Eli Lilly Enters $440M License Agreement with Fosun Pharma for BCL-2 Inhibitor FCN-338

On October 29, Fosun Pharmaceutical announced that its controlling subsidiary, Fuchuang Pharmaceuticals, had entered into a License Agreement with Eli Lilly and Company, granting Eli Lilly exclusive rights to Fuchuang’s BCL-2 inhibitor FCN-338 in all global regions excluding mainland China, Hong Kong, and Macau. The total value of this transaction amounts to up to $440 million.

BCL-2, short for B-cell lymphoma 2 protein, plays a crucial role in programmed cell death by inhibiting the apoptosis of various cells, including lymphocytes, and is overexpressed in certain types of cancer. In some hematologic malignancies, the accumulation of BCL-2 protein prevents cancer cells from undergoing apoptosis. Therefore, blocking BCL-2 protein can restore the normal apoptotic process, leading to the self-destruction of cancer cells and achieving an anticancer effect.

According to the announcement, FCN-338 is a BCL-2 selective small-molecule inhibitor independently developed by Fuchuang Pharmaceuticals. Its clinical trial application for the treatment of hematologic malignancies has been approved by both the National Medical Products Administration (NMPA) of China and the U.S. FDA, and it is currently in the preparation stage for Phase I clinical trials.

Pursuant to the License Agreement, Eli Lilly and Company will obtain exclusive rights to develop, manufacture, and commercialize FCN-338 in all countries and regions excluding mainland China, Hong Kong, and Macau. Eli Lilly will pay Chongqing Fuchuang Pharmaceuticals Research Co., Ltd. up to $440 million, comprising a $40 million upfront payment, up to $340 million in clinical development and regulatory milestone payments, and up to $60 million in sales milestone payments. In addition, Eli Lilly shall pay Chongqing Fuchuang tiered royalties based on the annual net sales of the product achieved within the licensed territory, according to agreed-upon percentage ranges.

Pursuant to the License Agreement, Eli Lilly and Company shall lead the global development plan for FCN-338. If the results of clinical trials recommend the development of any dosage form applicable to both the territory licensed to Eli Lilly and Company for development and the territory designated for Chongqing Fuchuang Pharmaceuticals Research Co., Ltd. (i.e., mainland China, Hong Kong, and Macau; hereinafter referred to as the “Fuchuang Development Territory”), the activities conducted by Eli Lilly and Company within its licensed territory shall serve as the standard. All activities undertaken by Chongqing Fuchuang Pharmaceuticals Research Co., Ltd. within the Fuchuang Development Territory shall adhere to the practices implemented by Eli Lilly and Company in its licensed territory and comply with the applicable laws and regulations within the Fuchuang Development Territory.

If any dosage form recommended by the clinical trial results is applicable solely to Fuchuang Pharmaceuticals’ Development Region, Fuchuang Pharmaceuticals’ activities within such Development Region shall serve as the standard and comply with the applicable laws and regulations in Fuchuang Pharmaceuticals’ Development Region. Within Fuchuang Pharmaceuticals’ Development Region, Fuchuang Pharmaceuticals’ research and development activities shall be obligated to align with the global research and development plan established by Eli Lilly and Company.

References:

[1] Fosun Pharmaceutical’s Announcement on the Signing of a Licensing Agreement by Its Controlled Subsidiary. Retrieved Oct 29, 2020, from http://data.eastmoney.com/notices/detail/600196/AN202010291424599011.html

Source: Medical Insights

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