Global Cell therapy will welcome the blowout of diabetes and open a new era of cell therapy

With the continuous efforts of domestic and foreign pharmaceutical companies in research and development, the global cell therapy track is accelerating into a harvest period.In addition to being successively approved for listing in the field of cancer, cell therapy has also achieved breakthroughs in the field of diabetes

With the continuous efforts of domestic and foreign pharmaceutical companies in research and development, the global cell therapy track is accelerating into a harvest period.

In addition to being successively approved for listing in the field of cancer, cell therapy has also achieved breakthroughs in the field of diabetes. The US Food and Drug Administration (FDA) recently announced that it has approved the launch of Lantidra, an allogeneic islet Cell therapy developed by CellTrans, for the treatment of type I diabetes. According to publicly available information, Lantidra is a single infusion drug that delivers donor pancreatic cells to the main hepatic vein. Patients receiving this treatment must take immunosuppressive drugs to prevent their immune system from damaging insulin producing donor cells. At present, Lantidra is approved for type 1 diabetic patients who repeatedly suffer from severe hypoglycemia despite strict management of diabetes.

Shortly after the news was announced, Lilly and its diabetes cell therapy partner Sigilon Therapeutics jointly announced that Lilly would purchase the latter at a price of more than 300 million dollars. And Sigilon is a company dedicated to developing functional healing therapies for patients with various acute and chronic diseases.

Judging from the layout of Lilly, a multinational diabetes giant, Cell therapy has a promising future in the diabetes market. Mei Heng, deputy director of Institute of Hematology of Huazhong University of Science and Technology, said in an interview with reporters from 21st Century Business Herald that Cell therapy has great market potential in metabolic diseases.

"Diabetes is a problem of pancreatic islet cells. No matter what type of pancreatic islet cells are, it also involves the abnormality of immune function. If the immune function cells are knocked out and the pancreatic islet function is rebuilt, metabolic diseases are also effectively treated. If antibody drugs changed the treatment method in the last century, then in this era, accurate adoptive cellular immunotherapy may bring new breakthroughs in treatment." Mei Heng said.

Diabetes ushers in Cell therapy

Diabetes is the eighth leading cause of death and disability in the world, affecting countries, age groups and different gender groups. The exponential growth of the number of patients with this disease in the world is bringing urgent challenges to public health and health care systems around the world.

A series of articles recently published by the British Lancet Weekly and the Lancet diabetes and Endocrinology Journal on diabetes in the world and the United States pointed out that by 2050, the number of patients with diabetes in the world is expected to exceed 1.31 billion, which will have a lasting impact in the coming decades. The global structural inequality, including race and geographical region, is rapidly exacerbating the crisis. As a major global public health problem, diabetes has brought a heavy burden to the health care system. In addition, according to the data of the International diabetes Federation, the global health expenditure caused by diabetes in 2021 will be about 966 billion dollars; It is expected that by 2045, this number will exceed $1054 billion.

Type I diabetes is a chronic disease, which usually occurs in children and young people. It is caused by the deficiency of insulin caused by the autoimmune system attacking insulin producing cells. At present, when some patients with type I diabetes use insulin to prevent hyperglycemia, they often correct to a low blood sugar level, which leads to hypoglycemia. Some people may experience unconscious hypoglycemia, where they are unable to notice a decrease in blood sugar and therefore cannot take intervention measures to prevent further drops in blood sugar.

According to Peter Marks of the FDA Biological Products Evaluation and Research Center in a press release, severe hypoglycemia in patients is very dangerous, which may lead to loss of consciousness or Seizure, thus causing injury. Based on this, the first Cell therapy approved by FDA for the treatment of type I diabetes is expected to provide more treatment options for patients with type I diabetes and patients with recurrent severe hypoglycemia, so as to help patients reach the ideal glucose control level.

Public information shows that Lantidra Cell therapy is to provide pancreatic tissue from donors, and then isolate and purify islet cells. At present, 90% of clinical islet transplantation operations are percutaneous Portal vein puncture to inject islet cells. The liver is the new home of these grafts, and the surviving islet cells can independently regulate the blood sugar level. Postoperative immunosuppressive therapy is necessary.

The FDA's approval of Lantidra Cell therapy is mainly based on two clinical trials. In both trials, 30 participants received one to three Drug injection. About 70% of people no longer need insulin injections for 1 year or more, and 30% no longer need insulin injections for more than 5 years.

At the time of Lantidra's approval for listing, many companies are also accelerating their layout. ClinicalTrials, the clinical trial registration website of the National Institutes of Health, shows that up to now, 351 clinical trials of diabetes Cell therapy are being carried out worldwide.

Among them, Sigilon Therapeutics, a partner of Lilly, is one of the strong designers. As early as 2018, Lilly provided $63 million of initial investment and equity investment to Sigilon to develop its research therapy into a functional Sex therapy for type I diabetes. SIG-002 is the main asset of Lilly's cooperation with Sigilon. It is expected to complete the validation research before IND this year and submit it to IND in 2024.

