Category: Bio & Healthcare

Fact Source: Financial Supervisory Service DART 💡 3-Second Summary Celltrion received final marketing authorization from the US Food and Drug Administration (FDA) for Steqeyma (CT-P43), a Stelara biosimilar, for key indications including plaque psoriasis and Crohn’s disease across the United States. 📊 Key Disclosure Content & Financial Highlights 📝 Editor’s Comment (Key Follow-up Checkpoint) 📌…

Read More “[Disclosure] Celltrion (068270) – Approval of US FDA Marketing Authorization for Steqeyma (CT-P43, Stelara Biosimilar) / 2024-12-18” »

Fact Source: Financial Supervisory Service DART 💡 3-Second Summary The Korea Exchange (KRX) issued an advance notice regarding scheduled derivatives market measures—including adjustments to base prices, contract multipliers, and strike prices—for Celltrion equity futures and options, effective December 27, 2024 (ex-dividend date), following Celltrion’s stock dividend decision. 📊 Key Disclosure Content & Financial Highlights 📝…

Read More “[Disclosure] Celltrion (068270) – Advance Notice of Equity Futures & Options Market Measures (Planned Market Measures Due to Stock Dividend) / 2024-12-18” »

Fact Source: Financial Supervisory Service DART 💡 3-Second Summary Samsung Biologics has issued a correction disclosure regarding its pharmaceutical contract manufacturing agreement with Checkpoint Therapeutics, Inc., moving forward the contract end date from October 2, 2030, to December 17, 2024, following the completion of contract performance. 📊 [Key Disclosure Details & Financial Figures] 📝 Editor’s…

Read More “[Disclosure] Samsung Biologics (207940) – (Correction) Single Sales and Supply Contract / 2024-12-17” »

Fact Source: Financial Supervisory Service DART 💡 3-Second Summary Samsung Biologics has disclosed the signing of a pharmaceutical contract manufacturing agreement with a US-based pharmaceutical company valued at approx. KRW 111.3B (USD 77,544,000), representing 3.01% of its FY2023 consolidated revenue. 📊 [Key Disclosure Details & Financial Figures] 📝 Editor’s Comment (Key Follow-up Checkpoint) 📌 Monitoring…

Read More “[Disclosure] Samsung Biologics (207940) – Single Sales and Supply Contract / 2024-12-17” »

Fact Source: Financial Supervisory Service DART 💡 3-Second Summary Celltrion acquired 2,000,000 shares (KRW 10 billion) of its newly established Contract Development and Manufacturing Organization (CDMO) entity, ‘Celltrion BioSolutions,’ via cash contribution, securing a 100% equity stake as a wholly-owned subsidiary. 📊 Key Disclosure Content & Financial Highlights 📝 Editor’s Comment (Key Follow-up Checkpoint) 📌…

Read More “[Disclosure] Celltrion (068270) – Acquisition of Shares and Investment Certificates in Another Corporation (Voluntary Disclosure) / 2024-12-17” »

Fact Source: Financial Supervisory Service DART 💡 3-Second Summary Celltrion received Phase 3 Clinical Trial Application (CTA) (Part 1 & Part 2) approval from the European Medicines Agency (EMA) for CT-P13 SC (Zymfentra), targeting patients with rheumatoid arthritis. 📊 Key Disclosure Content & Financial Highlights 📝 Editor’s Comment (Key Follow-up Checkpoint) 📌 Monitoring Clinical Trial…

Read More “[Disclosure] Celltrion (068270) – Approval of Phase 3 Clinical Trial Plan for CT-P13 SC (Zymfentra) in Europe (Part 1 & 2) (Rheumatoid Arthritis Patients) / 2024-12-17” »

Fact Source: Financial Supervisory Service DART 💡 3-Second Summary Samsung Biologics has disclosed the setting of December 31, 2024, as the record date and the closure of its shareholder register (suspension of entry of alteration in the register) from January 1, 2025, to January 31, 2025, to determine entitled shareholders for its 14th Annual General…

Read More “[Disclosure] Samsung Biologics (207940) – Setting of Record Date or Period for Closure of Shareholder Register / 2024-12-16” »

Fact Source: Financial Supervisory Service DART 💡 3-Second Summary Celltrion received a recommendation for marketing authorization from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) for CT-P41, a biosimilar referencing Prolia and Xgeva, across 30 European countries for all target indications including osteoporosis and prevention of skeletal-related events….

Read More “[Disclosure] Celltrion (068270) – CHMP Recommendation for Marketing Authorization for CT-P41 (Prolia & Xgeva Biosimilar) / 2024-12-16” »

Fact Source: Financial Supervisory Service DART 💡 3-Second Summary Celltrion received a recommendation for marketing authorization from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) for CT-P42, a biosimilar referencing Eylea, across 30 European countries for four indications including neovascular (wet) age-related macular degeneration. 📊 Key Disclosure Content…

Read More “[Disclosure] Celltrion (068270) – CHMP Recommendation for Marketing Authorization for CT-P42 (Eylea Biosimilar) / 2024-12-16” »

Fact Source: Financial Supervisory Service DART 💡 3-Second Summary Celltrion received a recommendation for marketing authorization from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) for CT-P47, a biosimilar referencing RoActemra, across 30 European countries for six indications including rheumatoid arthritis. 📊 Key Disclosure Content & Financial Highlights…

Read More “[Disclosure] Celltrion (068270) – CHMP Recommendation for Marketing Authorization for CT-P47 (RoActemra Biosimilar) / 2024-12-16” »