China-based biotech company Shanghai Henlius Biotech has expanded its existing collaboration with Indian pharmaceutical company Intas Pharmaceuticals to develop and commercialise Henlius’ Hansizhuang (serplulimab) injection in Europe and India.
In June 2018, Intas’ subsidiary Accord Healthcare signed a licence agreement with Henlius to obtain exclusive rights to Henlius’ HLX02 (trastuzumab) injection in Europe, the Middle East, North Africa, and the Commonwealth countries.
In 2021, Intas secured exclusive rights to develop and commercialise Henlius’ HLX02 in the US and Canada.
Under the terms of the expanded collaboration, the Chinese biotech company is responsible for the clinical development, manufacturing, and supply of Hansizhuang to Intas.
It will receive €42m in upfront payment, up to €143m in milestone payments, along with double-digit royalties on net profit from Intas.
Henlius executive director, CEO, and chief financial officer Jason Zhu said: “With superior efficacy and data quality, Hansizhuang (serplulimab) has become the world’s first anti-PD-1 monoclonal antibody approved for the first-line treatment of small cell lung cancer.”
Henlius senior vice president and chief business development officer Ping Cao said: “We look forward to working with Intas to accelerate the launch of serplulimab in Europe and India, and to continue our mission to offering high-quality and affordable biologics to patients around the world.”
Intas Pharmaceuticals vice-chairman and managing director Binish Chudgar said: “This collaboration will further bolster Intas’ global oncology portfolio, underlining our commitment to delivering innovative healthcare solutions worldwide.
“The forthcoming launch of serplulimab in Europe and India will mark a crucial landmark in our mission to enable access to advanced biologics, ensuring patients across the world receive the high-quality treatments they deserve.”
In a separate development, Henlius has secured the National Medical Products Administration (NMPA) approval for its investigational new drug (IND) applications for HLX42 and HLX43.
HLX42 is a novel EGFR-targeting antibody-drug conjugate (ADC) and HLX43 is a novel PD-L1-targeting ADC, intended for the treatment of metastatic solid tumours.
Henlius developed the two products, under collaboration with MediLink Therapeutics.
Both HLX42 and HLX43 comprise a high-affinity humanised IgG1 mAb targeting EGFR and PD-L1 respectively, conjugated with a novel cytotoxic payload through cleavable linkers.
They showed significant anti-tumour effects and favourable safety profiles in non-clinical pharmacological studies, pharmacokinetic studies and safety evaluation, said Henlius.
