Announcement on the Receipt of the "Administrative Penalty Notice" from Guizhou Provincial Drug Administration
Securities code: 600594 Securities abbreviation: Yibai Pharmaceutical Announcement number: 2026-024
Guizhou Yibai Pharmaceutical Co., Ltd.
Regarding receipt from the Guizhou Provincial Food and Drug Administration
Announcement of "Administrative Penalty Notice"
The company's board of directors and all directors guarantee that the contents of this announcement do not contain any false records, misleading statements or major omissions, and assume legal responsibility for the authenticity, accuracy and completeness of its contents.
In August 2025, Guizhou Yibai Pharmaceutical Co., Ltd. (hereinafter referred to as the "Company") received the "Production and Sales Suspension Notice" (Qian Drug Administration Production (Yaohua) Suspension [2025] No. 4) issued by the Guizhou Provincial Food and Drug Administration (hereinafter referred to as the "Guizhou Provincial Food and Drug Administration"). After receiving the notice, the company immediately suspended the production and sales of pediatric cough syrup. In September 2025, after rectification, the company received the "Notice of Lifting the Production/Sales Suspension" issued by the Guizhou Provincial Food and Drug Administration (Qian Food and Drug Administration Production (Yaohua) Stop Jie [2025] No. 6), and the company resumed the production and sales of pediatric cough syrup products. For details, please refer to the "Announcement of the Company on the Receipt of the "Notice of Suspension of Production and Sales" from the Guizhou Provincial Food and Drug Administration" (Announcement Number: 2025-021) and the "Announcement of the Company on the Receipt of the "Notice of Lifting the Suspension of Production and Sales" from the Guizhou Provincial Food and Drug Administration (Announcement No.: 2025-029) disclosed by the company on August 6, 2025 and September 18, 2025 respectively.
Recently, the company received the "Administrative Penalty Notice" (Qian Drug Administration Penalty Notice [2026] No. 19-1) issued by the Guizhou Provincial Food and Drug Administration due to the above matters. The relevant information is now announced as follows:
1. Main contents of the “Administrative Penalty Notice”
Guizhou Yibai Pharmaceutical Co., Ltd.:
The investigation of your company's suspected failure to comply with Good Manufacturing Practices for Drugs, which was initiated by this Bureau, has been concluded. In accordance with the provisions of Article 44 of the "Administrative Penalty Law of the People's Republic of China", the content, facts, reasons, and basis of the administrative penalties planned to be imposed by this bureau are hereby notified as follows:
When the Food and Drug Review and Inspection Center of the State Food and Drug Administration and this bureau inspected your company, they found that your company did not use reference materials for infrared identification items when sucrose, vanillin and other excipients were inspected when they entered the factory, and the manual and printed records of pasteurization of the purified water preparation system were inconsistent with the pharmaceutical production quality management standards. Your company is suspected of not complying with the Good Manufacturing Practices for Drugs, and this bureau has opened a case for investigation.
After investigation, your company has 27 batches of sucrose, 1 The batches of vanillin excipients were not inspected according to the operating procedures when they entered the factory, and the infrared identification items were inspected without using reference substances for inspection; the disinfection time recorded in the map printed by the purified water preparation system equipment was inconsistent with the manually filled disinfection time; the pediatric cough syrup dispensing system did not establish a paper cleaning operation record, and the number of retained samples recorded in the sample retention ledger was inconsistent with the actual number of retained samples; three equipment including the infrared spectrophotometer of the quality assurance center The computer used to prepare the equipment did not lock the time zone, and the data displayed on the air-conditioning system primary filter pressure differential table was inconsistent with the manually filled data; the reference substance receipt record could not intuitively reflect the remaining quantity after use, and the raw material weighing record could not directly reflect the original weighing data and other information; the titrant preparation, calibration and receipt records did not meet the traceability requirements; a batch of sodium benzoate had abnormal test results during content testing and no deviation investigation was carried out. Your company's above-mentioned behavior does not comply with the requirements of Articles 159, 163 and 171 of the "Good Manufacturing Practice for Pharmaceutical Products".
