Hanmi Pharmaceutical announced on the 21st that it has changed the counterparty of its technology transfer contracts for Rolontis (Rolvadon), a treatment for neutropenia, and poziotinib, an anti-cancer candidate, to Zydus Life Sciences.

■ Contract Counterparty Changed Due to Assertio Acquisition

Through a correction filing that day, Hanmi Pharmaceutical changed the existing counterparty of the Rolvadon technology transfer contract, U.S.-based Assertio Holdings, to Zydus Life Sciences of India and the United States. As Zydus signed a contract to acquire all issued shares of Assertio, the counterparty of the technology transfer contracts Hanmi had previously signed with Spectrum and Assertio was changed to Zydus.

■ Details of the Rolontis (Rolvadon) Contract

The contract concerns Rolontis (Rolvadon, ingredient name eflapegrastim), a treatment for neutropenia, with the contract territory covering the entire world except Asia and Africa. The contract was signed on January 31, 2012, and runs until September 26, 2036, when the patent expires. The contract value was not disclosed due to mutual agreement and confidentiality obligations under the contract.

Rolontis received approval from the U.S. Food and Drug Administration (FDA) on September 9, 2022, and was launched in the United States on October 21 of the same year.

■ Details of the Poziotinib Contract

Hanmi Pharmaceutical also changed the counterparty of the poziotinib technology transfer contract to Zydus Life Sciences. According to the company, Zydus completed the acquisition of 100% of Assertio Holdings' shares, and as the procedure to transfer matters related to the existing technology transfer contract progressed, the contract counterparty was changed.

The poziotinib contract concerns poziotinib, a pan-HER agent that effectively acts on the ERBB (erythroblastic leukemia viral oncogene homolog) receptor, with the contract territory covering the entire world except South Korea and China. The contract was signed on February 27, 2015, and runs for 10 years after first sales. The contract value is undisclosed due to confidentiality obligations.

According to the filing, for this technology export, the company submitted a New Drug Application (NDA) to the U.S. FDA and received a Complete Response Letter (CRL), and is currently preparing for global Phase 3 clinical trials.

■ Rights Succession Procedure

The fact-confirmation date for both filings is August 21, 2026, the date Hanmi Pharmaceutical received a notification letter regarding the rights transfer from the contract counterparty. The company stated that, under the contract by which Assertio is being acquired by Zydus, Zydus Life Sciences, the current holder of rights and obligations, is expected to succeed to the technology development and sales rights within the contract territories defined in the existing technology transfer contracts.