How to Plan Ahead for New Pesticide Product Registration in China: Case Study of Prothioconazole
What is Prothioconazole?
Prothioconazole is a broad-spectrum triazole fungicide with functions of protection, treatment, eradication and good systemic property. It is developed by Bayer and is mainly used to control many diseases of cereal crops such as wheat and barley and other plants such as rape, peanut, rice and legume crops. It has a good control effect on wheat scabs and other wheat diseases. It is one of the top ten fungicides in the world and has been registered and used in more than 60 countries and regions such as the European Union, the United States, Canada and Australia.
Registration of Prothioconazole in China
On January 29, 2019, Anhui Jiuyi Agriculture Co., Ltd. (hereinafter referred to as Jiuyi) and Shandong Hailier Chemical Co., Ltd. (Hailier Pharmaceutical Group Co., Ltd.) seized the opportunity when the prothioconazole compound patent expired to obtain the registration of prothioconazole technical ingredient and preparation, respectively. Jiuyi registered the 97% technical ingredient and 30% dispersible oil suspension formulation on wheat rust, powdery mildew and scab, and in 2022, Jiuyi got the export registration of 250 G/L emulsifiable concentrate.
In 2022, Jiuyi\’s revenue doubled in the first half of the year, successfully listed in the second-board market and raised more than 900 million yuan for the 5000 tons/year prothioconazole technical ingredient synthesis project. According to the information disclosed by Jiuyi, the registration, sales, brand and network construction in China and other places of the technical ingredient and preparation of Prothioconazole, the key product, has been continuously strengthened. See Table 1 for the sales and promotion of technical ingredients and preparations in 2019-2021.
Table 1 Prothioconazole Promotion and Application of Jiuyi from 2019 to 2021
|Product||Year||Sales volume (ton)||Sales (RMB 10,000)||Promotion area (including export)Note|
|Preparation||2019||103.09||2,319.81||2.5772 milion mu times|
|2020||223.98||4,333.84||5.5995 million mu times|
|2021||458.73||8,334.20||11.4683 million times|
Note: Promotion area of preparation = sales volume * 25,000 mu times
At present, Jiuyi is one of the main suppliers of prothioconazole technical material in China with an annual production capacity of 1,000 tons. With the help of REACH24H Consulting Group, Jiuyi obtained the equivalent registration of prothioconazole in the European Union in 2019 and the independent registration in Australia. Jiuyi actively explores international customers and establishes stable cooperation with GLOBACHEM, UPL, HELM and other multinational companies, maintaining a continuously growing overseas sales revenue of prothioconazole products.
As the production technology of prothioconazole technical material continues to mature, the product yield has increased, the output has risen year by year, the unit production cost has decreased in 2020 and 2021, and the gross profit rate has increased. From 2019 to 2021, the gross profit rate of prothioconazole technical ingredient has reached 20.11%, 32.07% and 33.89% respectively. Benefiting from the growth of prothioconazole sales, Jiuyi jumped from 93rd place in 2019 to 78th place in 2021 on the \”China Pesticide Industry Top 100 Enterprises on Sales\”.
Prothioconazole, one of the world\’s top ten fungicides, attracted the attention of many Chinese pesticide enterprises, who started to prepare test data for registration according to the registration requirements when the patent expired or was about to expire. Jiuyi successfully obtained prothioconazole in the last batch of 2019 according to the old pesticide registration data requirements, becoming the first benefited Chinese pesticide enterprise on prothioconazole.
Up to now, the registration of prothioconazole in China is shown in Table 2.
