{"topic_id":"cn_moa_ann1026_new_veterinary_drugs_pet","category":"cn-2026-approvals","context":"---\ntopic_id: cn_moa_ann1026_new_veterinary_drugs_pet\ncategory: cn-2026-approvals\ntitle: \"农业农村部公告第1026号 (MOA Announcement No. 1026) — 10 New Veterinary Drugs Including Dog Distemper Antiserum and Mink Distemper Vaccine (2026-06-04)\"\nlang: en\nsource: ivdc-202606-t20260605_63436.html\ndate_parsed: 2026-07-21\ntokens_estimated: 1000\nverification:\n  method: substring_match\n  claims: 7\n  passed: 7\n  date: 2026-07-21\nsource_document: \"China MOA Announcement / 农业农村部公告 (2026 approvals) — 公告第1026号\"\ncitation:\n  authority: \"China MOA — Announcement & Gazette series\"\n  title: \"农业农村部公告第1026号 (MOA Announcement No. 1026) — 10 New Veterinary Drugs Including Dog Distemper Antiserum and Mink Distemper Vaccine (2026-06-04)\"\n  url: \"\"\n  retrieved: \"2026-07-21\"\n  ref: \"公告第1026号\"\n  doc_type: \"official web page\"\n  needs_review: true\nauthority_tier: T1\nauthority_tier_basis: \"T1:cn-gov\"\nauthority_tier_date: 2026-08-04\n---\n\n# MOA Announcement No. 1026 — 10 New Veterinary Drugs Including Dog Distemper Antiserum and Mink Distemper Vaccine (2026-06-04)\n\n**MOA Announcement No. 1026** (农业农村部公告第1026号) was issued by the Ministry of Agriculture and Rural Affairs on **2026年6月4日** (June 4, 2026), pursuant to the *Regulations on the Administration of Veterinary Drugs* (《兽药管理条例》) and the *Measures for the Registration of Veterinary Drugs* (《兽药注册办法》).\n\nThe announcement approves **10 new veterinary drugs** (新兽药), **4 veterinary drug product registrations** (兽药产品注册), and **3 change registrations** (变更注册), effective from the date of promulgation.\n\n> Source: Ministry of Agriculture and Rural Affairs, *Announcement No. 1026* (农业农村部公告第1026号), 2026-06-04.\n\n## Annex 1 — New Veterinary Drug Registration Catalogue (附件1 新兽药注册目录)\n\n### Pet-Specific New Drugs (宠物专用新兽药)\n\n#### 1. Gralen / Gralen Tablets (格拉匹仑 / 格拉匹仑片) — canine osteoarthritis analgesia (犬用骨关节炎镇痛)\n\n| Field | Detail |\n|---|---|\n| Class (类别) | Category 2 (二类) |\n| Registration certificate (新兽药注册证书号) | （2026）新兽药证字56号 / 57号 |\n| Monitoring period (监测期) | 4 years (4年) |\n| Research units (研制单位) | 湖北龙翔药业科技股份有限公司、瑞普生物股份有限公司 et al. |\n\n**Package insert excerpt (from PDF attachment, pp. 1–3, labeled pet-use / 宠物用):**\n- **Generic name (通用名称):** 格拉匹仑片 (Gralen Tablets)\n- **Indications (适应症):** 用于控制犬骨关节炎的疼痛和炎症 (For control of pain and inflammation associated with osteoarthritis in dogs)\n- **Usage and dosage (用法用量):** 以格拉匹仑计；内服：每1kg体重，犬2mg，一日1次 (Calculated as gralen; oral: 2 mg per kg body weight, once daily for dogs)\n- **Pharmacokinetics (药动学):** 犬以每1kg体重2mg单次空腹内服后，吸收迅速，血药浓度达峰时间（Tmax）约为1小时，血药峰浓度（Cmax）约为951ng/ml (After a single fasted oral dose of 2 mg/kg in dogs, absorption is rapid; Tmax ≈ 1 h; Cmax ≈ 951 ng/ml)\n- **Adverse reactions (不良反应):** 犬常见的不良反应为呕吐、软便、腹泻和食欲下降 (Common adverse reactions in dogs: vomiting, soft stools, diarrhea and decreased appetite)\n\n> Source text: `格拉匹仑片 / 瑞普（天津）生物药业有限公司... / 二类 / （2026）新兽药证字57号 / 4年 / /`\n\n#### 2. Canine Distemper Virus Antiserum (犬瘟热病毒抗血清) — pet-use (宠物用)\n\n| Field | Detail |\n|---|---|\n| Class (类别) | Category 3 (三类) |\n| Registration certificate (新兽药注册证书号) | （2026）新兽药证字59号 |\n| Monitoring period (监测期) | 3 years (3年) |\n| Research units (研制单位) | 瑞普生物股份有限公司、天津瑞普生物技术股份有限公司空港经济区分公司、瑞普（保定）生物药业有限公司 |\n\n> Source text: `犬瘟热病毒抗血清 / 瑞普生物股份有限公司、天津瑞普生物技术股份有限公司... / 三类 / （2026）新兽药证字59号 / 3年 / /`\n\n#### 3. Itraconazole Ointment (伊曲康唑软膏) — pet antifungal (宠物用抗真菌)\n\n| Field | Detail |\n|---|---|\n| Class (类别) | Category 4 (四类) |\n| Registration certificate (新兽药注册证书号) | （2026）新兽药证字65号 |\n| Monitoring period (监测期) | 3 years (3年) |\n| Research units (研制单位) | 青岛蔚蓝至宠生物科技有限公司、青岛蔚蓝生物股份有限公司、江西保灵动物保健品有限公司、江苏朗博特动物药品有限公司 et al. |\n\nNotable research units include **青岛蔚蓝至宠生物科技有限公司** (a dedicated pet subsidiary) and **上海信元动物药品有限公司** (another pet pharmaceutical company).