Category: Bio & Healthcare

Fact Source: Financial Supervisory Service DART 💡 3-Second Summary Samsung Biologics announced an amendment disclosing the counterparty of a 2023 contract manufacturing LOI as ‘Kiniksa Pharmaceuticals (UK), Ltd’ following the execution of the main contract. 📊 [Key Disclosure Details & Summary Statistics] 📝 Editor’s Comment (Key Follow-up Checkpoint) 📌 Verifying Main Contract Execution and Confirmed…

Read More “[Disclosure] Samsung Biologics (207940) – Major Management Matters (Correction) / 2024-06-25” »

Fact Source: Financial Supervisory Service DART 💡 3-Second Summary Celltrion announced that it has obtained marketing authorization from the Ministry of Food and Drug Safety (MFDS) of South Korea for Omlyclo (CT-P39), a biosimilar to Xolair, for the treatment of allergic asthma and chronic idiopathic urticaria. 📊 [Key Disclosure Details & Financial Highlights] 📝 Editor’s…

Read More “[Disclosure] Celltrion (068270) – Marketing Authorization Granted by South Korean MFDS for Omlyclo (CT-P39, Xolair Biosimilar) / 2024-06-24” »

Fact Source: Financial Supervisory Service DART 💡 3-Second Summary Celltrion announced that it has submitted an application for a global Phase 3 clinical trial plan to the U.S. Food and Drug Administration (FDA) to evaluate the efficacy and safety of CT-P13 SC (Zymfentra) in patients with rheumatoid arthritis. 📊 [Key Disclosure Details & Financial Highlights]…

Read More “[Disclosure] Celltrion (068270) – Application for Phase 3 Clinical Trial Plan for CT-P13 SC (Zymfentra) in the U.S. (Rheumatoid Arthritis) / 2024-06-19” »

Fact Source: Financial Supervisory Service DART 💡 3-Second Summary Celltrion announced that the European Medicines Agency (EMA) has approved Part 1 (trial design and methodology) of its global Phase 3 clinical trial plan for CT-P13 SC (Remsima SC) in pediatric patients with ulcerative colitis. 📊 [Key Disclosure Details & Financial Highlights] 📝 Editor’s Comment (Key…

Read More “[Disclosure] Celltrion (068270) – Approval of Phase 3 Clinical Trial Plan (Part 1) in Europe for CT-P13 SC (Pediatric Ulcerative Colitis) / 2024-06-18” »

Fact Source: Financial Supervisory Service DART 💡 3-Second Summary Celltrion announced that the European Medicines Agency (EMA) has approved Part 1 (trial design and methodology) of its global Phase 3 clinical trial plan for CT-P13 SC (Remsima SC) in pediatric patients with Crohn’s disease. 📊 [Key Disclosure Details & Financial Highlights] 📝 Editor’s Comment (Key…

Read More “[Disclosure] Celltrion (068270) – Approval of Phase 3 Clinical Trial Plan (Part 1) in Europe for CT-P13 SC (Pediatric Crohn’s Disease) / 2024-06-18” »

Fact Source: Financial Supervisory Service DART 💡 3-Second Summary Samsung Biologics announced a disclosure correction regarding a 2017 contract manufacturing agreement, significantly increasing the contract value from ~KRW 16.8B to ~KRW 250.9B while fully disclosing the counterparty (Baxter Healthcare Corporation) and the contract end date (December 31, 2034). 📊 [Key Disclosure Details & Summary Statistics]…

Read More “[Disclosure] Samsung Biologics (207940) – Execution of Material Sales/Supply Contract (Correction) / 2024-06-18” »

Fact Source: Financial Supervisory Service DART 💡 3-Second Summary Celltrion announced that it has submitted an application for a global Phase 3 clinical trial plan to the U.S. Food and Drug Administration (FDA) to evaluate the efficacy and safety of CT-P51 compared with Keytruda in patients with non-small cell lung cancer. 📊 [Key Disclosure Details…

Read More “[Disclosure] Celltrion (068270) – Application for Phase 3 Clinical Trial Plan for CT-P51 (Keytruda Biosimilar) in the U.S. / 2024-06-17” »

Fact Source: Financial Supervisory Service DART 💡 3-Second Summary Celltrion announced its decision to acquire 410,734 treasury common shares (valued at approximately KRW 75.0B) through on-market purchases to stabilize stock price and enhance shareholder value. 📊 [Key Disclosure Details & Financial Highlights] 📝 Editor’s Comment (Key Follow-up Checkpoint) 📌 Verification of On-Market Purchase Execution and…

Read More “[Disclosure] Celltrion (068270) – Treasury Share Acquisition Decision / 2024-06-14” »

Fact Source: Financial Supervisory Service DART 💡 3-Second Summary Celltrion announced that it has obtained marketing authorization from the Ministry of Food and Drug Safety (MFDS) of South Korea for Steqeyma (CT-P43), a biosimilar to Stelara, covering all approved indications of the original drug, including plaque psoriasis, Crohn’s disease, and ulcerative colitis. 📊 [Key Disclosure…

Read More “[Disclosure] Celltrion (068270) – Marketing Authorization Granted by South Korean MFDS for Steqeyma (CT-P43, Stelara Biosimilar) / 2024-06-12” »

Fact Source: Financial Supervisory Service DART 💡 3-Second Summary Samsung Biologics announced an amendment extending the non-disclosure deadline for the counterparty of a contract manufacturing LOI signed with a U.S. pharmaceutical company to June 30, 2024, in consultation with the client. 📊 [Key Disclosure Details & Summary Statistics] 📝 Editor’s Comment (Key Follow-up Checkpoint) 📌…

Read More “[Disclosure] Samsung Biologics (207940) – Major Management Matters (Correction) / 2024-05-31” »