德英生物科技

Innovation and R&D

New Drug Development and Innovation Management

Item Description
Policy / Commitment Continuously develop innovative products to meet customer needs and market expectations.
Short-Term Goals Achieve at least one new R&D project per year (combined across pharmaceutical, clinical, food, and cosmetic categories).
Medium- to Long-Term Goals 1. Develop a new injectable formulation, SR-T100 Injection, proceed to human clinical trials, and apply for new drug registration upon completion of Phase III.
2. Submit an Investigational New Drug (IND) application for SR-T100 Injection to the U.S. FDA.
3. Restart the Phase II clinical trial in Taiwan for genital warts.
Resources Invested / Concrete Outcomes 1. Pharmaceuticals: SR-T100 Injection (for malignant ascites in cancer patients)
▲ Commissioned professional institutions to complete animal pharmacology and preclinical toxicology studies.
▲ Completed 9 months of accelerated stability data; Phase I human clinical trial is scheduled to begin in Q3 2025.
▲ Study results show efficacy in treating malignant ascites in cancer patients, with high safety and no chemotherapy-like side effects.
2. SR-T100 Topical Gel (actinic keratosis & genital warts)
▲ Completed Phase II clinical trials in Taiwan and the United States and obtained TFDA approval.
▲ Plan to prioritize the Phase III trial for genital warts to move toward new drug market approval.
3. Hepanamin®
▲ Our PIC/S GMP pharmaceutical plant obtained TFDA certification in 2019 and 2020 for capsule and semi-solid dosage forms, respectively.
▲ The drug license was approved in 2019 for in-house manufacturing, and mass production and sales have formally commenced.
▲ Products have been exported to Singapore, Malaysia, and South Korea.
4. Foods (Health Supplements)
▲ “SR-100 Capsules” have been on the market for over 20 years, with sales continuing to grow.
▲ Eye-care supplements are sold through major channels, and calcium and joint-support products were developed for launch in 2024.
5. Skincare Products
▲ “SR-100 Repair Gel” has been adopted by hospitals such as National Cheng Kung University Hospital and Tzu Chi Hospital, with clinical results published.
▲ Developing specialized skincare products for dialysis patients, with a clinical trial involving 165 subjects scheduled to begin in 2025.

New Drug Development and Innovation Management — Three-Year Track Record

1. Pharmaceuticals:

  • 2022: Preliminary toxicity study (NON-GLP) of SR-T100 Injection in rodent models.
  • 2023: Preliminary toxicity study (NON-GLP) of SR-T100 Injection in non-rodent models.
  • 2024: Repeated-dose toxicology study (GLP) of SR-T100 Injection and submission of a Pre-IND consultation request.

2. Foods:

  • 2023: Development of eye-care product (Lipojing).

3. Skincare Products:

  • 2022: Development of SR-100 lubricant portable sachets.
  • 2024: Market launch of SR-100 “Instant Relief” cream.