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KRX:068270

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Asia

Celltrion Files Phase 3 Trial Amendment for CT-P44 Biosimilar for Myeloma

Celltrion (KRX:068270) said it submitted an amendment to the Phase 3 clinical trial protocol for CT-P44, a biosimilar candidate for Darzalex, to South Korea's Ministry of Food and Drug Safety.The trials will evaluate the efficacy and safety of CT-P44 against Darzalex Faspro in patients with relapsed or refractory multiple myeloma, according to a Tuesday filing with the Korea Exchange.The amendment is filed to adjust the number of trial participants following a change in its regulatory strategy, and the randomized, double-blind trial is expected to involve 394 participants and run for two years.

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Asia

Celltrion Submits EMA Marketing Authorization Application for Cosentyx Biosimilar CT-P55

Celltrion (KRX:068270) has submitted a marketing authorization application to the European Medicines Agency and European Commission for CT-P55, a biosimilar to Cosentyx (secukinumab), according to a bourse filing on Friday.The company seeks approval for adult plaque psoriasis, psoriatic arthritis, hidradenitis suppurativa, and axial spondyloarthritis, plus pediatric plaque psoriasis and juvenile idiopathic arthritis subtypes.The application is based on a Phase 1 trial in 172 healthy subjects that demonstrated pharmacokinetic equivalence to Cosentyx, with similar safety profiles and low immunogenicity across both groups.The company cautions that submitting an application does not guarantee final approval, and regulatory reviews may yield unexpected outcomes or lead to changes in commercialization plans.This MAA follows prior EMA submissions and approvals for the drug's clinical trial applications between 2023 and 2026.

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Asia

Celltrion Submits Dual-Part EMA Application for Subcutaneous Rheumatoid Arthritis Drug

Celltrion (KRX:068270) has submitted applications for its subcutaneous rheumatoid arthritis drug CT-P13 SC (Zymfentra) to both the U.S. FDA (IND) and the European Medicines Agency (CTA Parts 1 and 2).The company seeks to demonstrate superiority over placebo at 12 weeks in a 296-patient, 52-week global Phase 3 trial, according to a bourse filing on Friday.The subcutaneous formulation, already approved for ulcerative colitis and Crohn's disease in multiple regions, aims to expand its indications and improve patient convenience through a broader treatment population.The company cautions that historically only about 10% of clinical trial drugs ultimately receive marketing approval, and results may fall short of expectations.While both filings share the same clinical design and commercial rationale, the EMA submission explicitly addresses the EU's revised Clinical Trials Regulation requiring separate Part 1 (methodology) and Part 2 (site operations) approvals.Both submissions support commercial differentiation through patient diversity, though investors are urged to carefully review all periodic risk disclosures before making investment decisions.

KRX:068270
Asia

Celltrion Submits South Korean IND for Subcutaneous Rheumatoid Arthritis Drug

Celltrion (KRX:068270) has filed a Phase 3 IND application with the MFDS for CT-P13 SC (Zymfentra) in rheumatoid arthritis, aiming to demonstrate superiority over placebo at 12 weeks.The 296-patient, 52-week trial seeks to expand the drug's approved uses beyond ulcerative colitis and Crohn's disease, leveraging its subcutaneous formulation for patient convenience, according to a bourse filing on Friday.The company cautions that only about 10% of trial drugs ultimately gain marketing approval, and outcomes may not meet expectations.This filing, confirmed on Friday, also supports commercial differentiation and regulatory trends favoring patient diversity, though investors should review all risk disclosures.

KRX:068270
Asia

Celltrion Terminates, Withdraws EMA Trial Application for CT-P51 Biosimilar

Celltrion (KRX:068270) voluntarily terminated and withdrew its European Phase 3 clinical trial application for CT-P51, its biosimilar to cancer drug Keytruda, from the European Medicines Agency, according to a regulatory filing on Tuesday.The South Korean biopharmaceutical company said the withdrawal follows changes in the global regulatory environment for biosimilar clinical trials.The company has updated its clinical and regulatory strategy for Phase 3 trials in previously untreated metastatic non-squamous non-small cell lung cancer, reducing the number of patients recruited for the trial.The company will continue the Phase 3 study in participating countries outside the European Union, comparing the efficacy and safety of CT-P51 against the reference drug Keytruda.

