Blue Whale News, July 4 (Reporter Tu Jun) Following lecanemab jointly developed by Bojian/Eisai, the second monoclonal antibody drug targeting beta amyloid (Aβ) was approved for marketing.
On July 3, Eli Lilly of the United States announced that the US Food and Drug Administration (FDA) has approved Kisunla (generic name: Donanemab) for the treatment of adults with early symptoms of Alzheimer's disease (AD), including patients with mild cognitive impairment and patients in the mild stage of neurodegenerative dementia.
In fact, in addition to the above two drugs, aducanumab (aducanumab, trade name Aduhelm), which was jointly developed by Bojian/Eisai, was approved for marketing at an accelerated pace in 2021, becoming the first drug that can slow the progression of AD. Previously approved drugs can only relieve symptoms of dementia in patients.
However, once aducanumab was approved, controversy ensued: the results of the two phase 3 clinical trials were conflicting, and the clinical benefits were unclear. However, due to the controversy over the accelerated approval process, the US federal health insurance Medicare introduced in a special way — regulations that are not fully approved for beta-amyloid antibody drugs only pay for drugs in clinical trials. The regulation allowed Aducanumab to go through the fastest rollercoaster transition in pharmaceutical history from launch to failure.
On January 31 this year, Bojian announced that it will stop developing and marketing ADUHELM (aducanumab-avwa) 100 mg/mL injection solution for intravenous administration.
In July 2023, luncanizumab was fully approved in the US to treat AD. It became the first AD drug to be fully approved by the FDA in 20 years, while Eli Lilly's Kisunla is the second drug on the US market aimed at slowing the progression of Alzheimer's disease.
Drug development for Alzheimer's disease has always been called the “Valley of Death” by academics. According to data from the American Pharmaceutical Production and Development Association, the total global R&D investment in AD exceeds 600 billion US dollars, and more than 300 clinical drugs have failed, and the failure rate is as high as 99.6%. Some industry insiders pointed out that now that the two drugs have been approved, not only does it mean that more and more drugs are beginning to cross the 'death valley', but it also means that beta-amyloid antibody drugs that have received market attention have actually begun to embark on the path of commercialization.
In terms of frequency and price of the two drugs, luncanemab needs to be given every two weeks, and Donanemab every four weeks. The unit price of Eli Lilly's Alzheimer's medicine is more expensive, reaching 695.65 US dollars per bottle, and the annual treatment cost is 32,000 US dollars, while the treatment cost of lencarnezumab in the US is about 26,500 US dollars. However, Lilly emphasized that Donanemab can stop treatment after removing amyloid plaques, and the actual total cost of treatment for patients will depend on when the patient completes treatment.
Alzheimer's disease (AD) is a neurodegenerative disease with hidden onset and progressive development. The clinical features are mainly cognitive impairment, abnormal mental behavior, and decreased social life function. Among Chinese people aged 60 and above, the prevalence of Alzheimer's disease is 3.9%, which is equivalent to 9.83 million having Alzheimer's disease.
According to a research report by Huafu Securities, due to the high R&D threshold, there are few participants in the new AD drug development market in China. Currently, domestic manufacturers mainly focus on cholinesterase (AChE) inhibitors and methyl-D-aspartate (NMDA) receptor antagonists, mostly in the early clinical stages. These include Tonghua Jinma's succinyl octahydroaminoacridine tablets, Xiansheng Pharmaceutical's varoglutamstat tablets, and Xinhua Pharmaceuticals' OAB-14 dry suspension.
In terms of Abeta inhibitors, Hengrui Pharmaceutical's Abeta monoclonal antibody SHR-1707 is currently being developed in China. The fastest progress in domestic antibody drug research and development is Lecanemab, which has been approved in the US. It was declared for listing domestically in December 2022. It has now entered the Hainan Boao Lecheng International Medical Tourism Pilot Zone. Lilly Donanemab was declared for listing domestically on October 31, 2023.