Bayer Expands Strategic Partnership with Tsinghua University
Bayer has extended its strategic partnership with Tsinghua University, with the goal of accelerating pharmaceutical research and innovation in China. The ongoing collaboration focuses on translating fundamental scientific research into drug discovery and development in areas such as oncology, cardiorenal diseases, immunology, and advanced therapies.
Under the renewed agreement, Bayer will provide funding and support for joint research projects, recognizing the research excellence of Tsinghua University's scientists in life sciences and drug innovation. The partnership had already established the Peking-Tsinghua Center for Life Sciences – a joint research center dedicated to advancing drug discovery and research.
Christian Rommel, Global Head of Research and Development at Bayer Pharmaceuticals, said, “The innovation ecosystem in China is rapidly evolving, marked with remarkable advancements in scientific and medical research. This progress is driven by the dedicated efforts and strong collaborations among innovators of science and business. We are proud that our partnership with Tsinghua University has set a benchmark for scientific research collaboration between multinational pharmaceutical companies and high profile academic institutions in China.”
EMA Accepts GSK’s Linerixibat for Review
The European Medicines Agency (EMA) has accepted GSK’s Marketing Authorisation Application for linerixibat, an investigational oral treatment targeting cholestatic pruritus in patients with primary biliary cholangitis (PBC), a rare autoimmune liver disease. This application is supported by positive results from the phase III GLISTEN trial, which demonstrated that linerixibat significantly reduced itch severity and improved sleep interference compared to placebo. Both the EMA and the FDA have granted orphan drug designation to linerixibat for this indication.
Two Phase III Positives for Eli Lilly’s Diabetes Drugs
Eli Lilly says its investigational oral GLP-1 receptor agonist, orforglipron, has demonstrated significant efficacy and a safety profile comparable to injectable GLP-1 medications in the phase III ACHIEVE-1 trial. Type 2 diabetes patients taking orforglipron experienced average reductions in HbA1c levels between 1.3 and 1.6 percent, along with an average weight loss of 16 pounds at the highest dose. Side effects observed include nausea and diarrhea, with no observed liver safety concerns. Lilly plans to seek regulatory approval for orforglipron in weight management by the end of 2025 and for type 2 diabetes treatment in 2026.
Furthermore, Lilly's, efsitora alfa, an investigational once-weekly insulin, has demonstrated promising results in phase III trials for both type 1 and type 2 diabetes. In the QWINT-1 and QWINT-3 studies, efsitora achieved non-inferior A1C reductions compared to daily basal insulins, with reductions of 1.31 percent versus 1.27 percent in insulin-naïve type 2 patients, and 0.86 percent versus 0.75 percent in those switching from daily insulin. The QWINT-5 trial in type 1 diabetes also met its primary endpoint, showing similar A1C reductions to insulin degludec.
Ozempic Label Expansions
The EMA’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion to update the label of Ozempic to include benefits for patients with peripheral arterial disease. This recommendation is based on the phase IIIb STRIDE trial, which demonstrated that Ozempic significantly improved walking capacity in individuals with type 2 diabetes and symptomatic PAD. Pending European Commission approval, Ozempic would become the first GLP-1 receptor agonist with proven benefits across blood sugar control, weight management, cardiovascular outcomes, kidney disease, and PAD. Novo Nordisk anticipates the label update within two months, also submitting applications for similar label expansions in the US.
Further approval for Daiichi and AZ’s Datroway
Datroway (datopotamab deruxtecan-dlnk) has received accelerated approval from the FDA as the first TROP2-directed therapy for adults with advanced EGFR-mutated non-small cell lung cancer (NSCLC) previously treated with EGFR-directed therapy and chemotherapy. Developed by Daiichi Sankyo and AstraZeneca, the approval is based on promising objective response rate and duration of response results from the phase II TROPION-Lung05 and phase II TROPION-Lung01 trials. Datroway showed a 45 percent confirmed response rate and a 6.5-month median duration of response. While offering a new option for a hard-to-treat population, Datroway’s safety profile includes risks such as stomatitis and interstitial lung disease. Additional trials are ongoing to confirm benefits and expand indications.
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