Iaso Biotherapeutics Advances Global Ambitions with Breakthrough CAR-T Therapy Fucaso: Strong Efficacy Data and Multi-Payer Access Strategy Drive Commercialization

Oct 10, 2023 14:36 CST Updated 14:36

IASO Biotechnology

Cancer Treatment New Drug Developer

Recently, IASO Bio presented two research findings on the CAR-T product Idecabtagene Vicleucel Injection at the 2023 International Myeloma Society (IMS) Annual Meeting.The follow-up data updated this time show that, in terms of effectiveness, the objective response rate (ORR) of subjects who have not previously received CAR-T therapy reached 98.9%, and the stringent complete response/complete response (sCR/CR) rate increased to 82.4%.。

It is reported that Ixcell-CAR Injection (trade name: Fokesu) was approved for marketing by the National Medical Products Administration on June 30 this year, becoming the third CAR-T product in China. More than three months after its approval, the commercialization of Fokesu is accelerating.

The launch of Focasu not only provides a new treatment option for patients with relapsed or refractory multiple myeloma, but as a "million-yuan-per-dose" CAR-T cell therapy, affordability has also become a focal point for the commercialization of Focasu in China.

It is reported that,The current price of Fokasol is 11.66 million yuan/vial.Public data shows that the previously listed Chinese products, Relma-cel and Axicabtagene Ciloleucel, were priced at 1.29 million yuan and 1.2 million yuan, respectively.

“Currently, Focasus has been included in the urban惠民insurance programs in multiple cities across China, such as Nanjing Ninghui Insurance. Meanwhile, the coverage progress of commercial insurance for Focasus is also relatively optimistic, with some patients already receiving health insurance support at the payment end.", Recently, a relevant person in charge of IASO Bio stated at a media event that the company is actively promoting Fokusu to enter various commercial insurances through negotiation and communication, improving the innovative payment system with multiple parties sharing the cost.

Regarding the pricing logic of the "million" CAR-T product, a relevant person in charge of IASO Bio explained,Unlike the international market, which typically adopts value-based pricing for CAR-T products, CAR-T products in China are mainly priced based on cost, taking into account various costs associated with drug production.Therefore, although the pricing of CAR-T products in China generally exceeds one million yuan, it is only about 1/2 to 1/3 of the price of similar products in the international market.

The person in charge introduced that, since CAR-T products are highly personalized customized therapies, it is difficult for companies to promote product sales by significantly reducing prices in the short term. However, in the long run, with the market scale effect becoming apparent and the increasing substitution rate of domestically produced raw materials and production equipment, the price of CAR-T products is also expected to decrease.

"IASO Bio will also reduce costs and increase efficiency by finding more economical alternative materials, optimizing staffing, and improving capacity utilization, further exploring the possibility of lowering CAR-T product prices from the cost side," the person mentioned.

Currently, internationalization has become a major trend in the commercialization of innovative drugs in China. IASO Bio also revealed, "The company owns the global market rights to the Elgacyta injection and will focus on the domestic market while further benefiting patients overseas."

Frost & Sullivan data shows that the global CAR-T cell therapy market sales value is expected to reach $21.8 billion in 2023. "The true 'blue ocean' for CAR-T products lies in the global market. Taking CD19-targeted CAR-T products as an example, the market share in China is less than 5% of the global market," said a relevant person in charge of IASO Bio. "Currently, the injectable Equecabtagene Autoleucel has received FDA clinical trial approval."

For the market competitive advantage of Fokasol, according to IASO Bio, Fokasol has the potential to become the first-in-class CAR-T product globally for multiple myeloma. Meanwhile, IASO Bio has achieved independent production of the lentiviral vector for CAR-T and possesses a resource system for the full-process independent production of Fokasol, effectively ensuring the production and supply of the product.

Source: China Finance Network

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