China-based Chengdu Kanghong Pharmaceutical Group Co., Ltd (SHE: 002773) has announced receiving clinical trial approvals from the National Medical Products Administration (NMPA) for its Category 1 innovative eye injection KH631 and a generic version of Acadia Pharmaceuticals Inc’s pimavanserin. The approvals are for the treatment of neovascular (wet) age-related macular degeneration (nAMD) and hallucinations and delusions related to psychotic disorders in Parkinson’s disease (PD), respectively.
KH631 Profile
KH631 delivers the target gene through adeno-associated virus (AAV) to treat nAMD. The drug features unique characteristics in terms of tissue specificity, immunogenicity, expression controllability, and infection efficiency. Preclinical studies have demonstrated continuous efficacy in disease models, positioning KH631 as a potential breakthrough in the treatment of nAMD.
Pimavanserin Profile
Pimavanserin was approved for marketing in the US in June 2018 but is not yet approved in China. Currently, Tasly Pharma’s version of the drug is under trial review. The NMPA approval for Kanghong’s generic version marks a significant step in expanding treatment options for patients with hallucinations and delusions related to psychotic disorders in Parkinson’s disease.
Future Implications
The clinical trial approvals for KH631 and pimavanserin underscore Kanghong Pharmaceutical’s commitment to advancing innovative treatments for ophthalmic and neurological conditions. These approvals position the company to enhance its presence in the global pharmaceutical market and address significant unmet medical needs.-Fineline Info & Tech
