Industry Leaders “Decipher” the Future Trends of Veterinary Chemical Pharmaceuticals

On the afternoon of September 16, the Chemical Pharmaceuticals and Traditional Chinese Veterinary Medicine Sub‑Forum of the High‑Level Forum on Veterinary Drug Industry Development and Livestock Product Safety was solemnly convened in the VIP Hall on the third floor of the Luoyang Modu Lihao International Hotel. Li Xiangdong, Vice President of the China Veterinary Drug Association, delivered a speech, expressing gratitude for the strong support from the Veterinary Bureau, the National Institute for Food and Drug Control, and the Henan Provincial Bureau, as well as for the enthusiastic participation of the leaders of leading veterinary drug enterprises and the representatives present. He emphasized that the central theme of the conference is “innovation”—including innovation in science and technology, management, and economic marketing—and that fostering innovative concepts and ways of thinking is the original driving force behind the industry’s development.

Xu Shixin, Director of the Safety Evaluation Department at the China Institute of Veterinary Drug Supervision, — Unveiling the “Antibiotic Ban”

Director Xu Shixin first outlined international standards for antibiotic use and highlighted that several drugs recently withdrawn in the United States and the European Union pose risks to food safety and environmental pollution. Using 2013 national data on antimicrobial use in China’s livestock sector, he estimated that 84,240 tons of antimicrobials were employed—equivalent to 16.2 kg per ton of meat produced. By contrast, Denmark, which adheres to EU standards, uses only 40–50 grams of antimicrobials per ton of meat, a difference of nearly twentyfold. This disparity underscores the overuse of antimicrobials in China. The Ministry of Agriculture withdrew four fluoroquinolone‑type antimicrobials because they are used in both humans and animals and lack established food‑safety limits and maximum residue limits (MRLs).

He particularly emphasized that “ban on antibiotics” should not be misinterpreted; rather, it should be understood as a “restriction on antibiotic use,” limiting the application of antimicrobial agents. Antibiotics are not to be used in food-producing animals, but they may be used in pets—provided they are administered prudently and appropriately.

Director Xu Shixin advocates strengthening research and development of antiparasitic drugs for herbivores, developing animal‑specific antibacterial agents, and creating veterinary medicines that are not intended for human use. He also proposes revising the definition of new veterinary drugs to include products that are unique to animals—drugs that do not exist either domestically or internationally—and extending the protection period for new veterinary drugs: ten years for Class I, seven years for Class II, and five years for formulations. Additionally, he calls for increased support for innovative scientific research and the outsourcing of GLP/GCP services, particularly safety‑evaluation services.

Professor Zeng Jianguo of Hunan Agricultural University — “Innovation in Traditional Chinese Veterinary Medicine and the Development of Feed-Grade Plants”

The markets for veterinary Chinese herbal medicines and medicinal plants used in animal husbandry overlap; therefore, emphasis should be placed on developing both veterinary Chinese medicines and feed‑grade medicinal plants. Veterinary Chinese medicines and human‑use Chinese medicines do not intersect, as feed‑grade resources typically consist of parts that are either unused or seldom utilized in human medicine. Research and development of veterinary Chinese herbal medicines is an essential strategy for controlling the cost of feed additives.

Chairman Li Chaoyang of Shandong Xinde Technology Co., Ltd. — “How Traditional Veterinary Pharmaceutical Enterprises Can Transform in the New Normal”

The “new normal” for veterinary pharmaceutical companies is a further restructuring of the livestock‑raising sector, with farming becoming increasingly large‑scale and intensive. Food safety has become a critical survival factor for producers, while the industry’s downturn has persisted. Meanwhile, well‑capitalized major veterinary firms are adopting more assertive strategies, and the mandatory implementation of QR‑code labeling is gaining momentum. Veterinary pharmaceutical companies seeking transformation face relatively higher entry barriers in areas such as biologics, active pharmaceutical ingredients, and traditional Chinese medicine extraction; they are also pursuing product upgrades, enhancing the efficacy of generic drugs, exploring new markets in pets and fur‑bearing animals, and narrowing their competitive footprint—while embracing digital transformation (either through “Internet Plus” or by leveraging the Internet). For such transformations to succeed, in addition to strong leadership commitment and resolve, companies must have solid resource foundations and develop organizational capabilities that align with their new business models.