Your company is suspected of not complying with the Good Manufacturing Practices for Pharmaceuticals, and its behavior violates Article 43, Paragraph 1, of the Drug Administration Law of the People's Republic of China, which stipulates that "when engaging in pharmaceutical production activities, one shall abide by the Good Manufacturing Practices, establish and improve the quality management system for pharmaceutical production, and ensure that the entire process of pharmaceutical production continues to comply with legal requirements."
In view of the fact that your company did not strictly implement the quality inspection management system and operating procedures during the incoming inspection of excipients, did not use reference materials for infrared inspection of multiple batches of excipients, the preparation, calibration and receipt records of titrants did not meet the traceability requirements, there were negligence and loopholes in management, and the traceability of the quality control process could not be guaranteed. According to the "Measures for the Supervision and Administration of Drug Production" and other regulations, your company's behavior is a serious situation. However, considering that your company promptly took measures such as re-inspecting the excipients involved in the case and refining relevant document records to actively correct the illegal behavior; the excipients involved in the case were re-inspected and all complied with the regulations. They were used as seasonings, mainly used to improve the taste, and the amount of ingredients was small; during the investigation of the case, they actively cooperated with the investigation and evidence collection, truthfully stated the illegal facts, and proactively provided relevant evidence materials and other factors. With reference to the "Guizhou Provincial Drug Supervision and Administration Rules for the Application of Administrative Punishment Discretion" and other regulations, your company is eligible for a lighter punishment.
Your company is suspected of not complying with the quality management regulations for pharmaceutical production. According to the provisions of Article 126 of the Drug Administration Law of the People's Republic of China, after comprehensive consideration of the facts, nature, circumstances, and degree of social harm of your company's violation, and based on the principles of commensurate punishment, combination of punishment and education, and comprehensive discretion, this bureau intends to impose the following administrative penalties on your company:
A fine of seven hundred thousand yuan (¥700,000.00).
According to Articles 44, 45, 63, and
According to the first paragraph of Article 64, Article 57 of the "Procedural Provisions on Administrative Punishments for Market Supervision and Administration" and Article 5 of the "Measures for Hearing on Administrative Punishments for Market Supervision and Administration", your company has the right to make statements, defend itself, and request a hearing. If you fail to exercise your right to statement or defense or request a hearing within five working days from the date of receipt of this notification, this right will be deemed to have been waived.
2. Impact on the company and risk warning
The content of the "Administrative Penalty Notice" received by the company this time does not involve the forced delisting of major violations stipulated in Article 9.5.1 of the "Shanghai Stock Exchange Stock Listing Rules" (revised in April 2026). The final result of this administrative penalty shall be subject to the "Administrative Penalty Decision" subsequently issued by the Guizhou Provincial Food and Drug Administration. The company will continue to pay attention to the progress of the above matters, strictly comply with the provisions and requirements of relevant laws and regulations, and perform its information disclosure obligations in a timely manner.
For this penalty matter, the amount of the penalty accounts for a small proportion of the company's net assets, operating income and net profit in the latest period, and is not expected to have a major impact on the performance of the current period.
This penalty is the follow-up administrative treatment of the company's 2025 suspension of production and rectification of pediatric cough syrup. After rectification, the company has received the "Notice of Lifting Production/Sales Suspension" from the Guizhou Provincial Food and Drug Administration in September 2025, and has resumed the production and sales of pediatric cough syrup products. This administrative penalty does not involve new violations of laws and regulations.
The company has no objection to the punishment in this "Administrative Penalty Notice".
The company's designated information disclosure media are China Securities Journal, Shanghai Securities News, Securities Daily, Securities Times and the Shanghai Stock Exchange website (http://www.sse.com.cn). The company's relevant information shall be subject to announcements disclosed in the above designated disclosure media.
Investors are kindly requested to invest rationally and pay attention to investment risks.
Announcement is hereby made.
Board of Directors of Guizhou Yibai Pharmaceutical Co., Ltd.
August 1, 2026