Skip to main content

Regulatory Approval

Solengepras Adds 36 Minutes of Daily 'Good' Movement; FDA Filing Next

Image
Solengepras Adds 36 Minutes of Daily 'Good' Movement; FDA Filing Next

Seoul – October 12, 2026 -- Parkinson's patients taking the investigational drug solengepras gained an average of 36 more minutes of "good" movement time per day than those on their regular medication alone, and the drug will now be submitted to the U.S. Food and Drug Administration for approval.

ARISE trial results presented at the MDS International Congress

The data from the ARISE clinical trial were presented at the International Congress of Parkinson's Disease and Movement Disorders. Patients, who can have difficulty moving, also reported improvements in measures of daily living, according to the source.

Patient-reported outcomes were positive across all measured areas of daily living. Drooling and saliva control showed the most significant self-reported change, while improved daytime sleepiness was also recorded.

China Approves Foresee's CAMCEVI 42 mg for Advanced Prostate Cancer

Image
China Approves Foresee's CAMCEVI 42 mg for Advanced Prostate Cancer

Taipei – October 12, 2026 -- China's National Medical Products Administration (NMPA) has approved CAMCEVI® 42 mg, a ready-to-use 6-month subcutaneous depot formulation of leuprolide mesylate, for adult patients with advanced prostate cancer, Foresee Pharmaceuticals (TPEx: 6576) said. Licensing partner Changchun GeneScience Pharmaceutical (GenSci) notified Foresee of the approval of the Marketing Authorization Application and will commercialize the product in China.

GenSci holds exclusive China rights across all CAMCEVI indications

The license covers all current and pipeline indications: advanced prostate cancer, central precocious puberty (CPP) and premenopausal breast cancer. Foresee Chairman and CEO Ben Chien said GenSci's China launch will "significantly contribute" to the growth of the company's global CAMCEVI franchise.