The second new Alzheimer's disease drug approved by Eli Lilly in China, following Lecanemab from Eisai/Bojian, has been launched.
On December 18th, Eli Lilly and Company announced that the world's second new Alzheimer's disease (AD) drug, Donanemab Injection (trade name: JND), has been approved by the China National Medical Products Administration for the treatment of mild cognitive impairment and mild dementia caused by Alzheimer's disease in adults.
Six months ago, the world's first targeted therapy for Alzheimer's disease, Lecanemab, was officially launched in Beijing, Shanghai, and other places. The first batch of 6 patients diagnosed with early-stage Alzheimer's disease in Shanghai will receive a treatment cycle of 18 months, with two infusions of lencanavir monoclonal antibody per month.
A medical expert in Shanghai told the Beijing News Shell Finance reporter that the new drug for Alzheimer's disease, lencanazumab, has shown significant efficacy in six months of clinical use. This drug takes anti beta amyloid protein as its core idea, breaking through the limitations of "symptomatic treatment" and targeting A β in the brain. By reducing A β, it delays the progression of early Alzheimer's disease patients from the source.
According to current clinical research results, the patient's A β load was significantly reduced after 3 months of medication, and it is expected to effectively alleviate disease progression by 27% after 18 months; 60% of early-stage patients achieve disease course reversal. In clinical trials in China, patients who received treatment with lencanavir monoclonal antibody showed significant improvements in memory and cognition, and some even recovered their daily living abilities.
The annual medication cost is about 32000 US dollars, and it is expected that the number of domestic patients will reach millions by 2050
This time, Eli Lilly and Company announced that the approval of the world's second new Alzheimer's disease drug, donenumab injection, in China marks the opening of another important market after the United States and Japan.
According to the "China Alzheimer's Disease Report 2024", 63% to 70% of dementia patients are Alzheimer's disease patients. In 2021, there were over 16.99 million cases of Alzheimer's disease and other dementia in China. With the intensification of population aging, it is expected that the number of Alzheimer's disease patients in China will reach tens of millions by 2050, providing a broad market space for these innovative drugs.
However, the high price of the new drug donenumab injection may become a major obstacle to its widespread application in China. Although Eli Lilly has not officially announced the specific pricing of the drug in China, based on existing information, its price level is likely to remain at a relatively high level.
Taking the first new drug, lencanavir monoclonal antibody, as an example, its price in China is 2508 yuan per bottle, with a specification of 200mg per bottle. According to this standard calculation, for an adult weighing about 60 kilograms, about 3 bottles of medicine need to be used per month, so the monthly treatment cost is about 7500 yuan, and the annual treatment cost is close to 180000 yuan. If we follow the clinical trial's principle of completing a treatment cycle in 18 months, the total treatment cost for one and a half years would be around 270000 to 300000 yuan.
Beike Finance reporters have noticed that the pricing of donenumab injection in the United States has been announced, with a price of $695.65 per bottle (approximately RMB 5059.67), and the total cost of a 12-month course of treatment is about $32000. Lilly has publicly stated that after entering the Chinese market, it will consider launching a patient assistance program or cooperating with government medical insurance departments to strive for the inclusion of donenumab injection in the national medical insurance reimbursement catalog, in order to improve drug accessibility and reduce patients' economic burden.
Regarding the question of whether the price of the world's second new Alzheimer's disease drug will decrease, medical experts told Shell Finance reporters that this usually depends on multiple factors, including market demand, drug efficacy, production costs, and market competition. With the development and market promotion of more similar drugs, market competition may intensify, leading to a decrease in prices. However, this also needs to take into account the high cost of drug development and the profitability needs of enterprises.
Pfizer and Roche, the 'Valley of Death' for pharmaceutical companies, are still on the path of research and development
According to data from The Lancet, according to a research report released by the American Society for Drug Manufacturing and Research, from 2000 to 2017, pharmaceutical companies invested over $600 billion in research and development for Alzheimer's disease. However, during this period, only four AD drugs were approved.
Even for powerful MNC giants, Alzheimer's disease remains a century old barrier that is difficult to overcome.
Public information shows that in March 2010, Pfizer announced the failure of the third phase clinical trial of Dimebon, a candidate drug for Alzheimer's disease jointly developed with Medivation. In August 2012, Johnson&Johnson and Pfizer announced the termination of their joint development of Bapineuzumab intravenous injection phase III clinical trial, as the drug failed to achieve the expected functional recovery goals in mild to moderate Alzheimer's disease patients who did not carry the ApoE4 gene in the phase III clinical trial. In August 2016, Eli Lilly announced that the FDA had granted fast track status to the clinical development project of oral BACE inhibitor AZD3293 for the treatment of Alzheimer's disease. However, by the end of 2016, its phase III clinical drug Solanezumab had not reached the primary clinical endpoint and was declared a failure. On August 2, 2022, a phase II clinical trial of Roche A β monoclonal antibody Crenezumab was declared unsuccessful. On November 14th of the same year, the Phase III clinical trial of the Alzheimer's disease (AD) drug (ganteneruma) under development failed.
In the face of such a high failure rate in research and development, the silence of the Alzheimer's disease drug market can also be understood.
However, under the blessing of the law of scarcity, its utility increases exponentially.
Taking Lenvatinib as an example, according to Eisai's Q1 2024 financial report, Lenvatinib has achieved growth in the past three months, with sales of approximately $41 million, a year-on-year increase of+8785%. Among them, the revenue in the US market is about 28 million US dollars, and the sales in the Chinese market are about 10 million yuan. Eisai predicts that Leqembi's global revenue will reach approximately $370 million in fiscal year 2024, and Leqembi's global sales may reach $7 billion by 2030.