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Home / Company News / Gan & Lee Pharmaceuticals Pass the EMA Pre-Approval (GMP) Inspection
Gan & Lee Pharmaceuticals Pass the EMA Pre-Approval (GMP) Inspection

Beijing, China/Bridgewater, New Jersey US, May 29,2024--Gan & Lee Pharmaceuticals (hereinafter referred to as “Gan & Lee”, stock code: 603087.SH) received a formal notification from the European Medicines Agency (hereinafter referred to as “EMA”), stating that the company's manufacturing facility comply with the requirements of EU GMP regulations and is ready for commercial manufacturing of Insulin Glargine Pre-filled Injection Pen, Insulin Lispro Pre-filled Injection Pen, Insulin Aspart Pre-filled Injection Pen. This signifies that Gan & Lee's drug substances, finished products and pre-filled injection pens manufacturing line has successfully passed the GMP Inspection by the EMA, and it is the first time domestic manufacturer Insulin analog injection passes the EMA inspection.

In mid-March 2024, an EMA inspection team conducted a five-day on-site inspection at Gan & Lee's manufacturing facility based in Tongzhou District of Beijing. They carried out a detailed and thorough evaluation of the company's manufacturing capabilities/standards, integrity of quality system, and readiness for commercial production. The successful result of this inspection is verification of Gan & Lee's world-leading quality standard in GMP compliance.

As the first company in China to master the technology of industrialized production of recombinant insulin analogs, Gan & Lee is a leading company in China's diabetes market in the research, development and production of biosynthesized human insulin and its analogs. The company will continue to adopt sound product standards, mature process standards, and strict quality standards to create trustworthy and high-quality medicines and provide high quality products and services to more patients. Passing the GMP inspection is an important milestone for subsequent commercialization of domestically produced insulin in the European Union by Gan & Lee's partner Sandoz. It also strengthens the company's global competitiveness and lays a solid foundation for more international business cooperation and market expansion in the future.

Cooperation with Sandoz AG

In 2018, Gan & Lee Pharmaceuticals signed a commercialization and supply agreement with Sandoz. Under the terms of the agreement, Sandoz has the right to commercialize the three Gan & Lee biosimilars upon approval in specific regions, including the United States, Europe, and other key regions. Gan & Lee is responsible for development (incl. clinical research) and supply.

About Gan & Lee

Gan & Lee Pharmaceuticals has developed the first Chinese domestic biosynthetic human insulin. Currently, we have six core insulin products, including five insulin analog varieties: long-acting glargine injection (Basalin®), fast-acting lispro injection (Prandilin), fast-acting aspart injection (Rapilin®), mixed protamine zinc lispro injection (25R) (Prandilin25), aspart 30 injection (Rapilin®30), and one human insulin injection - mixed protamine human insulin injection (30R) (Similin®30). We have two approved medical devices in China, namely reusable insulin injection pen (GanleePen), and disposable pen needle (GanleeFine®).

In the future, Gan & Lee strives to achieve a comprehensive coverage in the field of diabetes diagnosis and treatment. Moving forward to advance our goal of becoming a world-class pharmaceutical company, we will also take an active part in developing new chemical entities, and work on the treatment of cardiovascular diseases, metabolic diseases, cancer, and other therapeutics.

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