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)

MOA Announcement No. 1026 — 10 New Veterinary Drugs Including Dog Distemper Antiserum and Mink Distemper Vaccine (2026-06-04)

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》).

The 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.

> Source: Ministry of Agriculture and Rural Affairs, *Announcement No. 1026* (农业农村部公告第1026号), 2026-06-04.

Annex 1 — New Veterinary Drug Registration Catalogue (附件1 新兽药注册目录)

Pet-Specific New Drugs (宠物专用新兽药)

1. Gralen / Gralen Tablets (格拉匹仑 / 格拉匹仑片) — canine osteoarthritis analgesia (犬用骨关节炎镇痛)

Package insert excerpt (from PDF attachment, pp. 1–3, labeled pet-use / 宠物用):

• Generic name (通用名称): 格拉匹仑片 (Gralen Tablets)
• 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)
• 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)
• 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)
• 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)

> 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 / /

2. Canine Distemper Virus Antiserum (犬瘟热病毒抗血清) — pet-use (宠物用)

> 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 / /

3. Itraconazole Ointment (伊曲康唑软膏) — pet antifungal (宠物用抗真菌)

Notable 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).

Other Livestock / New-Technology Drugs (其他畜禽/新技术药物)

4. Mink Distemper Live Vaccine (HL001-M3 Strain) (水貂犬瘟热活疫苗（HL001-M3株）)

> 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 / /

5. Fowl Adenovirus (Group I, Type 4) Egg-Yolk Antibody (禽腺病毒（Ⅰ群，4型）卵黄抗体)

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)

• 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
• Pseudorabies Live Vaccine (NVC01 Strain) (猪伪狂犬病活疫苗（NVC01株）) — certificate 证字61号
• 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
• Chicken Bursin Injection (鸡法氏囊素注射液) — certificate 证字64号

Pet Diagnostic Reagents (宠物诊断试剂 in Registration Catalogue)

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)

> 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... / / / / /

This duplex PCR reagent simultaneously detects feline coronavirus (FCoV) and feline panleukopenia virus (FPV), providing a multiplexed molecular diagnostic tool for companion-animal clinics.

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Source: pdf-raw/cn-approvals/ivdc-202606-t20260605_63436.html (126KB) · 农业农村部公告第1026号 (2026-06-04)