相关临床试验
12
10 进行中
药物批准
0
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监管机构
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进行中（未招募）
10
83.3%
招募中
2
16.7%
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- Xbrane Biopharma and partner Intas Pharmaceuticals have agreed on revised financing arrangements for Xdivane, a biosimilar candidate referencing the cancer immunotherapy drug Opdivo (nivolumab). - Under the new terms, Intas will assume responsibility for financing certain chemistry, manufacturing, and controls (CMC) development activities, with costs accruing an 18% annual markup. - Intas has been granted an option to make a one-time lump-sum payment equivalent to 40 months of forecasted profit sharing to Xbrane in lieu of future profit-sharing payments. - Development of Xdivane continues according to plan, including the ongoing pivotal clinical trial under Intas' responsibility.
- Xbrane Biopharma has resubmitted its Biologics License Application (BLA) to the FDA for its ranibizumab biosimilar candidate following completion of corrective actions at a manufacturing facility. - The resubmission comes after the company received a Complete Response Letter in October 2025 regarding outstanding observations at one of the production sites, which have now been resolved. - The FDA review process for the resubmitted application is expected to take approximately six months, with the biosimilar targeting cost-effective treatment for retinal diseases. - Xbrane's ranibizumab biosimilar has already received approval from EMA and MHRA since November 2022 and has been commercially available in Europe since March 2023.
- The FDA has issued a second Complete Response Letter to Xbrane Biopharma's ranibizumab biosimilar application, citing unresolved manufacturing observations at one contract production site. - Xbrane had resubmitted its Biologics License Application in December 2024 following an initial CRL in April 2024, but manufacturing issues persist despite corrective actions. - The company's Lucentis biosimilar has been successfully approved in Europe since November 2022 and has shipped close to 200,000 vials without issues. - Xbrane remains committed to resolving the manufacturing concerns and resubmitting the application to provide US patients with a cost-efficient alternative for retinal disorders.
- Xbrane Biopharma has entered into a conditional SEK 60 million financing agreement with Fenja Capital II A/S to address potential delays in FDA approval of its Lucamzi biosimilar. - The company awaits FDA decision on October 21st for Lucamzi, a proposed biosimilar to Lucentis, with commercial supply chain already established through contract manufacturers. - Xbrane implemented a 1:125 reverse share split on October 13th to streamline its share structure and make it more accessible to institutional investors. - FDA re-inspections of both production sites during Q3 2025 resulted in observations that were addressed within the standard 15-day response timeframe.
- Alvotech achieved over 200% year-on-year growth in product revenues for the first six months of 2025, reaching $204.7 million compared to $65.9 million in the same period of 2024. - The company reported its best quarter in history for operating cash flows and completed strategic acquisitions including Xbrane's R&D facilities in Sweden and Ivers-Lee Group in Switzerland. - New commercial partnerships were expanded with Advanz Pharma covering four biosimilar candidates and a collaboration agreement was signed with Dr. Reddy's for AVT32, a pembrolizumab biosimilar. - Alvotech successfully raised approximately SEK 789 million through Swedish offerings and achieved its third stock exchange listing on Nasdaq Stockholm in May 2025.
- Xbrane Biopharma has received an FDA decision date of October 21, 2025 for its biosimilar candidate to Lucentis (ranibizumab) following BLA resubmission in December 2024. - The approval remains contingent on successful re-inspections of manufacturing sites, which have already addressed previous FDA observations and submitted required documentation. - If approved, Xbrane's biosimilar aims to provide a cost-effective alternative for patients with age-related macular degeneration, retinal vein occlusion, and myopic choroidal neovascularization.
- Recent communications from the FDA to Xbrane Biopharma and Formycon suggest a significant shift in the agency's approach to biosimilar development requirements. - The FDA appears to be reconsidering the necessity of Phase III trials for biosimilar approvals, potentially streamlining the development process. - This regulatory evolution could accelerate biosimilar market entry and reduce development costs, ultimately improving patient access to biological treatments.
- Xbrane Biopharma has resubmitted its Biologics License Application (BLA) for a ranibizumab biosimilar to the FDA after addressing concerns raised in an April 2024 Complete Response Letter. - The company qualified a new reference standard and worked with manufacturing partners to complete requested follow-up actions, with the typical review cycle for resubmitted BLAs being approximately 6 months. - If approved, the biosimilar would provide a cost-effective treatment alternative for patients with age-related macular degeneration, retinal vein occlusion, and myopic choroidal neovascularization.
• Xbrane Biopharma received positive scientific advice from the FDA regarding its Opdivo biosimilar candidate, Xdivane, aligning with EMA feedback. • The FDA supports Xbrane's streamlined clinical development plan, which includes a single clinical trial, significantly reducing the development budget by at least 60%. • Xbrane is focusing on a global market strategy for Xdivane, targeting US launch by December 2028, and is actively seeking commercialization partners. • Opdivo, an immune-oncology drug (PD-1 inhibitor), had global sales of approximately $8 billion in 2023, projected to reach $14 billion by 2028.
