Leqembi included in China's commercial insurance innovative drug list

Rhea-AI Summary

BioArctic (Nasdaq: B) partner Eisai announced that Leqembi (lecanemab) has been included in China’s new Commercial Insurance Innovative Drug List, effective January 1, 2026. The list enables commercial insurers to negotiate coverage products for listed innovative medicines, aiming to narrow the gap with the National Reimbursement Drug List.

Eisai launched Leqembi in China in June 2024 and estimates 17 million people had MCI or mild dementia due to Alzheimer’s in China in 2024. Leqembi was originally developed by BioArctic and is commercialized in China by Eisai; BioArctic retains Nordic commercialization rights and is preparing joint commercialization with Eisai in that region.

Key Figures

Alzheimer’s MCI/mild dementia patients in China 17 million Estimated 2024 patient population per Eisai

Policy effective date January 1, 2026 Commercial Insurance Innovative Drug List start date

China launch timing June 2024 Leqembi launch in China private market

Market Reality Check

$12.06 Last Close

Volume Volume 7,468,472 is about 0.39x the 20-day average 19,138,203, indicating subdued trading before this news. low

Technical Price at 40.02 is trading above the 200-day MA of 32.53, after a -2.49% day.

Peers on Argus

Gold peers like WPM (-2.98%), FNV (-2.06%), AU (-3.09%), AEM (-2.76%) and KGC (-3.08%) also declined, indicating broader sector weakness alongside the stock’s -2.49% move.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 03	Product launch	Positive	-1.3%	Launch of ETQ Reliance Go EQMS SaaS offering for manufacturers.
Dec 02	Asset divestiture	Positive	-3.1%	Sale of Tongon mine and exploration interests for up to $305M.
Dec 01	IPO evaluation	Positive	+2.4%	Board authorized exploring IPO of North American gold assets.
Nov 26	Asset divestiture	Positive	+4.8%	Completed Hemlo mine divestiture for up to $1.09B consideration.
Nov 26	Board changes	Neutral	+4.8%	Lead Independent Director transition and board refresh announcement.

Pattern Detected

Recent corporate and portfolio news often saw mixed reactions, with some strategic asset sales and restructuring moves selling off despite seemingly constructive narratives, while other portfolio optimization steps were rewarded.

Recent Company History

Over the last few weeks, the company reported several portfolio and corporate governance updates. On Nov 26, it completed the Hemlo divestiture for up to $1.09 billion and announced board changes the same day, which coincided with a +4.75% move. A Tongon divestiture for up to $305 million on Dec 02 led to a -3.07% reaction, while an evaluation of a North American gold assets IPO on Dec 01 saw a +2.39% move. This context frames today’s external-partner drug access news against a backdrop of active portfolio management and strategic reshaping.

Market Pulse Summary

This announcement highlights Leqembi’s inclusion on China’s Commercial Insurance Innovative Drug List, effective January 1, 2026, as a step toward expanding coverage for an estimated 17 million early Alzheimer’s patients. For the company, it adds another external validation point alongside recent portfolio transactions and governance changes. Investors monitoring this story would likely focus on how quickly commercial insurance products form around the list and how this translates into real-world adoption and revenue contributions over time.

Key Terms

mild cognitive impairment medical

"there were 17 million patients with mild cognitive impairment (MCI) or mild dementia"

Mild cognitive impairment (MCI) is a medical condition where a person experiences noticeable decline in memory or thinking that is greater than expected for their age but does not yet interfere significantly with daily life, like forgetting appointments more often while still managing basic tasks. For investors, MCI matters because it defines a target patient group, shapes the size and urgency of markets for diagnostics and treatments, and influences clinical trial design, regulatory pathways and potential revenue for companies developing related drugs or tests.

Alzheimer's Disease medical

"expanding access to early Alzheimer's Disease (AD) treatment in China"

A progressive brain disorder that slowly erodes memory, thinking and the ability to carry out daily tasks as nerve cells are damaged and lost; symptoms typically worsen over years and can lead to severe impairment. Investors care because it drives a large, growing market for diagnostics, treatments and care services, but also carries high scientific, regulatory and commercial risk—similar to developing a complex new product that must pass difficult safety tests before it can reach patients.

dementia medical

"mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease in China"

Dementia is a gradual decline in thinking, memory, and daily functioning caused by damage to the brain, like an operating system losing files and slowing down. Investors should care because dementia drives demand for healthcare services, long-term care, medicines, diagnostics, and caregiver support, creating large, long-term markets and cost pressures that affect healthcare companies, insurers, government spending, and workforce productivity.

commercial insurance financial

"commercial insurance companies will discuss and reach an agreement"

Commercial insurance is a bundle of policies businesses purchase to protect their physical assets, income and legal exposure—covering risks like property damage, lawsuits, business interruption and employee-related claims. It matters to investors because insurance acts like a safety net that limits the chance a single accident or legal claim will create large, unexpected losses; coverage levels and costs therefore affect a company’s risk profile, operating expenses, borrowing terms and valuation.

National Healthcare Security Administration regulatory

"recently introduced by the National Healthcare Security Administration (NHSA) of China"

A national healthcare security administration is a government agency that manages a country’s public health insurance programs, drug reimbursement rules, and large-scale purchasing of medical services and medicines. Think of it as the nation’s chief health insurer and bulk buyer combined: its decisions about which treatments are paid for, at what price, and how procurement is run can quickly change demand, revenue and margins for healthcare companies, so investors watch it closely.