According to the terms of this public acquisition, Lilly will purchase tradable shares at a price of $14.92 per share, plus $111.64 per share to acquire non tradable valuable rights, with a total transaction amount of more than $300 million. After the news was announced, Sigilon's stock price surged by 470% before trading. The transaction is expected to be completed in the third quarter of this year.

An analyst from the pharmaceutical industry of a securities firm told the 21st Century Business Herald that, considering that China's diabetes drug market has reached about 67 billion yuan in 2021, the forward-looking nature of the multinational pharmaceutical enterprises' gold digging type I diabetes market is worth affirming. Faced with the huge and unmet demand for treatment in the field of diabetes, diabetes patients need "better drugs". However, due to the high prices of cell therapy drugs, there is a high pricing system on one side and a huge market demand on the other. As a high priced drug, how to commercialize it and further seize market share will also become a focus that enterprises need to pay attention to in the future.

Difficulty in commercializing innovative therapies

In terms of the layout of diabetes, Lilly also holds Trulicity, Mounjaro, Humulin, Humalog, and Jardiance in addition to the field of cell therapy. According to the 2022 financial report data released by Lilly, the company's total revenue for the year was $28.541 billion, a year-on-year increase of 1%. The diabetes business portfolio contributed 13.829 billion dollars in revenue, accounting for 48.5% of Lilly's total revenue.

However, it should be noted that the growth rate of Lilly's GLP-1 receptor agonist dulaglutide declined from 2021, and the annual revenue of Novo Nordisk's GLP-1 business was 83.371 billion Danish krone (about 12.244 billion US dollars), a year-on-year increase of 56%. In addition, some insiders believe that the market size of type I diabetes is expected to exceed US $7 billion by 2030, so Lilly will not be absent, and the layout of cell therapy will also become a new market growth point for diabetes.

However, the cell therapy market is not as easy as imagined. When talking about the market prospect of cell therapy, a senior executive of a pharmaceutical enterprise said in an interview with the reporter of the 21st Century Business Herald that in the field of clinical therapy, cell therapy will certainly become a more and more mainstream treatment method, but the current industry development is still in a relatively early stage. Cell therapy is a technically complex, high production cost, and relatively personalized treatment method, with some uncertainty regarding patient accessibility and the future size of the entire market.

Frost&Sullivan data also pointed out that since 2015, the global cell therapy industry has begun to develop at a high speed. From 2016 to 2020, the market size increased from $50.4 million to $2.08 billion, and it is expected that by 2025, the global cell therapy market size will reach nearly $30.54 billion. Although there are many clinical studies conducted in China, there are few products that have been marketed and commercialized in China, which also reflects the imbalance between research and output.

In addition, according to Sullivan's statistics, by the end of November 2022, the National Medical Products Administration had approved more than 200 clinical trial licenses (INDs) of new drugs for cell gene therapy, but only a few of them were promoted to the phase II of registered clinical trials or critical clinical research. The distribution of indications for cell therapy drugs is also concentrated in the field of cancer. How to stand out in the competition, quickly promote registered clinical research, and achieve future commercial success is an important issue that many enterprises need to consider.

From the perspective of research and development pipelines, about 13% of the pharmaceutical industry's products belong to cell therapy, but the current number of products is less than 1%. The industry is still in a rapid growth stage, which is a cross era category after small and large molecules. For example, we also need to pay attention to the need for further breakthroughs in new indications and process innovation for cell therapy products to become larger. "The executive of the pharmaceutical company emphasized, The cost of cell therapy remains high, and improving patient access to medication remains a major direction. Next, further attention needs to be paid to expanding the market application prospects, and the industry needs to further explore the development possibilities of more disease fields on the basis of tumors.

In addition, Li Xiangyu, Deputy Director of the Shanghai Drug Evaluation and Verification Center, previously pointed out that cell therapy products have gone through a stage where industry insiders question their safety and effectiveness. After the safety and effectiveness of cell gene therapy products developed by enterprises have been improved, the number of approved gene therapy products has increased in recent years. The vast majority of cell therapy products that have already been commercialized and marketed in the existing cell therapy market are targeted at a relatively concentrated target, which has also attracted attention to differentiated target products.

It should be noted that the regulation of cell gene therapy products at the national level is also becoming increasingly strict. For example, the GMP of cell therapy products has certain specificity compared to traditional biological products, such as the number of disposable equipment, and the production process should focus on shear force. In addition, cell stability, process stability, and donor variability need to be considered. "Li Xiangyu emphasized.

How can companies respond to these situations? The above analysts also pointed out that the reason why Chinese cell therapy products cannot become the Red Sea market is due to the relatively high R&D barriers compared to antibody drugs and chemical targeted drugs. However, in various environments such as applying for registration, clinical registration, and approval for listing, there are process barriers that many pharmaceutical companies face. This also leads to the termination of the evaluation process due to poor process, which wastes a lot of energy and resources. In addition, the overall penetration rate of cell therapy is currently higher than expected, but the overall penetration rate is still very low. Therefore, comprehensive consideration is still needed for enterprise layout in this race track.

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