The 21st Century Economic Reporter Han Liming reports from Shanghai
On May 28, Asahi Kasei Corporation (hereinafter referred to as "Asahi Kasei"), a Japanese enterprise, announced its intention to acquire Calliditas Therapeutics AB (hereinafter referred to as "Calliditas") at a price of 11.164 billion Swedish kronor (about 1.1 billion US dollars) as part of its international expansion plan in the field of health care. This tender offer is about 83% higher than the closing price of Calliditas on May 27.
"The product Tarpeyo of Calliditas is currently the only fully approved product for the treatment of adult patients with primary immunoglobulin A nephropathy (IgA) at risk of disease progression to reduce their renal function loss, which is highly complementary to the existing treatment fields of Asahi Kasei." Asahi Kasei said in the announcement, "By releasing Calliditas's existing business operation potential, it will accelerate its transformation to a global pharmaceutical enterprise."
Since the field of immunity has been concerned by pharmaceutical companies, and in many sub tracks, the fever of IgA nephropathy is rising rapidly. Since the second half of last year, Novartis, Biogen and Vertex Pharmaceuticals have made great efforts in the field of IgA nephropathy. In the domestic market, Hengrui Pharmaceutical 、 Rongchang Biology , Hansen Pharmaceutical and other pharmaceutical enterprises are also competing in research and development.
"In the past few years, the research and development of new drugs has piled up in tumor, immune and other fields. Against the background of intensified homogenization competition, chronic diseases such as obesity, hair loss and kidney disease have become a new track for innovative drug companies to compete, and are expected to produce blockbuster products." An analyst from a securities firm told the 21st Century Economic Reporter that, "In the next few years, many blockbuster products of multinational pharmaceutical enterprises will face the patent cliff and need to find new business growth points. The common practice is to enrich the pipeline through continuous mergers and acquisitions of innovative pharmaceutical enterprises."
Large amount of acquisitions
The World Health Organization (WHO) once pointed out in December 2020 that the cause of death of kidney disease has risen from the 13th to the 10th in the world, and the number of deaths has increased from 813000 in 2000 to 1.3 million in 2019. The Chinese Journal of Nephrology recently pointed out that IgA nephropathy (IgAN) is the most common primary glomerulonephritis worldwide, and 20%~40% of patients progress to end-stage renal disease within 20 years after diagnosis.
IgA nephropathy is mainly characterized by the accumulation of immunoglobulin A in the kidney. The most common clinical manifestation is asymptomatic hematuria with different degrees of proteinuria. Most of the diseases start in young adults, and patients aged 20-40 account for about 80%. The Sullivan report shows that the number of patients with IgA nephropathy in the world will increase from 8.8 million in 2015 to 9.3 million in 2020, and it is estimated that the number of patients in the world will reach 10.2 million in 2030.
There is a large number of patients, but there is no specific treatment for IgA nephropathy at present. The main goal is to control blood pressure and proteinuria, and delay renal function and disease progress. Many multinational pharmaceutical enterprises have taken over the "blue ocean" market. On May 22 local time, Bo Jian announced the acquisition of Human Immunology Biosciences (HI Bio) with a potential total amount of $1.8 billion, including an advance payment of $1.15 billion and the remaining $650 million as milestone payments. The transaction is expected to be completed in the third quarter of 2024.
HI Bio focuses on developing immunotherapy for the field of immune-mediated diseases. Its core asset, felzartamab, is a monoclonal antibody targeting CD38. It has obtained the breakthrough treatment qualification (BTD) and orphan drug qualification (ODD) issued by the US FDA, and is used to develop clinical research on multiple indications such as primary membranous nephropathy, IgA nephropathy, antibody mediated rejection, etc. The clinical trial of IgA nephropathy is in phase 2.
On April 10, Futai Pharmaceutical announced that it would purchase Alpine Immune Sciences (hereinafter referred to as "Alpine") for about 4.9 billion dollars to obtain the latter's drugs for treating kidney autoimmune diseases. In the pipeline laid out by Alpine, Povetacicept shows the potential best efficacy in IgA nephropathy (IgAN), and is expected to launch phase 3 clinical trials in the second half of this year.
Alpine said that "povetacicept has huge market opportunities in many therapeutic fields, including but not limited to nephrology, connective tissue diseases (such as lupus), hematology, neurology and dermatology." It is reported that Alpine plans to launch a phase II study of povetacicept for the treatment of systemic lupus erythematosus (SLE).