Table 2 Registration of Prothioconazole in China
|Registration Number||Pesticide Name||Pesticide Category||Dosage form||Total content||Expire date||Registration Holder|
|PD20220171||Prothioconazole||Fungicide||Technical ingredient||95%||2027-8-30||Nantong Taihe Chemical Co., Ltd.|
|EX20220078||Prothioconazole·Bixafen·Trifloxystrobin||Fungicide||Suspension agent||450g/L||2027-4-23||Shandong Weifang Rainbow Chemical Co., Ltd.|
|EX20220050||Prothioconazole·Bixafen||Fungicide||EC||225g/L||2027-4-23||Shandong Weifang Rainbow Chemical Co., Ltd.|
|PD20220002||Prothioconazole||Fungicide||Technical ingredient||94%||2027-1-17||Hebei Xingbai Agricultural Technology Co., Ltd.|
|EX20220024||Prothioconazole||Fungicide||EC||250g/L||2027-1-17||Anhui Jiuyi Agriculture Co., Ltd.|
|PD20190041||Prothioconazole||Fungicide||Technical ingredient||95%||2024-1-29||Shandong Hailier Chemical Co., Ltd.|
|PD20190015||Prothioconazole· Carbendazim||Fungicide||Suspension agent||28%||2024-1-29||Hailier Pharmaceutical Group Co., Ltd|
|PD20190014||Prothioconazole·Tebuconazole||Fungicide||Suspension agent||40%||2024-1-29||Jiangsu Liyang Zhongnan Chemical Co., Ltd.|
|PD20190005||Prothioconazole||Fungicide||Dispersible suspending agent||30%||2024-1-29||Anhui Jiuyi Agriculture Co., Ltd.|
|PD20190004||Prothioconazole||Fungicide||Technical ingredient||97%||2024-1-29||Anhui Jiuyi Agriculture Co., Ltd.|
In addition, prothioconazole technical ingredient registration for seven companies, including Wuxi Jiabao Pharmaceutical Co., Ltd., Liaoning Zhonghui Biotechnology Co., Ltd., Shandong United Pesticide Industry Co., Ltd. and Shandong Aokun Crop Science Co. Ltd., Inner Mongolia Lingsheng Crop Science Co., Xiangshui Zhongshan Biotechnology Co., Ltd. And Ningxia Yifan Biotechnology Co., Ltd. were also approved in the seventh batch in 2022 published by the Pesticide Inspection Institute of the Ministry of Agriculture and Rural Areas on September 16, 2022. Many other domestic enterprises have submitted prothioconazole registration data or are preparing to submit registration data for registration. However, how many market shares can the later registered enterprises occupy depends on the global registration layout, market planning and promotion of enterprises.
Tips for Global Enterprises
The successful cases of Jiuyi registering prothioconazole in major markets in China and other places are worth learning. The following tips are summarized for global enterprises registering new pesticides or expired patented pesticides.
- Product selection
Prothioconazole is one of the top ten fungicides in the world, which can prevent and control many diseases of cereal crops such as wheat, and barley, and of other crops such as rape, peanut, rice, and legumes, especially the main diseases of wheat such as scab, powdery mildew, and rust. It has great market potential in China and other places. In addition, Bayer did not register the product in China when the patent expired.
- Global market analysis
The main market of prothioconazole in the world is to prevent and control diseases of cereal crops. The largest market of this product in the world is Europe, and Australia is also an important market for cereal crops. While registering in China, Jiuyi chose to register abroad in the European Union and Australia to facilitate sales in China and other places and cooperation with foreign multinational companies. As the first Chinese enterprise registered in China, the European Union and Australia, Jiuyi expanded the domestic wheat market sales, while taking advantage of low production costs to cooperate with global enterprises to expand the sales of technical ingredients.
- Pre-risk assessment and registration planning for product registration
The EU equivalent registration of Jiuyi was completed by REACH24H. REACH24H carried out the pre-risk assessment and European registration planning for Jiuyi to ensure that the EU registration and China registration of the product should be both completed in early 2019. For China registration, Jiuyi completed all tests in accordance with the old Pesticide Registration Data Requirements and submitted complete data in time and was approved and registered in January 2019 as the last batch approved in accordance with the old Pesticide Registration Data Requirements. The enterprise has made a careful pre-risk assessment and registration planning of prothioconazole.
After the implementation of the new policy of pesticide registration in China, pesticide registration has become a risk-oriented strategy of pesticide safety assessment, which requires a lot of test data and a long period of pesticide safety assessment. At present, the registration cost of new pesticides in China is high and uncertain. Development opportunities and risks coexist for the registration of new pesticides or expired patents of pesticide enterprises. Therefore, while selecting new pesticides or pesticides with expired patents, pesticide enterprises should also carry out product global market analysis, registration planning, pre-risk assessment of product registration, registration test supervision and preparation of test data, aiming to get the registration certificate in the main target market as soon as possible and be the first one to get a slice of the cake.
REACH24H Consulting Group has been working on pesticide registration in China for many years, especially for the current new pesticide registration. We have rich experience and many successful cases and are good at the whole process of pesticide registration, especially the key steps such as trial efficacy test design, risk assessment, metabolite identification, and experiment supervision which can solve difficult problems in the process of pesticide registration comprehensively in China. If you have any questions, please feel free to contact us via email@example.com.