Sunny Pharmtech Inc. (TWSE: 6676) today (6th) announced a strategic collaboration with Company S for its developmental drug, TFM-SC for rare cardiovascular disease, targeting the U.S. market. This agreement marks a significant milestone in the companies shared mission to ensure consistent, high-quality, and scalable supply of critical pharmaceutical products for patients across the United States.

TFM-SC is a niche pharmaceutical product jointly developed by Sunny and Anxo (TWSE: 6677). Anxo is responsible for R&D, while Sunny will manufacture the drug using its proprietary softgel capsule production line. Both parties have invested in development and will share in marketing efforts and profits. TFM-SC is a highly potent and cytotoxic softgel formulation, requiring strict manufacturing conditions that can only be met by a limited number of facilities worldwide.

Under these agreement, Sunny Pharmtech will receive milestone payments based on development progress. Once the product reaches the market, Sunny Pharmtech will also share in the sales revenue.

This alliance is expanding their collaboration, building on a previous licensing deal for a pulmonary fibrosis treatment, and are strengthening their partnership to pursue opportunities in the U.S. generic drug market. The collaboration includes:
? Successful Development and regulatory filing in US market.
? Full-scale GMP commercial manufacturing of TFM-SC
? Regulatory-compliant packaging and release for the U.S. market
? Long-term supply planning to support anticipated growth

According to IQVIA data, TFM-SC currently faces no generic competition in the U.S., with only one branded drug available. That brand-name product generates approximately USD 2.7 billion in annual U.S. sales. As the original drug is still under patent protection, Sunny and Anxo plan to pursue a patent bypass strategy for TFM-SC. The goal is to complete development and regulatory filing by 2027 and enter the lucrative, oligopolistic market.