Shanghai, China, 23rd February, 2022 - Shanghai Henlius Biotech, Inc. (2696.HK) announced that the Company has entered into a licensing and supply agreement with Getz Pharma (Private) Limited and its affiliated company, Getz Pharma International FZ -LLC (together, “Getz Pharma”), pursuant to which, the company agreed to grant a license to Getz Pharma to commercialise adalimumab biosimilar 汉达远® in Islamic Republic of Pakistan, the Philippines, Vietnam, Cambodia, Myanmar, Nigeria, Kenya, Sri Lanka, Ukraine, Kazakhstan and Uzbekistan, and any other territories to be mutually agreed.

汉达远® is the company's first self-developed monoclonal antibody in autoimmune treatment. 汉达远® was approved by the NMPA for the treatment of rheumatoid arthritis (RA), ankylosing spondylitis, psoriasis (Ps) and uveitis (UV). Jiangsu Wanbang is responsible for the commercial sales of 汉达远® in China. Adalimumab has been approved for over 10 indications worldwide. Due to its significant efficacy, it has been recommended by guidelines for different autoimmune diseases in North America and Europe, and it is also one of the world's best-selling drugs.

 

The penetration rate of biologics in emerging markets is relatively low. For example, DMARDs are still the main treatment for RA, and the treatment needs are far from being met. The total population of the signed region is about 840 million, and there is a large unmet demand for adalimumab. Leveraging Getz Pharma's strong business network in South Asia, Southeast Asia, Africa and the CIS, the commercial layout of 汉达远® will be expanded to emerging markets, and Henlius will bring more high-quality treatment options to patients in these countries and regions, accelerating Henlius’ global commercialisation and enhance brand awareness in emerging markets.

 

Up to now, 4 marketed products, 汉利康® (rituximab), 汉曲优® (trastuzumab, Zercepac® in EU), 汉达远® (adalimumab), 汉贝泰® (bevacizumab), and 2 under development products, HLX04-O (recombinant anti-VEGF humanized monoclonal antibody) and Serplulimab (innovative anti-PD-1 monoclonal antibody) have reached cooperation with a number of leading pharmaceutical companies, covering the global major market as well as emerging market. In the future, with the long-term commitment to “affordable innovation”, Henlius will actively collaborate with more global industry leaders, maximizing the value of biosimilars and accelerating diversified innovation to develop more products based on clinical and market needs to deliver more affordable products to patients worldwide.

About Getz Pharma
Getz Pharma (Private) Limited was established in the Islamic Republic of Pakistan in 1995, which mainly specializes in the formulation development, manufacturing and marketing of a wide range of pharmaceutical products. It currently operates in more than 25 countries in South Asia, Central Asia, South East Asia, the Middle East and Africa and has more than 6,000 employees worldwide.

Getz Pharma International FZ-LLC was established in the United Arab Emirates in 2006, which mainly specializes in sales, marketing, export and distribution of a wide range of pharmaceutical products in the Middle East, Africa, Southeast Asia and CIS countries.

About Henlius
Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases and ophthalmic diseases. Up to date, 4 products have been launched in China, 1 in the European Union (EU), 3 New Drug Applications (NDAs) accepted for review in China. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialisation. It has established global R&D centres and a Shanghai-based manufacturing facility certificated by China and the EU Good Manufacturing Practice (GMP).

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 serplulimab (anti-PD-1 mAb) as backbone. Apart from the launched products 汉利康® (rituximab), the first China-developed biosimilar, 汉曲优® (trastuzumab, Zercepac® in the EU), the first China-developed mAb biosimilar approved both in China and in the EU, 汉达远® (adalimumab) and 汉贝泰® (bevacizumab), the NDA of innovative product serplulimab indicated for MSI-H solid tumors has been granted priority review, and the NDAs of HLX01 (rituximab) for the treatment of rheumatoid arthritis and serplulimab for the treatment of squamous non-small cell lung cancer are also under review. What's more, Henlius has conducted over 20 clinical studies for 11 products and 9 combination therapies worldwide, expanding its presence in major market as well as emerging market.