Category: Bio & Healthcare

Fact Source: Financial Supervisory Service DART 💡 3-Second Summary Samsung Biologics has disclosed the signing of a pharmaceutical contract manufacturing agreement with an Asia-based pharmaceutical company valued at approx. KRW 1.7028T (USD 1,242,560,000), representing 46.09% 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 / 2024-10-22” »

Fact Source: Financial Supervisory Service DART 💡 3-Second Summary Celltrion announced that it has signed a contract manufacturing and development (CDMO) supply agreement worth approximately KRW 100.0B with TEVA Pharmaceuticals International GmbH for the active pharmaceutical ingredient (API) of the migraine treatment AJOVY®. 📊 [Key Disclosure Details & Financial Highlights] 📝 Editor’s Comment (Key Follow-up…

Read More “[Disclosure] Celltrion (068270) – Single Sales / Supply Contract / 2024-10-22” »

Fact Source: Financial Supervisory Service DART 💡 3-Second Summary Celltrion announced that it has submitted an application for the Phase 3 clinical trial plan (Part 1 & 2) of CT-P55, a biosimilar to the plaque psoriasis treatment Cosentyx, to the European Medicines Agency (EMA). 📊 [Key Disclosure Details & Financial Highlights] 📝 Editor’s Comment (Key…

Read More “[Disclosure] Celltrion (068270) – Application for Phase 3 Clinical Trial Plan for CT-P55 (Cosentyx Biosimilar) in Europe (Part 1 & 2) / 2024-10-14” »

Fact Source: Financial Supervisory Service DART 💡 3-Second Summary Samsung Biologics has issued an advance notice indicating that it plans to release its cumulative Q3 2024 financial results on October 23, 2024. 📊 [Key Disclosure Details & Summary Statistics] 📝 Editor’s Comment (Key Follow-up Checkpoint) 📌 Verification of Confirmed Figures and Official Materials on Earnings…

Read More “[Disclosure] Samsung Biologics (207940) – Preview of Financial Results / 2024-10-10” »

Fact Source: Financial Supervisory Service DART 💡 3-Second Summary Celltrion announced that it has submitted an application for a Phase 3 clinical trial plan to the Ministry of Food and Drug Safety (MFDS) of South Korea to evaluate the efficacy and safety of CT-P13 SC in pediatric patients with ulcerative colitis. 📊 [Key Disclosure Details…

Read More “[Disclosure] Celltrion (068270) – Application for Phase 3 Clinical Trial Plan for CT-P13 SC in South Korea (Pediatric Ulcerative Colitis) / 2024-09-30” »

Fact Source: Financial Supervisory Service DART 💡 3-Second Summary Celltrion announced that it has submitted an application for a Phase 3 clinical trial plan to the Ministry of Food and Drug Safety (MFDS) of South Korea to evaluate the efficacy and safety of CT-P13 SC in pediatric patients with Crohn’s disease. 📊 [Key Disclosure Details…

Read More “[Disclosure] Celltrion (068270) – Application for Phase 3 Clinical Trial Plan for CT-P13 SC in South Korea (Pediatric Crohn’s Disease) / 2024-09-30” »

Fact Source: Financial Supervisory Service DART 💡 3-Second Summary Celltrion reconfirmed that while it signed an MOU with Yesan County for a KRW 300.0B facility investment, the specific details of the investment plan remain unconfirmed. 📊 [Key Disclosure Details & Financial Highlights] 📝 Editor’s Comment (Key Follow-up Checkpoint) 📌 Verification of Final Investment Plan Confirmation…

Read More “[Disclosure] Celltrion (068270) – Clarification on Rumors or Reports (Unconfirmed) / 2024-09-27” »

Fact Source: Financial Supervisory Service DART 💡 3-Second Summary Samsung Biologics announced that it has executed a contract manufacturing agreement worth approximately KRW 119.1B with a pharmaceutical company based in Asia. 📊 [Key Disclosure Details & Summary Statistics] 📝 Editor’s Comment (Key Follow-up Checkpoint) 📌 Monitoring Contract Revisions and Order Backlog Status in Periodic Reports…

Read More “[Disclosure] Samsung Biologics (207940) – Execution of Material Sales/Supply Contract / 2024-09-13” »

Fact Source: Financial Supervisory Service DART 💡 3-Second Summary Alteogen submitted an application for marketing authorization to the Ministry of Food and Drug Safety (MFDS) for EYZANFY (aflibercept, ALT-L9), an Eylea biosimilar, for all approved indications including wet age-related macular degeneration, based on Phase 3 clinical trial results. 📊 [Key Disclosure Details & Financial Highlights]…

Read More “[Disclosure] ALTEOGEN (196170) – Application for Domestic Marketing Authorization for EYZANFY (ALT-L9) / 2024-09-12” »

Fact Source: Financial Supervisory Service DART 💡 3-Second Summary Celltrion disclosed its mid-to-long-term management plan, setting revenue targets of KRW 3.5T for 2024 and KRW 5.0T for 2025, while outlining plans for its CDMO business including reviewing the securing of new facilities through subsidiary investment. 📊 [Key Disclosure Details & Financial Highlights] 📝 Editor’s Comment…

Read More “[Disclosure] Celltrion (068270) – Future Business and Management Plan / 2024-09-09” »