Today's Information

Provided by: Foresee Pharmaceuticals Co., Ltd.
SEQ_NO 1 Date of announcement 2022/07/27 Time of announcement 05:50:19
Subject 
 The Submission of CAMCEVI 42 mg Marketing
Authorization Application by Accord Healthcare,
Foresee's Licensing Partner, to the MHRA of the UK
Date of events 2022/07/26 To which item it meets paragraph 10
Statement 
1.Date of occurrence of the event: 2022/07/26
2.New drug name or code: CAMCEVI 42 mg (FP-001 50 mg, 6-month depot
  formulation)
3.Indication: for the treatment of advanced prostate cancer
4.Planned development stages: Regulatory review on the Marketing Authorization
  Application (MAA) by the Medicines and Healthcare products Regulatory
  Agency (MHRA) of the UK
5.Current development stage:
  (1) Application submission/approval/disapproval/each of clinical trials
      (include interim analysis):
      a. The MAA of CAMCEVI 42 mg prolonged-release suspension for injection
         has been approved by European Commission (EC) on May 31, 2022, 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. The approval is applicable to all 27 European Union
          (EU) Member States, Iceland, Norway and Liechtenstein.
      b. Accord Healthcare, Foresee's licensing partner, submitted a
         Marketing Authorization Application for CAMCEVI 42 mg prolonged-
         release suspension for injection to the MHRA (Medicines and
         Healthcare products Regulatory Agency) of the UK.
  (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 3 to 6 months. The actual date and final decision
      are at the MHRA's discretion.
  (2) Estimated responsibilities: None. Accord Healthcare, Foresee's
      licensing partner, is 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.:

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Foresee Pharmaceuticals Co. Ltd. published this content on 27 July 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 26 July 2022 22:01:06 UTC.