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Asia

South Korean Shares Jump on Bargain-Hunting, Chip Stock Gains

South Korean shares closed sharply higher on Friday as investors took to bargain-hunting after Thursday's 8% plunge in the country's primary index. Major market bigwigs Samsung Electronics (KRX:005930), SK Hynix (KRX:000660), and LG Energy Solution (KRX:373220) added 8%, 11%, and over 2%, respectively, at market close.The benchmark Korea Composite Stock Price Index, or Kospi, rose by 5.8%, or 440.25 points, to close at 8,088.34. The Kosdaq, also increased by 0.2%, or 1.69 points, to end at 868.41.In economic news, South Korea's economy is expected to accelerate to 2.6% in 2026 from 1% in 2025, supported by consumption, fiscal stimulus, and strong chip exports, the Organisation for Economic Co-operation and Development (OECD) said in a Thursday release.Inflation is projected to rise to 2.6% in 2026 from 2.1% in 2025, due to higher energy prices before easing to 2.2% in 2027.Strong chip exports supported South Korea's growth despite Middle East-related setbacks, while fiscal and monetary stimulus boosted consumption. The OECD said strengthening the fiscal framework, including further pension reform and rules-based expenditure, will help ensure long-term sustainability, according to the release.On the corporate front, Celltrion (KRX:068270) posted second-quarter sales of 1.3 trillion won, up 35% from 961.5 billion won a year earlier, according to a Friday filing with the Korea Exchange.The South Korean biopharmaceutical company's operating income jumped 77% year over year to 430 billion won from 242.5 billion won, the filing said.Shares of Celltrion rose nearly 4% at market close.

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Asia

Celltrion's Sales Jump 35% in Q2; Shares Rise 4%

Celltrion (KRX:068270) posted second-quarter sales of 1.3 trillion won, up 35% from 961.5 billion won a year earlier, according to a Friday filing with the Korea Exchange.The South Korean biopharmaceutical company's operating income jumped 77% year over year to 430 billion won from 242.5 billion won, the filing said.Shares of Celltrion rose nearly 4% in recent trade.

KRX:068270
Samsung, SK Hynix Lead KRW 392 Trillion Investment in South Korea's Chungcheong Region
US Markets

Samsung, SK Hynix Lead KRW 392 Trillion Investment in South Korea's Chungcheong Region

Samsung Electronics (KRX:005930), SK Hynix (KRX:000660) and Celltrion (KRX:068270) have pledged a combined 392 trillion won ($254 billion) to build a tech and biotech hub in South Korea's Chungcheong region.South Korea's Ministry of Trade, Industry and Energy announced the plans at a Thursday briefing held at Samsung Display's Asan campus.The event, which coincided with the first glass substrate delivery for Samsung Display's 8.6-generation OLED production line, follows the government's mega-projects briefing last week, where the ministry also announced a 550 trillion won project in cooperation with the government, Samsung, SK Hynix and Naver (KRX:035420).At the latest event, Samsung outlined a 140 trillion-won plan to transform Chungcheong into "a hub for materials and components."Through Samsung Display, the group plans to expand high-value-added OLED lines in Asan for smartphones, IT devices, XR, automotive and humanoid and wearable applications, according to a separate press release from Samsung.The company will also build an HBM manufacturing base with five fab lines in Onyang, plus expanded facilities in Cheonan.Samsung expects the plan to create 250,000 jobs.Separately, SK Hynix CEO Kwak Noh-Jung said the company will invest a total of 100 trillion won in Cheongju, of which 80 trillion won will be spent on M17 NAND production and 20 trillion won for P&T7 advanced packaging.P&T7 is targeted for completion by the end of 2027, while M17 construction is expected to begin next year, with operations slated to start in the first half of 2029.Kwak cited an increasing demand for enterprise SSDs and NAND flash memory tied to the adoption of AI services as the reason for the expansion.SK Group separately plans to build a 1-gigawatt AI data center in the Chungcheong region as part of a push to build a total of 15 GW of AI data center capacity across the country.Meanwhile, biopharmaceutical company Celltrion (KRX:068270) will also invest 2 trillion won in biopharmaceutical production facilities within Chungcheong, according to the ministry.The planned facility will manufacture pre-filled syringes, with plans to boost production capacity by 50 million syringes, raising Celltrion's total annual capacity in the region to 70 million syringes, Korea JoongAng Daily reported, citing the event.The ministry also hinted that other companies have earmarked about 150 trillion won in the region.

