On July 12th, it was reported that Legendary Biology had received a merger offer. As a result of the news, the US stock market closed up more than 12%, with a market value of 9.911 billion US dollars. However, regarding the authenticity of the above report, Legendary Biology replied to the Daily Economic News reporter that they have not received any further relevant information.
Recently, innovative pharmaceutical companies in China that focus on the research and production of CAR-T (chimeric antigen receptor T-cell immunotherapy) have been making frequent moves in commercial cooperation and equity mergers and acquisitions.
On July 5th, Reindeer Biology announced the signing of a series of cooperation agreements with Xinda Biology, which involve Reindeer Biology's purchase of the profit rights and intellectual property license of the cooperative product Ikiolun Sai from Xinda Biology, as well as Xinda Biology's investment in Reindeer Biology.
The original intention behind our decision to update our cooperation model is based on a thorough analysis of the current market environment and future development trends. CAR-T cell therapy, as a cutting-edge technology in the field of biomedicine, has enormous potential for development and market demand, "reindeer biology replied to reporters
Legendary Biotech responds to merger rumors: no further information available
CAR-T is considered the most promising field among innovative drugs in China and one of the few areas where research and development are at the forefront internationally. According to statistics, since the first CAR-T product was launched in 2017, there have been 11 CAR-T products globally, of which 6 are from Chinese companies and 5 are listed in China. According to industry data, the Chinese CGT (Cell and Gene Therapy) market has shown tremendous vitality, with over 647 CGT research pipelines and most projects in Phase I/II clinical stages, mainly focused on CAR-T technology. At the same time, China's patent application volume has also ranked second in the world, second only to the United States.
From the perspective of commercialized products, the FDA has approved a total of six CAR-T drugs for sale, including Novartis' Kymriah, Gilead/Kate's Yescarta and Tecatus, BMS's Breyanzi, BMS/Bluebird Biologics' Abecma, and Johnson&Johnson/Legendary Biologics' Carvykti. In China, the National Medical Products Administration has approved a total of five CAR-T drugs for market launch, including Fosun Kite's Akilence, WuXi AppTec-B (2126.HK, stock price 1.82 Hong Kong dollars, market value 755 million Hong Kong dollars)'s Rickiolenze, Reindeer Biotech's Ikiolenze, Heyuan Biotech's Nakiolenze, and Koji Pharma-B (2171.HK, stock price 4.2 Hong Kong dollars, market value 2.418 billion Hong Kong dollars)'s Zewawo Orlenze.
According to Frost& Sullivan predicts that the global CAR-T market size has increased from $10 million in 2017 to $1.1 billion in 2020 in terms of sales value. It is expected that the global CAR-T cell therapy market sales value will reach $21.8 billion in 2030, with a compound annual growth rate of 34.8% from 2021 to 2030. The market size of CAR-T therapy in China was 200 million yuan in 2021, and it is expected to increase to 28.9 billion yuan by 2030, with a compound annual growth rate of 64.4% from 2021 to 2030.
In terms of market conditions, since 2017, as the first CAR-T therapy approved by the FDA, Gilead's Yescarta has achieved considerable market returns by seizing market opportunities. According to the financial report, Yescarta won the top spot in the CAR-T therapy field with sales of $1.5 billion in 2023, becoming the only CAR-T therapy with sales exceeding $1 billion.
Previously, Legendary Biology was considered a "top student" of CAR-T therapy in China. Unlike its domestic counterparts, Legend Biotech has already established a strategic partnership with renowned multinational pharmaceutical company Johnson&Johnson in the clinical stage - reaching a global cooperation agreement with Carvykti in 2017. In addition, Legendary Biotech has received a down payment of $350 million and milestone payments in stages.
The direct result of the collaboration is that Carvykti has rapidly advanced clinical trials in multiple global markets and was approved for market by the FDA in 2022. Its commercial progress has greatly increased the market value of Legendary Biotech, bringing significant revenue and profit growth to the company; Meanwhile, Legendary Biotech has also expanded its international influence by leveraging Johnson&Johnson's network and resources in the global market.
Financial report data shows that Carvykti's sales in 2022 were $134 million; In 2023, the sales revenue reached 500 million US dollars, a year-on-year increase of 273%; The sales revenue for the first quarter of 2024 was 157 million US dollars. At present, this sales volume ranks second among CAR-T products that have disclosed sales performance, second only to Gilead's Yescarta, and the growth rate ranks first. Johnson&Johnson also predicts that Carvykti's sales are expected to exceed $1 billion this year.
Therefore, it is widely speculated in the industry that Johnson&Johnson, as the partner of Carvykti, the core product of Legendary Biotech, is the most likely competitor in this acquisition invitation. However, this speculation has not received a response from the legendary creature.
On the morning of July 15th, Kingsray Biotechnology, the parent company of Legendary Biotech, released a voluntary announcement stating that "after making reasonable inquiries about the company in relevant circumstances, the board of directors confirms that as of the time of this announcement, it is not aware of any reasons for such fluctuations in stock prices or trading volumes, or any insider information required to be disclosed under the Securities and Futures Ordinance".
