The Reply6 May 2026 09:28
Many thanks for your email.
We fully recognise and share your disappointment regarding the EU sales performance by Recordati. By way of context, it may be helpful to reiterate the Company’s business model.
Regent Pacific operates a focused model centered on the development and strategic out-licensing of Fortacin / Senstend. The Group has successfully developed Fortacin through its in-house R&D platform and has subsequently entered into territorial licensing arrangements with established pharmaceutical partners.
Under these agreements, the Group receives upfront consideration, regulatory and commercial milestone payments, and ongoing royalties based on net sales within the licensed territories. Our partners assume full responsibility for all downstream activities, including manufacturing, regulatory approval, marketing, distribution and sales. The Group is not involved in these activities; they are undertaken by our partners at their own risk and cost, with the Company receiving the contracted economic benefits.
This partnership-led approach enables the Group to leverage the scale, infrastructure and commercial expertise of leading pharmaceutical companies, while maintaining a lean operating structure and a less capital intensive framework.
With respect to manufacturing, the contract manufacturing organisation (“CMO”) Genetic was engaged by Recordati. The Group does not contract directly with Genetic or any other CMO, and manufacturing risk and cost remain the responsibility of our pharmaceutical partners. We understand from Genetic that it has capacity to produce approximately 23 million Fortacin canisters per annum and is targeting an additional c.20 million units through a new PMDI production line currently under construction.
The license agreement with Recordati remains in force and unchanged since execution.
In China, our partner Fosun Pharma continues to progress the regulatory approval process. Based on their latest guidance, they remain hopeful of securing approval by the end of Q2. To date, Fosun has addressed over 35 queries from the NMPA and CDE across clinical, non-clinical and CMC sections and is progressing towards completion.
With regard to DLI, the business has currently secured eight customers, and further details are available on its website. The longevity sector remains at an early stage of development, and we are encouraged by the initial commercial traction achieved by a lean team.
Looking ahead, the potential approval of Senstend in China represents a significant opportunity for the Group, given the size of the market and Fosun’s view of the product’s commercial potential.
In parallel, we are actively engaging with potential strategic pharmaceutical partners for the US market who would undertake Phase III studies, regulatory approval and subsequent commercialisation. This remains a key strategic priority. ...... Continues