Ire-cel (Fucaso®), China's First Fully Self-developed CAR-T Therapy Priced at RMB 1.166 Million per Dose, Accelerates Commercialization with Impressive Clinical Data

Nov 16, 2023 08:36 CST Updated 08:36

IASO Biotechnology

Cancer Treatment New Drug Developer

Recently, IASO Bio has reached agreements with several top pharmaceutical institutions regarding its world's first fully human CAR-T product, Fokosu.^®'s diversified strategic cooperation, jointly committed to promoting the development of the cell therapy field. ThroughShared Resources and Technology, IASO Bio and its partners willJoin Forces to Create Innovative Service Solutions, Making Cell Therapy Drugs Benefit More Patients。

Explore Innovative Patient Service Solutions, Unite Multilateral Forces

Promote Fokasol^®Commercialization Process

IASO Bio is committed to serving patients worldwide, this signing collaborationSinopharm Group、Shanghai Pharmaceuticals HoldingAndChina Resources PharmaceuticalAdvanced by multiple parties, including IASO Bio^®The commercialization process, expanding market channels, and improving the accessibility of medicines. Through deepening cooperation with leading enterprises in China's pharmaceutical industry, it will benefit Fokasol.^®The commercialization process provides strong support and guarantees, benefiting more patients. Meanwhile, IASO Bio continues to focus on the accessibility and affordability of innovative drugs for patients, working with...Magnesium Health、Chenxi HealthFurther deepened the cooperation in patient care and service. As an industry-leading innovative medical service and security platform, they will collaborate with IASO Bio to explore diversified payment methods and cooperation models, further building a multi-layered payment system for patients with hematological tumors, providing more flexible and sustainable medical security.

Not long ago, 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 from this update shows that, in terms of efficacy, the objective response rate (ORR) for subjects who had 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 IASO Bio's Cilta-cel Injection (trade name: Focusa) was approved for marketing by the National Medical Products Administration on June 30 this year, becoming the third CAR-T product in China. Since its approval for marketing over three months ago, the commercialization process of Focusa has been accelerating.

The launch of Fokas 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 of attention for the commercialization of Fokas in China.

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

“Currently, Focasol has been included in the urban惠民insurance plans in multiple cities across China, such as Nanjing Ninghui Insurance. At the same time, the coverage progress of commercial insurance for Focasol is also relatively optimistic, with some patients already receiving health insurance coverage at the payment end.", Recently, a relevant person in charge of IASO Bio said 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 belong to highly personalized customized therapies, it is difficult for companies to promote product sales through significant price reductions 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 injectable product Equecabtagene Autoleucel 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 injection of Equecabtagene Autoleucel has received FDA clinical trial approval."

For the market competitive advantage of Focasol, according to IASO Bio, Focasol has the potential to become the first-in-class CAR-T product globally for treating 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 Focasol, effectively ensuring the product's supply.

Source: Caixin, IASO Bio, Official Account "Cell and Gene Therapy Field"

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