The Zhitong Finance App learned that Fangzheng Securities released a research report saying that AD is a difficult global disease, and the treatment and diagnosis market is broad. Currently, many domestic companies are investing in relevant research. It is recommended to focus on Hengrui Pharmaceutical (600276.SH), Haizheng Pharmaceutical (600267.SH), etc. in drug development. In terms of diagnostic reagents, it is recommended to focus on Dongcheng Pharmaceutical (002675.SZ) to maintain a “recommended” rating for the pharmaceutical industry.

Incidents:

On January 9, lecanemab (lecanemab) was approved for the treatment of early-stage Alzheimer's disease (AD), that is, AD-derived mild cognitive impairment (MCI) and mild AD dementia, which confirm amyloid pathology.

▍ The main views of Fangzheng Securities are as follows:

1) Open a new era of AD from “symptomatic treatment” to “causal treatment”.

Scientists believe that the accumulation of soluble beta amyloid protein (“fibrils”) is the real cause of AD. The luncanizumab jointly developed by Eisai Japan and Bojian of the United States can accurately bind to the most toxic Abeta fibrils and then be ingested by immune cells, thereby stopping damage to neuronal cells.

Clinically, the decline in cognitive (37%), daily and social abilities of patients with early Alzheimer's disease was significantly delayed, and the course of the disease was delayed (549% slower), and some early-stage patients even reversed the course of the disease. Luncanizumab is regarded as the first drug to date with clear evidence that it can slow the progression of Alzheimer's disease.

2) Domestic approval of luncanemab will effectively promote the development of the Alzheimer's treatment and diagnosis market in China, which is of far-reaching significance.

Lecanemab is the first new drug for Alzheimer's disease to be fully approved by the FDA in 20 years. Eisai predicts that by 2030, the annual AD treatment cost of Lecanemab of 26,500 US dollars will generate 7 billion US dollars (about 50 billion yuan) of global sales. China has a huge Alzheimer's patient base. In 2019, the number of existing AD and other dementia patients in China was 13.24 million, and the diagnosis and treatment market for this symptom is vast. In 2024, lecanemab's sales are estimated to be around RMB 224 million, with a peak sales of around RMB 3,073 million. Furthermore, with the launch of lecanemab, it is expected to drive the gradual growth of the AD testing market.

According to the “Chinese Alzheimer's Disease Dementia Diagnosis and Treatment Guidelines”, there are currently three main methods for Alzheimer's diagnosis: clinical evaluation, brain imaging, and laboratory examination. Clinical evaluation is a routine test, and the performance is average. Currently, the standard for testing Alzheimer's disease is PET/CT brain imaging or cerebrospinal fluid testing, but cerebrospinal fluid testing requires puncture, so PET/CT brain imaging is currently the main diagnostic method.

In terms of PET testing, Xiantong Pharmaceutical's Ovenin (fluorine [18F] betaben injection) was officially approved by the National Drug Administration (NMPA) in September 2023. This is the first Aβ-PET tracer approved in China for the diagnosis of Alzheimer's disease; in addition, Dongcheng Pharmaceutical's 18f-lobepine injection targeting Aβ has been declared for marketing with CDE. The TAU protein PET tracer 18f-florolotau is in the global phase III clinical phase and is expected to be submitted for NDA in 2024.

Risk warning:

AD drug and diagnostic research and development fell short of expectations; marketing fell short of expectations; industry policies fell short of expectations, etc.