Smooth Drug Development March 2026 News Release

Monthly News – March 2026

Throughout March, our clinical programs demonstrated consistent advancement, driven by significant regulatory submissions, promising feasibility studies, and strategic partnerships established in various global regions.

• Phase I Clinical Trial – Mucopolysaccharidosis study: A total of 28 subjects were screened, of whom 23 were successfully randomized. The first dosing visit was conducted in January.
• Phase III Clinical Trial – HIV Study: The first Site Initiation Visit (SIV) took place on February 27. Additionally, six more sites were approved by the Ministry of Health.
• Phase III Clinical Trial – Hemorrhoids Study: Close-out visits have been successfully conducted.
• Phase III Clinical Trial – Gynecology Study: A total of 71 patients have been randomized, and one additional site has been opened.
• Phase III Clinical Trial – topical antiseptic and wound-healing Study: The agreement between the Sponsor and SDD has been signed, and the regulatory submission documents have been fully prepared.
• Phase III Clinical Trial- Hepatitis Study: Enrollment has been completed. Pakistan enrolled 25 patients, while Uzbekistan enrolled 22 patients.
• Phase IV Clinical Trial – Spinal Muscular Atrophy Study: 9 subjects were screened, and three were successfully randomized into the study.

• Prostatic Hyperplasia: A total of 34 subjects were screened, and 28 were successfully randomized into the study.
• Sedative and Anti‑Anxiety: A total of 29 subjects were screened, of whom 28 were randomized.
• Bacteriostatic Drug: A total of 40 subjects were screened, and 38 were successfully randomized.
• Oncology study: Out of the planned 48 patients, 24 have been enrolled in the study to date.

Business Development News:

Our Business Development team has been actively expanding partnerships and exploring new opportunities through strategic discussions and conference participation:

Key Partner Engagements

Our Business Development team planned participation in BioChina (March 2026).