Gan & Lee Pharmaceuticals (Gan & Lee, stock code: 603087.SH) recently announced that its manufactured insulin aspart 30 injection has been granted import and marketing approval by India's Central Drugs Standard Control Organization (CDSCO). This product marks the first biosimilar insulin aspart 30 injection to secure regulatory approval in the country.

Breaking the Originator Monopoly and Expanding Access to Diabetes Care in India

India has one of the world's largest populations of people living with diabetes. According to the latest figures from the International Diabetes Federation (IDF), approximately 89.8 million adults aged 20–79 in India are living with diabetes. This number is projected to rise by 75% to 157 million by 2050¹. As the country's diabetes population continues to grow, the demand for high-quality and affordable insulin products is becoming increasingly urgent. Nevertheless, the Indian market for insulin aspart 30 injection has long been monopolized by originator pharmaceutical companies, creating persistent barriers for patients in terms of treatment accessibility and affordability.

Backed by Gan & Lee's mature large-scale production capacity, robust supply chain system and its Indian partners' local commercial channels, the newly approved product is expected to introduce greater competition into a market long dominated by multinational originator companies. It will also help expand the availability of high-quality insulin products across primary healthcare facilities and provide patients with a stable, sustainable and more affordable treatment option, contributing to improved standards of diabetes care in India.

Dual-Track Strategy Strengthens Competitiveness in South Asia

India serves as a core strategic market for Gan & Lee across South Asia. The company is pursuing a dual-track strategy that combines the ongoing expansion of mature products with the forward-looking development of innovative therapies, steadily enriching its product portfolio in the country.

In the mature insulin segment, Gan & Lee has introduced products in stages based on local clinical needs. The company first launched insulin glargine cartridges, followed by insulin glargine prefilled pens, addressing both the need for reliable basal insulin supply and the need for more convenient delivery options. Collectively, these two presentations cater to a wider spectrum of clinical treatment scenarios. Gan & Lee's insulin glargine products have been commercially available in India for over a decade and rank among the top three brands in the local insulin glargine market. The approval of insulin aspart 30 injection expands Gan & Lee's product portfolio in India from long-acting basal insulin to premixed insulin. It further strengthens the company's core diabetes treatment portfolio and supports the development of a more diversified product offering across multiple treatment scenarios.

Alongside its mature insulin business, Gan & Lee is also building an early foothold in innovative therapies. In December 2025, the company entered into an exclusive licensing and supply agreement for Bofanglutide (GZR18) with a leading Indian pharmaceutical company, granting its partner the rights to conduct local clinical development and commercialization of the product in India.

Gan & Lee has thus established a mature dual-track product portfolio in India, combining biosimilar insulins with innovative therapies. This strategy continues to strengthen the company's core competitiveness and positions it as a benchmark of a Chinese pharmaceutical company with sustainable long-term deployment in South Asia's biopharmaceutical market.

In recent years, Gan & Lee has continued to advance its global strategy, evolving from product exports to the development of collaborative local healthcare ecosystems. Its core insulin products have reached milestones in Europe, the Middle East, Latin America and Asia, introducing greater competition into markets historically dominated by multinational companies.

Looking ahead, Gan & Lee will accelerate overseas registration and commercialization, deepen strategic partnerships in India and across South Asia, and expand its treatment portfolio for diabetes and other metabolic diseases. Driven by high-quality products and sustained innovation, the company aims to advance improved chronic disease management globally.

Reference:

1. IDF Diabetes Atlas 11th edition 2025. Available at: https://diabetesatlas.org/resources/idf-diabetes-atlas-2025/

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.