Ministry of Food and Drug Safety 국민 안심이 기준입니다 YOUR SAFETY IS OUR STANDARD

Ministry of Food and Drug Safety 국민 안심이 기준입니다 YOUR SAFETY IS OUR STANDARD

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Biological Products

(Recombinant DNA products) Celltrion, Inc.
  • Registration Date 2016-03-24
  • Hit 2425

Company Information

1. Name

Celltrion, Inc.

2. Website Address

http://www.celltrion.com/en/main.do

3. Location

Plant 1: 23, Academy ro, Yeonsu-gu, Incheon, Republic of Korea

Plant 2: 19, Academy ro 51beon-gil, Yeonsu-gu, Incheon, Republic of Korea

4. Contacts

Business : contact@celltrion.com

Investment Relations : investor@celltrion.com

Pharmaceutical Product Information

1. Brand Name

Remsima

2. Active Ingredient

Infliximab

3. Indication

Rheumatoid Arthritis, Ankylosing Spondylitis, Adult Crohn’s Disease, Pediatric Crohn’s Disease, Ulcerative Colitis, Pediatric Ulcerative Colitis, Psoriatic Arthritis, Plaque Psoriasis

4. Information

The world first biosimilar monoclonal antibody(mAb), approved in 79 countries including MFDS(2012), EMA(2013) and FDA(2016).

Remsima is a tumor necrosis factor α (TNF-α) antagonist used to treat rheumatoid arthritis, ankylosing spondylitis, ulcerative colitis, pediatric ulcerative colitis, adult Crohn's disease, pediatric Crohn’s disease, plaque psoriasis, and psoriatic arthritis.

5. Images

Pharmaceutical Product Information

1. Brand Name

Truxima

2. Active Ingredient

Rituximab

3. Indication

Non-Hodgkin’s lymphoma (NHL), Chronic lymphocytic leukaemia (CLL), Rheumatoid arthritis, Granulomatosis with polyangiitis and microscopic polyangiitis

4. Information

A monoclonal antibody biosimilar approved by MFDS in 2016.

Truxima is an antibody against CD20 intended for the treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis.

5. Images

Pharmaceutical Product Information

1. Brand Name

Herzuma(150mg / 440mg)

2. Active Ingredient

Trastuzumab

3. Indication

early breast cancer, metastatic breast cancer, metastatic gastric cancer

4. Information

A humanized monoclonal antibody(mAb) biosimilar approved by MFDS in 2014.

Herzuma is an antibody against epidermal growth factor (EGF) receptor 2 (HER2; ErbB2; neu) to treat early breast cancer, metastatic breast cancer, metastatic gastric cancer.

5. Images


Attached File

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