Shanghai-based Henlius Biotech Inc. and India’s Intas Pharmaceuticals Ltd. agreed upon a potential €185 million (US$195.38 million) licensing deal for Intas to develop and sell Henlius’ China NMPA-approved lung cancer drug, serplulimab, across Europe and India. Serplulimab (HLX-02) is a recombinant humanized PD-1 monoclonal antibody (MAb) injection that first gained approval as Hansizhuang in March 2022.
Shanghai-based Henlius Biotech Inc. and India’s Intas Pharmaceuticals Ltd. agreed upon a potential €185 million (US$195.38 million) licensing deal for Intas to develop and sell Henlius’ China NMPA-approved lung cancer drug, serplulimab, across Europe and India. Serplulimab (HLX-02) is a recombinant humanized PD-1 monoclonal antibody (MAb) injection that first gained approval as Hansizhuang in March 2022.
Geethanjali Radhakrishnan, founder and managing director of Chennai, India-based Adiuvo Diagnostics Pvt. Ltd. reported filing for patent protection for a digital assistant for wound triaging and treatment recommendations.
India is taking steps to separate how it regulates medical devices and pharmaceuticals, as it works to reduce its dependency on imports of devices and turn itself into a global hub for med-tech innovation and manufacturing.
With a new medical device policy, India is laying the groundwork for a spurt in domestic manufacturing and to emerge as an innovative and globally competitive in the space, which is currently heavily reliant on imports. The new National Medical Devices Policy 2023, approved by the government at the end of April and notified in May, aims to place the Indian medical devices sector on an accelerated growth path.
India has revised its policy to make quality tests by government-certified laboratories mandatory for cough syrups to be exported beginning June 1. The decision is the result of numerous safety alerts involving the death of children.
India has revised its policy to make quality tests by government-certified laboratories mandatory for cough syrups to be exported beginning June 1. The decision is the result of numerous safety alerts involving the death of children.
Facing a chronic dependency on imports for medical devices, particularly more advanced and high-end products, India is working on programs to ramp up investment in the sector and improve the availability of skilled human resources, but many say these efforts are not enough.
India’s drug regulatory system is under the lens again after the World Health Organization’s (WHO) latest medical product alert on two substandard cough syrups manufactured in the country.
India’s drug regulatory system is under the lens again after the World Health Organization’s (WHO) latest medical product alert on two substandard cough syrups manufactured in the country, varieties of which have led to the deaths of scores of children in late 2022.
