I-Med Biotech (6576-TW) announced today (20th) that its licensing partner, Changchun Jinshai Pharmaceutical, has received confirmation from Singapore’s Health Sciences Authority (HSA) that the new drug application for CAMCEVI 42mg, a 6-month sustained-release formulation of leuprolide for prostate cancer, has completed review and been granted market approval.
In addition to the Singapore approval, I-Med Biotech highlighted key upcoming milestones for CAMCEVI. The 3-month formulation is expected to launch sequentially in Europe and the U.S. in the second half of the year, with a potential market size several times larger than the 6-month version. The company anticipates that the dual offering of both 6-month and 3-month formulations will create product portfolio synergies, further enhancing market share and revenue.
Regarding FP-001 42mg, a drug for central precocious puberty, I-Med Biotech plans to submit a New Drug Application (NDA) to the U.S. FDA in the second half of this year, with self-commercialization in the U.S. market targeted by the end of 2027.
The company reported June revenue of NT$10.95 million, down 90.76% month-on-month and 71.84% year-on-year. Cumulative revenue for the first half of the year reached NT$262 million, up 17.9% year-on-year. June’s revenue included NT$7.88 million in royalty income from CAMCEVI’s 6-month formulation sales in the U.S. and European markets, along with NT$3.07 million in service income.
FACT BOX
- Source: PR Times
- Category: New Product
- Products / services: CAMCEVI 42mg / FP-001 42mg