YiDa Reports August Revenue of NT$26.72 Million, Down YoY; CAMCEVI 3-Month Formulation to Launch in US and Europe in Second Half

YiDa (6576-TW) announced August revenue of NT$26.72 million, representing an 11.74% decrease from the previous month and an 8.15% decline year-on-year. Cumulative revenue for the first eight months of the year reached NT$319 million, down 14.42% compared to the same period last year. The August revenue included NT$22.38 million from sales of the six-month formulation of CAMCEVI in the U.S. end market, NT$2.16 million in royalty income from sales of the six-month formulation in the U.S. and European markets, and NT$2.18 million in service income.

YiDa stated that the three-month formulation of CAMCEVI has successfully obtained regulatory approval in both Europe and the United States and is expected to launch commercially in these regions during the second half of the year. The company also received notification from its licensing partner that marketing authorization has been granted in the UK. In the Taiwan market, YiDa has submitted an application to the Taiwan TFDA for the registration of 'KangShuWei' (Leuprolide) 21mg injection, also known as CAMCEVI 21mg.

The company noted that the potential market size for the three-month formulation is several times larger than that of the existing six-month version. As the rollout progresses across Europe and the U.S., the dual offering of three- and six-month formulations is expected to create product synergy, driving increased market share and revenue.

Additionally, YiDa plans to submit a New Drug Application (NDA) to the U.S. FDA in the fourth quarter for FP-001 42mg, a ready-to-use six-month subcutaneous sustained-release injectable (leuprolide mesylate) for the treatment of Central Precocious Puberty (CPP), a rare disease. The company has already begun assembling a marketing team and aims to obtain U.S. regulatory approval in the second half of 2027, followed by direct commercialization in the U.S. market.