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Asia

South Korean Shares Snap Six-Day Winning Streak on Profit-Booking

South Korean shares snapped a six-day winning streak on Friday to close lower after investors took the opportunity of the recent rally to book profits.Starting the day on a strong chip rally, shares lost momentum in the afternoon after news broke of the cancellation of the talks scheduled for Friday between the US ⁠and ​Iran in Switzerland to implement a peace agreement. The talks were expected to take place in the Swiss village of Obbürgen, two days after a memorandum of understanding (MoU) established a 60-day negotiation window for a long-term agreement on Iran's nuclear program and the resumption of oil shipments via the Strait of Hormuz.The benchmark Korea Composite Stock Price Index, or Kospi, fell by 0.13%, or 11.42 points, to close at 9,052.42. The Kosdaq also decreased by 3.4%, or 34.34 points, to end at 966.59.In economic news, producer prices in South Korea increased 8.5% in May from a year earlier, accelerating from 7.2% in April and marking the strongest annual increase since July 2022, according to preliminary data from the Bank of Korea on Friday.The year-on-year gains were driven by higher costs across all categories. On a month-on-month basis, producer prices increased 0.8% in May, according to the data.On the corporate front, Celltrion (KRX:068270) said approval for Part 1 of its European Phase 3 clinical trial application for Remsima (CT-P13 SC) in pediatric patients with Crohn's Disease has lapsed, according to a Friday filing with the Korea Exchange.Shares of the company fell nearly 3% at market close.

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Asia

Celltrion's EU Clinical Trial Nod for Crohn's Disease Drug Lapses

Celltrion's (KRX:068270) said approval for Part 1 of its European Phase 3 clinical trial application for Remsima (CT-P13 SC) in pediatric patients with Crohn's Disease has lapsed, according to a Friday filing with the Korea Exchange.The approval lapsed on June 18 after the South Korean biopharmaceutical company opted not to submit Part 2 of the application, citing changes to its clinical development strategy.Under the European Union Clinical Trials Regulation, approval for Part 1 automatically lapses if Part 2 is not filed within two years.Celltrion said plans and timelines for the study will be determined following consultations with regulators on the trial design.Shares of Celltrion fell over 2% in recent trade.

KRX:068270
Asia

Celltrion's EU Clinical Trial Nod for Ulcerative Colitis Drug Lapses

Celltrion (KRX:068270) said approval for Part 1 of its European Phase 3 clinical trial application for Remsima (CT-P13 SC) in pediatric patients with moderately to severely active ulcerative colitis has lapsed, according to a Friday filing with the Korea Exchange.The approval lapsed on June 18 after the South Korean biopharmaceutical company opted not to submit Part 2 of the application, citing changes to its clinical development strategy.Under the European Union Clinical Trials Regulation, approval for Part 1 automatically lapses if Part 2 is not filed within two years.Celltrion said plans and timelines for the study will be determined following consultations with regulators on the trial design.Shares of Celltrion fell over 2% in recent trade.

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Asia

Market Chatter: Celltrion Workers Form Labor Union

Workers at bio firm Celltrion (KRX:068270) have formed a labor union, with a view to have compensation transparency, according to a report by the Yonhap News Agency on Monday.The union aims to increase staffing and improve employee benefits, the report said.Meanwhile, the company plans to respond to the formation in "good faith", the report added.(Market Chatter news is derived from conversations with market professionals globally. This information is believed to be from reliable sources but may include rumor and speculation. Accuracy is not guaranteed.)

KRX:068270
Asia

Celltrion's Net Attributable Income Jumps 219% in Q1

Celltrion (KRX:068270) posted first-quarter net income attributable to shareholders of 346.1 billion won, up 219% from 108.7 billion won a year earlier, according to a Wednesday filing with the Korea Exchange.The South Korean biopharmaceutical company's sales rose 36% year over year to 1.144 trillion won from 841.9 billion won.Shares of Celltrion fell nearly 2% at market close.

KRX:068270
Asia

Celltrion to Retire KRW100 Billion Worth of Treasury Shares

South Korean biopharmaceutical company Celltrion (KRX:068270) plans to retire 488,983 treasury shares, valued at 100 billion won, according to a Wednesday filing with the Korea Exchange.The shares will be retired on May 21 at a par value of 1,000 won apiece.

KRX:068270

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