BGM-0504

Vor Bio and RemeGen's market-dividing licensing deal, Otsuka and Harbour BioMed's BCMA T-cell engager pact, and Datroway's second FDA nod made our news this week. A potential $4 billion licensing deal with Vor Bio triggered a slide in RemeGen's stock price. Otsuka obtained a BCMAXCD3 bispecific from Harbour BioMed to develop against autoimmune diseases. AstraZeneca and Daiichi Sankyo's Datroway secured a lung cancer approval from the FDA. And more.1. Vor Bio's surprise $4B revival deal for RemeGen's autoimmune drug triggers divergent stock reactionsOn the brink of shutting down, Vor Bio has been revived by a licensing deal with China’s RemeGen. For $45 million upfront and up to $4.1 billion in milestones, the Massachusetts biotech is gaining ex-China rights to RemeGen’s BLyS/APRIL dual-target fusion protein telitacicept, which is approved in China to treat several autoimmune diseases. However, RemeGen’s stock price dropped sharply after the news.2. Otsuka pens $670M pact to point Harbour's preclinical T-cell engager toward autoimmune diseaseIn another autoimmune-focused deal involving a Chinese biotech, Otsuka agreed to pay Harbour BioMed $47 million upfront for ex-China rights to a preclinical BCMAxCD3 bispecific candidate. While Harbour got the Chinese green light to test the asset in cancer patients, Otsuka plans to test the drug, HBM7020, against autoimmune conditions.3. AZ, Daiichi's Datroway scores its 2nd FDA approval—this time in lung cancer subsetAstraZeneca and Daiichi Sankyo’s TROP2-targeted antibody-drug conjugate Datroway has picked up its second FDA nod after a refile. Datroway secured the EGFR-mutated non-small cell lung cancer indication after the companies had withdrawn an earlier application in nonsquamous NSCLC following a phase 3 overall survival miss.4. Corxel, Sciwind post GLP-1 data as China's obesity push gathers paceGLP-1 assets from China are showing their power at the American Diabetes Association Scientific Sessions. Sciwind’s phase 3 data linked its injectable GLP-1 receptor agonist ecnoglutide to a mean weight loss of 15.4% after 48 weeks. Phase 2 data on Corxel and Vincentage’s small-molecule GLP-1 candidate showed a 9.7% weight reduction in 16 weeks when given at a fast titration to the highest dose.5. BrightGene tops Novo drug in diabetes ahead of Zepbound showdownAlso at ADA, China’s BrightGene reported that its GLP-1/GIP receptor agonist BGM0504 topped Novo Nordisk’s Ozempic in Chinese patients with Type 2 diabetes in a midstage trial. The drug saw dose-dependent reductions in HbA1c of up to 2.48% after 12 weeks, versus 1.43% for Ozempic and 0.28% for placebo. The biotech also shared phase 2 obesity data comparing BGM0504 against placebo, and the company is pitting the drug against Eli Lilly’s Zepbound in another phase 2 study.6. FDA moves to block Olympus endoscope imports over manufacturing issuesThe FDA warned healthcare providers that it’s shutting down imports of 58 models of aparoscopes, bronchoscopes, nasopharyngoscopes and ureteroscopes, as well as automated cleaners and reprocessing accessories, made by Olympus. The agency cited concerns around quality requirements at a production site in Japan.Other News of Note:7. GSK, Bharat Biotech to slash the price of first malaria vaccine to less than $5 per dose by 20288. Hummingbird uses VISTA buzz to secure $290M pact for phase 2-ready tumor drug9. Arbutus regains China rights to potential functional hep B cure as part of strategic rethink10. Korea’s Abion Bio inks $1.3B deal over CLDN3, other cancer targets (Korea Biomedical Review)

BrightGene Pharmaceutical reported upbeat mid-stage results for its investigational dual GLP-1/GIP agonist BGM0504, demonstrating superior glycaemic control over Novo Nordisk’s GLP-1 agonist semaglutide (Wegovy/Ozempic) in patients with type 2 diabetes and significant weight reduction in obese individuals compared with placebo. The data were presented at the American Diabetes Association (ADA) annual meeting.Diabetes trial shows benefitA Phase II diabetes study involving 67 participants evaluated once-weekly subcutaneous BGM0504 across three dose levels against semaglutide and placebo controls. Primary endpoint analysis at week 12 demonstrated dose-dependent HbA1c reductions of -1.72%, -1.94%, and -2.48% for 5 mg, 10 mg and 15 mg BGM0504 groups, respectively, compared with -1.43% for semaglutide and -0.28% for placebo.Notable improvements were observed on secondary endpoints — two-hour postprandial glucose, fasting glucose, body weight, HbA1c and combined HbA1c/weight target proportions — while HOMA2-B, lipids, and blood pressure showed varied improvements. The most common treatment-related gastrointestinal adverse events (AEs) included diarrhoea, nausea, and abdominal distension; no hypoglycaemia or unexpected AEs were reported.Obesity study echoesIn a separate Phase II obesity trial of 120 Chinese patients, BGM0504 across all three dose levels demonstrated significant placebo-adjusted reductions in waist circumference ranging from -8.0 cm to -12.98 cm and body weight in the range of -10.77% to -19.78%. Significant reductions were also noted with BGM0504 in systolic blood pressure (-11.60 to -13.03 mmHg) and diastolic blood pressure (-5.98 to -7.50 mmHg) versus placebo. Moreover, secondary outcomes further reinforced BGM0504’s efficacy, with all doses well tolerated. “These Phase II data highlight the significant, best-in-class potential of BGM0504 as a treatment for type 2 diabetes and obesity,” remarked Jiandong Yuan, chief executive of BrightGene.The results are likely to bring some optimism as BrightGene readies to challenge Eli Lilly’s GLP-1/GIP dual agonist tirzepatide (Mounjaro/Zepbound) in an ongoing head-to-head Phase II obesity trial in China. The company also noted BGM0504 has progressed to late-stage testing in China for weight management and type 2 diabetes, while Phase I bridging studies have concluded in the US.