Collaboration deepens strategic partnership between two Indian-Chinese companies
Ahmedabad-headquartered Intas Pharmaceuticals Limited has entered into an exclusive license agreement with Shanghai Henlius Biotech, Inc. (2696.HK) for the development and commercialisation of serplulimab for the European and Indian markets.
Serplulimab, a recombinant humanised anti-PD-1 monoclonal antibody (mAb) injection, is the first innovative monoclonal antibody developed by Henlius. It has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) and the European Commission (EC) for the treatment of Small Cell Lung Cancer (SCLC).
Its marketing application for the first-line treatment for extensive-stage small cell lung cancer (ES-SCLC) is under review by the EMA. Serplulimab was launched in China under the trade name HANSIZHUANG in March 2022 and has been approved by the NMPA for the treatment of MSI-H solid tumours, squamous non-small cell lung cancer (sqNSCLC), ES-SCLC, and esophageal squamous cell carcinoma (ESCC).
This collaboration, announced on 28 Oct 2023, deepens the strategic partnership between the two companies and opens new development opportunities for serplulimab’s global layout. Under the terms of the agreement, Henlius will be responsible for clinical development, manufacturing, and supply upon launch.
Henlius will receive: i) a Euro42 million upfront payment, ii) up to Euro43 million in regulatory milestones, iii) up to Euro100 million in commercial sales milestones, and iv) double-digit royalties on net profit from Intas in the licensed territory.
Serplulimab will be commercialised by Intas in India and by its subsidiary, Accord Healthcare Ltd, in Europe. As one of the key players in the global oncology market, Accord has a longstanding commitment to oncology with proven commercial capabilities and currently supplies around one in three injectable oncology medicines in Europe.
In June 2018, Henlius and Accord entered into a license agreement, under which Henlius granted Accord exclusive commercialisation rights of HLX02. Fiinews.com
