Fosun Pharma Acquires Full Ownership of Fosun Kite with $37 Million Investment and Plans Renaming to Fosun Carey

On September 13, 2024, Fosun Pharmaceutical announced that its holding subsidiary, Fosun Pharmaceutical Industry, plans to pay US$27 million in cash to acquire 50% of the equity in Fosun Kite Biotechnology Co., Ltd. held by Kite Pharma.

Upon the completion of this transfer, Fosun Pharmaceutical will hold 100% of the equity in Fosun Kite and plans to make a cash contribution of US$10 million or its equivalent in RMB as the sole shareholder to increase the capital of Fosun Kite.

On the same day as the signing of the "Equity Transfer Agreement," Fosun Kite and Kite Pharma comprehensively amended and restated the original licensing agreement, reaching the "Amended and Restated Licensing Agreement." According to this, Fosun Kite obtained an exclusive license from Kite Pharma to develop, manufacture, and commercialize Yikaida® and Brexu-Cel (Fosun Kite's R&D project FKC889) within the region (mainland China, Hong Kong, and Macao) and field (cancer treatment).

In addition, Fosun Kite, a wholly-owned subsidiary of Fosun Pharmaceutical, is proposed to be renamed as Fosun Kite Biotechnology Co., Ltd., and will serve as the core platform for Fosun Pharmaceutical's cell therapy technology. It will continue to focus on the field of tumor immunotherapy, promote CAR-T cell therapy products to benefit more patients, and meet unmet clinical needs. In the future, Fosun Pharmaceutical and Kite Pharma will maintain a long-term strategic partnership through a licensing cooperation model.

Wu Yifang, Chairman of Fosun PharmaceuticalStated: "Since establishing a strategic cooperation with Kite Pharma in 2017, both parties have worked closely to advance the rapid development of CAR-T technology and the cell therapy product Yikaida® in China. Fosun Pharmaceutical remains firmly optimistic about the future of cell therapy and is committed to continuously building leading global technology platforms. Moving forward, we will further expand the application of cell therapies in areas such as oncology and autoimmune diseases, focusing on unmet clinical needs, fulfilling our commitment to patients, and ensuring that the fruits of scientific innovation benefit more patients."

Zhang Wenjie, Executive President of Fosun Pharmaceutical and Chairman of Fosun KiteStated: "As a pioneer in China's CAR-T field, Fosun Kite is committed to advancing the paradigm shift in treatment and exploring more innovative possibilities. In the future, Fosun Kite will continue to focus on unmet clinical needs, making every effort to improve the accessibility and affordability of CAR-T cell therapy products for more patients. We will actively explore new models of cooperation with the government and other industry players to build a CAR-T ecosystem that continuously leads the development and upgrading of the industry."

Kite PharmaStated: "We are pleased with the progress made by Fosun Kite, and we are delighted to see hundreds of patients in China benefit from Yikaida®. Fosun Pharmaceutical is now fully capable of independently operating Fosun Kite and leveraging its experience to develop and commercialize Yikaida and Brexu-Cel in Greater China. Kite Pharma will continue to advance its leadership in the CAR-T field and bring next-generation CAR-T therapies to patients worldwide, with a near-term focus on covering patients in other regions, including the United States, Europe, and Japan."

Previously, Fosun Pharmaceutical introduced China's first approved CAR-T product, Yikaida® (Axicabtagene Ciloleucel Injection, hereinafter referred to as Axi-cel), through collaboration with Kite Pharma (a subsidiary of Gilead Sciences).

Yikaida® (Axicabtagene Ciloleucel Injection) was approved in June 2021 for the treatment of patients with relapsed/refractory large B-cell lymphoma after second-line or later systemic therapy. In June 2023, Yikaida® received conditional approval from the National Medical Products Administration for the treatment of adult patients with large B-cell lymphoma who are refractory to first-line immunochemotherapy or relapse within 12 months after first-line immunochemotherapy. The approval of Yikaida® as a second-line treatment represents a significant advancement in the treatment of adult patients with large B-cell lymphoma, offering new hope to those who do not respond or relapse after first-line chemoimmunotherapy.

As the first CAR-T cell therapy product approved in China, Yikaida® has ushered in the inaugural year of CAR-T treatment in China, filling the gap in the domestic lymphoma-related treatment field and becoming the first and currently the only CAR-T cell therapy product approved for second-line indications in China.

The clinical trial application for the third indication of Axicabtagene Ciloleucel Injection has been approved in China, targeting adult patients with relapsed/refractory indolent non-Hodgkin lymphoma (r/r iNHL, including follicular lymphoma and marginal zone lymphoma). Currently, this indication is in the bridging clinical trial phase in China.

To date, Fosun Kite has established more than 170 high-standard Yikai Da® treatment centers across 28 provinces, municipalities, and autonomous regions in China. It has also promoted the inclusion of Yikai Da® in over 110 city-level惠民insurance programs and more than 80 commercial health insurance programs, further extending the reach of innovative cell therapies to benefit more patients and help them regain hope for survival.

This reorganization of Fosun Kite will open up new development opportunities. Previously, Fosun Kite actively promoted accessibility and curability, pioneering the Yikai Da® Pay-for-Performance plan in China, which has explored a new development path for payment models of high-value innovative drugs in China.

In terms of "curability," Fosun Kite has continuously improved its production processes and enhanced the efficacy of its drugs, achieving safety standards that surpass those of leading international manufacturers. In third-line treatment, it has achieved a complete response rate of over 55%. Real-world research data from a Chinese multicenter study published in June 2023 showed that Yikai Da® (Axicabtagene Ciloleucel) demonstrated real-world efficacy consistent with global results for patients with relapsed or refractory non-Hodgkin lymphoma in China. The 12-month overall survival rate was as high as 84.3%, the best overall response rate reached 83.2%, the best complete response rate was 58.4%, and the drug exhibited better safety.

In the future, Fosun Kite will continue to serve as the core platform for cell therapy technology of Fosun Pharmaceutical. It will fully leverage the autonomy and flexibility of innovative R&D, further deepen product innovation, strive to enhance the capabilities in innovative R&D and industrialization, focus on improving the accessibility of high-value innovative drugs, unleash its innovation potential, and bring hope of a cure to more cancer patients worldwide.

References

1.Wang L,et al. 2023 EHA- Poster 1203. 2023 ICML-Poster 337