On March 1st, the FDA officially approved Legend Biologics' CAR-T product, which is the first CAR-T therapy in China to receive FDA approval. Affected by this news, Legend Biologics soared by 11.16% after the market closed, with a market value of $6.051 billion.
Legendary Biologics CEO Huang Ying also publicly stated that they have established a local team, including sales staff, nurse educators, and Medical Social Liaisonists (MSL), with plans to start treatment at the first wave of hospitals on the day of approval. They will then expand to other treatment centers in the coming months, with initial production capacity supplied by factories in New Jersey, USA. As of now, the US FDA has approved six CAR-T cell therapies for market launch.Analysts from Frost & Sullivan (hereinafter referred to as 'Frost & Sullivan') were interviewed by Economic Observer Network to discuss whether Chinese pharmaceutical companies can refer to their overseas market expansion strategies after the approval of the legendary biotech company's CAR-T therapy.
Economic Observer Network
The FDA has officially approved Legend Biologics' CAR-T product, which is the first CAR-T therapy in China to receive FDA approval. This therapy uses genetic engineering technology to modify T cells in vitro, expand them, and then reinfuse these cells into the patient's body to directly kill cancer cells.
Affected by this news, Legend Biotech soared 11.16% after the market closed, with a market value of $6.051 billion. Its staff told Economic Observer that preparations have been made in terms of production capacity, and production bases compliant with GMP standards have been established in New Jersey and Nanjing, USA. In November last year, the second phase of Legend Biotech's industrialization project officially started in Nanjing, also to ensure supply of production capacity.
The staff also introduced that this FDA clearance process was advanced by the clinical team of Legend Biologics in the United States and its partner, Johnson & Johnson's team. It is understood that the CAR-T product was initially developed independently by Legend Biologics. In 2018, Legend Biologics reached a cooperation agreement with Johnson & Johnson to jointly develop it, with the Chinese rights held by both parties divided equally at 70:30, and the overseas rights divided equally at 50:50. As of now, Johnson & Johnson has paid Legend Biologics a prepayment of $350 million and milestone payments of $250 million.
According to Scott White, president of Johnson & Johnson North America's Pharmaceutical Business Group, the therapy is priced at $465,000. In the US market, Legend Biologics and Janssen are jointly conducting marketing efforts, with Legend Biologics responsible for smaller but more targeted sales teams targeting hospital markets, while Janssen's team will focus on a broader community.
As of now, the US FDA has approved six CAR-T cell therapies for market launch. After Legend Biologics' product was approved for marketing, its direct competitor is Bristol-Myers Squibb's CAR-T product targeting the same target. In March last year, Bristol-Myers Squibb's product was approved for marketing, leading Legend Biologics by nearly a year. Its pricing is $419,500, slightly lower than Legend Biologics', with sales last year amounting to $1640 million.
Analysts from Frost & Sullivan told the Economic Observer that although Legend Biologics' product pricing is slightly higher than those of Bristol-Myers Squibb, it is still within a reasonable range. Moreover, multiple myeloma is considered a blue ocean in the niche market segment. In 2020, there were 450,000 patients globally with this indication, and the efficacy of traditional therapies is far inferior to CAR-T therapy. Currently, only two have been approved, while other similar products are progressing relatively slowly. The market potential is sufficient to support this, and Legend Biologics has also found a partnership with Janssen, which is very advantageous.
At the same time, the approval of Legend Biologics' CAR-T therapy indicates that the FDA's doors are still open. Considering the previous rejection of Innovent Biologics' PD-1 drug for overseas markets, she believes that for pharmaceutical companies seeking to expand into overseas markets, Legend Biologics' approach is worth considering. Finding a relatively innovative direction at the technical level rather than highly homogenized targets like PD-1, choosing global multi-center trials clinically, and simultaneously considering cooperation with international big pharmaceutical companies to advance research and development and commercialization may be a relatively feasible path for going global.
*This article is reprinted from 'Economic Observer Network', authored by Yu Shiqi, with the original title 'The Legendary Biotech CAR-T Therapy Approves in the US, and Does It Look Like the FDA's Doors That Were About to 'Close' Are Reopening?'.
