Shanghai, China, May 11th, 2022 - Shanghai Henlius Biotech, Inc. (2696.HK) today announced it has entered into a license and collaboration agreement with Eurofarma Laboratórios SA ("Eurofarma"), a leading Brazilian pharmaceutical company with considerable experience in introducing and marketing innovative medical products throughout Latin America, for the development, manufacturing and commercialization in 16 Latin American countries of Henlius' independently developed HANLIKANG (rituximab biosimilar), HANQUYOU (trastuzumab biosimilar, trade name in Europe: Zercepac®), and HANBEITAI (bevacizumab biosimilar). This collaboration is not only an endorsement of Henlius' product quality and operational strength, but also a continuation of the company's goal of advancing its worldwide footprint, building momentum for the company's evolution from biotechnology to biopharma.
Under the agreement terms, Henlius will receive up to a total of $50.5 million, including a $4.5 million upfront payment. Meanwhile, Eurofarma will acquire exclusive rights to rituximab HANLIKANG in 12 countries, including Mexico, Guatemala and Panama, as well as trastuzumab HANQUYOU in 11 countries, including Mexico, Chile and Ecuador, and bevacizumab HANBEITAI in 15 countries, including Mexico, Argentina and Chile. In addition, Eurofarma will obtain semi-exclusive rights to the three products in Brazil.
Mr. Jason Zhu, President of Henlius, said, "We feel really honored to partner with Eurofarma. Henlius has always adhered to our intention to improve patients' lives by timely providing them with quality and affordable protein therapeutics. Eurofarma has one of the largest sales teams in Latin America. Its robust business network and resources will effectively promote the commercialization of Henlius products in Latin America and the availability to patients. It is hoped that our three products can become effective treatment options for more patients in Latin American countries and light up their lives."
"We are extremely proud of this new partnership, which marks our more robust coverage in biosimilars and confirms our recent moves and work to provide Latin America with the greatest products of the world. We are putting together two of our main strategies to achieve our goals: expanding our presence regionally to increase the revenues from international operations and deploying new technology to the medicine, that definitely helps us become a reference in innovative matter", says Martha Penna, Vice President of Innovation at Eurofarma.
Bearing patients' needs in mind, Henlius has actively expanded the global markets by leveraging its strong product development, manufacturing and quality systems, and commercialization capabilities, as well as joining hands with partners in the value chain. HANQUYOU (trade name in Europe: Zercepac®), the first Chinese mAb biosimilar approved in both Europe and China, and HANBEITAI are commercialized by the company's in-house team in China market. At present, both 150mg and 60mg dosage forms of HANQUYOU have been included in China's National Reimbursement Drug List (NRDL), benefiting over 50,000 patients to date. HANLIKANG (rituximab injection) is the first-ever China-manufactured biosimilar approved by the National Medical Products Administration (NMPA). As of now, it has benefited more than 100,000 Chinese patients. Meanwhile, Henlius has aggressively pursued international commercialization of HANQUYOU and HANLIKANG. The company actively collaborated with global partners such as Accord Healthcare, Cipla, Mabxience, and the Jacobson Group to bring its HANQUYOU to patients in the United States, Canada, Europe, and other emerging markets, covering over 80 countries and regions worldwide. Zercepac® is now available in around 20 European nations and regions, including the United Kingdom, Germany, Spain, France, Italy, Ireland, Hungary, and Switzerland. Moreover, the company has also reached a cooperation agreement with Colombian pharmaceutical company Farma de Colombia to promote the commercialization of HANLIKANG in Colombia, Peru, Ecuador and Venezuela. Including the cooperation with Eurofarma, Henlius' products have reached 19 populous countries in Latin America, covering more than 90% of the Latin American population.
Since its establishment in 1972, Eurofarma has been operating in the health industry, producing and marketing products and services to improve people's quality of life. Focused on generating shared value, it operates in the areas of Prescription, Non-Prescription, Generic Drugs, Hospital and Oncology. It offers over 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 R$ 7.1 billion in 2021, growth of 23% over the previous year, and employs more than 8,100 people.
HANLIKNAG (rituximab) is the company's first proprietary product. It is the first-ever China-manufactured biosimilar approved by the NMPA in accordance with the Technical Guidelines for the Development and Evaluation of Biosimilars (Tentative) issued in 2015. As of now, HANLIKANG has been approved by NMPA for the treatment of non-Hodgkin's lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis for which the originator rituximab has not been approved in China, benefiting a wider patient population with differentiated strategies. The domestic commercialization of HANLIKANG (rituximab) is being handled by Jiangsu Fosun, a subsidiary of Fosun Pharma. In 2021, HANLIKANG received a profit-sharing of RMB 542.5 million from Fosun Pharma and licensing revenue of RMB 10.4 million.
HANQUYOU (trastuzumab, trade name in Europe: Zercepac®) was successfully launched in China and Europe, becoming the first Chinese mAb biosimilar entering both the EU and China market. It is indicated for the treatment of HER2 positive early breast cancer, metastatic breast cancer and metastatic gastric cancer, which corresponds to all the approved indications of the trastuzumab originator. It will bring more treatment options to patients with HER2 positive breast and gastric cancer worldwide. In 2021, HANQUYOU (trastuzumab, trade name in Europe: Zercepac®) delivered solid growth in China and Europe, reaching a sales revenue of RMB 868.0 million with a 692.7% YoY increase and RMB 62.2 million from the Chinese market and international market, respectively. The company also received an oversea licensing revenue and revenue from R&D services of RMB 30.2 million.
HANBEITAI (bevacizumab) was approved by the NMPA in December 2021, for the treatment of metastatic colorectal cancer (mCRC) and unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer (nsNSCLC). Meanwhile, clinical studies of its combination therapy with in-house immunotherapy products serplulimab (anti-PD-1 mAb) are also in progress.