High costs and treatment expenses hinder market promotion
Accessibility issues have always been the main factor hindering the expansion of the domestic CAR-T market. Due to its personalized and customized treatment methods, the high research and development costs and complex production processes of CAR-T have resulted in high prices, hindering large-scale market promotion and popularization.
From the currently disclosed prices, the treatment cost of CAR-T can easily reach millions of yuan, far exceeding the economic affordability of most patients. However, the domestic medical insurance system has not fully covered such high priced innovative drugs, leading to enormous pressure on patients in terms of payment.
The reporter noticed that in order to solve this problem, most CAR-T companies currently choose to cooperate with commercial health insurance companies to find another important payment method besides medical insurance. For example, as of April this year, Fosun Kate has established more than 160 high standard treatment centers for Akilun Sai in 26 provinces, autonomous regions, and municipalities across the country, and has promoted the inclusion of Akilun Sai in over 100 urban welfare insurance projects and over 75 commercial health insurance projects.
In addition, production and supply chain management are also major challenges. The production of CAR-T products requires highly specialized facilities and strict quality control, and many domestic enterprises do not yet have mature capabilities in this regard. This not only increases production costs, but also limits capacity expansion, further affecting market supply.
Recently, Li Lei, President of Cytiva China, stated in an interview with the Daily Economic News that, taking CAR-T and other cell therapy drugs as examples, the biggest challenge in their production process comes from the development, optimization, and production of cell technology. Successful cell production depends on the overall process optimization ability, including process simplification, capacity planning, production compliance, and scalability.
Li Lei believes that in the face of complex sample sources and current treatment costs for different cancer patients, how to reduce cell production costs through efficient, standardized, and large-scale production preparation is the key breakthrough. Cost reduction and efficiency improvement at the enterprise level are crucial for promoting accessibility, including the selection of processes, production instruments, and consumables. In the future, with the expansion of market demand, if production still remains at manual operation, on the one hand, it requires a very high level of technical proficiency, which is a challenge to production capacity, and on the other hand, it is not conducive to reducing production costs. Therefore, the use of automated closed production systems has become a development trend in the industry; In addition, building a stable and scalable production platform and collaborating with leading equipment and consumables suppliers will also help accelerate the research and industrialization process of cell and gene therapy drugs.
Looking ahead to the development of cell gene therapy drugs such as CAR-T in the future, Li Lei said, "With the development of technology, the cost and price of all new drugs will gradually decrease from the initial stage of birth to popularization. For example, vaccines and antibody drugs have gone through a process of price change from expensive to affordable. I believe that cell and gene therapy will also follow this trend. In the next few decades, we are very hopeful to see the popularization of CAR-T and other drugs
Recently, cooperation in the CAR-T field has become increasingly close
In order to solve the problem of sustainable commercial operation, domestic CAR-T research and production enterprises generally adopt a strategy of cooperating with powerful biopharmaceutical companies, or originated from such large pharmaceutical companies at the beginning of their establishment.
For example, as the first CAR-T cell therapy product approved in China, Akilensai was introduced to China by Fosun Pharma through a joint venture company established with Kite Pharma in 2017 through source layout; Initially, WuXi AppTec, a leading domestic pharmaceutical outsourcing company, was jointly established with Juno Therapeutics.
In order to promote the sales of Zewawo Orense by Koji Pharmaceutical in China, Koji Pharmaceutical has partnered with Huadong Pharmaceutical in January 2023. Huadong Pharmaceutical also announced on the same day that its subsidiary, Kaixing Life Technology (Shanghai) Co., Ltd., has signed an exclusive commercial cooperation agreement with Zhejiang Pharmaceutical (Hangzhou), a wholly-owned subsidiary of Keji Pharmaceutical. Huadong Pharmaceutical (Hangzhou) owns the exclusive commercial rights of Zhejiang Pharmaceutical in China.
From the specific terms of the agreement signed on July 5th between Reindeer Biology and Xinda Biology, Reindeer Biology will purchase Xinda Biology's relevant rights and interests under the original BCMA CAR-T cooperation agreement at the agreed price; At the same time, Xinda Biotechnology will invest in Reindeer Biology at the same price, and after the investment, it will hold 18% of the shares in Reindeer Biology. Under the new strategic cooperation framework, both parties will achieve a high degree of resource integration in the field of cellular immunotherapy. Reindeer animals will obtain the global market commercialization rights and intellectual property licensing rights of Ikuolunsai, and independently be responsible for and make decisions on the development, production, and sales of products; At the same time, Xinda Biology has become a strategic shareholder of Reindeer Biology.
Reindeer Biology told reporters, "In order to better seize the development opportunities of CAR-T cell therapy, we believe it is necessary to improve overall operational efficiency through closer cooperation and more effective integration of resources from both parties. Reindeer will be solely responsible for the commercialization of Ikoron Sai, which can more effectively promote the commercialization of Ikoron Sai nationwide, maximize its commercial value, and rapidly expand globally. Based on years of cooperation trust and recognition, Xinda Biology will continue to support Reindeer Biology as a shareholder
For the next move of the legendary creature, reporters from the Daily Economic News will continue to pay attention.