Lotus Pharmaceutical Announces Global Launch of Nintedanib Across 30 Markets

Taipei, Taiwan, 4 May 2026 — Lotus Pharmaceutical Co., Ltd. (Taiwan Stock Exchange: 1795), a global pharmaceutical company headquartered in Taiwan, today announced the successful global launch of its Nintedanib soft gel capsules (100mg and 150mg), marking a significant milestone in the Company’s specialty and complex generics portfolio.        

Following recent regulatory approval from the U.S. Food and Drug Administration (US FDA), building on prior approvals from European regulatory authorities, Health Canada, and the Taiwan Food and Drug Administration (TFDA) - the launch of Nintedanib has expanded to 30 markets worldwide. These include the North America and European regulatory markets, as well as the Taiwan market, with a total of 185 SKUs introduced to date across 13 commercial clients globally, delivered by leveraging Lotus’ strategic partnerships with multinational pharmaceutical partners. Initial launch volumes have exceeded 15 million doses, underscoring Lotus’ strong execution capabilities and a well-coordinated, multi-regional rollout globally. Looking ahead, Lotus plans to expand over the next couple of years into an additional 20 markets across Asia—including Japan, Korea and Southeast Asia—further markets in Europe, parts of Latin America, and select markets across the Middle East, Oceania and Africa.

Nintedanib, a well-established tyrosine kinase inhibitor, is the generic version of Boehringer Ingelheim’s OFEV® and Vargatef®. This product represents a key addition to Lotus’ oncology and respiratory portfolio, reinforcing the Company’s capabilities in complex dosage forms and high-value specialty pharmaceuticals. According to IQVIA data, global sales of OFEV® and Vargatef® combined reached approximately US$4.6 billion in 2024.

Petar Vazharov, Chief Executive Officer of Lotus, commented, “Nintedanib represents another important milestone for Lotus, marking the successful global launch of an in-house developed complex generic. This achievement underscores our integrated capabilities across R&D, regulatory, manufacturing, and commercialisation. We will continue to leverage our global commercial infrastructure and strategic partnerships to drive portfolio expansion and deliver essential therapies across key markets.”

Disclaimer: All trademarks are the property of their respective owners. This communication includes forward-looking statements, including with respect to anticipated market expansion and regulatory approvals, which reflect the Company’s current expectations and assumptions and are subject to change.

Founded in 1966, Lotus (1795: TT) is an international pharmaceutical company with a global presence, focused on commercializing both novel and generic pharmaceuticals to provide patients with better, safer, and more accessible medicines. The company boasts a best-in-class R&D and manufacturing platform in Asia, certified by leading regulatory authorities around the world, including the US FDA, EU EMA, Japan PMDA, China FDA, and Brazil ANVISA. Lotus has established partnerships in nearly every major global market, including the U.S., Europe, Japan, China, and Brazil. The company is currently developing and registering over 100 strategically selected pharmaceutical projects across Asia and the U.S., with more than 250 commercial products. Lotus invests in a diversified portfolio, consisting of high-barrier oncology, complex generics, 505(b)2, NCEs, and biosimilars, through both internal R&D investments and licensing-in partnerships to strengthen its portfolio competitiveness.