Vivesto signs Apealea option agreement with Zhida Pharmaceutical
Solna, Sweden, November 7, 2024 – Vivesto AB, an oncology-focused research and development company, today announced that it has entered into an agreement with Zhejiang Zhida Pharmaceutical Ltd (Zhida Pharma) - a China based pharmaceutical company - which includes an option to enter into an already finalized license agreement for Vivesto’s anticancer product Apealea® (paclitaxel micellar) with milestone payments worth of up to USD 5.85 million and sales royalties.
In the agreement Zhida Pharma has, after a regulatory due diligence, the option to enter a fully negotiated license agreement that grants Zhida Pharma the exclusive rights for the development, production and commercialization of Apealea, a proprietary formulation of paclitaxel, in China, Hong Kong, Macau and Taiwan. The terms of such a license agreement include milestone payments with a potential of up to USD 5.85 million depending on Zhida Pharma’s achievement of future sales, clinical development, regulatory approval, and market authorization milestones, as well as high single-digit to low double-digit royalties on sales of Apealea.
“We are very excited to enter into this agreement with Zhida Pharma and on the potential of having Apealea launched in these large markets. There is a significant market opportunity in ovarian cancer for an approved product and, depending on whether they exercise the option, we believe Zhida Pharma has the resources and know-how to bring Apealea to the market quickly,” said Erik Kinnman, CEO of Vivesto. “Their focus on commercialization and solid production capabilities are an excellent combination, making Zhida Pharma a perfect partner for Vivesto and the future for our paclitaxel portfolio. We look forward to the partnership.”
Zhida Pharma will under the option agreement bring the existing Apealea documentation provided by Vivesto to a Pre-IND Meeting with the National Medical Products Administration in China (NMPA) to determinine the regulatory submission requirements for Apealea. After the meeting, which is expected to take place during the first half of 2025, Zhida Pharma has the option to enter into the license agreement. Within the license agreement, Zhida Pharma will be responsible for all regulatory application processes in China, Hong Kong, Macau and Taiwan, including the submission of the approval application to the NMPA.
“Apealea is a strong match for the medical need we see in our region and a good fit for our production capabilities,” said Paul Geng, Director of Zhida Pharma. “We look forward to discussions with the regulators and the potential license agreement with Vivesto.”