Company: OSRH
Filing Date: 2025-01-29
Form Type: S-4/A
Source: 0001213900-25-007923
Chunk: 421

Company: OSR Holdings, Inc.
Filing Date: 2025-01-29
Form: S-4/A
Chunk 421
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 our current product candidates and will face competition with respect to future product candidates, from pharmaceutical and biotechnology companies to public and private research institutions, among others. If our current and/or our future product candidates do not offer sustainable advantages over competing products, we may otherwise not be able to successfully compete against current and future competitors. Our competitors may obtain regulatory approval of their products more rapidly than we may or may obtain patent protection or other intellectual property rights that limit our ability to develop or commercialize our product candidates. Our competitors may also develop drugs that are more effective, more convenient, more widely used and less costly or have a better safety profile than our products and these competitors may also be more successful than us in manufacturing and marketing their products. The most common methods of treating patients with cancer are surgery, radiation and drug therapy, including chemotherapy, hormone therapy and targeted drug therapy or a combination of such methods. There are a variety of available drug therapies marketed for cancer. In many cases, these drugs are administered in combination to enhance efficacy. Our product candidates, if any are approved, may compete with these existing drug and other therapies.

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The table below summarizes the main competitors we have identified for Vaximm’s VXM01. Each of these identified competitors are developing therapies for glioblastoma and have active clinical trials ongoing assessing the safety and efficacy of their product candidates.

| Drug Name                         |     | Company              |     | Mechanism                              |     | Indication                                 |     | Clinical  
 Phase     |     | NCT                      
 Number(s)                |
| Depatuxizumab mafodotin (ABT-414) |     | AbbVie               |     | Antibody-drug conjugate targeting EGFR |     | Newly diagnosed glioblastoma               |     | Phase 2/3 |     | NCT02573324              |
| Durvalumab (MEDI4736)             |     | AstraZeneca          |     | PD-L1 checkpoint inhibitor             |     | Newly diagnosed and recurrent glioblastoma |     | Phase 2   |     | NCT02336165              |
| Regorafenib                       |     | Bayer                |     | Multi-kinase inhibitor                 |     | Recurrent glioblastoma                     |     | Phase 2   |     | NCT02926222              |
| Tasadenoturev (DNX-2401)          |     | DNAtrix              |     | Oncolytic adenov