Saturday, October 28, 2023
Shanghai Henlius Biotech, Inc. (2696.HK) has recently entered an exclusive licensing agreement with Intas Pharmaceuticals Limited ("Intas") for the development and commercialization of multiple indications, including ES-SCLC (extensive-stage small cell lung cancer), and a specific formulation of HANSIZHUANG (serplulimab injection), Henlius' innovative anti-PD-1 monoclonal antibody. This collaboration marks an expansion of the strategic partnership between the two companies, paving the way for the global deployment of serplulimab.
Under this agreement, Henlius will oversee clinical development, manufacturing, and supply upon launch. In return, they will receive a €42 million upfront payment, up to €43 million in regulatory milestones, up to €100 million in commercial sales milestones, and double-digit royalties on net profit from Intas in the licensed regions, which include Europe and India.
Henlius, highlighted the exceptional efficacy and data quality of HANSIZHUANG (serplulimab). He emphasized that it is the first anti-PD-1 monoclonal antibody approved for the first-line treatment of small cell lung cancer and has garnered approvals for four indications in China. Furthermore, its marketing application has been validated by the European Medicines Agency (EMA) in March 2023.
Intas Pharmaceuticals Ltd., expressed enthusiasm about strengthening their partnership with Henlius and the impending launch of serplulimab in Europe and India. This collaboration reflects their dedication to providing innovative healthcare solutions globally.
EMENA at Accord, conveyed his delight at reinforcing their partnership with Henlius and the significance of introducing serplulimab, which will enhance Accord's position as a provider of specialty medicines.
HANSIZHUANG (serplulimab) is Henlius' pioneering product, approved in China in March 2022, and has been authorized for four indications in China. It has displayed remarkable efficacy in various clinical trials, which have been published in prestigious medical journals. Furthermore, it has received orphan drug designations from the U.S. Food and Drug Administration (FDA) and the European Commission (EC) for the treatment of SCLC, granting it policy support in the U.S. and Europe.
The EMA is expected to approve serplulimab in the first half of 2024. Henlius is actively conducting a head-to-head trial in the U.S. to compare serplulimab with atezolizumab for the first-line treatment of ES-SCLC. Simultaneously, Henlius is rapidly advancing the global commercialization of HANSIZHUANG, having granted exclusive rights for its development and commercialization in various countries and regions.
In the future, Henlius plans to collaborate with international partners to expand the global development and commercialization of HANSIZHUANG, offering patients in diverse regions more therapeutic options.
HANSIZHUANG is a recombinant humanized anti-PD-1 monoclonal antibody injection and is the first-line treatment for SCLC. It has been approved for multiple indications in China and is under review by the EMA. Henlius is actively promoting its use in combination therapies for various types of cancer. The extensive clinical data collected from trials globally supports its effectiveness. The product has received orphan drug designations in the U.S. and Europe for SCLC treatment, and Henlius is pursuing approval in these markets.
Source: prnasia.com
