September 18, 2026 — Gan & Lee Pharmaceuticals (hereinafter referred to as "Gan & Lee Pharmaceuticals"; stock code: 603087.SH) announced that its independently developed recombinant human albumin GLR1075 Injection has officially received Investigational New Drug (IND) approval from the National Medical Products Administration (NMPA). It is intended for the treatment of cirrhotic ascites with hypoalbuminemia.

GLR1075 Injection is a recombinant human albumin preparation independently developed by Gan & Lee Pharmaceuticals. It is a humanized recombinant protein drug, and its core therapeutic features center on "replacing plasma-derived albumin." The active pharmaceutical ingredient of GLR1075 Injection, recombinant human albumin, has an identical amino acid sequence and spatial conformation identical to those of plasma-derived albumin. It can exert the core physiological functions of albumin: correcting colloid osmotic pressure imbalance and improving the pathological microenvironment. The development of GLR1075 Injection is expected to further expand the supply sources and clinical accessibility of albumin drugs.

Albumin is a core plasma protein that maintains plasma colloid osmotic pressure and substance transport, and it has important value in the clinical management of cirrhotic ascites and related complications. Cirrhosis is one of the major fatal chronic liver diseases worldwide, and China has approximately 7 million patients with cirrhosis.^[1] As the disease progresses to the decompensated stage, patients may develop complications such as ascites, hepatic encephalopathy, and gastrointestinal bleeding. Ascites is a common and serious complication in patients with decompensated cirrhosis. Once ascites develops, the 5-year mortality rate is approximately 44%.^[2] Decreased serum albumin is one of the important manifestations of impaired hepatic synthetic function in patients with cirrhosis, and there is a sustained clinical need for related treatment and disease management.

For a long time, human albumin used in clinical practice has mainly relied on extraction from healthy human plasma. It is not only constrained by scarce plasma sources and high costs, but also carries the potential risk of blood-borne pathogen transmission. Against the backdrop of persistently tight global blood product supply, achieving large-scale, high-purity, and controllable production of albumin through recombinant DNA technology has become one of the important strategic development directions in biomedicine.

The IND approval of GLR1075 Injection marks Gan & Lee Pharmaceuticals' official entry into the field of innovative research on recombinant human albumin drugs, and is a key milestone in the company's expansion into non-diabetic fields. Leveraging the company's R&D platforms in peptides, PROTACs, antibodies, and other areas, as well as its years of accumulated industrialization experience, this project will further broaden the company's R&D pipeline and create significant social value by alleviating pressure on China's blood product supply and improving the safety of clinical medication.

Notice

This release is an objective information update on the company's R&D progress and does not constitute drug promotion, diagnostic or treatment advice, or performance commitments. GLR1075 Injection is currently in the clinical trial stage. Complete information on subsequent R&D and registration approval results should be subject to the announcements disclosed by the Shanghai Stock Exchange on the same date. Investors should be aware of investment risks.

References

1.Xiao J, Wang F, Wong NK, et al. Global liver disease burdens and research trends: analysis from a Chinese perspective. J Hepatol. 2019;71(1):212-221. doi:10.1016/j.jhep.2019.03.004.

2.Chinese Society of Hepatology, Chinese Medical Association. Guidelines for the diagnosis and treatment of ascites in cirrhosis (2023 edition) [J]. Chinese Journal of Hepatology, 2023, 31(08): 813-826. DOI:10.3760/cma.j.cn501113-20230719-00011.

About Gan & Lee

Gan & Lee Pharmaceuticals is a high-tech biopharmaceutical company and the first in China to master industrial-scale manufacturing technologies for recombinant insulin analogs. The Company has established a comprehensive insulin research and development pipeline.

Currently, Gan & Lee offers six core insulin products, including five insulin analogs: insulin glargine injection (Basalin^®; EU brand name Ondibta^®), insulin lispro injection (Prandilin^®; EU brand name: Bysumlog^®), insulin aspart injection (Rapilin^®; EU brand name: Dazparda^®), premixed insulin lispro protamine suspension injection (25R) (Prandilin^®25), and insulin aspart 30 injection (Rapilin^®30); as well as one human insulin product, premixed human insulin protamine suspension injection (30R) (Similin^®30), together with related delivery devices. These products cover the long-acting, rapid-acting, and premixed insulins.

In China's second round of national volume-based procurement for insulin, Gan & Lee ranked first among selected companies by contracted volume for insulin analogs, further strengthening its domestic market position. In parallel, the Company continues to advance its international expansion.  Insulin glargine injection, insulin lispro injection, and insulin aspart injection have all received marketing authorization from the European Commission (EC). Gan & Lee is steadily progressing toward its goal of becoming a key global participant in the field of metabolic diseases.

Looking forward, Gan & Lee is committed to achieving comprehensive coverage across the diabetes treatment landscape and further enhancing its competitive position in this therapeutic area. The Company will also actively pursue the development of innovative chemical drugs and biologics, with a strategic focus on metabolic diseases, cardiovascular diseases, and other therapeutic areas.