China-based Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has negotiated a new “supplemental terms agreement” with UK-based partner ReNeuron Group plc (OTCMKTS: RNUGF) worth GBP 6 million (USD 7.3 million). This deal builds on an earlier agreement signed in April 2019, under which Fosun obtained exclusive development, manufacturing, and commercialization rights in China to ReNeuron’s off-the-shelf stem-cell therapy programs. The latest renewal will lead to the technology transfer of ReNeuron’s CTX cell therapy for recovering stroke patients to Fosun for local manufacturing.
Deal Terms
Under the deal terms, Fosun will pay GBP 1 million upfront within 24 months, including a GBP 320,000 (USD 387,676) down-payment made in January this year, to cover the initial supply of CTX cell bank vials and services for technology transfer. The remaining GBP 5 million (USD 6 million) will be paid over the medium to longer term for ReNeuron to continue providing CTX cell bank vials to Fosun.
Manufacturing Facility
Fosun is reportedly set to establish a dedicated 20,000-square-foot GMP facility to manufacture the CTX products in Pudong, Shanghai, expected to be operational by Q1, 2023. This will enable later-stage clinical and commercial use of CTX in Greater China and allow Fosun to explore more clinical uses for CTX in neurological diseases.
CTX Cell Therapy
ReNeuron’s CTX stem cell therapy candidate consists of a neural stem cell line generated using the UK firm’s cell expansion and selection technologies before full-scale manufacturing. This results in a cryopreserved, clinical, and commercial-grade cell therapy product capable of treating patients who have suffered an ischemic stroke and are in the recovery / rehabilitative stage. In the Phase IIa PISCES II study, the therapy produced a response rate of 35% in 23 enrolled subjects, indicating a clinically meaningful improvement in the level of disability after 12 months.-Fineline Info & Tech
