Gan & Lee Pharmaceuticals Secures $420 Million Deal to Supply Insulin Glargine to Brazil Through Technology Transfer and Local Production Partnership

September 23, Gan&Lee Pharmaceuticals(Stock Code: 603087.SH)Announced partnership with the Brazilian state-owned research institution Fundação Oswaldo Cruz-Bio-Manguinhos(abbreviated as Bio-Manguinhos)and local biotech company BIOMM S.A.(abbreviated as BIOMM)Sign the "Technology Transfer and Supply Agreement", and entered into a Supply Framework Agreement with BIOMM for an estimated total amount of no less than RMB 3 billion (tax inclusive). The agreement covers the technology transfer related to insulin glargine, as well as the supply of active pharmaceutical ingredients, injections, and syringes, with a term of ten years from the date of signing.

Gan&Lee Pharmaceuticalsis one of the earliest domestic enterprises in China to master industrialized production technology for recombinant insulin analogs, and itsCore business covers rapid-acting, long-acting, and premixed insulin formulations for diabetes treatment, as well as配套 injection devices.

In 2005, the company developed China’s first recombinant insulin glargine injection, “Basalin.”^®”, breaking the monopoly of multinational pharmaceutical companies such as Novo Nordisk and Sanofi on the long-acting insulin market. Currently, six core products have been commercialized, including five insulin analogs (Basalin^®, Suxiulin^®, Ruixiulin^®, Suxiulin^®25. Ruixiulin^®30) and one human insulin product (Puxulin^®30), accompanied by a reusable insulin injection pen (Xiulin Pen)^®), Disposable Pen Needles (Xiulin Needle^®) and other medical devices.

The refinement of the product portfolio has laid a solid foundation for Gan&Lee Pharmaceuticals in market competition.According to the 2025 semi-annual report, Gan&Lee Pharmaceuticals successfully secured inclusion for six products in two rounds of the National Centralized Drug Procurement with Guaranteed Volume, four of which were awarded Category A winning status. In the first year of the renewed centralized procurement for insulin in 2025, the company’s procured volume reached 41.77 million units, representing a year-on-year increase of over 30%. Its market share in the third-generation insulin segment approached 30%, ranking second in the industry, only behind Novo Nordisk. Benefiting from sales growth and price optimization,In the first half of 2025, the company's operating revenue reached RMB 2.067 billion, a year-on-year increase of 57.18%.; Net profit attributable to shareholders of the listed company amounted to RMB 604 million, representing a significant year-on-year increase of 101.96%.

Business growth relies on the support of production capacity and R&D.In terms of production capacity layout, the Beijing base has an annual production capacity of 3.5 metric tons of active pharmaceutical ingredients (APIs) and 200 million units of formulated products. Upon completion of equipment commissioning at the Shandong production base, the company will further expand its capacity reserves. Regarding R&D investment, the company’s R&D expenses reached RMB 552 million in the first half of 2025, accounting for 26.70% of its revenue.

In terms of international business,Gan&Lee Pharmaceuticals’ insulin products have gained market access and sales coverage in nearly 20 countries and regions overseas.In the first half of 2025, its international market revenue reached RMB 220 million, representing a year-on-year increase of 75.08%, with a growth rate significantly higher than that of the domestic market.

In the Brazilian public health system,PDP (Productive Development Partnership) is a core policy tool promoted by the government to advance pharmaceutical localization and ensure drug accessibility.Through long-term collaboration among the government, research institutions, and pharmaceutical companies, this model gradually transfers the production of key medicines to domestic enterprises, thereby reducing import dependence and ensuring a stable supply for the Unified Health System (SUS). According to the Brazilian Ministry of Health’s plan, PDP projects typically have an implementation period of more than ten years, requiring companies to achieve a phased transition from imports to localized production.

As a key participant in the PDP model, Fiocruz, Brazil’s national scientific research institution, is responsible for disease surveillance, biological product manufacturing, and public health research. Its subsidiaryBio-Manguinhos is the core platform for implementing Productive Development Partnerships (PDPs), with a long-standing role in vaccine and biopharmaceutical manufacturing., and serve as a technical liaison between the government and enterprises.

