September 27, 2024 Source: drugdu 73
On the same day of signing the Equity Transfer Agreement, Fosun Kate and Kite revised the original license agreement. According to the revised content, Fosun Kate has obtained exclusive rights to develop, produce, and commercialize Yikaida and Brexu Cel (Fosun Kate's ongoing project FKC889) within the Kite license area (mainland China, Hong Kong, and Macau) and field (cancer treatment field).
Kite will receive a tiered royalty fee of 7% to 13% of drug sales. For Fosun Kate's pipeline assets, Kite has the right to receive a sales royalty of 2% to 4%.
In addition, Fosun Pharma will increase its capital by $10 million in addition to the $27 million equity acquisition, to strengthen Fosun Pharma's layout in the biopharmaceutical field. It is reported that four CAR-T therapies, including Achilles' heel injection, have submitted application information in the upcoming 2024 national medical insurance negotiations.
Kite, Fuxing Medicine and Gilead
2017 is the first year of CAR-T therapy. In July of that year, Novartis' CAR-T therapy product tisagenlecleucel was unanimously recommended by 10 members of the expert advisory committee at the ODAC conference. One month later, on August 30, 2017, the product was officially approved by the FDA for the treatment of refractory/secondary/later relapsed B-cell precursor acute lymphoblastic leukemia patients under the age of 25, under the brand name Kymriah. It is reported that this is the first CAR-T therapy approved by the FDA.
Kite is one of the leading companies in the field of CAR-T research and development. At the end of 2016, Kite announced that the BLA application for its CAR-T therapy axicabtagene ciloleucel (KTE-C19) had been accepted by the FDA. The PDUFA date was November 29, 2017, and it is expected to become the first CAR-T therapy approved by the FDA for the treatment of non Hodgkin lymphoma.
In early 2017, Fosun Pharma established a Sino foreign joint venture with Kite through its wholly-owned subsidiary - Fosun Kite. Among them, Fosun Pharma contributed 20 million US dollars in cash, while Kite valued the exclusive use rights of its products and proprietary technology at 20 million US dollars, with each party holding 50% equity of the joint venture. According to the terms of the agreement at that time, Fosun Pharma will pay an additional $40 million to the joint venture for related patent and technology fees. The joint venture will pay a milestone of $35 million to Kite based on research and development progress and market conditions, as well as a sales rebate for the Akilensai injection product. That is to say, in this cooperation at that time, Fosun Pharma promised a maximum amount of $9500.
The acquisition transaction between Gilead and Kite was also in 2017. On August 28, 2017, Gilead/Kite jointly announced that Gilead would acquire Kite for a cash price of $118 per share (total value of approximately $11.9 billion). The acquisition behavior was related to the dilemma Geely faced at that time. At that time, its sales of hepatitis C products were shrinking, AIDS business was challenged, and pipeline product reserves were insufficient. But according to Gilead's H1 financial report at the time, its book funds were sufficient, with approximately $36 billion in cash. Therefore, the acquisition was actually the most direct way for Gilead to solve the difficulties at that time.
Listed successively at home and abroad
Two months after Gilead announced its acquisition of Kite, on October 18, 2017, the FDA approved the launch of Akyranthine Injection under the trade name Yescarta.
Currently, Gilead's cell therapy division has two CAR-T products on the market, Yescarta and Tecatus, both from Kite. Among them, Tecatus was first approved for market by the FDA in 2020. According to Gilead's 2024H1 financial report, the two CAR-T products have generated a total revenue of $1.001 billion in the past six months, with Yescarta contributing the majority, approximately $794 million.
Yescarta is currently the only CAR-T therapy product on the market worldwide with a revenue exceeding $1 billion.
Since Fuxing Medicine introduced this product to China through a joint venture, the product was approved for market by NMPA on June 22, 2021, under the brand name Yikaida. It is the first CAR-T therapy approved for market in China, used to treat adult patients with relapsed or refractory large B-cell lymphoma who have previously received second-line or above systemic treatment. On June 26, 2023, Akilensai injection was again approved by NMPA for the treatment of second-line recurrent adult large B-cell lymphoma.
It is reported that Yikaida has treated over 600 patients with relapsed/refractory large B-cell lymphoma.
According to official news from Fosun Pharma, after fully controlling the company, it will further improve product accessibility. In addition, the clinical trial application for the third indication of Akilensai injection has been approved within China, targeting adult patients with relapsed/refractory indolent non Hodgkin lymphoma. At present, this indication is in the bridging clinical trial stage within China.
Summary
Recently, apart from Kite, several other companies have split their Chinese businesses and left the equity to local pharmaceutical manufacturers. This includes:
On August 31, 2024, Beijing Tiantan Biological Products Co., Ltd. issued a notice on the acquisition of 100% equity of Wuhan Zhongyuan Ruide Biological Products Co., Ltd. by Chengdu Rongsheng, announcing that its controlling subsidiary Chengdu Rongsheng Pharmaceutical Co., Ltd. plans to acquire 100% equity of Wuhan Zhongyuan Ruide Biological Products Co., Ltd., a wholly-owned subsidiary of CSL Behring Asia Pacific Limited, for a total amount of $185 million.
On August 26, 2024, UCB announced that it would sell its mature business in China (including 5 drugs and a production base in Zhuhai) to Cambridge Capital and Abu Dhabi's investment company Mubadala for $680 million.
Source: https://pharm.jgvogel.cn/c1445656.shtml
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