Smooth Drug Development May 2026 News Release

Monthly News – May 2026

Throughout May, our clinical programs demonstrated consistent advancement, driven by significant regulatory submissions, feasibility studies, and strategic partnerships that spanned various global regions.

• Phase I Clinical Trial – Metastatic Breast Cancer study: The study has achieved 25% of the planned patient enrollment target.
• Phase I Clinical Trial – Hodgkin Lymphoma (HL) study: A total of 18 screening visits have been completed. Approval has been received from the Ministry of Health of the Republic of Uzbekistan.
• Phase I Clinical Trial – Metastatic Non-Small Cell Lung Cancer (NSCLC) study: 20 screening visits have been completed. Approval has been obtained from the Ministry of Health for the addition of new clinical sites.
• Phase III Clinical Trial – topical antiseptic and wound-healing Study: Approval has been received from the Ministry of Health.
• Phase III Clinical Trial – Gynecology study: A total of 185 patients have been randomized.
• Phase IV Clinical Trial – Spinal Muscular Atrophy study: 18 patients have been screened, of which 17 have been enrolled in the study. The study has achieved 50% of the planned patient enrollment target.
• Phase III HIV study: 240 patients have been screened, and 170 patients have been enrolled. The study has achieved 75% of the planned patient enrollment target.

• Malignant Ovarian Neoplasm BE Study: All patients have completed the study, and the clinical database is currently in the process of being closed.
• Bacteriostatic Drug: 40 healthy volunteers have been randomized. The second period of dosing is scheduled for June.
• Urology BE study I: 48 healthy volunteers have been randomized. Dosing for Period 2 is scheduled for 25 May 2026 (Cohort 1) and 30 May 2026 (Cohort 2). The contract is currently pending signature. The clinical phase is planned to continue in June.
• Urology BE study II: 48 healthy volunteers have been randomized. Dosing for Period 2 is scheduled for 1 June 2026 (Cohort 1) and 7 June 2026 (Cohort 2).
• Psychiatry BE study: The final clinical study report has been completed.

Business Development News:

The Business Development team is diligently working to grow our network of partnerships and uncover fresh possibilities by engaging in strategic conversations and attending industry events:

Key Partner Engagements

• Our Business Development Director, Kamran Khan, attended the Global Clinical Trials Connect 2026 (May 27–28) in Greater London, United Kingdom, where he met with various stakeholders from the clinical research industry to discuss ongoing trends, innovations, and potential collaboration opportunities in global clinical trials.
• The Smooth Corporate Development team will participate in key international industry events in June 2026, including CPHI China, the BioChina US Forum, and the BIO International Convention 2026 in the United States.
• As part of this visit, the team will also conduct a meeting and site visit with one of our partner biotechnology companies in the United States to further strengthen collaboration and explore new opportunities for partnership and project development.