{ "schema": "chinese_medi_public_evidence_review_v1", "as_of": "2026-09-21", "generated_at": "2026-09-21T10:00:39.700Z", "review_scope": "Public-source presence and evidence completeness only. Not supplier certification, export authorisation, a legal opinion, or an adverse finding about any company.", "destination_scope": { "user_selection": "No destination selected; public credentials and evidence completeness only", "assessed_markets": [] }, "limitations": [ "Name matching confirms an occurrence in a public directory, not current registration or licensed activity.", "No complete issuer-verified licence/certificate dossier was available for any supplier.", "No batch, importer, manufacturer authorisation or destination-specific product dossier was supplied.", "Successful HTTP retrieval is not verification of page claims or website ownership.", "Failed access, maintenance pages and insufficient text are collection limitations, not evidence of invalid qualifications.", "The NMPA public query portal was accessible; the GSXT entry returned HTTP 403 during this review. No access controls were bypassed." ], "summary": { "suppliers_reviewed": 1000, "products_reviewed": 144, "supplier_names_matched": 1000, "automated_name_matches": 999, "manually_corrected_name_records": 1, "source_requests": 73, "sources_accessible": 64, "source_access_followups": 9, "source_linked_products": 36, "sourcing_candidates": 108, "products_with_source_access_followups": 4, "products_with_limited_regulatory_records": 5, "suppliers_with_completed_qualification_review": 0, "products_with_completed_export_review": 0 }, "gap_dictionary": { "entity_identity": "需核对法定主体、统一社会信用代码及当前登记状态；名录名称出现不是主体认证。", "role_and_site": "需核对实际供货角色与生产地址，不能把品牌或展会所在地当作产地。", "applicable_licence": "按实际生产、经营或代理角色核对适用许可证或备案、覆盖范围及有效期。", "certificate_scope": "需向发证机构核对所提供证书的主体、场所、产品范围、有效期及状态。", "authorized_supply": "需核对供货授权、批次追溯和商业主体关系，名录收录不表示合作。", "product_identity": "需落实完整成分、规格、剂型或设备型号与配置，以及对应生产企业。", "batch_quality": "需取得对应批次检验报告、适用质量标准及储运资料。", "product_primary_source": "目前是待寻源方向，尚无产品级公开来源。", "linked_source_access": "本轮未取得至少一个所链接来源的完整可读正文；不能据此推断产品或企业不合格。", "destination_not_selected": "用户本轮未指定目的地，未进行任何产品与目的地组合的准入判断。" }, "corrections": [ { "id": "CM-SUP-2B80716FEA22", "source_url": "https://efile.imsinoexpo.com/efile/CPhI/file/2026-CPHI-Guide.pdf#page=53", "page": 53, "booth": "E5B90", "corrected_name_zh": "山东海根生物技术有限公司", "corrected_name_en": "Shandong Haigen Biotechnogy Co.,Ltd（Haigen Bio-tech）", "note": "英文括号中的 Haigen 跨列进入中文名称，已按指南文字修正；原始英文拼写及稳定编号保留。" }, { "id": "R01/E06", "source_url": "https://english.nmpa.gov.cn/2025-12/24/c_1156463.htm", "page_updated_at": "2025-12-24", "document_signed_at": "2025-11-17", "effective_at": "2026-01-01", "note": "英文页面更新时间不是文件公告日期；未取得准确网页发布日期的字段留空。" } ], "regulatory_records": [ { "id": "REG-01", "product_id": "P08-04", "jurisdiction": "US", "record_type": "historical_accelerated_approval", "event_date": "2025-07-02", "product": "ZEGFROVY (sunvozertinib)", "source_url": 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"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-toripalimab-tpzi-nasopharyngeal-carcinoma", "scope": "FDA 历史批准公告，不替代现行许可、标签或采购主体授权复核。", "checked_at": "2026-09-21", "destination_eligibility_decision": null }, { "id": "REG-04", "product_id": "P09-02", "jurisdiction": "EU", "record_type": "marketing_authorisation_epar", "event_date": "2024-09-19", "product": "LOQTORZI (toripalimab)", "source_url": "https://www.ema.europa.eu/en/medicines/human/EPAR/loqtorzi", "scope": "EMA EPAR 记录该品牌的欧盟上市许可事件；本库未把该许可扩展为其他版本或供应商的准入结论。", "checked_at": "2026-09-21", "destination_eligibility_decision": null }, { "id": "REG-05", "product_id": "P09-03", "jurisdiction": "US", "record_type": "historical_initial_approval_snapshot", "event_date": "2024-03-14", "product": "TEVIMBRA (tislelizumab-jsgr)", "source_url": "https://www.fda.gov/drugs/drug-trials-snapshots/drug-trials-snapshots-tevimbra", "scope": "FDA 首次批准资料快照，后续适应证、许可变更及实际供货资格另行核对。", "checked_at": "2026-09-21", 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