Pizuglanstat

Regulatory approvals for Innovent Biologics and Dizal, and a positive phase 3 readout for Biokin's Bristol Myers Squibb-partnered bispecific ADC made our news this week. In the past two weeks, China approved a first-in-class weight loss drug that Innovent Biologics licensed from Eli Lilly, Dizal won an FDA approval for a challenger to Johnson & Johnson's Rybrevant, while Biokin said a China phase 3 trial of its Bristol Myers Squibb-partnered bispecific antibody-drug conjugate has met a primary endpoint. And more.1. With China approval, Lilly and Innovent's mazdutide breaks into new class for GLP-1 obesity drugsChina has approved Innovent Biologics’ mazdutide as the world’s first dual GLP-1/glucagon receptor agonist for chronic weight management. Innovent obtained Chinese rights to the drug from Eli Lilly in 2019. In a Chinese phase 3 trial in patients who were overweight or obese, mazdutide 6mg achieved 14.8% average weight loss at 48 weeks, compared with just 0.5% for placebo.2. Dizal to challenge J&J with FDA approval for lung cancer drug ZegfrovyAstraZeneca spinout Dizal Pharmaceuticals won an FDA accelerated approval for sunvozertinib for previously treated EGFR ex 20-mutated non-small cell lung cancer. To be marketed as Zegfrovy, the oral drug will compete with Johnson & Johnson’s infused Rybrevant, which recently moved into the first-line setting as part of a chemotherapy combination.3. Biokin, having landed BMS deal, posts ph. 3 cancer win for bispecific ADCA phase 3 trial of Biokin’s bispecific antibody-drug conjugate, iza-bren, has hit at least one primary endpoint. The Chinese phase 3 is testing the EGFRxHER3 ADC in pre-treated nasopharyngeal carcinoma with objective response rate and overall survival as the primary endpoints. Bristol Myers Squibb owns ex-China rights to the drug after paying $800 million upfront.4. Roche’s Chugai inks $250M Gero deal to access age-related disease targetsIn a deal potentially worth $250 million, Roche’s Chugai Pharmaceutical is tapping Gero’s AI-based platform to develop antibodies against age-related diseases. Singapore-based Gero will identify therapeutic targets, while Chugai will utilize its antibody engineering technologies. The Japanese company will hold worldwide rights to drugs born from the collaboration.5. Alphabet's Calico stitches $596M deal for Mabwell's anti-aging assetIn another pact around age-related diseases, Alphabet’s Calico Life Sciences is licensing Mabwell Bioscience’s investigational IL-11-directed therapeutics. The deal includes $25 million upfront and up to $571 million in biobucks. It covers 9MW3811, which is in phase 1 trials across China and Australia, as the Chinese biotech highlights the drug’s potential in idiopathic pulmonary fibrosis. 6. Torrent Pharma shells out $1.4B to take over controlling stake in India's JB Pharma from KKRTorrent Pharma has obtained a 46.39% stake in India’s J.B. Chemicals and Pharmaceuticals from private equity firm KKR for 119 billion rupees ($1.4 billion). Torrent can further purchase another 25% of J.B.’s shares from public shareholders. J.B.’s offerings include some hypertension and eye disease brands and CDMO services.7. Taiho’s DMD asset fails to improve functional motor test results in phase 3 trialTaiho Pharmaceutical’s Duchenne muscular dystrophy candidate pizuglanstat failed to better placebo in a phase 3 study. In ambulatory patients, the oral drug failed to show a significant difference in time to rise from the floor after one year of treatment. Another cohort, conducted in non-ambulatory patients, has also been discontinued.8. Shionogi puts more than $600M on the table for Swiss biotech's antibiotic programShionogi is paying about $6.3 million upfront and up to $604 million in milestones for a preclinical antibiotic asset from BioVersys. The candidate, coded BV500, belongs to the antibiotic class of ansamycin and is being developed for nontuberculous mycobacterial infections.Other News of Note: 9. China approves 4 new drugs, including a global first-in-class medicine10. Cell therapy biotech shares first clinical data for in vivo CAR-T that attracted $1B AstraZeneca acquisition11. Novo keeps China manufacturing investments rolling with $112M for new quality testing lab in Tianjin12. Pressuring Merck's Gardasil, China's home-made 9-valent HPV vaccine priced at 60% discount13. Southwest Airlines sues dozens of generic drugmakers for alleged price-fixing scheme14. Biotech VC raises $200M to focus on Japan’s ‘untapped source’ of innovation15. Pfizer, Astellas boost case for Xtandi in early-stage prostate cancer with combo survival win16. Fujifilm Biotechnologies takes lessons from Denmark as debut of massive NC cell culture facility looms17. Fosun's Henlius pens $202M pact for regional rights to HanchorBio's phase 2 CD47 blocker18. US lawmakers refresh scrutiny over GenScript's ties to China (Reuters)19. Takeda survey finds colon cancer patients feel unheard by HCPs, want more info on diagnosis, treatment20. CStone out-licenses PD-L1 inhibitor’s certain European rights to Gentili (release)