China-based Jiangxi Jemincare Group has announced the first prescriptions in China for its sonidegib, a smoothened (Smo) inhibitor used to treat basal cell carcinoma (BCC). The initial batch of prescriptions covers more than 50 special drug pharmacies and online platforms across the country. This marks a significant milestone in the availability of targeted therapies for BCC patients in China.
Basal Cell Carcinoma and Treatment Landscape
Basal cell carcinoma (BCC) is a common skin cancer, accounting for 80% of all non-melanoma skin cancer cases. Currently, surgery is the primary treatment for BCC in China, and most patients can be cured through surgical intervention. However, for patients with refractory BCC—such as locally advanced, recurrent, or metastatic BCC—surgical resection has limitations. These limitations include the inability to remove all cancerous cells, the potential for tumor recurrence, and the risk of local deformity.
Sonidegib Mechanism and Regulatory History
Sonidegib, originally developed by Swiss giant Novartis, prevents or delays the growth of cancerous lesions by inhibiting the Hedgehog (HH) pathway, which is active in basal cell carcinoma. Smoothened (Smo) is a key component of the HH pathway. The drug was approved in the US in July 2015 under the trade name Odomzo for the treatment of locally advanced BCC recurring after surgery or radiotherapy, or in patients unfit for these treatments. It was also approved in the European Union in August 2015. Sun Pharma acquired global rights to the product via a USD 175 million deal with Novartis in December 2016. Jemincare secured a licensing deal with Sun Pharma in 2020, obtaining development and commercialization rights for the drug in Greater China. The drug received market approval in China in July 2021 for use in adult patients with BCC not suitable for surgery or radiotherapy, or recurring after these treatments.
Future Outlook
The first prescriptions for sonidegib in China highlight Jemincare’s commitment to bringing innovative cancer treatments to patients. By expanding access to this targeted therapy, Jemincare aims to improve outcomes for patients with refractory BCC and address significant unmet medical needs in oncology.-Fineline Info & Tech
