Announcement from China Resources Shuanghe on the fact that its holding subsidiary Hunan Xiangzhong Pharmaceutical Co., Ltd. Oxcarbazepine Tablets has obtained a drug registration certificate
Securities code: 600062 Securities abbreviation: China Resources Shuanghe Announcement number: Lin 2025-097
China Resources Shuanghe Pharmaceutical Co., Ltd.
About the holding subsidiary Hunan Xiangzhong Pharmaceutical Co., Ltd.
Announcement that Oxcarbazepine Tablets Obtained Drug Registration Certificate
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.
Recently, Hunan Xiangzhong Pharmaceutical Co., Ltd. (hereinafter referred to as "Xiangzhong Pharmaceutical"), a holding subsidiary of China Resources Shuanghe Pharmaceutical Co., Ltd. (hereinafter referred to as the "Company"), received the "Drug Registration Certificate" for Oxcarbazepine Tablets (hereinafter referred to as the "drug") issued by the State Food and Drug Administration (hereinafter referred to as the "NMPA"). The relevant information is now announced as follows:
1. Main contents of drug registration certificate
Generic name of the drug: Oxcarbazepine tablets
Drug name
English name/Latin name: Oxcarbazepine Tablets
Dosage form tablet
Registration Classification Chemicals Class 4
Specification 0.3g
No. 2025S03399
Drug approval number: National Drug Approval Number H20255934
Application Matters Drug Registration (Domestic Production)
According to the "Drug Administration Law of the People's Republic of China" and relevant regulations, the review and approval conclusion: After review, this product meets the relevant requirements for drug registration, and the registration is approved.
Register and issue a drug registration certificate. Quality standards, instructions, labels
Sign and execute the production process as attached. Pharmaceutical manufacturing enterprises must comply with the requirements of pharmaceutical quality management regulations before they can produce and sell drugs. Marketing Authorization Holder Name: Hunan Xiangzhong Pharmaceutical Co., Ltd.
Manufacturer Name: Hunan Xiangzhong Pharmaceutical Co., Ltd.
2. Drug-related situations
Oxcarbazepine tablets are indicated for the treatment of primary generalized tonic-clonic and partial seizures, with or without secondary generalized seizures, in adults and children 5 years and older.
Xiangzhong Pharmaceutical started the research and development of generic drugs of this drug in August 2021, submitted a marketing license application to the State Food and Drug Administration on July 26, 2024, received an acceptance notice on August 14, 2024, and was approved for marketing by the State Food and Drug Administration on November 12, 2025. According to relevant national policies and regulations, obtaining the "Drug Registration Certificate" this time is deemed to have passed the consistency evaluation.
As of the date of this announcement, the company's cumulative R&D investment in this drug is RMB 14.2164 million (unaudited).
3. Market status of similar drugs
Oxcarbazepine tablets were developed by Novartis Pharmaceuticals Corp. They were approved for marketing in the United States in January 2000 under the trade name "Trileptal®" and were approved for marketing in China in June 2003. According to the global drug sales database in 71 countries, global sales of oxcarbazepine tablets in 2024 were US$351 million, of which sales of "Trileptal®" were US$162 million.
In the domestic market, according to information on the website of the State Food and Drug Administration, there are 10 oxcarbazepine tablet manufacturers in mainland China that have been approved for marketing (including Xiangzhong Pharmaceutical), of which 9 manufacturers (including Xiangzhong Pharmaceutical) have passed or are deemed to have passed the consistency evaluation. According to data from Minai.com, the total sales (terminal price) of oxcarbazepine tablets in the domestic medical market and retail market in 2024 will be 738 million yuan, of which the top three companies and their market shares are Novartis 74.17%, Beijing Sihuan Pharmaceutical 13.78%, and Wuhan Renfu Pharmaceutical 11.85%.
4. Impact on the company and risk warning
The drug has obtained the "Drug Registration Certificate", which will further enrich the company's product line, help enhance the market competitiveness of the company's products, and accumulate valuable experience for subsequent research and development of other products.
Since pharmaceutical products are characterized by high technology, high risk and high added value, the sales of pharmaceuticals may be affected by national policies, market environment changes and other factors, and are highly uncertain. Investors are kindly requested to make prudent decisions and pay attention to preventing investment risks.
Announcement is hereby made.
Board of Directors of China Resources Shuanghe Pharmaceutical Co., Ltd.
November 19, 2025