Announcement from Lianhuan Pharmaceutical on the unblinded results of the Phase III clinical trial of the company’s Class 1 new drug LH-1801 tablets combined with metformin
Securities code: 600513 Securities abbreviation: Lianhuan Pharmaceutical Announcement number: 2026-028
Jiangsu Lianhuan Pharmaceutical Co., Ltd.
About the company’s Class 1 new drug LH-1801 tablets phase III clinical trial combined with metformin
Announcement of unblinded results
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.
Important content reminder:
There are two key phase III clinical studies supporting the marketing of LH-1801 tablets: one is a study on the effectiveness and safety of LH-1801 tablets combined with metformin in the treatment of Chinese adult patients with type 2 diabetes; the other is a study on the effectiveness and safety of LH-1801 tablets alone in the treatment of Chinese adult patients with type 2 diabetes who are poorly controlled by diet and exercise. What is disclosed in this announcement is the preliminary statistical analysis results of the first key clinical study. It is still necessary to wait for the statistical analysis results after the single-drug project is unblinded. If the final results of both studies are in line with expectations, the application can be submitted.
According to the relevant national regulations on chemical drug registration management, LH-1801 tablets must complete "pharmaceutical, pharmacological and toxicological and drug clinical trials to support drug marketing registration, determine quality standards, complete commercial-scale production process verification, and be prepared to accept drug registration verification and inspection" before applying for registration. After application, it must undergo comprehensive review, production site inspection and other procedures. There is still uncertainty in the final approval and the time of approval.
There are currently about 8 products for the treatment of type 2 diabetes on the market. The sales of LH-1801 tablets after its launch are affected by many factors such as the market competition environment and sales channels, and there is uncertainty in the subsequent market sales.
LH-1801 tablets are affected by factors such as the increased research and verification workload, process running-in, and rectification improvements brought about by the scale-up of commercial production. There is a risk that the subsequent commercialization and production process will be delayed and the progress will be slower than expected.
The Phase III clinical trial of the Class 1 new drug LH-1801 tablets combined with metformin organized by Jiangsu Lianhuan Pharmaceutical Co., Ltd. (hereinafter referred to as the "Company" and "Lianhuan Pharmaceutical") has been unblinded and the preliminary analysis results of the main data have been obtained recently. Details are as follows:
1. Overview of projects under research
LH-1801 tablets are a new type of SGLT-2 inhibitor. It is a new anti-diabetic drug with my country’s independent intellectual property rights developed by the company in cooperation with the Shanghai Institute of Materia Medica, Chinese Academy of Sciences. It is indicated for type 2 diabetes. There are two key phase III clinical studies supporting the marketing of LH-1801 tablets: one is a study on the effectiveness and safety of LH-1801 tablets combined with metformin in the treatment of Chinese adult patients with type 2 diabetes; the other is a study on the effectiveness and safety of LH-1801 tablets alone in the treatment of Chinese adult patients with type 2 diabetes who are poorly controlled by diet and exercise.
2. Results of this analysis
This trial is a multi-center, randomized, double-blind, dapagliflozin tablet-controlled phase III clinical study to evaluate the effectiveness and safety of LH-1801 tablets combined with metformin in patients with type 2 diabetes who have poor blood glucose control after at least 8 weeks of stable dose metformin treatment. Peking University People's Hospital serves as the team leader and is jointly carried out in 60 centers across the country. The study was divided into screening period, placebo introduction period, core treatment period, extended treatment period and follow-up period, and a total of 615 subjects were included. With the completion of data cleaning and review, database locking, data unblinding and statistical analysis, CRO (Contract Research Organization Pharmaceutical Industry Contract Research Organization) Rundong Pharmaceutical R&D (Shanghai) Co., Ltd. delivered preliminary statistical analysis results to the company on April 28, 2026, and the primary endpoint was in line with expectations.
3. Project follow-up work
The data obtained from the unblinded phase III clinical trial of LH-1801 tablets combined with metformin, a Class 1 new drug, are only partial results. We still need to wait for the statistical analysis results after the single-drug project is unblinded. If the final results of both studies are in line with expectations, the application can be submitted.
The company will subsequently conduct a comprehensive and in-depth analysis based on the statistical results, complete the clinical trial summary report, organize the new drug registration information and submit the application. The new drug registration application must pass the technical review, on-site verification of clinical trial data, and production on-site inspection by relevant national departments before the drug registration approval can be obtained.
4. Impact on the company and risk warning
The preliminary statistical analysis results disclosed in this announcement are the first key clinical study. We still need to wait for the statistical analysis results after the single-drug project is unblinded. If the final results of both studies are in line with expectations, the application can be submitted.
According to the relevant national regulations on chemical drug registration management, LH-1801 tablets must complete "pharmaceutical, pharmacological and toxicological and drug clinical trials to support drug marketing registration, determine quality standards, complete commercial-scale production process verification, and be prepared to accept drug registration verification and inspection" before applying for registration. After application, it must undergo comprehensive review, production site inspection and other procedures. There is still uncertainty in the final approval and the time of approval.
There are currently about 8 products for the treatment of type 2 diabetes on the market. The sales of LH-1801 tablets after its launch are affected by many factors such as the market competition environment and sales channels, and there is uncertainty in the subsequent market sales.
LH-1801 tablets are affected by factors such as the increased research and verification workload, process adaptation and rectification brought about by the scale-up of commercial production, and there is a risk that the subsequent commercialization and production process will be delayed and the progress will be slower than expected.
The company will actively promote the above-mentioned research and development projects and perform its information disclosure obligations on the subsequent progress of the projects in a timely manner in strict accordance with relevant regulations. For relevant company information, please refer to the announcements published in the company's designated disclosure media "Shanghai Securities News", "Securities Times" and the website of the Shanghai Stock Exchange (http://www.sse.com.cn).
Announcement is hereby made.
Board of Directors of Jiangsu Lianhuan Pharmaceutical Co., Ltd.
April 30, 2026