\n\n### Other Livestock / New-Technology Drugs (其他畜禽/新技术药物)\n\n#### 4. Mink Distemper Live Vaccine (HL001-M3 Strain) (水貂犬瘟热活疫苗（HL001-M3株）)\n\n| Field | Detail |\n|---|---|\n| Class (类别) | Category 3 (三类) |\n| Registration certificate (新兽药注册证书号) | （2026）新兽药证字62号 |\n| Research units (研制单位) | 普莱柯生物工程股份有限公司、洛阳惠中生物技术有限公司 |\n\n> Source text: `水貂犬瘟热活疫苗（HL001-M3株） / 普莱柯生物工程股份有限公司... / 三类 / （2026）新兽药证字62号 / 3年 / /`\n\n#### 5. Fowl Adenovirus (Group I, Type 4) Egg-Yolk Antibody (禽腺病毒（Ⅰ群，4型）卵黄抗体)\n\n| Field | Detail |\n|---|---|\n| Class (类别) | Category 3 (三类) |\n| Registration certificate (新兽药注册证书号) | （2026）新兽药证字58号 |\n\n#### 6–10. Other drugs (poultry vaccines, swine vaccines, feed additive) (其他药物：禽用疫苗、猪用疫苗、饲料添加剂)\n\n- **Newcastle Disease, Infectious Bronchitis, Egg-Drop Syndrome Combined Inactivated Vaccine (鸡新城疫、传染性支气管炎、减蛋综合征三联灭活疫苗)** — certificate 证字60号\n- **Pseudorabies Live Vaccine (NVC01 Strain) (猪伪狂犬病活疫苗（NVC01株）)** — certificate 证字61号\n- **Porcine Circovirus Type 2 + Mycoplasma Hyopneumoniae Combined Inactivated Vaccine (Cap protein + CJX Strain) (猪圆环病毒2型、猪肺炎支原体二联灭活疫苗（Cap蛋白+CJX株）)** — certificate 证字63号\n- **Chicken Bursin Injection (鸡法氏囊素注射液)** — certificate 证字64号\n\n## Pet Diagnostic Reagents (宠物诊断试剂 in Registration Catalogue)\n\n### Feline Coronavirus + Feline Panleukopenia Virus Duplex Fluorescent PCR Detection Kit (猫冠状病毒、猫泛白细胞减少症病毒二重荧光PCR检测试剂盒)\n\n| Field | Detail |\n|---|---|\n| Research units (研制单位) | 基灵（西安）生物科技有限公司、上海基灵生物科技有限公司、上海市动物疫病预防控制中心 |\n\n> Source text: `猫冠状病毒、猫泛白细胞减少症病毒二重荧光PCR检测试剂盒 / 基灵（西安）生物科技有限公司... / / / / /`\n\nThis duplex PCR reagent simultaneously detects feline coronavirus (FCoV) and feline panleukopenia virus (FPV), providing a multiplexed molecular diagnostic tool for companion-animal clinics.\n\n---\n\n**Source:** `pdf-raw/cn-approvals/ivdc-202606-t20260605_63436.html` (126KB) · 农业农村部公告第1026号 (2026-06-04)\n","sources":["China MOA — Announcement & Gazette series — 农业农村部公告第1026号 (MOA Announcement No. 1026) — 10 New Veterinary Drugs Including Dog Distemper Antiserum and Mink Distemper Vaccine (2026-06-04) (retrieved 2026-07-21)"],"source":{"authority":"China MOA — Announcement & Gazette series","title":"农业农村部公告第1026号 (MOA Announcement No. 1026) — 10 New Veterinary Drugs Including Dog Distemper Antiserum and Mink Distemper Vaccine (2026-06-04)","url":"http://www.moa.gov.cn/","retrieved":"2026-07-21","ref":"公告第1026号","doc_type":"official web page","source_document":"China MOA Announcement / 农业农村部公告 (2026 approvals) — 公告第1026号","verification_file":"ivdc-202606-t20260605_63436.html"},"source_document":"China MOA Announcement / 农业农村部公告 (2026 approvals) — 公告第1026号","source_file":"ivdc-202606-t20260605_63436.html","trust":{"authority_tier":"T1","fidelity":"verbatim","license":null,"display_grade":"A"},"tokens_estimated":1000,"generated_at":null,"tip":"Use /api/v1/topics to discover more topics. /api/v1/nutrient for precise single-point queries. /api/v1/cross_compare for 2-3 standard comparisons."}