Beijing, September 3, 2026 — Gan & Lee Pharmaceuticals Co., Ltd. (hereinafter referred to as "Gan & Lee", stock code: 603087.SH) today announced that its independently developed ultra-long-acting oral peptide GLP-1 RA weekly  formulation, GZC8072 Tablet, has officially received clinical trial approval from the National Medical Products Administration (NMPA) for the treatment of type 2 diabetes mellitus (T2DM). This marks the second indication for GZC8072 Tablet to receive clinical approval, following the obesity/overweight indication.

According to the International Diabetes Federation (IDF) 2025 report, approximately 589 million adults aged 20–79 worldwide are living with diabetes, and this number is projected to rise to 853 million by 2050, with type 2 diabetes accounting for over 95% of cases. Diabetes can lead to serious complications such as cardiovascular disease, kidney failure, blindness, and lower-limb amputation^1,2. As a chronic condition requiring long-term management, patients with type 2 diabetes continue to have unmet needs for therapeutic options that combine good efficacy with treatment convenience.

GZC8072 Tablet is a biased ultra-long-acting peptide analog developed based on native glucagon-like peptide‑1 (GLP-1). Leveraging Gan & Lee's innovative NovaPeptide^™ peptide technology platform and SupOraTide^™ oral peptide technology platform, GZC8072 Tablet features a once‑weekly oral dosing regimen. This regimen is expected to achieve favorable glycemic control and weight management while significantly improving patient medication adherence and enhancing the long‑term treatment experience, thereby offering a more convenient long‑term therapeutic option for patients with chronic diseases.

The clinical approval of GZC8072 Tablet for the type 2 diabetes indication further expands its development scope, with clinical studies now covering two core metabolic indications—"glycemic control and weight reduction". This also strengthens Gan & Lee's overall competitiveness in the oral long‑acting GLP‑1 pipeline. As the clinical development of GZC8072 Tablet progresses, it is expected to further enrich Gan & Lee's long‑acting metabolic management product portfolio, help address treatment gaps, and provide more accessible and diverse treatment choices for patients worldwide.

Disclaimer
This press release is an objective update on the Company's research and development progress and does not constitute drug promotion, medical advice, or performance commitments. GZC8072 Tablet is currently in the clinical trial stage; for complete information on subsequent R&D and regulatory approval outcomes, please refer to the announcement disclosed on the Shanghai Stock Exchange on the same day. Investors should be mindful of investment risks.

References

1.https://idf.org/news-and-resources/resources/idf-diabetes-atlas-11th-edition-2025/

2. https://www.who.int/zh/news-room/fact-sheets/detail/diabetes

About GZC8072 Tablet
GZC8072 Tablet is a Class 1 innovative biased ultra‑long‑acting oral peptide GLP‑1 receptor agonist (GLP‑1 RA) with once‑weekly dosing, independently developed by Gan & Lee based on native GLP‑1, and holding independent intellectual property rights. The intended indications include type 2 diabetes and weight management in obesity or overweight. The development of GZC8072 Tablet leverages Gan & Lee's innovative NovaPeptide^™ peptide technology platform and SupOraTide^™ oral peptide technology platform, which significantly extend the molecular half‑life, enhance biological activity, and substantially improve oral bioavailability. Preclinical study results have demonstrated favorable pharmacodynamic and pharmacokinetic profiles, as well as a good safety profile. Currently, the global development of GZC8072 Tablet has entered Phase I clinical studies.

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.