Beijing, China – 04 Sep 2026 – China’s National Medical Products Administration (NMPA) announced that, pursuant to the Regulations on the Protection of Traditional Chinese Medicine Varieties, five traditional Chinese medicine (TCM) products have been approved as first‑instance Class II protected TCM varieties, each receiving a protection term of seven years from the announcement date. The designated products are Jinrong Granules of Guangzhou Qiji Pharmaceutical Technology Co., Ltd., Compound Ciwujia Granules of Heilongjiang Hanhong Pharmaceutical Co., Ltd., Xiao’er Chaigui Antipyretic Oral Liquid of Jilin Aodong Yanbian Pharmaceutical Co., Ltd., Danlong Oral Liquid of Zhejiang Kangde Pharmaceutical Group Co., Ltd., and Compound Shangtong Capsules of Licai Gansu Xifeng Pharmaceutical Co., Ltd. (Announcement No. 38, 2026 No. 89).
Regulatory Milestone
| Item | Detail |
|---|---|
| Agency | NMPA (China) |
| Announcement | Announcement on Protected TCM Varieties No. 38 (2026 No. 89) |
| Legal Basis | Regulations on the Protection of Traditional Chinese Medicine Varieties |
| Designation | Class II protected TCM varieties – first instance (initial protection) |
| Protection Term | Seven years from the announcement date (through September 2033) |
| Announcement Date | 4 September 2026 |
Protected Products & Manufacturers
| Product | Manufacturer | Protection No. |
|---|---|---|
| Jinrong Granules (金蓉颗粒) | Guangzhou Qiji Pharmaceutical Technology Co., Ltd. (private) | ZYB2072026021 |
| Compound Ciwujia Granules (复方刺五加颗粒) | Heilongjiang Hanhong Pharmaceutical Co., Ltd. (private) | ZYB2072026019 |
| Xiao’er Chaigui Antipyretic Oral Liquid (小儿柴桂退热口服液) | Jilin Aodong Yanbian Pharmaceutical Co., Ltd. – affiliate of listed Jilin Aodong Pharmaceutical Group (000623.SZ) | ZYB2072026020 |
| Danlong Oral Liquid (丹龙口服液) | Zhejiang Kangde Pharmaceutical Group Co., Ltd. (private) | ZYB2072026023 |
| Compound Shangtong Capsules (复方伤痛胶囊) | Licai Gansu Xifeng Pharmaceutical Co., Ltd. (private) | ZYB2072026022 |
- Dosage Forms Covered: granules, oral liquids, and capsules – reflecting the breadth of TCM manufacturing formats recognized in this batch.
- Indications & Clinical Data: Not restated in the announcement; no therapeutic claims or trial figures were disclosed.
Protection Framework – Class II TCM Variety Status
- Scope: Under the TCM Variety Protection Regulations, a protected variety enjoys market exclusivity during the protection term; unauthorized enterprises may not produce the same variety, subject to statutory procedures for prior producers within prescribed deadlines.
- Term Structure: Initial Class II protection runs seven years – consistent with the term stated in the announcement; holders may apply for extension upon expiry in accordance with the regulations.
- Strategic Value: The designation functions as a TCM‑specific exclusivity instrument, complementing patents and trade‑secret protection to deter copycat production of established formulations.
Market Impact & Outlook
- Exclusivity Window: All five varieties are shielded through September 2033, granting holders a multi‑year moat against new entrants seeking to launch the same formulations.
- Listed‑Company Angle: Jilin Aodong Pharmaceutical Group (000623.SZ) reinforces its pediatric product portfolio through the protection of its Yanbian affiliate’s Xiao’er Chaigui Antipyretic Oral Liquid; the remaining four holders are private companies.
- TCM Policy Tailwind: The batch designation aligns with Beijing’s sustained policy support for TCM innovation and quality upgrading, with the NMPA deploying the variety‑protection system to reward established products.
- Financial Impact: Revenue contribution and pricing implications were not disclosed in the announcement.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding the regulatory status, protection timelines, and commercial expectations for the five protected TCM varieties. Actual outcomes may differ due to risks including extension decisions, changes in TCM regulation, market competition, and pricing policy.-China Health Reform Pulse
Policy Source: https://www.nmpa.gov.cn/xxgk/ggtg/ypggtg/zhybhpzh/zhybhpzhgg/20260908150355107.html