Category: Bio & Healthcare

Fact Source: Financial Supervisory Service DART 💡 3-Second Summary Samsung Biologics announced that it has executed a definitive contract manufacturing agreement worth approximately KRW 1.464T with a pharmaceutical company based in the U.S. 📊 [Key Disclosure Details & Summary Statistics] 📝 Editor’s Comment (Key Follow-up Checkpoint) 📌 Monitoring Main Contract Terms and Order Backlog Status…

Read More “[Disclosure] Samsung Biologics (207940) – Execution of Material Sales/Supply Contract / 2024-07-02” »

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 December 31, 2030. 📊 [Key Disclosure Details & Summary Statistics] 📝 Editor’s Comment (Key Follow-up Checkpoint) 📌 Tracking Execution of Main Contract…

Read More “[Disclosure] Samsung Biologics (207940) – Major Management Matters (Correction) / 2024-07-02” »

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-P55 compared with Cosentyx in patients with plaque psoriasis. 📊 [Key Disclosure Details & Financial…

Read More “[Disclosure] Celltrion (068270) – Application for Phase 3 Clinical Trial Plan for CT-P55 (Cosentyx Biosimilar) in the U.S. / 2024-07-01” »

Fact Source: Financial Supervisory Service DART 💡 3-Second Summary Celltrion announced that the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) has issued a positive opinion recommending marketing authorization for CT-P43, a biosimilar to Stelara, across 30 European countries. 📊 [Key Disclosure Details & Financial Highlights] 📝 Editor’s Comment…

Read More “[Disclosure] Celltrion (068270) – CHMP Positive Opinion Granted for CT-P43 (Stelara Biosimilar) by EMA / 2024-07-01” »

Fact Source: Financial Supervisory Service DART 💡 3-Second Summary This notice from the Korea Exchange announces that Samsung Biologics’ sub-class industry designation has been revised to ‘Manufacture of Basic Pharmaceutical Products’ due to amendments in standard classification regulations. 📊 [Key Disclosure Details & Summary Statistics] 📝 Editor’s Comment (Key Follow-up Checkpoint) 📌 Verifying Reclassification Updates…

Read More “[Disclosure] Samsung Biologics (207940) – Other Market Information (Industry Reclassification) / 2024-06-28” »

Fact Source: Financial Supervisory Service DART 💡 3-Second Summary Following revisions to Statistics Korea’s Korean Standard Industrial Classification (KSIC) and KRX KOSPI market regulations, Celltrion’s sub-industry classification will be changed from “Manufacture of basic pharmaceutical products and biological preparations” to “Manufacture of basic pharmaceutical products” effective July 1, 2024. 📊 [Key Disclosure Details & Financial…

Read More “[Disclosure] Celltrion (068270) – Other Market Notice (Industry Reclassification) / 2024-06-28” »

Fact Source: Financial Supervisory Service DART 💡 3-Second Summary Samsung Biologics announced an amendment extending both the contract period end date and the non-disclosure deadline for a contract manufacturing LOI signed with a European pharmaceutical company to July 31, 2024, at the client’s request. 📊 [Key Disclosure Details & Summary Statistics] 📝 Editor’s Comment (Key…

Read More “[Disclosure] Samsung Biologics (207940) – Major Management Matters (Correction) / 2024-06-26” »

Fact Source: Financial Supervisory Service DART 💡 3-Second Summary Samsung Biologics announced an amendment extending both the contract period end date and the non-disclosure deadline for a contract manufacturing LOI signed with a European pharmaceutical company to July 31, 2024, at the client’s request. 📊 [Key Disclosure Details & Summary Statistics] 📝 Editor’s Comment (Key…

Read More “[Disclosure] Samsung Biologics (207940) – Major Management Matters (Correction) / 2024-06-26” »

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 July 30, 2024, at the client’s request. 📊 [Key Disclosure Details & Summary Statistics] 📝 Editor’s Comment (Key Follow-up Checkpoint) 📌 Tracking…

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

Fact Source: Financial Supervisory Service DART 💡 3-Second Summary Samsung Biologics announced that it has executed a definitive contract manufacturing agreement worth approximately KRW 211.5B with Kiniksa Pharmaceuticals (UK), Ltd. 📊 [Key Disclosure Details & Summary Statistics] 📝 Editor’s Comment (Key Follow-up Checkpoint) 📌 Monitoring Main Contract Terms and Order Backlog Status in Periodic Reports…

Read More “[Disclosure] Samsung Biologics (207940) – Execution of Material Sales/Supply Contract / 2024-06-25” »