Category: Bio & Healthcare

[Disclosure] Celltrion (068270) – Approval of U.S. FDA BLA for Omlyclo (CT-P39, Xolair Biosimilar) / 2025-03-10

March 10, 2025August 6, 2026 K-STOCK Editor

Fact Source: Financial Supervisory Service DART 💡 3-Second Summary Celltrion received final marketing approval from the U.S. FDA for Omlyclo (CT-P39), a biosimilar to Xolair, covering all indications held by the reference product. 📊 Key Disclosure Content & Financial Highlights 📝 Editor’s Comment (Key Follow-up Checkpoint) 📌 Verification of Final FDA Approval Listing in Official…

Disclosures, Bio & Healthcare

[Disclosure] Celltrion (068270) – Approval of U.S. FDA BLA for Stoboclo & Osenvelt (CT-P41, Prolia & Xgeva Biosimilars) / 2025-03-04

March 4, 2025August 6, 2026 K-STOCK Editor

Fact Source: Financial Supervisory Service DART 💡 3-Second Summary Celltrion received final marketing approval from the U.S. FDA for Stoboclo and Osenvelt (CT-P41), biosimilars to Prolia and Xgeva, covering all indications held by the reference products. 📊 Key Disclosure Content & Financial Highlights 📝 Editor’s Comment (Key Follow-up Checkpoint) 📌 Verification of Final FDA Approval…

Disclosures, Bio & Healthcare

[Disclosure] Celltrion (068270) – Clarification of Rumors or News Reports (Unconfirmed) / 2025-02-27

February 27, 2025August 6, 2026 K-STOCK Editor

Fact Source: Financial Supervisory Service DART 💡 3-Second Summary Celltrion issued a clarification disclosure stating that it signed a KRW 300.0B Memorandum of Agreement (MOA) with South Chungcheong Province, Yesan-gun, and Chungnam Development Corporation for the construction of a drug product (DP) facility in Yesan, with a re-disclosure planned upon confirmation or within 6 months…

Disclosures, Bio & Healthcare

[Disclosure] Samsung Biologics (207940) – Submission of Audit Report / 2025-02-25

February 25, 2025August 7, 2026 K-STOCK Editor

Fact Source: Financial Supervisory Service DART 💡 3-Second Summary Samsung Biologics has disclosed the submission of its Audit Report for FY2024, receiving an ‘Unqualified’ audit opinion from Samil PricewaterhouseCoopers for both consolidated and separate financial statements. Consolidated revenue reached KRW 4.547T, with an operating profit of KRW 1.320T. 📊 [Key Disclosure Details & Financial Figures]…

Disclosures, Bio & Healthcare

[Disclosure] Celltrion (068270) – Change in Revenue or Profit/Loss Structure Exceeding 15% / 2025-02-25

February 25, 2025August 6, 2026 K-STOCK Editor

Fact Source: Financial Supervisory Service DART 💡 3-Second Summary Celltrion achieved record-high annual consolidated revenue of KRW 3.56T in 2024 (up 63.45% YoY), driven by expanded global prescriptions of existing products and rapid growth of new products. However, due to higher cost-of-goods-sold from legacy Celltrion Healthcare inventory, amortization of intangible assets (such as sales rights)…

Disclosures, Bio & Healthcare

[Disclosure] Celltrion (068270) – Provisional Separate Financial Results / 2025-02-25

February 25, 2025August 6, 2026 K-STOCK Editor

Fact Source: Financial Supervisory Service DART 💡 3-Second Summary Celltrion reported Q4 2024 separate revenue of KRW 1.06T (up 235.96% YoY) and operating profit of KRW 407.5B, with full-year 2024 cumulative separate revenue reaching KRW 3.71T, an increase of 97.99% YoY. 📊 Key Disclosure Content & Financial Highlights 📝 Editor’s Comment (Key Follow-up Checkpoint) 📌…

Disclosures, Bio & Healthcare

[Disclosure] Celltrion (068270) – Provisional Consolidated Financial Results / 2025-02-25

February 25, 2025August 6, 2026 K-STOCK Editor

Fact Source: Financial Supervisory Service DART 💡 3-Second Summary Celltrion reported Q4 2024 consolidated revenue of KRW 1.06T (up 178.01% YoY) and operating profit of KRW 196.4B, with full-year 2024 cumulative revenue reaching KRW 3.56T, an increase of 63.45% YoY. 📊 Key Disclosure Content & Financial Highlights 📝 Editor’s Comment (Key Follow-up Checkpoint) 📌 Verification…

Disclosures, Bio & Healthcare

[Disclosure] Celltrion (068270) – Resolution on Convening Annual General Meeting of Shareholders / 2025-02-25

February 25, 2025August 6, 2026 K-STOCK Editor

Fact Source: Financial Supervisory Service DART 💡 3-Second Summary Celltrion decided to convene its 34th Annual General Meeting of Shareholders on March 25, 2025, to vote on agenda items including financial statement approval, capital reserve reduction, and the re-election of Chairman Seo Jung-jin as a director. 📊 Key Disclosure Content & Financial Highlights 📝 Editor’s…

Disclosures, Bio & Healthcare

[Disclosure] Celltrion (068270) – Approval of Phase 3 Clinical Trial Application for CT-P13 SC (Remsima Subcutaneous) in Pediatric Ulcerative Colitis in Korea / 2025-02-24

February 24, 2025August 6, 2026 K-STOCK Editor

Fact Source: Financial Supervisory Service DART 💡 3-Second Summary Celltrion received approval from the Ministry of Food and Drug Safety (MFDS) of South Korea for its Phase 3 Clinical Trial Application (IND) of CT-P13 SC (Remsima Subcutaneous) in pediatric patients with moderately to severely active ulcerative colitis. 📊 Key Disclosure Content & Financial Highlights 📝…

Disclosures, Bio & Healthcare

[Disclosure] Celltrion (068270) – Approval of European Commission Marketing Authorization for Avtozma (CT-P47, Actemra/RoActemra Biosimilar) / 2025-02-24

February 24, 2025August 6, 2026 K-STOCK Editor

Fact Source: Financial Supervisory Service DART 💡 3-Second Summary Celltrion received final marketing authorization from the European Commission (EC) for Avtozma (CT-P47), a biosimilar to Actemra/RoActemra, covering all reference indications across 30 European countries. 📊 Key Disclosure Content & Financial Highlights 📝 Editor’s Comment (Key Follow-up Checkpoint) 📌 Verification of EC Marketing Authorization Listing in…

Disclosures, Bio & Healthcare