Foresee announces the submission of New Drug
Application for CAMCEVI 42 mg to TFDA
Date of events
2022/06/09
To which item it meets
paragraph 10
Statement
1.Date of occurrence of the event: 2022/06/09
2.New drug name or code: CAMCEVI 42 mg (FP-001 50 mg, 6-month depot
formulation)
3.Indication: for the treatment of hormone-dependent advanced prostate cancer
and for the treatment of high-risk localized prostate cancer and locally
advanced hormone-dependent prostate cancer in combination with
radiotherapy.
4.Planned development stages: regulatory review on the New Drug Application
by TFDA
5.Current development stage:
(1) Application submission/approval/disapproval/each of clinical trials
(include interim analysis):
Foresee has submitted a New Drug Application for CAMCEVI (leuprolide)
injectable emulsion, 42 mg to TFDA.
(2) Once disapproved by competent authority or each of clinical trials
(include interim analysis) results less than statistically significant
sense, the risks & the associated measures the Company may occur: N/A
(3) After obtaining official approval or the results of statistically
significant sense, the future strategy: N/A
(4) Accumulated investment expenditure incurred: Undisclosed
6.Upcoming development plan:
(1) Estimated date of completion: the regulatory review is expected to
complete in around 1 year. The actual date and final decision are at
authorities' discretion.
(2) Estimated responsibilities: NDA submission fee
7.Market situation:
As the population grows and gradually ages, prostate cancer patients has
grown in number. According to Transparency Market Research, the global
prostate cancer therapeutics market was worth about US$10 billion in 2019.
By estimation, the global prostate cancer drug market value will grow to
US$19.6 billion in 2027, with a CAGR of 8%.
According to IMS data, the market value of GnRH/LHRH therapy in 2018 was
approximately US$4.4 billion (all indications included), with sales of
drugs containing Leuprolide reaching approximately US$2.492 billion
(56.6%) in 2018.
Designed and developed through Foresee's pioneering Stabilized Injectable
Formulation technologies, CAMCEVI 42 mg is a differentiated ready-to-use
6-month depot injection, which overcomes the requirement of manual
reconstitution-an obstacle that the already marketed leuprolide products
face that can lead to handling inconvenience and potential risks of
handing errors.
8.Any other matters that need to be specified: None
9.New drug development requires long process, vast investments and with
no guarantee in success which may pose investment risks.The investors
are advised to exercise caution and conduct thorough evaluation.:
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Foresee Pharmaceuticals Co. Ltd. published this content on 09 June 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 09 June 2022 09:21:04 UTC.
Foresee Pharmaceuticals Co., Ltd. is a Taiwan-based company mainly engaged in the research and development of new pharmaceuticals. The Company's main products include prostate cancer treatment product FP-001 and asthmatic/chronic obstructive pulmonary disease treatment product FP-025. It also engages in new pharmaceuticals clinic trial business.
FORESEE PHARMACEUTICALS CO., LTD. 
