Smooth Drug Development June 2026 News Release

Clinical and Scientific Departments News: 

Phase I-IV Clinical Trials 

• Phase I Clinical Trial – Hodgkin Lymphoma (HL) study: A total of 8 site initiation visits were successfully conducted in the EAEU region. 

• Phase I Clinical Trial – An Orphan Disease study: The site close-out visit for the healthy volunteers Phase I study in an orphan disease indication was conducted. 

• Phase I – Infertility Study:  A new study for Follitropin Alfa is currently in development. The study is planned in the Gynecology therapeutic area and is designed as a bioequivalence (BE) trial in healthy volunteers in Europe. 

• A Phase II–III Obesity Study: Tirzepatide for the treatment of morbid obesity is currently in progress.  

• A Phase I-III Breast Cancer Study: In the breast cancer study, a total of 37 patients were screened, of whom 31 patients were randomized in the EAEU region. 

• A Phase III Proctology Study: The preparation of regulatory documents for submission to the Ministry of Health of the Russian Federation is currently underway. 

• A Phase III Gynecology Study: The regulatory documents have been submitted to the Ministry of Health, and screening visits have been conducted. A total of 237 patients were screened, of whom 186 patients were randomized. Two site initiation visits (SIVs) were conducted. 

• Phase III HIV study: A total of 257 patients were screened, and 206 patients were randomized in EAEU region. In Russia, 9 site selection visits were conducted in June. 

• A Phase III Infectious Diseases Study: The study is being conducted across Pakistan, Uzbekistan, and Georgia, with initial regulatory progress achieved in all participating countries.  

• A Phase IV Neurology (SMA) Study: In Russia, 20 patients have been enrolled. Bioequivalence (BE) Study 

• Malignant Ovarian Neoplasm BE Study: In a study on malignant neoplasms, all patients have completed the study, and the database has been closed.  

• Urology BE study I: A site initiation visit was conducted for a bioequivalence (BE) study in healthy volunteers.  

• Urology BE study II: The clinical phase of the healthy volunteer study has been successfully completed. 

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 Corporate Development team successfully participated in both the BIO CHINA US Forum 2026 and the BIO International Convention 2026 in San Diego. During these events, the team met with existing clients and established new connections with prospective partners from across the global biopharmaceutical industry. The meetings provided valuable opportunities to discuss potential clinical development collaborations, present our service capabilities, and explore new business opportunities. Follow-up communications are ongoing with multiple companies, with several discussions advancing toward potential partnerships and future clinical development projects.