On the 7th, Anxo Pharmaceutical announced the signing of a cooperation agreement with Sunny Pharmtech to jointly develop high-margin cardiovascular drugs that challenge original patents (Paragraph IV). This collaboration targets a market opportunity with global sales exceeding USD 3.2 billion (approximately NTD 103.6 billion).
Under the agreement, Anxo Pharmaceutical will be responsible for early-stage research and development, patent circumvention studies, and technology transfer. Sunny Pharmtech will handle subsequent technical adoption and commercial-scale production. The two companies will share the development costs and later split the profits from the product sales once it hits the market.
Lin-Chuan Yen, General Manager of Anxo Pharmaceutical, stated that since the initial strategic partnership agreement with Sunny Pharmtech in 2021, both parties have already begun cooperation on two oral soft gel products, both of which have shown promising preliminary results. One of these, a treatment for moderate to severe acne, is expected to submit for regulatory approval in Taiwan by the end of this year, while a pulmonary fibrosis treatment is planned for submission in Q1 next year. The synergy from this collaboration will gradually become evident. Building on their past successful partnership, the third product they have chosen to develop is also a high-value, high-margin item with market growth potential, and they plan to expand into global markets including the Asia-Pacific, North America, and Europe.
Sunny Pharmtech Chairman, Yon-Lian Wu, expressed that over the past four years, the sharing and division of resources between their R&D and production lines have helped reduce redundant investments, positively contributing to operational efficiency and cost control. He added that the products jointly developed by both companies are steadily delivering results. Wu is pleased to further deepen their partnership with Anxo, with the next phase focusing on aggressively expanding their global market presence and enhancing their operational scale and international competitiveness.
The product that the two companies will jointly develop is a second-generation drug for treating a rare cardiovascular disease, recognized as an orphan drug in the European and American markets. This second-generation drug improves the drug's bioavailability, reducing the patient’s dosage from four pills per day to just one, significantly improving medication adherence. As a result, the second-generation drug has seen rapid growth since its launch.
According to IQVIA data, the original second-generation drug achieved global sales of USD 3.244 billion in 2023, with a staggering compound annual growth rate of 287% over the past five years. It is currently the only drug approved by the U.S. FDA for the treatment of this rare cardiovascular disease, with a high price and unmet medical demand.
Lin-Chuan Yen noted that the second-generation drug is still under patent protection, with its patent tied to its specialized manufacturing process, which presents a significant technical barrier. Anxo and Sunny Pharmtech have completed evaluations and preparations, leveraging Anxo’s expertise in dosage form development and Sunny Pharmtech’s internationally recognized soft gel production line, which has passed multiple FDA audits and has experience working with European clients. The two companies aim to complete the early-stage development of the drug within a year and are confident in their ability to challenge the original patent and compete in the market with the first generic version.
Resource (mandarin): 瑩碩與祥翊深化結盟 搶攻全球心血管罕病千億商機
