On July 4, Lecanemab, the second monoclonal antibody drug targeting beta-amyloid protein (Aβ) jointly developed by Bojiang and Weichai, was approved for listing. In terms of product structure, the operating income of 10-30 billion yuan products is 401/1288/60 million yuan respectively.
On July 3, Eli Lilly and Co announced that the US Food and Drug Administration (FDA) has approved Kisunla (generic name: Donanemab) for the treatment of adults with early symptomatic Alzheimer's disease (AD), including patients with mild cognitive impairment and those in the early dementia stage of neurodegenerative disease.
In addition to the above two drugs, Aduhelm, the aducanumab monoclonal antibody (aducanumab, trade name Aduhelm) jointly developed by Bojiang and Weichai, was approved for accelerated listing in 2021 and became the first drug that can slow down the progression of AD, while previously approved drugs only alleviated dementia symptoms in patients.
However, controversy followed the approval of Aduhelm: the results of the two Phase 3 clinical trials were contradictory, and the clinical benefits were not clear. Due to the huge controversy surrounding accelerated approval, Medicare, the US federal health insurance, has specifically adopted regulations that only pay for the drug costs in clinical trials, rather than fully approved beta-amyloid protein antibody drugs. This regulation has made Aducanumab the fastest drug in medical history to go from listing to market failure rollercoaster.
On January 31 of this year, Bojiang announced that it would stop the development and listing of the intravenous injection of ADUHELM (aducanumab-avwa) 100mg/mL injection.
In July 2023, Lunkenai monoclonal antibody was fully approved in the United States for the treatment of AD, becoming the first AD drug to be fully approved by the FDA in 20 years, while Eli Lilly's Kisunla is the second drug in the US market aimed at slowing down the progression of Alzheimer's disease.
Drug development for Alzheimer's disease has always been referred to as the 'valley of death' by academia. Data from the American Prescription Drug Production and Research Association show that the total research and development investment in AD worldwide has exceeded 600 billion US dollars, and more than 300 clinical drugs have failed, with a failure rate of up to 99.6%. Some industry insiders pointed out that the approval of two drugs not only represents more and more drugs starting to cross the 'valley of death,' but also means that the beta-amyloid protein antibody drugs that are of interest to the market are truly starting to move towards commercialization.
Regarding the dosing frequency and price of the two drugs: Lundbeck monoclonal antibody needs to be administered once every two weeks, Donanemab once every four weeks. The unit price of Eli Lilly's Alzheimer's disease drug is higher, reaching $695.65 per bottle, with an annual treatment cost of $32000, while Lundbeck monoclonal antibody's treatment cost in the US is about $26500. However, Eli Lilly emphasized that Donanemab can stop treatment after removing amyloid plaques, and the actual total treatment cost of patients will depend on when they complete treatment.
Alzheimer's disease (AD) is a neurodegenerative disease with insidious onset and progressive development, characterized clinically by cognitive impairment, behavioral abnormalities, and deterioration of social and life functions. Among Chinese people aged 60 or older, the prevalence of Alzheimer's disease is 3.9%, which is equivalent to 9.83 million people with Alzheimer's disease.
According to the research report of Huafu Securities, due to the high research and development threshold, there are relatively few participants in the Chinese AD new drug research and development market. Domestic manufacturers are currently mainly focused on inhibiting acetylcholinesterase (AChE) inhibitors and methyldopa -D-aspartic acid (NMDA) receptor antagonists, which are mostly in the early stage of clinical development. These include tonghua golden-horse pharmaceutical industry co,ltd's ambrutanol tablets, simcere pharma's varoglutamstat hydrochloride tablets, and Shandong Xinhua Pharmaceutical's OAB-14 granule suspensions.
Regarding Aβ inhibitors, the main drugs currently under research and development in China include Jiangsu Hengrui Pharmaceuticals' Aβ monoclonal antibody SHR-1707. Lecanemab, the beta-amyloid protein antibody drug that has been approved in the United States, has the fastest progress in antibody drug development in China. It was declared for listing in December 2022 and has entered the Boao Lecheng International Medical Tourism Pioneer Zone in Hainan. Eli Lilly's Donanemab will be applied for listing in China on October 31, 2023.