In June 2023, Novartis announced that it would purchase Chinook Therapeutics at a price of 3.5 billion US dollars, including the latter two late stage drugs for clinical development of IgA. Half a year later, Novartis announced its acquisition of Rino Pharmaceuticals, further strengthening its layout in the field of nephrosis. Novartis official website shows that Rino Pharmaceuticals is a joint venture established by Chinook and several life science investors.
The core assets of Rino Pharmaceuticals include two drugs in clinical development stage, namely atrasentan and zigakibart (BION-1301), which are used to treat IgA nephropathy. Among them, Novartis plans to seek opportunities for accelerated approval of atlasentan in the United States in 2024; Zigakibart has entered the phase III clinical study of IgA nephropathy in the third quarter of 2023.
"There is a large group of patients in the field of nephrosis, and more innovative therapies are urgently needed. It is not difficult to see from the large acquisitions of multinational pharmaceutical enterprises in the past year that the potential and value of innovative pharmaceutical enterprises focusing on the research and development of IgA nephrosis drugs are being re evaluated and recognized by the market." The analysts of the above securities companies added.
R&D competition of domestic pharmaceutical enterprises
Some studies have shown that IgA nephropathy has regional and ethnic differences, especially in the Chinese population with more serious pathological changes and faster disease progression. According to Sullivan's report, IgA nephropathy is a rare disease in the United States, with a small number of patients, only about 130000~150000 patients. In contrast, the number of IgA patients in China is expected to reach 2.4 million in 2030, with a large population base.
The 2021 edition of KDIGO guidelines pointed out that for patients with primary IgA without variant forms, the treatment method is mainly to optimize supportive treatment, including blood pressure control, lifestyle guidance, cardiovascular risk assessment, etc., and to initiate the use of immunosuppressive therapy when necessary. However, the therapeutic value of immunosuppressants for IgA is still controversial.
"The incidence of IgA nephropathy in China is higher than that in other countries and regions in the world. There are millions of confirmed IgA patients in China. At present, the treatment of IgA nephropathy is mainly supportive treatment. The large population of patients and clinical needs have not been met." Ping An Securities Research News pointed out. IgA treatment urgently needs targeted treatment methods to change the disease progress from the source of the disease.
The research report of Ping An Securities shows that the widely accepted theory believes that IgA nephropathy is caused by multiple mechanisms, rather than a single mechanism, and is called the "multiple hit hypothesis". According to each step of this hypothesis, the treatment of primary IgA nephropathy includes inhibition of excessive mucosal immune response, B cell factor (BAFF/APRIL) inhibitor, endothelin/angiotensin antagonist, and complement system targeted treatment. Many domestic pharmaceutical enterprises also seek breakthroughs in innovative therapies.
On May 17, Rongchang Biological announced that the domestic phase III clinical trial of etaxil (BAFF&APRIL dual inhibitor) in the treatment of IgA nephropathy had completed the patient enrollment. At present, a number of clinical studies have been carried out on the pre filled injection of Titasip at home and abroad. In China, in addition to the completion of enrollment this time, the bridging test between the pre filled injection dosage form and the freeze-dried powder injection form has been started. Overseas, the international phase III clinical trials for the treatment of systemic lupus erythematosus, myasthenia gravis, Sjogren's syndrome, IgA nephropathy and other indications use pre filled injection.
On May 14, Hengrui Pharmaceutical announced that its subsidiaries had received the Notice of Drug Clinical Trial Approval on SHR-2173 injection approved and issued by the State Food and Drug Administration. Hengrui Medicine said that this product can play a biological effect of anti inflammation and suppression of immunity by targeting abnormally activated immune cells, which is expected to reduce the level of autoantibodies, improve the disease activity of patients with IgA nephropathy, and bring new treatment options to patients. In addition, Hengrui Pharmaceutical still has two IgA nephropathy drugs (complement system targeted treatment) in phase 2 clinical.
On February 7, Hansen Pharmaceutical announced that the HS-10398 capsule, a class 1 new drug independently developed by its subsidiary Hansen Pharmaceutical/Hansen Biology, was approved for clinical trials. The 21st Century Business Herald reporter found that the information released on the drug clinical trial registration and information publicity platform on April 23 showed that the indications for HS-10398 capsule registration were immunoglobulin A nephropathy and membranous nephropathy, and the first phase of the trial was still in progress.
In addition to developing the original new drugs of First in class, there are also pharmaceutical enterprises that carry out differentiated innovation by optimizing and improving dosage forms. On March 29, the State Drug Administration approved the application for new drug clinical trial of Triassic 3D printing drug product D23. Triassic said that D23 is a self-developed modified oral budesonide delayed release tablet, which can reduce the production of IgA (Gd IgA) lacking lactose acidification by acting on the Peyer lymph node in the ileum, and treat IgA nephropathy from the source.
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