Yescarta was 'returned' and Daiichi Sankyo returned the Japanese sales interest to Gilead

On December 8, Daiichi Sankyo said it would transfer the sales license of the CAR-T cell therapy Yescarta in Japan to Gilead's Japanese division.

Developed by Gilead's Kite Pharma (Kite), Yescarta was approved by the FDA in October 2017 and is the first CAR-T cell therapy to treat adult patients with relapsed or refractory large B-cell lymphoma (LBLC).

In January 2017, Daiichi Sankyo introduced Yescarta from Kite, obtaining exclusive rights to develop, manufacture and commercialize the drug in Japan. In January 2021, Japan's Ministry of Health, Labour and Welfare (MHLW) approved Yescarta for the treatment of certain adult patients with relapsed/refractory LBCL. In December of the same year, Japan's first Yescarta treatment center was approved, and six hospitals are now approved to implement personalized treatment.

Under the revised agreement, Gilead's Kite Cell Therapy division at GileadSciences K.K., a subsidiary of Gilead Japan, will be responsible for sales and promotion of Yescarta in Japan in 2023.

Currently, Yescarta is priced at $373,000/pin in the U.S. market. In 2020, Yescarta generated sales of $563 million and further increased sales to $695 million in 2021. In the first half of this year alone, Yescarta has exceeded $500 million in sales.

CAR-T therapy is a personalized treatment that is a personalized treatment that modifies a patient's own T cells to fight cancer, and the manufacturing process is complex, so many CAR-T therapy supplies are difficult to meet the demand quantity.

To ensure a steady supply and shorten turnaround times, Kite invested heavily in the manufacturing part and was approved by its Amsterdam plant during the pandemic. In the U.S., Kite's manufacturing facility in El Segundo, California, has been approved by Japanese regulators to produce Yescarta for Japanese patients, and supplies are expected to begin in early 2023.

Shoji Hirashima, head of Daiichi Sankyo Japan's business unit, said in a statement that the change in licensing agreements would benefit patients in Japan. They will increase their capacity to make this important blood cancer therapy accessible to more patients and will remain committed to working with Kite to ensure a smooth transition during this time."

Christi Shaw, CEO of Kite, also said he was pleased to build on "accelerating the momentum of Japan's efforts to maximize patient accessibility and impact."

CAR-T personalized products like Yescarta, which face capacity problems, are not alone. Earlier last year, BMS revealed that demand for Abecma, a newly launched multiple myeloma drug at the time, exceeded capacity. According to Kite and BMS, according to real-world data, the average time for Yescarta to draw blood from the patient's body to the birth of the final product is 16 days, while the time for BMS is 24 days.

Abecma is jointly developed, promoted and shared by BMS and Bluebird Biologics. Subsequently, Bluebird Biologics split the tumor pipeline to form an independent company, 2seventy bio, and Abecma was also included in it. In response to market demand, 2seventy bio and BMS will set out to improve capabilities throughout the supply chain.