Taipei, Taiwan, February 11, 2024 — Lotus Pharmaceutical Co., Ltd. (Taiwan Stock Exchange: 1795), a leading global pharmaceutical company, announces that Adcirca® (tadalafil) has been approved by the Taiwan Food and Drug Administration (TFDA) for treating pulmonary arterial hypertension (PAH).
PAH is a rare, progressive disease with no cure. The 2022 ESC/ERS Guidelines recommend tadalafil as the only Class I therapy in combination with endothelin receptor antagonists (ERAs) for first-line treatment. Previously, cardiologists in Taiwan relied on another PDE5 inhibitor with weaker evidence in combination therapy.
With this approval, Taiwanese PAH patients gain access to a well-endorsed, once-daily treatment. Between 2014 and 2023, Taiwan’s PAH-PDE5 inhibitor market has expanded from NT$130million to over NT$400million(1), underscoring a significant growth opportunity for Adcirca.
Petar Vazharov, Lotus' Chief Executive Officer, said, “We are honored to introduce Adcirca® in Taiwan, offering new hope for PAH’s patients. Adcirca® approval is another testimony to our commitment to provide patients with better, safe and more accessible medicines.
References:
(1) National Health Insurance Administration, MOHW https://search.app/AtApmhW8YSC8Kvcj6
About Lotus
Founded in 1966, Lotus (1795: TT) is a global pharmaceutical company focused on delivering novel and generic medicines that are safer, better, and more accessible. With a best-in-class R&D and manufacturing platform in Asia, Lotus has partnerships in key markets including the U.S., Europe, Japan, China, and Brazil. The company manages over 100 strategic projects in development and registration across Asia and the U.S., with a portfolio of more than 250 commercial products. Lotus invests in a diversified pipeline of high-barrier oncology treatments, complex generics, 505(b)2 products, and new chemical entities (NCEs), through internal R&D and licensing partnerships. Additionally, it bolsters its portfolio with biosimilars, supported by strategic alliances. Lotus's facilities are certified by top regulatory bodies, including the US FDA, EU EMA, Japan PMDA, China FDA, and Brazil ANVISA.
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