"
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}
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],
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|
||
"final_md_path": "projects/o-glycosidase-feasibility-2026/phase4/final.md",
|
||
"completed_at": "2026-04-21T08:59:22",
|
||
"pdf_path": "projects/o-glycosidase-feasibility-2026/phase4/final.pdf",
|
||
"docx_path": "projects/o-glycosidase-feasibility-2026/phase4/final.docx"
|
||
}
|
||
} |