Category: Bio & Healthcare

Fact Source: Financial Supervisory Service DART 💡 3-Second Summary Celltrion has submitted an application for Part 1 & Part 2 of a Phase 3 clinical trial protocol amendment to the European Medicines Agency (EMA) for CT-P44, a biosimilar to Darzalex (a treatment for multiple myeloma). The amendment involves adjusting the number of clinical trial participants…

Read More “[Disclosure] Celltrion (068270) – CT-P44 (Darzalex Biosimilar) Europe Phase 3 Clinical Trial Plan Amendment Application (Part 1 & 2) / 2026-07-14” »

Fact Source: Financial Supervisory Service DART 💡 3-Second Summary Samsung Biologics has announced that it plans to disclose its financial results for H1 2026 (January–June) on July 23, 2026. 📊 [Key Disclosure Details & Financial Summary] 📝 Editor’s Comment (Key Follow-up Checkpoint) 📌 Actual Release of Financial Results on the Scheduled Disclosure Date This advance…

Read More “[Disclosure] Samsung Biologics (207940) – Advance Notice of Financial Results Disclosure / 2026-07-09” »

Fact Source: Financial Supervisory Service DART 💡 3-Second Summary Celltrion has submitted an application to the U.S. FDA to amend its Phase 3 clinical trial plan for CT-P51, a biosimilar candidate referencing Keytruda. 📊 [Key Disclosure Details & Financial Summary] 📝 Editor’s Comment (Key Follow-up Checkpoint) 📌 FDA Approval Status and Subsequent R&D Progress Reports…

Read More “[Disclosure] Celltrion (068270) – CT-P51 (Keytruda Biosimilar) U.S. Phase 3 Clinical Trial Plan Amendment Filing / 2026-07-06” »

Fact Source: Financial Supervisory Service DART 💡 3-Second Summary Celltrion reported provisional Q2 2026 consolidated revenue of KRW 1.30T and operating profit of KRW 430.0B, reflecting significant YoY increases of 35.21% and 77.32%, respectively. 📊 [Key Disclosure Details & Financial Summary] 📝 Editor’s Comment (Key Follow-up Checkpoint) 📌 Verification of Final Audited Figures and Detailed…

Read More “[Disclosure] Celltrion (068270) – Consolidated Financial Results (Provisional Earnings Release) / 2026-07-03” »

Fact Source: Financial Supervisory Service DART 💡 3-Second Summary Celltrion has submitted an application for marketing authorization of CT-P55, a biosimilar candidate referencing Cosentyx, to the Ministry of Food and Drug Safety (MFDS) in South Korea. 📊 [Key Disclosure Details & Financial Summary] 📝 Editor’s Comment (Key Follow-up Checkpoint) 📌 MFDS Final Approval Status and…

Read More “[Disclosure] Celltrion (068270) – CT-P55 (Cosentyx Biosimilar) Korea Marketing Authorization Application / 2026-06-26” »

Fact Source: Financial Supervisory Service DART 💡 3-Second Summary Celltrion is listing 10,920,342 new common shares issued through a bonus issue on June 30, 2026. 📊 [Key Disclosure Details & Financial Summary] 📝 Editor’s Comment (Key Follow-up Checkpoint) 📌 Verification of Increased Circulating Supply and Total Issued Shares This filing represents the final administrative execution…

Read More “[Disclosure] Celltrion (068270) – Additional Listing (Bonus Issue) / 2026-06-25” »

Fact Source: Financial Supervisory Service DART 💡 3-Second Summary Samsung Biologics has expanded a contract manufacturing agreement originally signed in August 2018, increasing the value from KRW 144.6B to KRW 215.9B upon the client’s request and extending the contract term through 2037. 📊 [Key Disclosure Details & Financial Summary] 📝 Editor’s Comment (Key Follow-up Checkpoint)…

Read More “[Disclosure] Samsung Biologics (207940) – (Correction) Contract Signings for Supply and Sales / 2026-06-22” »

Fact Source: Financial Supervisory Service DART 💡 3-Second Summary Celltrion’s Part 1 approval for the European Phase 3 trial of CT-P13 SC in pediatric ulcerative colitis has expired under EU CTR regulations as the company opted not to submit a Part 2 application due to a change in development strategy. 📊 [Key Disclosure Details &…

Read More “[Disclosure] Celltrion (068270) – Expiration of Part 1 Approval for Phase 3 Clinical Trial Plan of CT-P13 SC (Remsima Subcutaneous) in Europe Due to Development Strategy Change (Pediatric Ulcerative Colitis) / 2026-06-18” »

Fact Source: Financial Supervisory Service DART 💡 3-Second Summary Celltrion’s Part 1 approval for the European Phase 3 trial of CT-P13 SC in pediatric Crohn’s disease has expired under EU CTR regulations as the company opted not to submit a Part 2 application due to a change in development strategy. 📊 [Key Disclosure Details &…

Read More “[Disclosure] Celltrion (068270) – Expiration of Part 1 Approval for Phase 3 Clinical Trial Plan of CT-P13 SC (Remsima Subcutaneous) in Europe Due to Development Strategy Change (Pediatric Crohn’s Disease) / 2026-06-18” »

Fact Source: Financial Supervisory Service DART 💡 3-Second Summary Samsung Biologics has expanded a contract manufacturing agreement originally signed in April 2025, increasing the value from KRW 737.3B to KRW 835.7B upon the client’s request. 📊 [Key Disclosure Details & Financial Summary] 📝 Editor’s Comment (Key Follow-up Checkpoint) 📌 Future Amended Disclosures Regarding Changes in…

Read More “[Disclosure] Samsung Biologics (207940) – (Correction) Contract Signings for Supply and Sales / 2026-06-17” »