相关临床试验
39
20 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
2003
进行中（未招募）
19
48.7%
Approved For Marketing
1
2.6%
已完成
5
12.8%
尚未招募
1
2.6%
招募中
11
28.2%
终止
1
2.6%
撤回
1
2.6%
暂无批准数据
- Genmab has discontinued development of acasunlimab, a bispecific antibody targeting PD-L1 and 4-1BB that was in Phase III trials for non-small cell lung cancer treatment. - The decision follows a strategic pipeline prioritization and assessment of the competitive landscape, with analysts noting deterioration of overall survival curves in Phase II data. - The company will redirect resources to three late-stage oncology assets including Epkinly, petosemtamab, and Rina-S, which analysts project could generate $8 billion in combined peak sales.
- Merus N.V. and Halozyme Therapeutics have entered a global collaboration to develop a subcutaneous formulation of petosemtamab using Halozyme's ENHANZE® drug delivery technology. - Petosemtamab, an EGFR x LGR5 bispecific antibody, has shown encouraging results in clinical studies across numerous solid tumor cancers and has potential to become first-in-class treatment for head and neck cancer. - The collaboration aims to improve treatment efficiency and enhance patient experience through subcutaneous delivery, with Halozyme receiving upfront payments, milestone payments, and low-mid single digit royalties on net sales. - Halozyme's ENHANZE® technology has already touched one million patient lives across ten commercialized products in over 100 global markets with partners including Roche, Takeda, and Pfizer.
- Medicxi successfully raised €500 million ($581 million) for its sixth fund, demonstrating strong investor confidence in its asset-centric investment approach. - The fund will support biotechnology companies at all stages of drug development, focusing on single-asset companies with clear product visions to transform patient care. - Since its previous fund, Medicxi has created 16 new companies, achieved over 20 positive clinical data readouts, and realized more than $1 billion in returns across its portfolio. - The firm's total capital commitments now exceed €2 billion over the past decade, with notable portfolio successes including acquisitions of Merus, ProfoundBio, and ViceBio.
- Industry experts predict the biopharma job market will begin recovering in late 2026, despite over 57% of professionals expecting the turnaround to occur no earlier than 2027. - Biopharma hiring activity remains down 32% year-over-year in October 2025, with over 41,000 employees laid off or projected to be cut through October this year. - Early recovery signals include increased M&A activity with major deals totaling billions, October funding reaching $8.5 billion (up 87% year-over-year), and emerging opportunities in cell therapy, immunology, and radiopharma sectors. - Structural changes including AI-enabled regulatory modernization, biomanufacturing reshoring, and health-economic discipline are expected to accelerate the market turnaround.
- Genmab achieved 21% revenue growth to $2.66 billion in the first nine months of 2025, driven primarily by increased DARZALEX and Kesimpta royalties. - The FDA granted Breakthrough Therapy Designation to Rina-S for advanced endometrial cancer, while epcoritamab's Phase 3 trial met dual primary endpoints in follicular lymphoma. - The company announced an $8 billion all-cash acquisition of Merus to add petosemtamab, a late-stage asset with two BTDs, to its portfolio. - Operating profit increased significantly to $1.007 billion compared to $662 million in the same period last year, reflecting strong commercial execution.
- Abivax shares soared over 850% following positive Phase III data in ulcerative colitis, creating an "Abivax effect" that has reshaped market dynamics and reignited investor confidence in European biotech. - The NEXT BIOTECH index climbed 13.7% year-to-date with most gains driven by a sharp rally since April's "Liberation Day," while companies trading below cash dropped from 20% to 16%. - Major pharmaceutical companies accelerated M&A activity in September, with Pfizer acquiring Metsera for up to $7.3 billion and Genmab acquiring Merus for $8 billion, confirming pharma's willingness to pay premium for late-stage assets. - Investors are now laser-focused on companies with pivotal readouts within 12 months, with Valneva's Lyme disease vaccine and Nanobiotix's head and neck cancer therapy emerging as key European watchlist names.
- Zenocutuzumab demonstrated a 37% objective response rate in 19 patients with NRG1-positive cholangiocarcinoma in the phase II eNRGy trial, with a median duration of response of 7.4 months. - The bispecific antibody targeting HER2 and HER3 achieved a median progression-free survival of 9.2 months in this rare cancer subtype that affects fewer than 1% of cholangiocarcinoma patients. - All 16 evaluable patients showed declines in CA 19-9 cancer biomarker levels, with 69% experiencing more than 50% reduction, supporting the drug's anticancer activity. - The FDA granted zenocutuzumab Breakthrough Therapy designation for NRG1-positive cholangiocarcinoma based on these results, expanding beyond its current approvals for lung and pancreatic cancers.
- Merus announced that interim data from its phase 2 trial of petosemtamab in metastatic colorectal cancer has been selected for a prestigious plenary session oral presentation at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics. - The presentation will feature preliminary antitumor activity and safety data from the trial evaluating petosemtamab both as monotherapy in heavily pretreated patients and in combination with standard chemotherapy in first and second-line settings. - Petosemtamab is a novel bispecific antibody targeting EGFR and LGR5 with three independent mechanisms of action, including EGFR signaling inhibition, enhanced EGFR internalization, and improved immune-mediated cytotoxicity. - The company will also present preclinical data on petosemtamab's effects on cancer stem cells, highlighting the drug's potential broader therapeutic applications.
- The biopharmaceutical sector experienced a significant surge in high-value acquisitions during Q3 2025, with four of the year's five largest deals occurring in the past four months. - Major transactions totaled approximately $55.7 billion in Q3, including Merck's $10 billion acquisition of Verona and Genmab's $8 billion bid for bispecific antibody specialist Merus. - The number of deals increased from 15 in Q1 to 21 in Q3, with analysts attributing the surge to lowered interest rates and companies seeking to replace revenue losses from patent expirations.
- Debiopharm has licensed SunRock Biopharma's SRB21, a bispecific antibody targeting both HER2 and HER3 receptors, to develop the ADC Debio 2512 using their proprietary MultiLINK™ Linker Technology. - The dual-targeting approach aims to overcome resistance mechanisms that limit current HER2-directed therapies by simultaneously targeting HER2 and HER3 receptors in aggressive cancer types. - HER2-driven cancers are characterized by faster growth, earlier relapse, and higher treatment resistance, with many patients ultimately developing resistance and metastasis despite recent therapeutic advances. - The bispecific ADC strategy represents a potential breakthrough for patients with resistant cancer types by enabling more potent cytotoxic payload delivery while sparing healthy tissues.
