The FDA rejected Daiichi Sankyo and Merck's HER3 antibody-drug conjugate. Novo Nordisk's weight loss star Wegovy secured approval in China. After two large licensing deals, Takeda's CEO is open to more partnerships with Chinese biotechs. And more.
1. Daiichi's lung cancer ADC rejected by FDA in blow to first project under Merck partnership
Daiichi Sankyo’s Merck-partnered HER3 antibody-drug conjugate, patritumab deruxtecan, was rejected by the FDA because of third-party manufacturing issues. The drug is one of three ADC programs featured as part of a $4 billion upfront deal between the two companies, and it would have been Merck’s first ADC launch. The partners are working with the contractor and the FDA to address the problems.
2. Novo Nordisk wins approval in China for GLP-1 obesity drug Wegovy
China has approved Novo Nordisk’s Wegovy as a weight loss treatment for people with a body mass index of at least 30 or between 27 and 30 with one weight-related risk factor. However, the drug will be unlikely to get national reimbursement after China’s medical insurance authority in an April Q&A ruled out the inclusion of any anti-obesity drugs, along with seven other therapeutic categories, in the national insurance scheme.
3. Takeda keeps looking for China biotech partnerships, CEO says (Bloomberg)
Since last year, Takeda has signed major deals with Chinese biotechs Hutchmed and Ascentage Pharma. Now, CEO Christophe Weber told Bloomberg the Japanese pharma “should remain very open of potential partnerships with Chinese biotech.” He also said that the draft BIOSECURE Act would have no impact on Takeda as the company’s manufacturing in China is for the Chinese market.
4. Takeda's anti-CD38 antibody on track for phase 3 after boosting platelet count in bleeding disorder
Although Takeda has decided to wind down mezagitamab in myasthenia gravis and systemic lupus erythematosus, it’s still advancing the anti-CD38 antibody in primary immune thrombocytopenia. Latest data from 41 patients in a phase 2b trial showed that the drug improved platelet response compared with placebo across all three doses with what Takeda viewed as a favorable safety profile.
5. Sumitomo Pharma's new CEO weighs layoffs in Japan after sharp sales drop, US job cuts: report
Sumitomo Pharma’s new CEO Toru Kimura, who just officially took the helm this week, is weighing a restructuring that could be implemented “as soon as this fiscal year,” he told Nikkei Asia. The reorg would follow a recent layoff round affecting 400 U.S. staffers. Recent revenue declines give the company “no choice but to take further measures, including offering early retirement,” he told the publication.
The FDA has endorsed Dizal Pharma’s plan to file its China-approved sunvozertinib in the U.S. for an accelerated approval in previously treated EGFR exon 20 insertion-mutated non-small cell lung cancer, its CEO said. That’s despite the FDA’s recent full approval for Johnson & Johnson’s bispecific antibody Rybrevant in the same indication. The agency clearly sees the need for alternative or better therapies, Dizal’s CEO explained.
SK Bioscience has acquired a 60% stake in Germany’s IDT Biologika for 339 billion South Korean won ($244 million) as part of the company’s global expansion push. IDT ranks among the world’s top 10 firms in vaccine production. The transaction enables SK to expand its footprint geographically as well as in new treatment areas such as anti-cancer viruses and cell and gene therapy, SK said.
Other News of Note:
8. FDA slams Dr. Reddy's plants in India with a pair of Form 483s
9. Haleon reels in $633M with sale of ex-US nicotine replacement unit to Dr. Reddy's
10. Fosun Pharma offers $690M to take biotech subsidiary Henlius private (Reuters)
11. GenScript's ProBio arm debuts new gene therapy production plant in NJ
12. Terns' ex-MASH drug cuts fat, not muscle or food intake, in GLP-1 combo in mice