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    Home / Company News / Insulin Glargine PDP Project Officially Approved at the National Level in Brazil
    Insulin Glargine PDP Project Officially Approved at the National Level in Brazil
    Date:2025-03-13

    Beijing, China, Recently– Gan & Lee Pharmaceuticals, a leading global biopharmaceutical company (hereinafter referred to as Gan & Lee, stock code: 603087.SH), announced that its Productive Development Partnerships (Parcerias para o Desenvolvimento Produtivo, PDP) project, developed in collaboration with local Brazilian enterprises and entities under the Brazilian Health Ministry, has successfully passed evaluation by both the Brazilian Technical Evaluation Committee and the PDP Review Committee. The project was officially unveiled at the Palácio do Planalto by Brazilian President Luiz Inácio Lula da Silva and Health Minister Nísia Trindade. This milestone event signifies that Gan & Lee’s independently developed insulin production technology will facilitate Brazil’s establishment of the first fully localized insulin production industry in South America.


    The PDP project is a pivotal initiative in the reform of Brazil’s national public health system, designed to enhance the public health system by ensuring the stability of essential drug supplies through a full-lifecycle production strategy. The Brazilian government has allocated BRL 130 million (approximately USD 22.4 million, based on the international exchange rate as of March 13, 2025)1 to initiate the construction of manufacturing facilities for insulin glargine and other pharmaceutical products2.


    Brazilian Vice President Geraldo Alckmin and Health Minister Nísia Trindade have highlighted the vital role of insulin technology in the future of diabetes treatment in Brazil, underlining its significance in the country’s healthcare advancements. According to data from the International Diabetes Federation (IDF) and the Brazilian Federal Pharmacy Council, Brazil ranked sixth globally in the number of adult diabetes patients in 2021, with approximately 16 million cases and a prevalence rate of around 11%3. As of 2023, Brazil’s total insulin demand has reached approximately 110 million units, with basal insulin accounting for around 79% of the market, whereas third-generation long-acting insulin represented only 10%. The demand for basal insulin has been increasing at a compound annual growth rate of 6.31% over the past five years, driven by an aging population and improved diagnosis rates4.


    Brazil has faced the dual challenges of rising drug costs and an unstable supply chain due to its long-standing reliance on imported insulin. The financial toll of diabetes on Brazil’s healthcare system has climbed to a staggering USD 42.9 billion3, which not only imposes a significant economic burden but also restricts access to more advanced treatment options. The PDP project is anticipated to foster the shift towards third-generation insulin in Brazil, enhance diabetes management protocols, and is projected to create an annual market requirement for at least 70 million units of insulin glargine2.


    Gan & Lee CEO Mr. Du Kai stated: “The national-level approval of our insulin glargine PDP project in Brazil is a testament to the high international standing of Gan & Lee’s expertise. This recognition not only underscores our capabilities but also significantly boosts the status and influence of China’s biopharmaceutical industry on the global stage. Moving forward, we will seize this opportunity to actively contribute to building a global health community and strive to become an integral force in the global pharmaceutical industry.”


    Reference:

    1. Brazilian reais to US dollar USD exchange rate. convert BRL/USD. Wise. (2025, March 13). https://wise.com/au/currency-converter/brl-to-usd-rate

    2. CanalGov. (2025, February). Lula anuncia acordo para a produ??o de vacinas, medicamentos e outros insumos. YouTube. https://www.youtube.com/watch?v=kdlrSCYnNeU

    3. IDF Diabetes Atlas 10th edition 2021. Available at:https://diabetesatlas.org/data/en/country/120/my.html

    4. IQVIA NRC + PMB


    About Gan & Lee

    Gan & Lee Pharmaceuticals developed the first Chinese domestic insulin analog. Currently, Gan & Lee has 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) (Prandilin?25), aspart 30 injection (Rapilin?30), and one human insulin injection - mixed protamine human insulin injection (30R) (Similin?30). The company has two approved medical devices in China, namely reusable insulin injection pen (GanleePen), and disposable pen needle (GanleeFine?).

     

    In China's 2024 National Insulin-Specific Centralized Procurement, Gan & Lee Pharmaceuticals ranked  first among all selected companies in terms of procurement demand for insulin analogs. The company is also making strides in international markets, with the disposable pen needle (GanleeFine?) approved by the US Food and Drug Administration (FDA) in 2020 and received GMP inspection approval from the European Medicines Agency (EMA) in 2024. These achievements significantly boost Gan & Lee’s competitiveness in both international and domestic markets.

     

    In the future, Gan & Lee will strive for comprehensive coverage in diabetes treatment. Moving forward with its mission to become a world-class pharmaceutical company, Gan & Lee will also actively develop new chemical entities and biological drugs, focusing on treatments for metabolic diseases, cardiovascular diseases, and other therapeutic areas.





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