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On June 11, FDA Director Scott Gottlieb released a draft directive on the development of gene therapy products. In addition to development guidelines for individual diseases such as hemophilia, retinopathy and rare diseases, there are a total of six detailed guidelines that include information on production and long-term safety. According to the guidelines of this guideline, the market for gene therapy products will be expanded seriously in accordance with the specific direction of development. The global gene therapy market will grow at a CAGR of 108%, from $ 144 million in 2018 to about $ 11.5 billion by 2024
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In addition, the FDA is developing a Regenerative Medicine Advanced Therapy (RMAT) designation program. The types of drugs / treatments that may be referred to as RMAT include cell therapy products, therapeutic tissue engineering products, human cell and tissue products,
Includes gene therapy products containing mbad manipulated cells. In 2017, a total of 31 medications were needed to designate RMATs, of which 10 were allocated. As of July 3, 2018, a total of 21 drugs have been allocated to RMAT. Gene therapy focuses on diseases that have a significant unmet medical demand, such as conbad genetic diseases. Therefore, it can be said that there is an additional policy base for rapid development.
The gene therapy market is expected to become more aggressive in 2017, following the licensing of adenovirus-based gene therapy drugs to cell-based gene therapy drugs, Kimriah and Yukkata . Currently, 33 clinical trials are underway worldwide, including the Lenti-D treatment of Bluebird for migraine, and BMN270 for the treatment of hemophilia for Biomarin. We are developing VM-202, Invo, and Pexa-vec, which are related treatments for the national Vycomed, Kolon Tissue Jean and Silla Zen companies. Expanding investment of global pharmaceutical companies, the development of genetic publishing technology, the advancement of technology related to delivery and delivery systems and the opening of the US market will contribute future growth.
[지난주 탐방] – Samcheongdang Pharmaceutical (KQ; 000250)
The first Korean ophthalmic pharmaceutical company. Domestic market share about 10%, the market share of dry eye disease treatment market is No. 1. As domestic environmental competition intensifies, investments are increasing at the same time. foreign. There are 10 ongoing projects, some of which are being viewed. 1) Global Eye Drop Generic: Completion of the US and European partnership. First or second generic entry goal in the US market. The company is expected to achieve an annual business turnover of KRW 121.6 billion and an operating profit of KRW 85.2 billion. 2) Biosimilar: The biosimilar eyelid is under development. This year, we plan to launch licensed batch production in 23. We are in the process of partnering with a global pharmaceutical company. Other plans to continue investing for long-term growth, such as stem cell therapy and blood sugar-free glucose meter
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