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Fierce Pharma Asia—Daiichi, Merck's FDA rejection; Wegovy's expansion; Takeda CEO's hunt for China deals
2024-06-28
上市批准临床结果临床2期疫苗临床3期
The FDA's rejection of Daiichi and Merck's HER3 ADC, Wegovy's approval in China, and Takeda CEO's appetite for more deals with Chinese biotechs made our news this week.
1. DFDAchi's lungDaiichi SankyojecteMerckFDAHER3blow to first project undeNovo NordisknershipWegovyTakeda
DaiDaiichinkylung canceraADCered HER3 antFDAdy-drug conjugate, patritumab deMerckcan, 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.
Daiichi Sankyok wMerckpproval in HER3a for GLP-1 obesity drug WpatritumabderuxtecanFDAMerckFDA
ChiNovo Nordiskved Novo Nordisk’s Wegovy as a weiobesitys treaWegovyfor 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 looNovo Nordiskna Wegovyh partnerships, CEO says (Bloomberg)obesity
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-Takedantibody on track for phase 3 after boosting plHutchmedount Ascentage PharmarderTakeda
Although Takanti-CD38 antibody wind down mezagitamab in myasthenia gravis and systemibleeding disorderosus, 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 layofmezagitamab aftmyasthenia gravisop, Usystemic lupus erythematosusanti-CD38 antibodyprimary immune thrombocytopenia
SumSumitomo Pharmanew 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.
Sumitomo Pharmas Rybrevant full nod, FDA encourages Dizal to file rival lung cancer drug for accelerated approvalNikkei Asia
The FDA hasJ&JdorRybrevant Pharma’s pFDA to file its China-approved sunvlung cancern 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.
7. SFDAioscience begiDizal Pharmaation' push, paying $244M for majorsunvozertinibcontract manufacturer IDT BiologikaEGFR exon 20 insertion-mutated non-small cell lung cancerEGFR exon 20FDAJohnson & JohnsonRybrevant
SK SK Biosciences acquired a 60% stake in Germany’s IDT Biologika for 339 billion South Korean won ($24IDT Biologika 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.
8. FDA slams Dr. Reddy's plants in India with a pair of Form 483s
11. Fosun PharmaProBio arm debuts new gene therapy producHenliusant in NJ
12. GenScript-MASH drug cuts fat, not muscle or food intake, in GLP-1 combo in mice
13. Glenmark recalls 114 batches of low potassium drug in the US over potentially deadly hyperkalemia risk
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