South Korean biopharmaceutical company headquartered in Incheon, developing and distributing biosimilar monoclonal antibody therapies for rheumatoid arthritis, cancer, and inflammatory diseases.
Clinical Trials
169
78 active
Approvals
46
Total approvals
Agencies
3
Regulatory bodies
Founded
2002
Active, not recruiting
76
45.0%
Completed
68
40.2%
Not yet recruiting
2
1.2%
Recruiting
13
7.7%
Terminated
6
3.5%
Unknown
3
1.8%
Withdrawn
1
0.6%
- Celltrion has submitted an IND application to the FDA for a U.S. Phase 4 trial of a 240mg high-dose regimen of its subcutaneous infliximab, Zymfentra. - The trial will enroll 447 patients with Crohn's disease and ulcerative colitis across 55 U.S. sites, testing non-inferiority against high-dose intravenous infliximab. - Success would add a 240mg option to the current 120mg U.S. prescribing practice, mirroring a high-dose strategy that helped Remsima SC reach roughly 32% EU5 market share. - Zymfentra first-half sales reached 99.5 billion won (about $73.6 million), up 176.4% year-over-year, while a global trial to add a rheumatoid arthritis indication continues.
- Onconic Therapeutics has received a U.S. patent registration decision covering a novel high-purity, high-stability crystalline form and manufacturing method for its anticancer candidate nesuparib, valid through May 2042. - The new patent extends intellectual property protection beyond the existing compound patent (expiring 2036) to the crystal structure and production process critical for regulatory approval and commercial manufacturing. - Nesuparib is a dual-target synthetic lethal agent inhibiting both tankyrase and PARP, currently in Phase 2 trials across pancreatic, ovarian, endometrial, and gastric cancers. - The company holds three FDA orphan drug designations and is targeting submission of a U.S. Phase 2 IND application by the end of the year.
- Celltrion has launched the 300 mg strength of Omlyclo (omalizumab), a biosimilar of Xolair, in major European markets including Germany, the UK, and France. - The 300 mg dose enables patients requiring 300 mg to receive treatment with a single injection instead of two 150 mg injections, improving dosing convenience. - Omlyclo captured approximately 16% of the European omalizumab market in Q1, with market share in Spain reaching roughly 71%. - Celltrion plans to complete the 300 mg rollout across Europe by year-end, offering both pre-filled syringe and autoinjector presentations.
- Kaigene grants Taisho Pharmaceutical exclusive rights to develop and commercialize FcRn inhibitor KG006 in Japan, receiving a $5 million upfront payment. - The deal includes up to $22 million plus ¥57.5 billion JPY (~$351 million) in milestone payments, plus tiered royalties on Japanese net sales. - The agreement establishes a three-way MRCT collaboration among Kaigene, Taisho, and Celltrion to accelerate global Phase 3 development of KG006. - KG006 is a next-generation subcutaneous FcRn inhibitor targeting autoantibody-mediated autoimmune diseases with potential best-in-class properties.
- The global automated liquid handling technologies market is projected to grow from US$2.7 billion in 2024 to US$7.4 billion by 2034 at a CAGR of 10.6%. - Drug discovery and ADME-Tox research accounted for the largest application segment at 41.9% of market share in 2023, with pharmaceutical and biotechnology companies representing 52.3% of end users. - North America leads the market with 39.5% of global revenue, while Asia Pacific is expected to register the fastest growth driven by expanding R&D investments. - Integration of artificial intelligence, machine learning, and cloud-enabled laboratory automation is enhancing workflow optimization and data management capabilities across the sector.
- The global biosimilar market expanded fifteen-fold from US$2.2 billion in 2016 to roughly US$32.7 billion in 2024, with Korea and India serving as its manufacturing engine room. - Despite record revenues at Celltrion, Samsung Bioepis, and Biocon, APAC manufacturers face a structural "value trap" where US pharmacy benefit managers capture the economic upside through private-label biosimilars. - The FDA is dismantling interchangeability requirements, proposing to eliminate comparative clinical efficacy studies, which simultaneously lowers development costs and erodes product differentiation. - Some 118 biologics worth US$232 billion in US sales lose exclusivity through 2034, yet only 10% have a biosimilar in active development, revealing a "biosimilar void" driven by poor return economics.
- Samsung Biologics returns for its 14th consecutive year, showcasing 845,000 liters of total manufacturing capacity and its newly acquired Rockville, Maryland plant. - Celltrion marks its 17th appearance with a dedicated AI zone, promoting AI-driven drug discovery, antibody conjugates, and multispecific antibodies as next-generation growth engines. - For the first time, BIO International Convention hosts an official Korea-focused session titled "Korea Rising: Don't Be Late to Asia's Next Innovation Hub." - Over 20,000 attendees from more than 70 countries are expected, with 51 Korean companies presenting pipelines and platform technologies at the KoreaBio country pavilion.
- The global Herceptin biosimilars market is projected to grow from USD 4.3 billion in 2026 to USD 10.4 billion by 2036, at a 9.2% CAGR. - Trastuzumab biosimilars are forecast to hold 82.0% of product demand in 2026, with hospital pharmacies leading distribution at a 54.0% share. - HER2-positive breast cancer is expected to represent 64.0% of indications in 2026, while intravenous administration leads the route category at 78.0%. - WHO reported in February 2025 that trastuzumab biosimilars cost 65% less than reference therapy, driving adoption across oncology formularies.
- Global pharma M&A activity reached $106 billion in H1 2025, the most active period since 2019, driven by looming patent cliffs in the late 2020s. - GSK acquired NewValent for $10.6 billion at a 40% premium, gaining two lung cancer drugs under FDA review, reflecting the scarcity value of validated late-stage assets. - Korean biotech firms predominantly out-license at Phase 1, structurally missing late-stage premiums, while Chinese companies advance to Phase 3 using faster and cheaper clinical trials. - China's share of global technology deals surged from 8% to 30% in two years, and Korea's global clinical trial ranking fell from fourth to sixth place in 2024.
- Roche's pharmaceutical sales rose 11% to 48.5 billion Swiss francs in 2019, driven by strong performances from Ocrevus, Hemlibra, Tecentriq, and Perjeta. - The "big three" cancer drugs—Avastin, Herceptin, and Rituxan/MabThera—face biosimilar competition, with MabThera sales in Europe dropping sharply to 590 million francs. - CEO Severin Schwan stated the worst of biosimilar impact is over in Europe, with the region returning to growth, though Avastin biosimilars in the US pose a new threat. - Pfizer's rituximab biosimilar succeeded in a Phase 3 trial, demonstrating equivalence in overall response rate for CD20-positive follicular lymphoma, intensifying competitive pressure.
