São Paulo, May 2022 – Eurofarma, one of the Brazilian pharmaceutical companies that most invests in innovation, has just announced a partnership with Shanghai Henlius Biotech, Inc., a Chinese pharmaceutical company specializing in biologic drugs, for the production and marketing in Latin America of three biosimilars intended for the treatment of various types of cancer.

The new licensing agreement between the companies will allow Eurofarma to expand its portfolio of cancer products in the countries where it operates, offering more treatment options for the local market. It is worth noting that in 2020, there were almost 1.5 million new cases of cancer in Latin America and the Caribbean alone. Highlights among the main gains of the new partnership between the companies include:

• Operate with products of a high degree of non-synthetic complexity (monoclonal antibodies, biological drugs highly effective in fighting cancer and autoimmune diseases);
• Operate in new treatment lines;
• Expand the oncology portfolio, which today is already the largest in Brazil in number of molecules;
• Increase the portfolio in Latin American countries where the company operates, with high value-added products that can generate relevant increments to the international operations;
• Expand the possibilities of negotiation with strategic partners and health services;
• Offer more treatment options to patients in an affordable manner.

"We are extremely proud of this new partnership, which confirms our recent moves and work to provide Latin America with the best products in the world. We are joining two of our main strategies to reach our goals: expanding our presence in the region to increase revenues from international operations and implementing new technologies in medicines, which definitely help us to be a reference in innovation," says Martha Penna, vice president of Innovation at Eurofarma.

"We are very honored to partner with Eurofarma. Henlius has always been intended to improve patients' lives by providing quality and affordable therapeutic proteins in a timely manner. Eurofarma has one of the largest sales teams in Latin America. Its robust business network and resources will effectively promote the marketing of products in Latin America and their availability to patients. We hope that our three products can become effective treatment options for more patients," says  Jason Zhu, President of Henlius.

Products and indications

With the new products, Eurofarma seeks to offer a complete range of items that make up the therapeutic arsenal for treating various types of tumors. Biological drugs are already part of the oncological clinical routine and having a greater number of products available with better access allows physicians to offer more effective therapeutic options to a larger number of patients.

It is important to highlight that biosimilars, safe products widely used worldwide, make up a very peculiar class of medicines, because they have a structure very similar to that of their originators and, therefore, are able to produce exactly the same biological effects. This degree of similarity is proven by testing the physical-chemical and biological properties still in the laboratory. Only the most similar prototypes advance to the animal study phase, and of these, only the candidate with the best response advances to the final stage of investigation in humans.    

Through the partnership with Henlius, Eurofarma's portfolio will include the following products:

• Bevacizumab

The reference product2 has several indications, being able to treat different types of colorectal3, lung4 and ovarian5 cancers. Like the other products, the bevacizumab biosimilar was also investigated in colorectal indications and compared to the originator products supplied in the American, European, and Chinese markets during its clinical trials. It is noteworthy that this biosimilar has a specific study for the treatment of patients with macular degeneration (an indication that the originator itself does not have in a package insert)6. Among the results, it can be seen that the therapeutic effect is the same as the reference product, under the same level of safety.

• Rituximab

The product is indicated for the treatment of blood cell cancers (such as lymphomas and leukemias), as well as immunological diseases, such as rheumatoid arthritis. Its clinical studies used originator products produced in Europe and China as comparators, and its response was evaluated in two different indications: rheumatoid arthritis7 and lymphoma8 in two phase III studies. The findings of these studies revealed that this biosimilar produces an effect equivalent to that of the comparator products and under the same level of safety.

• Trastuzumab

The drug is used for the treatment of HER2+9  breast cancer (both in early and metastatic phase), in addition to gastric cancer10. Like the previous product, this drug also had its therapeutic effects compared to those of products supplied in the European and Chinese markets, obtaining results equivalent in safety and efficacy to those of the originators11.

Marketing

According to the partnership, Eurofarma will be responsible for the production, marketing and distribution of the drugs in Latin America. The agreement sets forth the following provisions:

*The term "semi-exclusive" refers to the possibility of Henlius granting an additional license to other companies in the location.

About Eurofarma

Eurofarma has been operating in the healthcare industry since its establishment in 1972, producing and marketing innovative products and services to improve people’s quality of life. Focused on generating shared value, it operates in the areas of Prescription, OTC and Generic Drugs, Hospital and Oncology. The company offers more than 700 products, over 2,000 SKUs, and serves 42 medical specialties. In Brazil, the company covers 100 therapeutic classes, which represent 70% of the prescriptions in the entire market.

Present in 20 countries, with a manufacturing park in Brazil and plants in six other Latin American countries, it generated net sales of BRL 7.1 billion in 2021, growth of 23% over the previous year, and employs more than 8,100 people.

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Press informartion

G&A – Relações Públicas – Eurofarma

Guilherme Gaspar - +55 11 98285-6000 - guilherme@gaspar.com.br

About Henlius

Henlius (2696.HK) is a global biopharmaceutical company with the goal of providing innovative, affordable, high-quality biological drugs to patients worldwide with a focus on oncology, autoimmune diseases, and ophthalmic diseases. To date, 5 products have been launched in China, 1 in Europe, 13 approved indications worldwide and 2 New Drug Applications (NDA) accepted for review in China. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core high-efficiency and innovation capabilities embedded across the product lifecycle, including R&D, manufacturing and marketing. It has established global innovation centers, with the Shanghai plant complying with global Good Manufacturing Practices, including the Xuhui Plant with certifications granted by China and the European Union and the Songjiang primary plant certified by China.

Henlius has proactively built a diverse, high-quality product pipeline spanning more than 20 innovative monoclonal antibodies (mAbs) and continued to explore immuno-oncology combination therapies with a proprietary anti-PD-1 mAb. In addition to the products launched, HANLIKANG (rituximab), the first biosimilar developed in China, HANQUYOU (trastuzumab, Zercepac® in Europe), the first biosimilar mAb developed in China approved in China and Europe, HANDAYUAN (adalimumab) and HANBEITAI (bevacizumab), the innovative product HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumors and its NDA for the treatment of non-small squamous cell lung cancer and extensive small cell lung cancer is under review. In addition, Henlius has conducted more than 20 clinical trials for 12 products and 9 combination therapies worldwide, expanding its presence in major as well as emerging markets.

References

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7. Lemos, Lívia Lovato Pires de et al. Rituximabe para o tratamento da artrite reumatoide: revisão sistemática. Brazilian Journal of Rheumatology [online]. 2014, v. 54, no. 3 [Accessed April 26, 2022] , pp. 220-230. Available at: <https://doi.org/10.1016/j.rbr.2013.08.001>. ISSN 0482-5004.
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