Beijing, August 24, 2026 – Gan & Lee Pharmaceuticals Co., Ltd. (hereinafter referred to as "Gan & Lee," Stock Code: 603087.SH) announced today that GZC8072 Tablets, a Class 1 innovative therapeutic biological product independently developed by its wholly-owned subsidiary, Gan & Lee Pharmaceuticals (Shandong) Co., Ltd., with proprietary intellectual property rights, has officially received clinical trial approval from the National Medical Products Administration (NMPA) for weight management in obese or overweight individuals. The drug is an ultra-long-acting peptide analogue developed based on native glucagon-like peptide-1 (GLP-1), with the potential to offer patients a more convenient treatment option through a once-weekly oral administration regimen.

Overweight and obesity are chronic metabolic diseases caused by multiple factors, fundamentally resulting from a chronic energy intake exceeding energy expenditure, leading to excessive fat accumulation in the body. These conditions significantly increase the risk of cardiovascular, cerebrovascular, respiratory, and endocrine disorders, severely impairing patients' quality of life. According to statistics, approximately 2.5 billion adults worldwide were overweight in 2022^¹. Without effective interventions, the global number of overweight and obese adults is projected to exceed 2.9 billion by 2030^².

GZC8072 Tablets is a biased ultra-long-acting peptide analogue new drug developed from native GLP-1, with intended indications including type 2 diabetes mellitus and obesity. The drug is developed leveraging Gan & Lee's proprietary NovaPeptide^™ peptide technology platform and SupOraTide^™ oral peptide technology platform, which significantly extend molecular half-life, enhance bioactivity, and substantially improve oral bioavailability. In preclinical animal model studies, GZC8072 demonstrated favorable pharmacodynamic and pharmacokinetic profiles. This differentiated design is expected to improve patient medication experience alongside weight reduction, offering a more patient-friendly and convenient therapeutic option for long-term weight management.

Previously, Gan & Lee's independently developed long-acting GLP-1 receptor agonist (GLP-1 RA) biweekly injection, Bofanglutide Injection (R&D code: GZR18), and the fourth-generation basal insulin weekly injection, Insulin Ludefen Injection, have successively achieved major clinical breakthroughs. GZC8072 Tablets, as an oral weekly GLP-1 RA, will further enrich Gan & Lee's innovative pipeline matrix and is expected to generate synergistic effects with Bofanglutide Injection, Insulin Ludefen Injection, and other innovative drugs, providing more diversified clinical solutions.

In recent years, Gan & Lee has established innovative drug development as its long-term strategic priority. While consolidating its existing advantages in insulin products, the company has continuously increased R&D investment, focusing on diabetes and weight management as core areas while proactively deploying in metabolism, autoimmunity, oncology, and other therapeutic fields. Through its four technology platforms—peptide, PROTAC, antibody, and cell therapy—Gan & Lee provides systematic support for sustained innovation.

Notably, from the biweekly GLP-1 RA Bofanglutide injection  to the weekly basal insulin Ludefen Injection and now to the ultra-long-acting oral weekly GZC8072 Tablets approved for clinical trials, "long-acting treatment and management solutions" have become a key strategic direction for Gan & Lee's innovative pipeline. As clinical research advances, Gan & Lee's innovative drug candidates are poised to better address unmet clinical needs, accommodate diverse therapeutic requirements, further enhance drug accessibility, and benefit a broader global patient population.

Statement

Insulin Ludefen (R&D code: GZR4; International Nonproprietary Name (INN): Insulin Ludefen;

Reminder

This document is an objective communication of the Company's R&D progress and does not constitute product promotion, medical advice, or performance commitments. GZC8072 Tablets are currently in the clinical trial stage. For complete information on subsequent R&D and regulatory review outcomes, please refer to the announcements disclosed on the Shanghai Stock Exchange on the same day. Investors should be aware of investment risks.

References

1.https://www.who.int/zh/news-room/fact-sheets/detail/obesity-and-overweight%5C#12. 

2.https://slim.medsci.cn/news/detail/be3e8660134f

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.