South Korean biopharmaceutical company headquartered in Incheon, developing and distributing biosimilar monoclonal antibody therapies for rheumatoid arthritis, cancer, and inflammatory diseases.
相关临床试验
169
78 进行中
药物批准
46
批准总数
监管机构
3
监管机构数
成立时间
2002
进行中（未招募）
76
45.0%
已完成
68
40.2%
尚未招募
2
1.2%
招募中
13
7.7%
终止
6
3.5%
Unknown
3
1.8%
撤回
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.
