Sungening Biotechnology and Lizhu Pharmaceutical (Shenzhen Stock Exchange code: 000513; Hong Kong Stock Exchange code: 01513) jointly announced that the antifungal DHODH inhibitor SG1001 has completed the first patient administration in phase II clinical trials on July 23, 2025. This important milestone marks the official entry of this innovative drug into the clinical efficacy verification stage, which will bring new treatment hope to patients with invasive aspergillosis infection.
The SG1001 Phase II clinical trial adopts a randomized, open label, multicenter design, aiming to systematically evaluate the efficacy and safety of SG1001 in the treatment of invasive aspergillosis infections. Professor Cao Bin, vice president of China-Japan Friendship Hospital, an authoritative expert in the field of respiratory infection, served as the main investigator (PI) of the study, which will be carried out simultaneously in more than 20 medical centers across the country.
"Invasive Aspergillus infection is a serious fungal infection with extremely high mortality rate, and there have been no innovative drugs launched in the field of antifungal treatment in China for nearly a decade. SG1001, as a Class 1.1 innovative drug, innovatively targets fungal dihydroorotate dehydrogenase (DHODH), which is expected to solve the problem of invasive Aspergillus resistance and poor first-line treatment efficacy. At present, the company is efficiently promoting the clinical development of the drug, and the project has successfully entered the phase II clinical trial stage. At the same time, we will actively evaluate the potential of SG1001 as a first-line treatment for invasive fungal diseases. In the future, we will continue to work closely with our partner Sungening Biotechnology to accelerate the development process and strive to benefit patients in China and even globally as soon as possible"
"Based on the excellent safety and pharmacokinetic properties demonstrated by SG1001 in clinical studies in China, we are confident in the development prospects of this innovative molecule. Meanwhile, we are pleased to announce that the drug has recently obtained clinical trial approval from the US FDA. In the future, we will continue to work together with Lizhu Pharmaceutical Group to efficiently promote the clinical research process and strive to provide better treatment options for invasive fungal disease patients worldwide"
About Lizhu Pharmaceutical
Lizhu Pharmaceutical (A-share code: 000513. SZ; H-share code: 01513. HK) is a large comprehensive pharmaceutical group that covers pharmaceutical research and development, production, and sales. It is also a pharmaceutical listed company on both the Shenzhen Stock Exchange and the Hong Kong Stock Exchange, with a wide range of products including chemical drugs, biopharmaceuticals, traditional Chinese medicine, active pharmaceutical ingredients, and diagnostic reagents. The company has a national level microsphere and traditional Chinese medicine research and development platform, as well as characteristic technology platforms such as antibody drugs and recombinant protein vaccines. It focuses on the development of innovative drugs, high barrier complex preparations, and high clinical value products, and has built a product matrix with international competitiveness.
About Sungening Biotechnology
Sungening, founded in 2021 by its founder in 2008, is an innovative drug research and development enterprise with cyclic peptide technology as its core. The company focuses on the treatment fields of antifungal and metabolic lipid-lowering, and is committed to developing differentiated innovative drugs with global competitiveness. Nanjing Jianyou (SH.603707), a well-known listed company, is an important investor in the company.
With mature commercialization capabilities and efficient research and development systems, Sungening Biotechnology has established an internationally competitive product pipeline: the first phase II patient of its core product SG1001 was administered on July 23, 2025, and phase I clinical trials were simultaneously conducted in the United States; The product has completed the equity authorization transaction in China, with the partner being the well-known pharmaceutical company Lizhu Pharmaceutical (SZ. 000513). In addition, the company has three innovation pipelines that have entered the IND application stage. Sungening Biotech is continuously pushing the boundaries of cyclic peptide drug development, providing patients with better treatment options.
