Hansoh Pharma

GSK plc announced the EMA granted PRIME Designation to GSK’227, a B7-H3-targeted ADC for relapsed ES-SCLC. This follows the US FDA’s Breakthrough Therapy Designation in 2024. The designation is supported by ARTEMIS-001 study data, with GSK initiating a global phase I trial for GSK’227. Lung cancer, particularly SCLC, is a significant global health issue.

Merck acquired exclusive rights from Hansoh Pharma to develop, manufacture, and commercialize an investigational GLP-1 receptor agonist for $112 million upfront, with potential additional payments up to $1.9 billion based on milestones. Hansoh Pharma retains rights to co-promote or commercialize the drug in China.

Merck & Co. pays Hansoh Pharma $112M for rights to a preclinical obesity pill, HS-10535, outside China, with potential $1.9B in milestone payouts. The deal suggests Merck's entry into the obesity market, disappointing potential acquisition targets. HS-10535 is an oral GLP-1 agonist, similar to Wegovy.

GSK plc received EMA's PRIME designation for its B7-H3 targeted antibody-drug conjugate, GSK’227, for extensive stage small-cell lung cancer. The FDA also awarded breakthrough therapy designation. The decision is based on early clinical outcomes from the ARTEMIS-001 study, a Phase I trial assessing safety and anti-tumour efficacy. GSK aims to accelerate development of GSK’227 for limited treatments in other tumour types.

GSK plc announced EMA's PRIME Designation for GSK5764227, a B7-H3-targeted ADC for relapsed extensive-stage small-cell lung cancer, supported by preliminary ARTEMIS-001 study data. This is GSK'227's second regulatory designation, following FDA's Breakthrough Therapy Designation in August 2024.

GSK's B7-H3-targeted ADC, GSK’227, received PRIME designation from EMA for relapsed ES-SCLC, following FDA's breakthrough therapy designation in 2024. The decision is based on ARTEMIS-0001 study outcomes. GSK aims to accelerate GSK’227's development in extensive-stage small-cell lung cancer and other tumor types.

GSK received EMA PRIME Designation for GSK5764227 (GSK’227), a B7-H3-targeted ADC for relapsed ES-SCLC. GSK acquired global rights from Hansoh Pharma, except in China regions. EMA based its decision on ARTEMIS-001 Phase 1 study data. GSK’227 also holds FDA Breakthrough Therapy Designation. Separately, GSK secured FDA Breakthrough Therapy Designation for Jemperli for rectal cancer and EMA CHMP recommendation for Jemperli plus chemotherapy for endometrial cancer.

Life sciences sector resilient despite challenges; significant investments in ADCs, CGTs, AI, and CDMOs. ADCs and CGTs driving growth, with China leading in clinical trials and innovation. AI transforming drug discovery and clinical trials. APAC region dominating clinical trials, especially in oncology. China's biopharma sector booming, attracting global investments. CDMOs adopting digital revolution and AI for agile manufacturing. BIOSECURE Act impacting Chinese biotech companies, benefiting Indian CDMOs.

Niven R. Narain emphasizes that AI investments in drug development require robust data and validation. GEN's A-List highlights 10 AI-based drug discovery leaders, including BPGbio, which focuses on cancer energy generation. Other notable companies include Nvidia and Palantir Technologies, though not on the A-List. The list includes specifics on companies like Anima Biotech, Atomwise, and Nimbus Therapeutics, detailing their AI platforms and drug development progress.