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 drugs
China 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 Zegfrovy
AstraZeneca 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 ADC
A 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 targets
In 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 asset
In 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 KKR
Torrent 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 trial
Taiho 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 program
Shionogi 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 medicine
11. Novo keeps China manufacturing investments rolling with $112M for new quality testing lab in Tianjin
12. Pressuring Merck's Gardasil, China's home-made 9-valent HPV vaccine priced at 60% discount
13. Southwest Airlines sues dozens of generic drugmakers for alleged price-fixing scheme
14. Biotech VC raises $200M to focus on Japan’s ‘untapped source’ of innovation
15. Pfizer, Astellas boost case for Xtandi in early-stage prostate cancer with combo survival win
17. Fosun's Henlius pens $202M pact for regional rights to HanchorBio's phase 2 CD47 blocker
18. US lawmakers refresh scrutiny over GenScript's ties to China (Reuters)
20. CStone out-licenses PD-L1 inhibitor’s certain European rights to Gentili (release)