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. |
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Resources Invested / Concrete Outcomes |
1. Pharmaceuticals – SR-T100 Injection (Malignant ascites) Resources Invested: ▲ 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. Concrete Outcomes: ▲ 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 (Actinic keratosis & Genital warts) Resources Invested: ▲ Phase III AK trial record-filed (Taiwan). ▲ Phase II genital warts trial completed and record-filed. ▲ Multiple-dose PK study completed. Concrete Outcomes: ▲ Phase III and Phase II trial records approved. ▲ Preparation for genital warts Phase III trial. |
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| 3. Hepanamin® Resources Invested: ▲ PIC/S GMP plant certified for capsule and semi-solid dosage forms. ▲ Manufacturing license approved by MOHW. ▲ Global distribution agreement signed. Concrete Outcomes: ▲ Mass production and sales since June 2019. ▲ Exported to Singapore, Malaysia, South Korea. |
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| 4. Food Supplements SR-100 SolaGen Capulse & SolaVision (Eye health) & SolaFlex (Joint health) Resources Invested: ▲The “SR-100 Capsule” has been continuously sold for over 20 years. ▲Food supplements factory are expanding automated equipment and hiring additional staff to meet demand for eye-care product orders. ▲Actively promoting eye-care food products through large-scale domestic channel advertising. ▲Developing calcium and joint-care products for an aging society, scheduled for launch in January 2024.
Concrete Outcomes: ▲ Increasing sales of SR-100 SolaGen Capsules.▲ Eye health foods distributed nationwide. ▲ Calcium & joint products launched in 2024. |
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5. Skincare Products SR-100 Topical Gel & Skincare products for dialysis patients Resources Invested: ▲SR-100 Topical Gel has been introduced as a skincare product for use at National Cheng Kung University Hospital, Tzu Chi Medical Center, and major hospitals and clinics in southern Taiwan. ▲Clinical results of SR-100 Topical Gel have been presented at the Taiwan Dermatological Association. ▲In October 2024, the Company initiated development and trial production of a topical skincare product targeting uremic pruritus and fistula patency in dialysis patients. ▲Human clinical trials will be conducted by specialist physicians (contract signing expected in February 2025, with 165 subjects to be enrolled). Concrete Outcomes: ▲Following human clinical trials, the skincare product for dialysis patients is expected to be launched and marketed. |
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. Food Supplements:
- 2023: Development of eye health product.
3. Skincare Products:
- 2022: Development of SR-100 personal-size lubricant pack.
- 2024: Launch of SR-100 Smile cream.
※The above content is sourced from the ESG Report