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Foresee Pharmaceuticals submits application to TFDA for Phase III clinical trial of drug for central precocious puberty in childrenDec 16, 2022

Foresee Pharmaceuticals announced that the company has submitted an application to the Taiwan Food and Drug Administration (TFDA) for a Phase III clinical trial of FP-001 42 mg (six-month extended-release injection) in children with central precocious puberty.

In addition, the company has been invited to participate in an earning call on the 20th of this month, which will be chaired by its Chairman, Dr. Ben Chien. At that time, he will announce the progress of the company's new dose formulations, new drug development and new plans for the future, said Chien.

Foresee's new dosage form for paediatric central precocious puberty is another indication drug being developed by the company after its first product, Camcevi, a prostate cancer drug, in the same dosage form and composition.

According to Data Bridge Market Research, the global market for central precocious puberty in children will be worth approximately US$1.483 billion in 2021 and is estimated to reach US$2.663 billion in 2029, representing a compound annual growth rate of approximately 7.6% over the next eight years. This represents a compound annual growth rate of approximately 7.6% over the next eight years.

According to Foresee, since the launch of Camcevi (FP-001), a new dosage form for prostate cancer, in the US in April this year, there has been continued interest in the subsequent sales performance and progress of other drugs. Originally, the six-month dose of Camcevi was scheduled to be launched in Europe by the end of this year, but after discussions with sales partner Accord BioPharma, it was decided to focus on the US market first and delay the launch of the European market.

The company pointed out that since the launch of Camcevi (FP-001) in the US, Etech and Accord BioPharma have agreed that the royalty profit for each quarter will only be estimated at the end of each quarter, i.e. March, June, September and December each year. In addition, the six-month dose of Camcevi was originally scheduled to be announced in October this year, but CMS has proposed to delay the announcement by one quarter and expects to announce it in January next year.