Domestic CAR-T Therapies Go Fully Localized as Six Products Enter Fierce Competition; Inclusion in National Reimbursement Drug List Becomes Critical
Fosun Pharmaceutical
Healthcare Industry Group
Fosun Kairos
Developer of Tumor Immune Cell Therapy Technologies and Products
Fosun Kite Biotechnology Co., Ltd. Becomes Wholly-Owned Subsidiary, a Recent Focal Point in the Biopharmaceutical Industry.
On September 13, Fosun Pharmaceutical announced that its subsidiary, Fosun Pharmaceutical Industry, plans to invest $27 million in cash to acquire 50% of Fosun Kite's equity held by U.S.-based Kite Pharma. After the completion of this transfer,Fosun Pharmaceutical Industry will hold 100% of the equity in Fosun Kite Biotechnology Co., Ltd.Fosun Pharmaceutical Obtains Exclusive Rights for the Development, Production, and Commercialization of Axicabtagene Ciloleucel Injection in China’s Cancer Field, as well as the Rights to Another CAR-T Product under Research. Fosun Kite will be Renamed Fosun Kite Biotechnology.
Fosun Kite was originally established as a joint venture between Fosun Pharmaceutical and U.S.-based Kite Pharma, with each party holding 50% of the shares. The company’s purpose was to jointly research, develop, and commercially promote CAR-T products. In June 2021, Fosun Kite's Axicabtagene Ciloleucel Injection was approved for marketing in China, becoming the first CAR-T product in the country. By the end of 2023, approximately 700 patients had been treated with Axicabtagene Ciloleucel Injection. However,For years, several CAR-T therapies in China have failed to be included in the medical insurance., which has a certain impact on the promotion and sales of CAR-T products.
After the equity transfer, the Axicabtagene Ciloleucel Injection will be completely produced in China, which may help reduce the production costs and market price of CAR-T products. Moreover, on August 27, the preliminary list for the 2024 National Medical Insurance Catalog was announced.The CAR-T products of Fosun Kite, Wuxi Jumo, He Yuan Bio, and Carsgen Therapeutics have all been shortlisted.Axicabtagene Ciloleucel Injection Again Hopes to Enter the Medical Insurance.
Foreign Investment Withdraws, Competition Intensifies
After Fosun acquires the equity held by Kite, it will also invest 10 million US dollars to increase the capital of Fosun Kite, which makes the valuation of this CAR-T subsidiary reach 64 million US dollars. Kite will mainly focus on the US, Europe, and Japanese markets.And continue to maintain a long-term strategic partnership with the newly renamed Fosun Kite.The clinical trial application for the third indication of Axicabtagene Ciloleucel Injection has been approved.
In addition, Fosun Kite can continue to develop the CAR-T products authorized by Kite Pharma that are still under research.Brexu-Cel, a CAR-T cell therapy product targeting CD19, has already been approved for marketing in the United States and the European Union.
The two parties did not explicitly state the background of the foreign capital withdrawal, but judging from Fosun Kite's past performance, the sales of Axicabtagene Ciloleucel Injection may not have been as robust as expected, which could be one of the reasons.
In 2023, the revenue of Axicabtagene Ciloleucel Injection was approximately 242 million yuan.Ranked first in sales among all domestically produced CAR-T products in China.Even so, the Axicabtagene Ciloleucel Injection still failed to meet the outside world's expectations for CAR-T. The development of cell and gene therapy drugs is highly challenging with very forward-thinking concepts. If the first attempt with CAR-T products did not succeed, it is bound to affect the subsequent enthusiasm of both capital and the industry.
High prices have always been a label for CAR-T drugs. The price of Axicabtagene Ciloleucel Injection is 1.2 million yuan per treatment course. A senior person in charge of CAR-T research and development admitted to Jianshiju that due to the limitations of autologous cell immunotherapy, it cannot be produced on a large scale, resulting in low production capacity and high product costs. Due to these technical barriers, the person predicted...China's CAR-T market will not see a "stampede" situation, and ultimately only 2-3 companies will emerge victorious in the market.
Six Products Battle: Entering Medical Insurance is Key
Fosun Kite has consistently maintained cooperation with commercial insurance, being included in over 110 city-level inclusive insurance programs and more than 80 commercial health insurance programs. Moreover, Fosun Kite has pioneered the "Value-Based Payment Program" for Axicabtagene Ciloleucel Injection in China.Patients who meet the criteria and fail to achieve "complete remission" after medication will receive a maximum refund of 600,000 yuan.
But overall, the high price issue of CAR-T products remains unresolved. Especially with the increasing competition in the CAR-T market, six CAR-T products have been approved for marketing: Fosun Kite, Wuxi Jw Therapeutics, IASO Biotherapeutics, CARsgen Therapeutics, Hrain Biotechnology, and Legend Biotech.Except for Legend Biotech, which has not yet announced the retail price, the prices of the other five products are around one million yuan.In the context of increasingly fierce competition, reducing prices to enter the medical insurance catalog is the best solution.
Fosun Pharmaceutical's Axicabtagene Ciloleucel Injection has established an early channel advantage and a nationwide sales network in China. According to the financial report, Fosun Kite has established more than 170 high-standard treatment centers across 28 provinces, municipalities, and autonomous regions in China. At this year’s Fosun Pharmaceutical annual meeting,Wu Yifang, Chairman of the Company, clearly stated: "CAR-T should be included in medical insurance."
In March this year, news came from India and Brazil that the cost of a single treatment with domestically developed CAR-T products in the two countries was only $30,000 to $40,000, approximately RMB 200,000 to 300,000, which is just one-tenth of the price in Europe and America, breaking the notion that "CAR-T must be astronomically expensive." If China's CAR-T products could reach a price level similar to that of India and Brazil, they would be very likely to be accepted by medical insurance.
Fosun Kite, newly renamed, will definitely "focus intensively" on the development of CAT-R in China. According to the company's plan,We will make every effort to promote CAR-T cell therapy products to benefit more patients in the future., build a CAR-T ecosystem, and continue to lead the industry's development and upgrading.
Author: Xiaomi
Editor | Jiang Yun, Jia Ting
Operation｜Han Jinrui
Illustration｜Visual China
Statement: Original content by Jian Shi Bureau, please do not reprint without permission.
