Sunny Pharmtech announced on the 16th that it has signed exclusive licensing agreements with Company S this month for two of its developing drugs: TMN-T, an anti-cancer therapy, and MSL-T, a treatment for ulcerative colitis. The agreements include upfront payments and milestone fees tied to development progress, totaling up to $2.6 million (approximately NT$83.2 million). Additionally, the company will share in future sales revenue once the drugs are commercialized.
Under the terms of the agreements, Sunny Pharmtech will oversee the research, development, and manufacturing of TMN-T and MSL-T, as well as assist with regulatory submissions. Company S will obtain the drug approvals for the U.S. market and handle post-approval marketing and sales.
This collaboration builds on the companies' partnership established in May, when Company S secured exclusive U.S. licensing rights for NTN, a treatment for pulmonary fibrosis. Upholding the principle of mutual benefit, the two companies aim to strengthen their long-term relationship and capitalize on the significant opportunities in the U.S. generic drug market—the largest in the world.
Chairman Yon-Lian Wu stated that both parties will continue leveraging this cooperative model to bring effective and safe treatment options to market, ultimately creating value for patients and stakeholders.
Founded in 2013, Company S has established extensive distribution channels across U.S. clinics and hospitals, with nearly 60 generic drug products currently on the market. Known for its expertise in sterile injectables and ophthalmic treatments, the company has recently expanded into oral formulations. Its partnership with Sunny Pharmtech underscores the latter’s strong development and manufacturing capabilities in oral drug products, enhancing Company S’s product portfolio.
Sunny Pharmtech highlighted that MSL-T, the ulcerative colitis drug in this collaboration, currently faces competition from two generic alternatives, as no branded drug is available on the market. According to IQVIA data, U.S. sales of these competing generics totaled $160 million in the past year.
As for TMN-T, the anti-cancer drug, it is designed to treat melanoma or advanced non-small cell lung cancer (NSCLC) with the BRAF V600E mutation. Currently, only one branded drug is available in the U.S. market for this indication, with no generic alternatives. IQVIA data shows annual U.S. sales of $450 million for the branded drug. Given its ongoing patent protection, Sunny Pharmtech plans to develop TMN-T as a patent-avoiding product, targeting completion in 2026. The company, in collaboration with Company S, aims to pursue a Paragraph IV (P4) abbreviated new drug application (ANDA), seeking to capture a share of this lucrative, oligopolistic market.
Resource: 祥翊簽2產品美國市場專屬授權 里程碑金達260萬美元
