New Drug R&D and Innovation Management
| Item | Description |
|---|---|
| Policy / Commitment | Continue developing innovative products to meet customer needs and market expectations. |
| Short-term Goals | Achieve at least 1 R&D project per year (combined across pharmaceuticals / clinical / foods / cosmetics). |
| Medium- to Long-term Goals | 1. Develop the new injectable SR-T100 Injection, enter human clinical trials, and, after completing Phase III, proceed with new drug review and registration. 2. Submit an IND application for SR-T100 Injection to the U.S. FDA. 3. Restart Taiwan Phase II clinical trial for Genital Warts. |
| Resource Input / Specific Outputs | 1. Pharmaceuticals – SR-T100 Injection Resource input: ▲ Two professional institutions commissioned for animal pharmacology studies. ▲ Two GLP-certified institutions commissioned for rat and dog toxicology studies. ▲ Accelerated stability testing completed (9-month data). ▲ Preclinical data and protocol submitted to TFDA CDE for consultation. ▲ Phase I human clinical trial expected in Q3 2025. Specific outputs: ▲ Animal studies confirm efficacy in malignant ascites. ▲ Toxicology results indicate high safety and no hematopoietic impact. ▲ 9-month stability data obtained. ▲ Phase I trial scheduled. |
| 2. Pharmaceuticals – SR-T100 Topical Gel Resource input: ▲ Phase III AK trial record-filed (Taiwan). ▲ Phase II genital warts trial completed and record-filed. ▲ Multiple-dose PK study completed. Specific outputs: ▲ Phase III and Phase II trial records approved. ▲ Preparation for genital warts Phase III trial. |
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| 3. Hepanamin® 利保肝 Resource input: ▲ PIC/S GMP plant certified for capsule and semi-solid dosage forms. ▲ Manufacturing license approved by MOHW. ▲ Global distribution agreement signed. Specific outputs: ▲ Mass production and sales since June 2019. ▲ Exported to Singapore, Malaysia, South Korea. |
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| 4. Foods ▲ Long-term sales of Alfalfa SR-100 Capsules. ▲ Eye health foods distributed nationwide. ▲ Calcium & joint products launched in 2024. |
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| 5. Skin Care Products ▲ SR-100 Repair Gel introduced to major hospitals. ▲ Dialysis skincare products under clinical trial. |
New Drug R&D and Innovation Management — Three-Year Track Record
1. Pharmaceuticals:
- 2022: SR-T100 Injection rodent toxicity pilot study (NON-GLP).
- 2023: SR-T100 Injection non-rodent toxicity pilot study (NON-GLP).
- 2024: SR-T100 Injection repeated-dose toxicology study (GLP) and Pre-IND consultation.
2. Foods:
- 2023: Development of eye health product (利保晶).
3. Skin Care Products:
- 2022: Development of SR-100 personal-size lubricant pack.
- 2024: Launch of SR-100 「秒舒脈」 cream.
※The above content is sourced from the ESG Report