BIOMM is a Brazilian biopharmaceutical company with business operations covering the research and development, manufacturing, and commercialization of biosimilars.Since 2021, BIOMM has been importing insulin glargine from Gan&Lee Pharmaceuticals (locally registered as Glargilin^®) to meet market demand. Under the new PDP framework, BIOMM will be responsible for the local production and supply of insulin, and will gradually adopt Gan&Lee Pharmaceuticals’ manufacturing processes and quality systems within the scope of the technology license; while Bio-Manguinhos will be responsible for regulatory coordination, standards validation, and ensuring public procurement.

Phase-specific targets disclosed by Fiocruz indicate that approximately 20 million vials of insulin glargine must be supplied to the Unified Health System (SUS) in 2025 to meet the treatment needs of patients with diabetes. This target not only underscores the emphasis placed by Brazil’s public health policy on ensuring insulin availability but also poses a long-term test for partners’ capacity to deliver at scale while maintaining consistent quality.

Gan&Lee Pharmaceuticals’ RMB 3 billion cooperation agreement with Brazil’s Bio-Manguinhos and BIOMM is the result of multiple factors.

From the perspective of the needs of Brazil's public health system,As the country with the largest number of diabetes patients in Latin America (approximately 15.7 million patients, accounting for about 47% of the total number of patients in South America), Brazil's insulin market has long relied on imports and been monopolized by the three giants Novo Nordisk, Eli Lilly, and Sanofi, facing the dual challenges of rising drug costs and unstable supply chains, with the related costs of diabetes treatment reaching as high as $42.9 billion.^[1]. In this context, the PDP project will rapidly drive the iteration of third-generation insulins in Brazil and upgrade insulin treatment regimens, with an estimated annual demand of at least 70 million units of insulin glargine.^[2]。

From an institutional perspective,PDP has become an important tool in Brazil’s public health system. The government exchanges long-term procurement commitments for technology transfer and localized production. As a baseline medication, insulin glargine’s inclusion in the PDP project approved for the Gan&Lee Pharmaceuticals/BIOMM/Bio-Manguinhos consortium demonstrates its competitiveness in terms of technological maturity, cost advantage, and operational feasibility.

In terms of technology and cost, while the import model ensures quality, it makes it difficult to achieve price reductions and supply flexibility. This collaboration leverages Gan&Lee Pharmaceuticals’ large-scale production experience and mature manufacturing processes in China, enabling long-term cost advantages through economies of scale and technology amortization. Meanwhile, Gan&Lee Pharmaceuticals not only supplies a single product but also provides a full-chain solution covering active pharmaceutical ingredients (APIs), finished formulations, and injection devices, thereby helping Brazil establish a complete insulin production system.

However, Collaboration Still Faces Challenges. Technology transfer demands strict quality consistency and stability, while uncertainties in local regulatory approvals, along with logistics and policy risks, may affect project progress. Gan&Lee Pharmaceuticals needs to continue investing in multinational GMP standards, supply chain assurance, and policy communication to ensure the long-term smooth execution of the project.

In recent years, Chinese biopharmaceutical companies have significantly accelerated their expansion into the Brazilian market., its role in the Brazilian market is gradually expanding from mere product importation to localized production, joint research and development, and policy alignment, with increasingly diversified cooperation models.

For example, Henlius introduced its biosimilar “Hanquyou®” (trastuzumab injection) to the Brazilian market through licensing agreements, leveraging local partners to achieve commercialization; Sinovac Biotech collaborated with Brazil’s Fiocruz on vaccine research and development and capacity building; and Mindray Medical established a local subsidiary and forged strategic partnerships with leading medical institutions such as the Albert Einstein Hospital.

From an industry perspective, this “technology transfer + localized supply” collaboration model offers a reference for Chinese biopharmaceutical companies seeking to enter public markets in developing countries.

In the future, as competition intensifies in innovative sectors such as GLP-1 receptor agonists and long-acting insulins, Chinese enterprises can leverage their technological and production capacity advantages to deeply engage in the development of the global public health system.This will not only open up markets in developing countries but also help Chinese companies align with international regulatory systems, thereby accumulating experience for the global expansion of more products.

References:

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

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