Li Shoujun, President of Tianjin Ripu Biotechnology Co., Ltd. — “Reflections on the Transformation and Development Trends of the Veterinary Pharmaceutical Industry”

General Manager Li began by outlining the current state of China’s veterinary pharmaceutical industry and the challenges it faces: ① Veterinary firms are small and fragmented, with low industry concentration and overcapacity; ② The review procedures and efficiency for veterinary products that meet the needs of modern animal husbandry urgently require improvement; ③ Fierce price‑driven competition, substandard practices, weak R&D aspirations, inadequate intellectual‑property protection, and dispersed R&D resources are the primary factors whereby high‑quality products are undermined by inferior ones; ④ Regional regulatory oversight remains uneven, with persistent management gaps, while a sluggish livestock sector has fueled robust supply and demand between small and medium‑sized enterprises and counterfeit‑producing firms.

After more than a century of development, foreign companies have established large-scale, automated farming operations. With policies gradually being liberalized, if these foreign firms enter the domestic market, Chinese enterprises will find it extremely challenging to maintain their current position in China.

Director Duan Wenlong, Chemical Drug Review Division, Veterinary Drug Review Center, Ministry of Agriculture — “A Preview of the Amendments to Announcement No. 442 and Emerging Trends in New Veterinary Drug Development”

There are four aspects that need to be considered in the evaluation of veterinary drugs:

① Veterinary medicines and safety assessments must be safe and controllable, ensuring the safety of food of animal origin and public health; ② Current veterinary drug policies should promote the scientific standardization and sustainable development of the veterinary pharmaceutical industry; ③ Veterinary drug approval processes must safeguard national interests, public interests, and the interests of users; ④ They must withstand scrutiny in terms of fiscal resource allocation.

The five requirements for review activities are:

① The review process shall be scientific, standardized, professional, and transparent; ② The review procedures shall comply with the requirements of openness and transparency; ③ The review process shall stand the test of time; ④ It shall withstand oversight and inspection; ⑤ It shall meet the requirements for electronic supervision.

Trends in New Veterinary Drug Development: ① Process‑related considerations: Following approval, new veterinary drugs should be swiftly translated into industrial production; registrants and review authorities must ensure seamless coordination; and R&D efforts should be more in‑depth and better articulated. ② The definition of “new veterinary drug” should be revised to align with international standards. ③ New drug development should be guided by clinical outcomes. ④ Classification should no longer rely solely on the active ingredient; it should also encompass other factors, including formulation aspects, to foster industry advancement. ⑤ Registration dossiers must include information on the stage of development, technical sophistication, and risk factors. ⑥ The post‑approval monitoring period, originally intended for adverse‑reaction surveillance, now serves to provide administrative protection. ⑦ The question remains: Is the new drug genuinely innovative, or merely an imitative innovation?

In response to future regulatory reforms and development trends in the veterinary pharmaceutical industry, the sub‑forum featured on‑site interactive Q&A sessions. Lin Diansheng, Director of the Drug Administration and Medical Device Division of the Veterinary Bureau of the Ministry of Agriculture; Duan Wenlong, Director of the Chemical Drug Review Division at the Veterinary Drug Review Center of the Ministry of Agriculture; Xu Shixin, Director of the Safety Evaluation Office at the China Veterinary Drug Supervision Institute; Zhao Yanling, Director of the Hebei Provincial Veterinary Drug and Feed Supervision Institute; Ban Fuguo, Director of the Henan Provincial Veterinary Drug Supervision Institute; Professor Zeng Jianguo of Henan Agricultural University; Li Shoujun, President of Tianjin Ruipu Biotechnology Co., Ltd.; Li Chaoyang, Chairman of Shandong Xinde Technology Co., Ltd.; Wu Liming, Chairman of Baoding Jizhong Pharmaceutical Co., Ltd.; Hu Wei, General Manager of Luoyang Huizhong Biotechnology Co., Ltd.; and Wei Lijuan, Technical Director of Hebei Yuanzheng Pharmaceutical Co., Ltd., engaged with the attendees. The session was chaired by Jiang Housheng, President of Beijing Shengtai’er Technology Co., Ltd. During the discussion, Director Lin Diansheng disclosed that the Veterinary Bureau is drafting guiding opinions for the pet‑care sector, which will impose stricter regulations; Director Duan Wenlong indicated that new administrative measures for approving pet‑related products are expected to take effect by the end of this year.