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[˷5] ̿, "淹̼ о ۷ι No.1 ǥ"

| ˷5 յ 5 Ʈ ˱ Ұϴ ڳԴϴ.
1. ڽ '强 õ' Ư

PEGylation ̿ ̿ ڳؽ ڽ Ѵ. ȸ 16ϰ 19 ϰ ڸ 俹 ߴ. 𰡸 Ȯ 22~23 Ϲ û ģ 10 ڽ 忡 ̴. ǥ ְ ϳ̴.

ִ 14000~16000̴. ֽ 616000ִ. Ȯ𰡰 ϴ(14000) ϸ ڱ 88 ̴. ȸ ޵Ǵ ݾ κ( 60) üڱݿ ȹ̶ . ڼ Ű ִ CAPA 3465kg ǰ ϰ 2023 8 ǥϰ ִ.



ռ ű ǰ Ǹſ ɷ 븦 2021 10 õ 439-3 ü߾. 2022 2 Ա 170, üڱ 47 Ϸ, ű /ȯ ȹ̴.

̿ ڽڽ '强 õ' 忹ɻ ȹߴ. ǥְ ϳ "̿ 强 Ϲ û ȣ ȯû ο Ͽ '强 õ' Ʈ ߴ"鼭 "̿ , ű Ȯ Ȳ, ű ǰ ȹ ٰŷ 簡 强 ϰ ִٰ Ǵߴ" ߴ.

2. ̿, PEGylation ߡ


̿ 1997 20Ⱓ PEG(Polyethylene glycol) ü ڸ ϴ پ Ļ 'PEG ü ' پ · Ͽ ռ, Ǹϰ ִ. 'PEGylation' ȰϿ پ ̿ùз ž Ǿǰ Ƿ ϰ ̸ (̼ ƿ) ̴.

PEGylation ฮȰ Ǵ ܹ ǥ鿡 PEG(ƿ۸) ü ü 縦 (ȭ )Ű ̴. ̷ PEGylation ฮȰ ڷ ü ð Ű, ฮȰ 뼺 ص Ű, ฮȰ ִ ŷ ȿ ׿ ߾ 鿪 ۿ ȭִ ۿ Ѵ.

̿ 2022 ݱ οƼ 30%, PEGü ǰ 70% еȴ. Ư PEGü ǰ κ ε Intas Pharmaceuticals Ltd. Pegfilgrastim ̿ùз Ǹſ Ǿ ߻ߴ. ū Intas Pegfilgrastim ̿ùз PEG ü P1PAL-20 뷮 ȸ ǹ 1 ̱ GMP ̵ ü ϰ , 40~80 kg P1PAL-20 , Ǹϰ ִ.

2021 ݱ⿡ ŷó Evonik Operations簡 Pfizer/BioNTech COVID-19 ſ Ḧ ϰ , ̿ mRNA ü PEG ü 縦 Evonik Operations翡 ϴ ü, Pfizer/BioNTech COVID-19 PEG ü 80 kg , Ǹߴ.


(ڷ : ̿ IR Book)

3. PEG ü ̿ùз Ƿ پ о߿

̿ PEGü PEGylation ߽ ȣ߱ ġ Ȯϰ, MucoPEG, Synogel ű Ǿǰ ϴ ǥ. δ ȸ ֿ ̾ ΰ óġ ϴ ǥ ϰ ִ. ü PEGylation Ͽ ؿ԰, ̷ ߰ ȭ 2016 01 22 ڳؽ 忡 ִ.

̿ Ʈʻ Intas Pegfilgrastim ̿ùз ȮǸ鼭 ϱ ߴ. Intas Pegfilgrastim ̿ùз ε , ȣ, ij  㰡 ޾Ұ, ̿ ü Ǹ ߴ. Intas Pegfilgrastim ִ ̱ ϱ FDA ɻ縦 ް ִ.

߰ ̿ űԻ ġ MucoPEG ̴. MucoPEG Ƿ ýƮ(sureassist)κ GMP ޾ ⵵ 3 GMP ü ߰ ġ, , ɿ ݼ 򰡸 Ϸߴ. 2019 1 MucoPEG 3 batch Ͽ ô, , Ȯ Ϸϱ⵵ ߴ.

ƿ﷯ üռ ڷ  , ش ڷḦ 2019 1 28 ̱ FDA MucoPEG(K190144; Product Code LFD) 510(k) Ű ߴ. ʿ ģ RTA Hydris Oral Rinse ǰ  ν, 2019 11 5 ι޾Ұ ǰ Ǹ ÿ Ȱ ڹ ߰ ' 㰡' ӻ ̴.


(ڷ : ̿ IR Book)

4. PEG ü Ǹſ οƼ Ȯ

̿ ۷ι 翡 Ǿǰ Ƿ ν οƼ νϴ ͸ ִ. Ǿǰ Ƿ⸦ ϱ ؼ Ⱓ ӻ 籹 㰡 ܰ踦 ؾ ϱ ð ҿǰ, ӻ ϴ ũ ּȭϱ ؼ. ȸ 9 ϰ ϰ ִ ϰ ִ.

̿ 2019 65, 2020 54 2021 99 ũ ߴ. ֿ ŷó Intas Pharmaseuticals űԱ ⿡ PEG ü þ ̴. ⿡ ۳⿡ ű԰ŷó Evonik Operations 翡 ڷγ ſ PEG ü ǰߴ. Ⱓ 2019 16 2021 33 2 ̻ ߴ. ʴ ø鼭.

ٸ 2022 ݱ ֿ ŷó ְ ʿ ߰, ڷ ȯߴ. ȸ ̿ùз ϳ, Ÿ ü 100 ̻ ̶ ߻ߴ. ƿ﷯ 2023 ̿ùз ü ̶ ٺô.

MucoPEG 2023 ߻ ̴. ̿ ڴ " 2019 11 ̱ FDA Ǹ ȭ Ͽ 2022 ӻ ߿ 2022 Ϲݱ ӻ Ϸ 2023 ̱ ߱ ǸŸ ǥ ϰ ִ" "̱ üϿ ܰ躰 /Ǹ Ͻ Ǹ οƼ ϴ ߰, ߱ ȸ簡 ǰ ϰ ǸżḦ ϴ ߴ" ߴ.


(ڷ : ̿ IR Book)

5. 뱤 ǥ 8

̿ ó η ġϰ Ż ϴ ȸ 忡 ߿ Ҵ. ű ĺ ߱, Ȱ ӻ ӻ , ȭ ü Ͽ츦 ͵ η ڿ ̴. ڼ ȸ ü 27(ӿ ) 8 29% η Ǿ ִ.

̿ CEO 뱤 ǥ̻ б ȭлкθ ̱ Rutgers п ڻ縦 ߴ. 1996 Enzon翡 R&D Project Leaderμ ٹϸ C ġ PEG-interferon alpha (PegIntron) ߰ PEG-hemoglobin پ Ʈ Ͽ ټ Ư, ׸ ǥϴ ̷.

Ҿ 30Ⱓ ̿ ǥ̻ μ þ ȸ縦 ̲ ִ. ٽη ش о ٹ 10 ̻ 뱤ǥ PEG ü PEGylation ȭ ȹ پ PEGylation ǰ ȹϰ ִ.

̿ ߺδ ̿žο ӻ еȴ. ̿žθ Ѱϴ ȹ åӿ() ѱ п ׿ؼ ٹϴ 2004⿡ ̿ շߴ. ӻ󿬱δ պ åӿ() Ѱϰ պ Zп ӻп ٹ 2010 ӻ󿬱 ϰ ִ.

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