Foresee Pharmaceuticals: Submission of Marketing Authorization Application by Megapharm for CAMCEVI 42mg to Israel Ministry of Health

Provided by: Foresee Pharmaceuticals Co., Ltd.

SEQ_NO

2

announcement date

2022/04/05

Announcement time

20:05:49

Topic

 The submission of Marketing Authorization
Application by Megapharm for CAMCEVI 42 mg to the
Ministry of Health of Israel

Date of events

2022/04/04

What item it responds to

paragraph 10

Declaration

1.Date of occurrence of the event: 2022/04/04
2.New drug name or code: CAMCEVI 42 mg (FP-001 LMIS 50 mg)
3.Indication: for the treatment of advanced prostate cancer (6-month depot
  formulation)
4.Planned development stages: Regulatory review on the Marketing Authorization
  Application by the Ministry of Health of Israel.
5.Current development stage:
  (1) Application submission/approval/disapproval/each of clinical trials
      (include interim analysis):
      Megapharm, Foresee's licensing partner in Israel and the Palestinian,
      submitted a Marketing Authorization Application for CAMCEVI 42 mg
      injectable emulsion to the MOH (Ministry of Health) of Israel.
  (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: Megapharm, Foresee's licensing partner,
      will be responsible for the submission of Marketing Authorization
      Application.
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.: