Innovent Exits Commercialization of BCMA CAR-T FUCASO® in Exchange for 18% Stake in IASO Bio

After the disclosure of a joint announcement released by the two companies, Innovent Bio became a strategic shareholder of IASO Bio.

In July 2024, the two companies announced that IASO Bio would purchase Innovent Bio's BCMA CAR-T product, Focusa, at the agreed price.^®(Idecabtagene Vicleucel Injection)Global market commercialization rights, intellectual property licensing, and other rights, as well as independently overseeing and making decisions on product development, production, and sales.

Innovent Bio and IASO Bio jointly developed the Ide-cel injection, which was approved by the NMPA on June 30, 2023, and officially launched in China.

This message means that,Innovent BioWill completely withdraw from the research and development, sales activities of Ixazomib Injection, just on the occasion of the one-year anniversary of this product's market launch.

At the same time, according to the press release, Innovent Bio will convert the full amount of this cooperation agreement into shares of IASO Bio, after which it will hold 18% of IASO Bio's shares. The official statement is that, based on the new cooperation framework, the two parties will achieve a high level of resource integration in the field of cellular immunotherapy.

After removing Idecabtagene Vicleucel Injection from the pipeline, Innovent Bio's pipeline only has one CAR-T product left.Payment IBI-345——CLDN18.2 Modular CAR-T，Currently in Phase I clinical stage.

As mentioned in previous articlesAs far as the CLDN18.2 target is concerned, monoclonal antibody products have only been approved for marketing in Japan so far, and are expected to be approved by the FDA by the end of this year.In addition, since last year, several companies, including Innovent Bio, have successively announced that their CLDN18.2 ADC products have entered Phase III clinical trials.Overall, the competition in the target track is extremely intense.

Innovent Bio's Idecabtagene Vicleucel Injection is the company's only marketed CAR-T product, approved by the NMPA for treating adult patients with relapsed/refractory multiple myeloma who have received at least three prior lines of therapy. Notably, this is also the first BCMA-targeted CAR-T product approved in China.

Currently, Idecabtagene Vicleucel Injection for the treatment of patients with relapsed/refractory multiple myeloma who have received 1-2 prior lines of therapy and are lenalidomide-resistant, as well as for autoimmune diseases(Refractory Myasthenia Gravis)The IND application has been approved by the relevant pharmaceutical regulatory authorities.

Moreover, according to the oral report information recently presented by IASO Bio at the 2024 EHA, in a Phase I clinical trial targeting high-risk NDMM patients who are ineligible for autologous stem cell transplantation, treatment with Inebilizumab injection resulted in...(Median follow-up time 7.46 months)，100% of subjects achieved MRD negativity, and 71.4% of subjects maintained MRD negativity for more than 12 months. The ORR of the trial(Objective Response Rate)Reaching 100%, with 93.8% achieving stringent complete remission. This indicates that the IASO Bio's injectable drug, Equecabtagene Autoleucel, has shown excellent prospects in first-line treatment for this patient population.

In terms of R&D progress, the early clinical trials of Idecabtagene Vicleucel Injection are sending positive signals.

As everyone knows, the biggest challenge faced by a range of CAR-T therapies, including Idecabtagene Vicleucel Injection, is the difficulty in commercialization.

The domestic price of Idecabtagene Vicleucel Injection exceeds one million yuan, which deters most patients based solely on cost. Meanwhile, for high-cost drugs like CAR-T therapies, significant concessions from manufacturers are required for inclusion in China's medical insurance system. Reportedly, common drugs entering the insurance scheme generally see a price reduction of around 60%. Based on this most conservative discount, a CAR-T therapy would require the manufacturer to concede at least 600,000 yuan to be included in the medical insurance.

In fact, considering the thresholds for some previously high-priced drugs entering the medical insurance, even after a 60% price reduction, CAR-T therapy still costs over 400,000 yuan, which remains relatively high compared to other products within the medical insurance. However, for companies, a price of 400,000 yuan, after deducting costs, will most likely result in negative revenue.

According to an article in the International Journal of Cancer, the production material cost per dose of CAR-T is approximately $43,000.(Approximately RMB 310,000)Among them, lentiviral vectors used for CAR-T transduction account for 66% of the cost, and magnetic beads used in the cell sorting process account for 14.4% of the cost. However, these are only the most basic production materials; R&D investment, failure risks, and later-stage promotion expenses are not included.

Among a group of CAR-T products made in China, the most successful one in terms of revenue is currently Legend Biotech's CARVYKTI. In its first full year on the market, it generated $500 million in revenue and is currently experiencing rapid growth. It is reported that its revenue for Q1 2024 reached $157 million. However, this product has not yet been approved for marketing in China; its application was accepted by the CDE at the end of 2022.

References

1.https://invivo.citeline.com/

2.Official Websites of Various Companies

3.Other Public Information

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