From breaking into the market with a single product to expanding overseas with a matrix of products, Gan & Lee Pharmaceuticals has obtained EU approval for three insulin analogues in less than six months. This is not only an authoritative recognition of the company's product quality and manufacturing process, but also signifies that insulin produced in China has reached a level comparable to original drugs. Gan & Lee Pharmaceuticals has become the first Chinese pharmaceutical company to obtain approval for three third-generation insulin products in the EU, breaking the long-standing monopoly of the European market by original drug giants.

Beijing, China, May 14, 2026 – Gan & Lee Pharmaceuticals Inc. (hereinafter referred to as Gan & Lee Pharmaceuticals, stock code: 603087.SH) announced that its product, insulin lispro injection (EU trade name: Bysumlog® , China trade name: Suxiulin®1 ) , has officially received marketing approval from the European Commission (EC).

This marks Gan & Lee Pharmaceuticals' third insulin product approved in the European market within just six months, following glargine insulin injection (EU brand name: Ondibta® , Chinese brand name: Changxiulin®2 ) and aspart insulin injection (EU brand name: Dazparda® , Chinese brand name: Ruixiulin®3 ). With this, Gan & Lee Pharmaceuticals becomes the first and currently the only Chinese pharmaceutical company to obtain approval for both long-acting and rapid-acting insulin in the EU, covering both basal insulin and rapid-acting/prandial insulin in two core treatment scenarios.

Comparable to original drugs, domestically produced insulin breaks into the European market.

For a long time, the European insulin market has been dominated by original drug manufacturers, resulting in a highly solidified market structure. Data shows that between 1996 and 2022, over 95% of the 43 insulin products approved by the European Medicines Agency (EMA) came from the three giants: Novo Nordisk, Sanofi, and Eli Lilly. As of 2022, biosimilars accounted for only 14% of all insulins approved by the EMA . ⁴

This situation stems primarily from the EU's stringent review and approval mechanism for biosimilars. The EMA has established a high-standard, systematic approval system, significantly raising the bar for market entry. Therefore, EU marketing authorization is not only considered a "hard pass" to the global pharmaceutical market, but also authoritative proof that a product's quality meets the highest international standards.

Due to the aforementioned factors, domestically produced insulin had virtually no presence in the European market in the past. This situation has been completely changed with the approval of three insulin products from Gan & Lee Pharmaceuticals in the European Union.

It is reported that Gan & Lee Pharmaceuticals' glargine insulin is the first and only domestically produced glargine insulin in China to complete head-to-head Phase III clinical trials with the original reference drug (Sanofi: Lantus®) in Europe and the United States , confirming its efficacy equivalence and comparable safety. Furthermore, its lispro insulin and aspart insulin have also shown PK/PD bioequivalence with the original reference drug through clinical comparative studies, and their safety profiles are comparable .⁵ Solid clinical data demonstrate that Gan & Lee Pharmaceuticals' three insulin products are highly equivalent to the original drugs in terms of efficacy and safety, possessing the feasibility of clinical interchangeability and can directly replace the original drugs in clinical practice.

The consecutive approvals of three products in Europe further demonstrate that Gan & Lee Pharmaceuticals' insulin products have reached international leading levels in quality and have passed the most stringent regulatory tests globally. The European market, previously monopolized by original drugs, is being rewritten step by step by domestically produced insulin.

Accelerate international expansion and unlock future development possibilities.

In recent years, Gan & Lee Pharmaceuticals has continued to advance its globalization strategy, and its international business has entered a new stage of rapid growth and momentum release. According to the company's 2025 annual report, its international sales revenue reached RMB 529 million, a year-on-year increase of 36.59%. Overseas markets have become an important engine driving the company's growth, laying a solid market foundation and operational experience for product exports.

The fact that all three insulin products have obtained EU marketing authorization is a significant milestone in the company's long-term commitment to its internationalization strategy and its adherence to high standards in overseas markets.

Based on its internationalization strategy, Gan & Lee Pharmaceuticals entered into a strategic partnership with Sandoz as early as 2018, signing commercial and supply agreements for three approved insulin analog products. Sandoz was responsible for the commercial sales in Europe and other designated regions. With the official approval of these three products in the European Union, they will not only provide European diabetes patients with new and high-quality treatment options and help improve local diabetes management, but also are expected to further expand Gan & Lee Pharmaceuticals' international business and bring new development possibilities.

From "breaking the deadlock" to "three victories in six months," Gan & Lee Pharmaceuticals has demonstrated to the world that China's insulin research and development and production have entered the world's top tier. Breaking the monopoly of original drugs is just the beginning. With the commercialization of three products in the European market, a feasible commercialization path will be laid for the global sales of the company's future fourth-generation insulin products. Domestically produced insulin is expected to write a more brilliant Chinese chapter in the global diabetes treatment field.

About Suxiulin® ( lispro insulin injection)

Suspro® (Lispro Insulin Injection) is a rapid-acting human insulin analog independently developed by Gan & Lee Pharmaceuticals . It is China's first domestically produced rapid-acting human insulin analog and has undergone long-term testing in domestic and international markets and clinical trials since its launch in 2007. Through B-chain amino acid modification, it takes effect 10-15 minutes after subcutaneous injection, reaches peak effect in 30-70 minutes, and lasts for 2-5 hours. It can be injected within 15 minutes before meals or immediately after meals, effectively controlling postprandial blood glucose with a low risk of nocturnal hypoglycemia. Currently, Suspro® has received marketing approval from the European Commission, and its global market expansion is progressing steadily.

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