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Lilly To Decide Next Steps After Formal FDA 'Nay' For First Chinese PD-1

A Chance To Reflect?

 
• By Brian Yang

The official verdict is in for sintilimab and the results are not surprising. But some view the setback for "Made In China" innovation as a chance to reflect and move forward.

FDA Complete response stamp holder
US FDA ISSUES COMPLETE RESPONSE LETTER TO LILLY/INNOVENT'S SINTILIMAB • Source: Nielsen Hobbs; the Pink Sheet | Alamy image

The US Food and Drug Administration has issued an official complete response letter to Eli Lilly and Company for the immuno-oncology agent, Tvvyt (sintilimab), developed by its partner Innovent Biologics, Inc.

The CRL follows an expert committee vote in February that recommended rejecting the approval of the first anti-PD-1 antibody from...

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Sun’s Alopecia Treatment Debuts In US - Can It Make Up For Lost Time?

 
• By Anju Ghangurde

Sun’s Leqselvi goes up against Lilly's Olumiant and Pfizer's Litfulo, which currently has the broadest label, in the US alopecia market. Can it shake things up early, amid growing activity in the space with several new mechanisms of action being investigated?

In Brief: Nanoscope Ploughs Forward With FDA Application For Retinitis Pigmentosa Gene Therapy

 
• By Manas Mishra

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Pipeline Watch: Ten Approvals And Two Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Moderna’s Spikevax Wins Pediatric Approval, But With Narrower Label

 
• By Alaric DeArment

The approval for young children, consistent with the FDA’s new COVID-19 vaccine policy, restricts Spikevax to those with conditions putting them at higher risk.

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Finance Watch: Karyopharm Cuts Jobs In Cash Crunch; Pacira’s Layoffs Attributed To Efficiency

 
• By Mandy Jackson

Restructuring Edition: Karyopharm is reducing its workforce by 20% as it seeks alternatives to extend its cash runway, but Pacira’s production improvements created efficiency that necessitate an 8% layoff in manufacturing. Jasper, Century, Sage, Leap and Prothena also cut jobs.

Kailera Eyes Global Obesity Market With Hengrui’s Phase III Dual Agonist

 
• By Joseph Haas

With China’s Hengrui reporting successful Phase III data for its dual GLP-1/GIP agonist, licensee Kailera is readying plans to demonstrate better efficacy than current obesity drugs.

Sellas Targets Tambiciclib To Adverse-Risk Frontline AML Patients After Phase II Success

 
• By Alaric DeArment

The biotech announced positive Phase II data for the drug combined with AbbVie/Roche’s Venclexta and BMS’s Vidaza in relapsed/refractory acute myeloid leukemia.