Lotus Pharmaceutical Receives PMDA Approval for Generic Pomalidomide Capsules in Japan

Taipei, Taiwan, 19 August 2026 — Lotus Pharmaceutical Co., Ltd. (Taiwan Stock Exchange: 1795), a leading global pharmaceutical company, today announced that its generic version of POMALYST® (pomalidomide) capsules, in 1 mg, 2 mg, 3 mg and 4 mg strengths, has received marketing approval in Japan following review by the Pharmaceuticals and Medical Devices Agency (“PMDA”).

The approval marks another step in Lotus’s expansion in Japan, with pomalidomide becoming the Company’s second product to receive marketing approval in the country, following lenalidomide in 2023. Lotus will launch the product in partnership with Fuji Pharma Co., Ltd. as part of the first wave of generic pomalidomide launches in Japan.

Pomalidomide is indicated for the treatment of relapsed or refractory multiple myeloma (RRMM) and is available in multiple strengths to support different dosing requirements. According to IQVIA MAT December 2025 data, sales of pomalidomide in Japan were approximately US$155 million, representing a sizeable market opportunity for the product.

Petar Vazharov, Chief Executive Officer of Lotus Pharmaceutical, commented: "The approval of our generic pomalidomide in Japan marks an important milestone for Lotus and reflects our ability to meet the rigorous regulatory and quality standards of this strategically important market. It further strengthens our oncology portfolio and expands our presence in Japan as we continue bringing high-quality medicines to patients across key international markets”.

POMALYST® is a registered trademark of Celgene Corporation. All other trademarks are the property of their respective owners.

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.