FDA Approves First-Ever Treatment for Non-Cystic Fibrosis Bronchiectasis
Late last week, the U.S. Food and Drug Administration approved Insmed’s Brinsupri (brensocatib), marking the first approved therapy for non-cystic fibrosis bronchiectasis, a chronic lung condition affecting an estimated 350,000 to 500,000 adults in the United States. The disease is characterized by persistent infection and inflammation in the airways, leading to frequent flare-ups and gradual lung damage. Brinsupri works by blocking the enzyme DPP1, which activates neutrophil proteases responsible for much of this inflammation. In a Phase 3 trial involving over 1,700 participants, the drug significantly reduced the annualized rate of pulmonary exacerbations compared with placebo. Pricing has been set at around $88,000 per year for both the 10 mg and 25 mg doses. Analysts project peak U.S. sales could reach $3.7 billion by 2031 due to the absence of direct competition. The prescribing information lists no boxed warnings, which may support rapid physician adoption. Patient advocacy groups have welcomed the decision, noting the years-long struggle to secure a dedicated therapy. With competitors like AstraZeneca still in earlier trial phases, Insmed appears well positioned to establish a dominant market share. Around the same time, Eli Lilly was in the headlines for a major research partnership.
Lilly Strikes $1.3 Billion GPCR Drug Discovery Pact with Superluminal
Earlier this week, Eli Lilly announced a collaboration with Superluminal Medicines valued at up to $1.3 billion to develop drugs targeting G protein–coupled receptors (GPCRs) for obesity and cardiometabolic disorders. GPCRs represent one of the largest families of drug targets, influencing a wide range of physiological processes. The agreement includes an upfront payment, milestone payments tied to clinical and regulatory progress, and an equity investment in the biotech. Superluminal will deploy its AI-enabled drug discovery platform to identify novel compounds, including a melanocortin 4 receptor agonist expected to enter human trials next year. Lilly is already a dominant force in the global obesity drug market, which could reach $150 billion annually within the next decade. This deal deepens Lilly’s capabilities while helping diversify beyond its existing GLP-1 pipeline. Industry analysts note the strategy mirrors Lilly’s past successes in leveraging external innovation to accelerate portfolio growth. The collaboration also strengthens Lilly’s competitive stance against Novo Nordisk and other challengers. By combining Superluminal’s technology with Lilly’s development and commercialization expertise, the companies aim to shorten the timeline from discovery to market. In sharp contrast, another biotech recently announced it would halt a promising program altogether.
Schrödinger Halts CDC7 Inhibitor After Two Patient Deaths
In an announcement made earlier today, Schrödinger confirmed it is discontinuing development of its CDC7 inhibitor SGR-2921 following two treatment-related deaths in a Phase 1 trial for acute myeloid leukemia (AML). The decision came after a comprehensive safety review that weighed early signs of anti-leukemia activity against the severity of adverse events observed. CDC7 is a kinase involved in DNA replication, and its inhibition is intended to disrupt uncontrolled cancer cell division. AML affects approximately 20,000 Americans each year and carries a poor prognosis, with five-year survival rates under 30 percent in older adults. The trial enrolled patients with relapsed or refractory AML who had exhausted standard treatment options. According to the company’s press statement, all trial participants are being transitioned to alternative therapies or palliative care. While the move disappointed investors, it underscores the importance of prioritizing patient safety in early-stage oncology programs. Schrödinger’s share price fell more than 9 percent in morning trading. As this program winds down, GSK is moving aggressively to expand its presence in Asia.
GSK and Hengrui Pharma Forge $500 Million China Collaboration
Two weeks ago, GSK announced it will pay Jiangsu Hengrui $500 million upfront in a deal that could exceed $12 billion in total value to develop up to 12 innovative medicines. The collaboration spans respiratory, immunology, inflammation, and oncology, with GSK obtaining exclusive commercialization rights outside China. Among the most closely watched assets is a PDE3/4 inhibitor for chronic obstructive pulmonary disease that could rival or surpass current standard-of-care options. The joint press release highlights Hengrui’s deep pipeline and GSK’s global marketing reach. Branded pharmaceutical sales in China are projected to grow more than 8 percent annually through 2030, offering significant revenue potential for both companies. Analysts see this as part of GSK’s broader push to secure mid-stage assets that can feed its late-stage pipeline. Hengrui will benefit from milestone payments and increased exposure in markets where it currently has little presence. The deal also reinforces the trend of cross-border R&D partnerships despite geopolitical complexities. For GSK, this agreement represents both a commercial and strategic foothold in one of the fastest-growing pharma markets globally.
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