Henlius granted exclusive development and commercialisation rights of HLX02 in the US and Canada to Accord

SHANGHAI, China I September 30, 2020 I Shanghai Henlius Biotech, Inc. (2696.HK) announced the Company entered into a collaboration with Accord Healthcare Inc. (Accord US), according to which Henlius will grant an exclusive license to Accord US to develop and commercialise HLX02 (trastuzumab biosimilar, Chinese brand name: 汉曲优®, EU brand name: Zercepac®) in the United States of America and Canada. With this collaboration, the commercialisation footprint of HLX02 has the potential to cover most of the global mainstream markets of biologics and to bring high-quality and affordable treatment options to global patients.

According to the amendment, relevant milestone payments from Accord US to Henlius include 1) upfront payment of US$27 million upon signature of the definitive agreement; 2) regulatory milestone payments of no more than US$13 million in total and Accord US will be responsible for regulatory filing in the United States of America and Canada, based on research data from Henlius; 3) commercial sales milestone payments of US$25 million for every US$500 million of cumulative net sales. Henlius will also be eligible to receive a tiered double digit royalty up to 50% of future net profit of HLX02. According to data from IQVIA, the total sales of the trastuzumab originator and its biosimilars has exceeded US$3 billion in 2019 in North America, with patient demand increasing year by year. Once the cumulative net sales of HLX02 reach US$3 billion in the United States of America and Canada, Henlius shall recieve a total of US$150 million from commercial sales milestone payments.

汉曲优®(EU brand name: Zercepac®) is a trastuzumab biosimilar independently developed by Henlius. The development process strictly followed the European Medicines Agency (EMA) and National Medical Products Administration (NMPA) biosimilar guidelines, and the product has been approved by the European Commission (EC) and the NMPA successively in July and August 2020, making it the first China-developed monoclonal antibody (mAb) biosimilar approved both in China and in the EU. Indications approved for this product include HER2-positive early breast cancer, HER2-positive metastatic breast cancer and HER2-positive metastatic gastric cancer, which correspond to all the indications approved for the trastuzumab originator. Henlius has built an in-house commercial team to be responsible for the commercialisation of 汉曲优® in China and the product has already been prescribed and used in clinical practice in China. Henlius collaboration partner, Accord Healthcare Ltd (Accord UK), is responsible for the commercialisation of this product in the EU. Zercepac® will been launched in all EU Member States, Iceland, Norway and Liechtenstein, and has recently been launched in the UK, Germany, Portugal and Spain. 

Henlius has formed multiple global partnership to accelerate the global commercialisation of HLX02. In June 2018, Henlius and Accord UK entered into a license agreement, under which Henlius granted Accord UK exclusive commercialisation rights of HLX02 in certain countries and regions in Europe, the Middle East, North Africa and the Commonwealth of Independent States. In June 2020, Henlius and Accord UK reached an amendment to the above-mentioned license agreement in regards of new dosage forms, arrangement of milestone payments and adjustment of royalties, with the aim to lower the unit cost for patients, enable flexible dosage combination and to satisfy customised dosing needs. The close collaboration between Accord UK and Henlius greatly strengthened Accord’s confidence in the quality of Henlius products, which has catalized the collaboration between Accord US and Henlius. The collaboration with Accord US is not only another recognition of Henlius’ independently developed and high-quality biologics from the global market but also an important step for Henlius to implement the Company’s global strategy. Jeff Hampton, President, Accord US said, “We are excited to expand our relationship with Henlius for the US and Canadian market for this product. This agreement further reinforces our commitment to bring high-quality, affordable medicines to improve patient access for the treatment of oncology, and this product will be a key addition to our already extensive oncology portfolio”.

Henlius will not only expand its footprint in the mature markets in Europe and North America, but also keep exploring emerging markets as its strategy focus. In addition to Accord, Henlius has also reached strategic collaboration agreements with many global leading pharmaceutical companies(including Jacobson Medical, Cipla and Mabxience) for HLX02, to access more than 80 countries and regions in Hong Kong (China), Macau (China), Malaysia, Australia, New Zealand, Colombia, Argentina, Uruguay, Paraguay and Europe, Middle East-North Africa and the Commonwealth of the Independent States. Consistently pursuing core values of "Affordable Innovation · Reliable Quality", Henlius will take HLX02 as a benchmark in developing high-quality products and exploring global markets. In the future, Henlius will carry on to expand the global layout of more products that are developed and made in China and are of international quality, highlighting the company’s vision of becoming the most trusted biotech company in the world.

SOURCE: Shanghai Henlius Biotech

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