/Panlong Pharmaceutical: Announcement on the Company Obtaining the Drug Clinical Trial Approval Notice
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Panlong Pharmaceutical: Announcement on the Company Obtaining the Drug Clinical Trial Approval Notice

Shenzhen Stock Exchange
2026/02/12

Securities code: 002864 Securities abbreviation: Panlong Pharmaceutical Announcement number: 2026-006

Shaanxi Panlong Pharmaceutical Group Co., Ltd.

Announcement on the Company Obtaining the Drug Clinical Trial Approval Notice

The company and all members of the board of directors guarantee that the information disclosed is true, accurate and complete, and contains no false records, misleading statements or major omissions.

Recently, Shaanxi Panlong Pharmaceutical Group Co., Ltd. (hereinafter referred to as the "Company") received the "Drug Clinical Trial Approval Notice" approved and issued by the State Food and Drug Administration, agreeing to conduct clinical trials of ketoprofen gel patch. The relevant situation is now announced as follows:

1. Drug-related situations

Product name: Ketoprofen gel patch

Application Matters: Drug Clinical Trial

Notice number: 2026LP00383

Applicant: Shaanxi Panlong Pharmaceutical Group Co., Ltd.

Approval conclusion: Agree to carry out clinical trials for analgesia with this product

2. Other related information about drugs

The ketoprofen gel patch that the company is applying for drug clinical trials this time has specifications: each patch (14cm × 10cm) contains 10g of paste and 30mg of ketoprofen. Its indications are analgesia and anti-inflammatory for the following diseases and symptoms: osteoarthritis, frozen shoulder, tendinitis, peritendinitis, lateral epicondylitis (tennis elbow), myalgia, swelling and pain caused by trauma. The method of administration is local application, one patch at a time, twice a day. The registration classification belongs to Class 3 chemicals.

Ketoprofen gel patch was first launched in Japan by Hisamitsu Pharmaceutical Co., Ltd. in 1988. As of the date of this announcement, the original drug of ketoprofen gel patch has not yet been marketed in China. In China, only Hunan Jiudian Pharmaceutical Co., Ltd. has been approved for marketing by the State Food and Drug Administration.

Minenet data shows that the sales of ketoprofen gel patch in China's three major terminals and six major markets in 2024 will be approximately 49.58 million yuan. In the first half of 2025, the sales of ketoprofen gel patch in China's three major terminals and six major markets were approximately 76.44 million yuan.

3. Impact on the company and risk warning

The product has been approved for clinical trials and will not have a significant impact on the company's financial status or operating results in the short term. If the research and development project progresses smoothly, it will further enrich the company's product pipeline in the field of orthopedic chronic diseases, form synergy and complementation with core varieties in the treatment field, terminal channels, and target customers, and help the company achieve its strategic goals and enhance its core competitiveness.

In view of the fact that drug research and development has the characteristics of long cycle and large investment, and is affected by multiple uncertain factors such as industry policies, there is a risk that the research and development project will be promoted and the research and development results will not meet expectations. There is uncertainty as to whether the drug can be approved for marketing and when it will be approved for marketing, as well as the production and sales after marketing. There is also uncertainty about the time when it will affect the company's performance. The company will fulfill its information disclosure obligations based on subsequent progress. Investors are advised to make prudent decisions and pay attention to investment risks.

Announcement is hereby made.

Shaanxi Panlong Pharmaceutical Group Co., Ltd. Board of Directors

February 11, 2026