Company: OSRH
Filing Date: 2025-01-24
Form Type: S-4/A
Source: 0001213900-25-006139
Chunk: 418

Company: OSR Holdings, Inc.
Filing Date: 2025-01-24
Form: S-4/A
Chunk 418
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 of the efficacy and safety of therapeutic candidates. These trials typically involve hundreds to thousands of patients and are typically conducted at multiple hospital sites worldwide. Darnatein will work closely with clinical investigators, regulatory authorities, and patient advocacy groups to design and execute initially Phase 2 and continue with Phase 3 clinical trials based on evaluation of Phase 2 studies for its tissue targets. 6.Seek regulatory approval: Following the successful completion of Phase 3 clinical trials, the result of the pre -clinicalstudies and clinical trials, together with detailed information relating to the product’s chemistry, manufacture, controls, and proposed labeling, among other things, are submitted to authorities, such as the FDA or EMA. This stage is known as the New Drug Application (NDA) review. Based on these steps and the timeline for regulatory approvals, Darnatein anticipates that its first therapeutic regimen to enter clinical trials within the next 2 – 3 years, with potential regulatory approval in the next 8 – 11 years. For a description of the regulatory steps for the implementation of Darnatein’s strategy described above, see “Business of OSR Holdings and Certain Information About OSR Holdings — Vaximm — Regulatory Steps”. Intellectual Property Darnatein owns exclusive intellectual property rights covered under 2 patent families relating to DRT -101, DRT -102and other associated candidates filed in the United States and across major markets, including Europe, China, India, and Japan. This patent family covers composition of matter, with a priority date of 2019 and estimated expiry in 2039, not including potential patent term adjustments or patent term extensions. 263

Designer ligands of TGF-ß superfamily (Licensed Patent Rights) (0)
WO 2010/099219, Exclusive License Agreement between Joint Center for Biosciences and Darnatein

| Country 
 Code    |     | Type |     | Filing date |     |        Filing no. |     | Grant Date |     |     Grant no. |     |     Publ. No. |     | Expiry     |     | Status            |
| WO      |     | PCT  |     | 24/02/2010  |     | PCT/US2010/025260 |     |            |     |               |     |   2010/099219 |     |            |     |                   |
| EP      |     | PCT  |     | 24/02