复宏汉霖合作巴西龙头药企 汉利康等三款产品深拓拉美
信息内容来在于于：复宏汉霖
2022年5月11日，复宏汉霖（2696.HK）宣布与巴西本土龙头药企Eurofarma Laboratórios S.A.（下称“Eurofarma”）公司签署许可协议，授予其在16个拉美地区国家对公司自主开发的利妥昔单抗汉利康®、曲妥珠单抗汉曲优®、贝伐珠单抗汉贝泰®三款产品进行开发、生产和商业化权益。Eurofarma在面向拉美区域的创新药品引入和推广上具有丰富经验。此项合作的达成，不仅代表着复宏汉霖领先的产品品质和企业综合实力再获国际认可，更是公司加速国际化布局战略的进一步实践，为公司由biotech向biopharma的进化蓄势聚力。
根据协议，复宏汉霖将从此次交易中获得高达5050万美元的潜在收入，其中450万美元为首付款。Eurofarma将获得利妥昔单抗汉利康®在墨西哥、危地马拉、巴拿马等12个国家的独家权益；曲妥珠单抗汉曲优®在墨西哥、智利、厄瓜多尔等11个国家的独家权益；贝伐珠单抗汉贝泰®在墨西哥、阿根廷、智利等15个国家的独家权益。此外，Eurofarma还将获得上述三款产品在巴西的半独家权益。
复宏汉霖立足患者需求，致力于凭借强大的产品研发、前沿的生产与质量体系及卓越的商业化能力，携手价值链上的伙伴积极布局拓展全球生物药市场。汉曲优®（欧洲商品名：Zercepac®）是首个中欧双批的国产单抗生物类似药，其与汉贝泰®均由公司自建团队进行中国市场的商业化推广。汉曲优®150mg/60mg双规格均已被纳入中国医保目录，迄今已惠及逾5万名患者。汉利康®是中国首个生物类似药，自2019年获批上市以来已惠及超10万名中国患者。此外，复宏汉霖围绕汉曲优®和汉利康®两款产品前瞻性地开展了国际商业化布局，积极开拓海外市场。公司针对汉曲优®携手全球商业合作伙伴Accord Healthcare、Cipla、Mabxience和雅各臣药业等国际一流的生物制药企业，全面布局美国、加拿大、欧洲以及众多新兴国家市场，覆盖全球80多个国家和地区。作为国产生物药“出海”代表，Zercepac®（150mg）已于英国、德国、西班牙、法国、意大利、爱尔兰、匈牙利、瑞士等近20个欧洲国家和地区成功上市。不仅如此，公司已与哥伦比亚制药企业Farma de Colombia达成合作协议，以促进汉利康®在哥伦比亚、秘鲁、厄瓜多尔及委内瑞拉的商业化。包括本次与Eurofarma的合作在内，公司产品已触达19个拉美地区人口大国，覆盖逾90%的拉美人口。
关于Eurofarma Laboratórios S.A.
关于复宏汉霖
复宏汉霖前瞻性布局了一个多元化、高质量的产品管线，涵盖20多种创新单克隆抗体，并全面推进基于自有抗PD-1单抗H药汉斯状®的肿瘤免疫联合疗法。继国内首个生物类似药汉利康®（利妥昔单抗）、中国首个自主研发的中欧双批单抗药物汉曲优®（曲妥珠单抗，欧洲商品名：Zercepac®）、汉达远®（阿达木单抗）和汉贝泰®（贝伐珠单抗）相继获批上市，创新产品汉斯状®（斯鲁利单抗）已获批用于治疗微卫星高度不稳定（MSI-H）实体瘤，其鳞状非小细胞肺癌和广泛期小细胞肺癌两项适应症的上市注册申请也正在审评中。公司亦同步就12个产品、9个免疫联合治疗方案在全球范围内开展20多项临床试验，对外授权全面覆盖欧美主流生物药市场和众多新兴市场。
关于汉利康®
复宏汉霖旗下首款产品汉利康®于2019年2月正式获得中国国家药监局上市注册申请批准，成为中国首个根据2015年发布的《生物类似药研发与评价技术指导原则（试行）》开发并批准上市的生物类似药。目前，汉利康®已获批治疗非霍奇金淋巴瘤、慢性淋巴细胞白血病及原研利妥昔单抗未在中国获批的类风湿关节炎（RA）适应症，以差异化的开发惠及广泛患者群体。汉利康®（利妥昔单抗）国内市场的销售推广由江苏银河集团官网 团队负责，2021年复宏汉霖基于与合作伙伴约定的利润分成安排获得销售收入约人民币5.425亿元，授权许可收入约1040万元。
关于汉曲优®
复宏汉霖旗下重磅产品汉曲优®（欧洲商品名：Zercepac®）于2020年7月及8月先后获得欧盟委员会与中国国家药监局批准上市，为首个中欧双批的国产单抗生物类似药。可用于HER2阳性早期乳腺癌、转移性乳腺癌和转移性胃癌，即涵盖原研已获批准的所有适应症，有望为全球HER2阳性乳腺癌和胃癌患者带来更多治疗选择。2021年，汉曲优®（曲妥珠单抗，欧洲商品名：Zercepac®）于中国和欧洲销售规模稳健增长，实现国内销售收入约8.680亿元，较2020年涨幅约692.7%，海外销售收入约6220万元，海外授权许可及研发服务收入约3020万元。
关于汉贝泰®
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.
About Eurofarma
About Henlius
Henlius has pro-actively built a diversified and high-quality product pipeline covering over 20 innovative monoclonal antibodies (mAbs) and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as backbone. Apart from the launched products HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab, trade name in Europe: Zercepac®), the first China-developed mAb biosimilar approved both 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 squamous non-small cell lung cancer and extensive small-cell lung cancer (ES-SCLC) are under review. What's more, Henlius has conducted over 20 clinical studies for 12 products and 9 combination therapies.
About HANLIKANG
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.
About HANQUYOU
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.
About HANBEITAI
联系方式
多媒体：PR@Henlius.com
项目普通投资者：IR@Henlius.com
