EirGenix : EMA has officially accepted the review of the MAA submitted by Sandoz AG (exclusive partner of EirGenix) for trastuzumab biosimilar EG12014 (150 mg, for IV use)

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Provided by: EirGenix Inc.
SEQ_NO	10	Date of announcement	2022/01/20	Time of announcement	21:38:50
Subject	EMA has officially accepted the review of the MAA submitted by Sandoz AG (exclusive partner of EirGenix) for trastuzumab biosimilar EG12014 (150 mg, for IV use)
Date of events	2022/01/20	To which item it meets	paragraph 53
Statement	1.Date of occurrence of the event:2022/01/20 2.Company name:EirGenix,Inc. 3.Relationship to the Company (please enter ��head office�� or ��subsidiaries��): head office 4.Reciprocal shareholding ratios: Not applicable. 5.Cause of occurrence: Sandoz AG,an exclusive partner of EirGenix,Inc.,has officially received the letter stating that EMA has accepted the review of the Marketing Authorization Application (MAA) for trastuzumab biosimilar EG12014 (150 mg, for intravenous use) on 2022/01/20 the European time. 6.Countermeasures: None. 7.Any other matters that need to be specified: (1) Name or code of new drug: EG12014 (proposed trastuzumab biosimilar) (2) Usage: The treatment of HER2 overexpressing early breast cancer, metastatic breast cancer and metastatic gastric cancer. Trastuzumab biosimilar EG12014 confirmatory phase III study in early HER2+ breast cancer: (https://www.clinicaltrials.gov/ct2/show/NCT03433313?term= EG12014&draw=2&rank=1) (3) All expected developmental stages: Marketing Authorization Application (MAA) application in review. (4) Stages of status: A. Filing an application / Approval/ Disapproval/ Results of different phase of human clinical trials (including interim analysis) / Any major events affecting the development of new drugs: Marketing Authorization Application (MAA) in review. B. Risks and responses faced and applied if the results of human clinical trials (including interim analysis) have not passed the approval from regulatory authorities, or the results do not reach statistical significance or any major events affecting the development of new drugs: Not applicable. C. Further steps when receiving approval from regulatory authorities, or the results of any phase of human clinical trials (including interim analysis) has statistical significance or other major events affecting the development of new drugs: (such as continuing in development, authorizing to others for sale, etc.): In April of 2019, EirGenix signed an exclusive license to Sandoz AG for right of commercialization of EirGenix's breast cancer biosimilar drug, EG12014 (proposed trastuzumab biosimilar) globally with the exception of Taiwan, mainland China, Japan, South Korea and Russia. EirGenix has received an upfront payment on signing the contract, milestone payments, and is responsible for the production of product to sell in the authorized markets and royalties and profit sharing according to the Licensing Agreement following product launch on market. D. Invested expenses: It was agreed to not to disclose this information in publicly in order to protect the company and investors�� rights according to the signed confidentiality agreement with Sandoz AG. (5) The following steps: A. Estimated completion time: After the EMA receives the application, they will assess the completeness of the submitted document package and notify the start of the review process. The review progress is carried out in accordance with the schedule set by the EMA and approval time of MAA are the decision of EMA and subject to the official notification of the EMA. B. Expected Obligations: (for example, fees payable for obtaining a technology license, etc.): None. (6) Current market situation: According to Roche��s annual report, global sales of Herceptin totaled 3.73 billion CHF in 2020. The US and EU Herceptin market are 1.36 billion CHF and 0.67 billion CHF respectively. Herceptin sales declined compared to 2019 driven by strong competition from biosimilars, which were introduced in 2018 and 2019 in Europe and US, respectively. The biosimilar drugs have taken a high proportion of the market since their entry into the market. Taking Amgen��s Trastuzumab biosimilar drug Kanjinti as example, in 2020, the sales were 567 million U.S. dollars. With the launches of more biosimilar drugs, the Trastuzumab's global market has continued to grow allowing more patients benefit from the biosimilar drugs. In 2019, Taiwan's health insurance payment for Trastuzumab products was nearly NT$1.66 billion and ranks the ninth place among the top ten drugs under the national health insurance program. (7) Due to the long duration of development for innovative drugs, the investment of development is high, therefore success of the innovative drug cannot be guaranteed. This will lead to investment risk, and investors should show due diligence in investment.