Sunny Pharmtech Co., Ltd. (TWSE: 6676), announced today (16th) that it has signed exclusive licensing agreements with Company S for two of its developmental drugs, TMN-T for oncology and MSL-T for ulcerative colitis, targeting the U.S. market. Under these agreements, Sunny Pharmtech will receive up to USD 2.6 million (approximately NTD 83.2 million) in upfront payments and milestone fees based on development progress. Once the products reach the market, Sunny Pharmtech will also share in the sales revenue.

According to the agreements, Sunny Pharmtech will oversee the research, development, manufacturing, and regulatory approval processes for TMN-T and MSL-T, while Company S will obtain the U.S. market authorization and handle post-approval promotion and sales activities.

This partnership marks an extension of the companies’ collaboration, following their exclusive licensing agreement in May for NTN, a treatment for pulmonary fibrosis. With a shared commitment to a win-win philosophy, the two companies are strengthening their long-term partnership to tap into the vast opportunities within the U.S. generic drug market—the largest in the world.

Sunny Pharmtech Chairman, Mr. Wu Yon-Lian, expressed his enthusiasm for the enhanced collaboration, stating, “We are delighted to deepen our partnership with Company S. Together, we will continue leveraging this cooperative model to bring effective and safe treatment options to patients, creating value for all stakeholders.”
Founded in 2013, Company S has rapidly emerged as a prominent player in the U.S. pharmaceutical market, offering nearly 60 generic drugs. Under the guidance of its experienced leadership team, the company has established unique technology platforms and a diverse product portfolio, with a strong distribution network in clinics and hospitals across the United States. While specializing in sterile injectables and ophthalmic drugs, Company S has recently been expanding into oral formulations—a key reason for its alliance with Sunny Pharmtech, which brings proven expertise in oral drug development and manufacturing.

Sunny Pharmtech highlighted the potential of MSL-T, the ulcerative colitis treatment involved in this agreement. Currently, there is no branded drug available for this indication in the U.S., with two competing generics dominating the market. According to IQVIA data, the U.S. sales of these generics amounted to USD 160 million over the past year.

Similarly, TMN-T, the oncology drug targeting BRAF V600E gene mutations in melanoma or advanced non-small cell lung cancer, presents a significant market opportunity. At present, only one branded drug is available in the U.S. for this indication, with no generic alternatives. According to IQVIA data, the branded drug generated annual sales of USD 450 million in the U.S. Given the ongoing patent protection for the branded drug, Sunny Pharmtech plans to develop TMN-T using a patent avoidance strategy, aiming for development completion by 2026. In collaboration with Company S, Sunny Pharmtech intends to submit an ANDA with a Paragraph IV certification (P4) to capture a share of this oligopolistic market opportunity.