2021-08-31| China

Another Homegrown Anti-PD-1 Antibody Scores Regulatory Win in China

by Tyler Chen
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China had approved its fifth homegrown PD-1 targeting therapy in early August. In less than a month, the country has given another nod to a sixth.  Zimberelimab (GLS-010), which is being developed by China’s Harbin Gloria Pharmaceutical (Harbin Gloria) and Ligand Pharmaceuticals (Ligand) has bagged the regulatory win from the National Medical Products Administration (NMPA).


The Sixth Approved Homegrown PD-1 Therapy in China

Zimberelimab is an anti-PD-1 monoclonal antibody that is approved as the second-line treatment for patients with recurrent or refractory classical Hodgkin’s lymphoma (cHL). 

The drug is able to target PD-1, a checkpoint protein on the surface of T cells that can regulate T cells’ activation. Cancer cells will bind to PD-1 with its PD-L1 protein to hinder the immune system from activating, so tumor cells can evade the attack of T cells.


Clinical Progress

In the Phase 2 trial, zimberelimab delivered an overall response rate of 90.6% and a 6-month progression-free survival rate of 88.2%. Besides, the antibody received the Breakthrough Therapy Designation in March 2021 for treatment of recurrent or metastatic cervical cancer by NMPA.

Zimberelimab is out-licensed to US-based Arcus Biosciences (Arcus). Arcus is currently working with Gilead to examine the drug’s safety and efficacy profile in a Phase 1/2 clinical trial that enrolls patients with prostate, colorectal, non-small cell lung (NSCLC), pancreatic, triple-negative breast, and renal cell cancers.


Other Homegrown Antibodies on the List

In addition to zimberelimab, China has approved five other homegrown anti-PD-1 antibodies. The second latest approval is Akeso and Sino Biopharmaceutical’s penpulimab in August 2021. The rest are camrelizumab from Hengrui, tislelizumab from BeiGene, toripalimab from Coherus BioSciences, and sintilimab from Innovent and Eli Lilly.

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