National Reimbursement Drug List regulatory

"the basic reimbursement system under the National Reimbursement Drug List (NRDL)"

A national reimbursement drug list is an official list of medicines that a country's public health system agrees to pay for, fully or in part, so patients pay little or nothing. Think of it like a government-approved shopping list that makes certain drugs affordable and widely available; inclusion usually boosts a drug’s sales and predictable pricing, while exclusion can limit market access and revenue, making it a key factor for investors assessing a drug maker’s future earnings.

clinical development medical

"Eisai is responsible for the clinical development, applications for market approval"

Clinical development is the process of testing a medical treatment in people to prove it is safe and works, moving from small early safety checks to larger trials that measure benefit and side effects. For investors it matters because each successful step reduces uncertainty and brings a product closer to regulatory approval and sales—like moving a prototype through road tests before mass production—while failures or delays can dramatically cut expected value.

market approval regulatory

"clinical development, applications for market approval and commercialization of Leqembi"

Market approval is the official permission from a government regulator that allows a product—most often a drug, medical device, or other regulated offering—to be sold to the public. For investors, market approval is a major milestone because it clears a key legal hurdle, unlocks the ability to generate revenue, and meaningfully reduces the risk that the product will be barred from sale; think of it like a safety inspection that lets a new car legally hit the road and earn money.

AI-generated analysis. Not financial advice.

STOCKHOLM, Dec. 8, 2025 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that Leqembi® (lecanemab), has been included in the "Commercial Insurance Innovative Drug List", recently introduced by the National Healthcare Security Administration (NHSA) of China. The inclusion of Leqembi in this list marks a meaningful step toward expanding access to early Alzheimer's Disease (AD) treatment in China.

The Commercial Insurance Innovative Drug List is based on new policies of the Chinese government to support the development and access of innovative medicines. The list aims to help narrow the coverage gap between the basic reimbursement system under the National Reimbursement Drug List (NRDL) and innovative medicines that address areas of significant unmet need. Based on the Commercial Insurance Innovative Drug List, commercial insurance companies will discuss and reach an agreement with pharmaceutical companies regarding coverage details and develop insurance products focusing on the listed medicines. The Commercial Insurance Innovative Drug List is scheduled to take effect on January 1, 2026.

Eisai estimates that there were 17 million patients with mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease in China in 2024, which is expected to increase with the aging of the population.

Eisai launched Leqembi in China in June 2024 and has delivered the product in the private market.

Leqembi is the result of a long-standing collaboration between BioArctic and Eisai, and the antibody was originally developed by BioArctic based on the work of Professor Lars Lannfelt and his discovery of the Arctic mutation in Alzheimer's disease. Eisai is responsible for the clinical development, applications for market approval and commercialization of Leqembi for Alzheimer's disease. BioArctic has the right to commercialize Leqembi in the Nordic region together with Eisai and the two companies are preparing for a joint commercialization in the region.

---

The information was released for public disclosure, through the agency of the contact person below, on December 9, 2025, at 00:30 a.m. CET.

For further information, please contact: 
Oskar Bosson, VP Communications and Investor Relations
E-mail: oskar.bosson@bioarctic.com
Telephone: +46 704 107 180

About lecanemab (Leqembi^®)
Lecanemab is the result of a strategic research alliance between BioArctic and Eisai. It is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ).

Lecanemab is approved in 51 countries and is under regulatory review in 9 countries. Following the initial phase with treatment every two weeks for 18 months, intravenous (IV) maintenance dosing with treatment every four weeks is approved in the United Kingdom, China, the U.S. and other countries, and applications have been filed in 4 countries and regions. In the U.S., Leqembi Iqlik™ is approved for subcutaneous dosing with an autoinjector for maintenance treatment of early Alzheimer's disease (AD). In November 2025, a rolling sBLA application to the U.S. FDA for the subcutaneous initiation dosing with Leqembi Iqlik was also completed and a new drug application for subcutaneous formulation of Leqembi was submitted in Japan.

Since July 2020, Eisai's Phase 3 clinical study (AHEAD 3-45) with lecanemab in individuals with preclinical Alzheimer's disease meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. The study was fully recruited in October 2024. AHEAD 3-45 is a four-year study conducted as a public-private partnership between Eisai, Biogen and the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the U.S., funded by the National Institute on Aging, part of the National Institutes of Health. Since January 2022, the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing and includes lecanemab as the backbone anti-amyloid therapy.

About the collaboration between BioArctic and Eisai
Since 2005, BioArctic has a long-term collaboration with Eisai regarding the development and commercialization of drugs for the treatment of Alzheimer's disease. The most important agreements are the Development and Commercialization agreement for the lecanemab antibody, which was signed 2007, and the Development and Commercialization agreement for the antibody Leqembi back-up for Alzheimer's disease, which was signed 2015. In 2014, Eisai and Biogen entered into a joint development and commercialization agreement for lecanemab. Eisai is responsible for the clinical development, application for market approval and commercialization of the products for Alzheimer's disease. BioArctic has the right to commercialize lecanemab in the Nordic region and is currently preparing for commercialization in the Nordics together with Eisai. BioArctic has no development costs for lecanemab in Alzheimer's disease and is entitled to payments in connection with sales milestones as well as royalties on global sales.

About BioArctic AB
BioArctic AB (publ) is a Swedish research-based biopharma company focusing on innovative treatments that can delay or stop the progression of neurodegenerative diseases. The company invented Leqembi® (lecanemab) – the world's first drug proven to slow the progression of the disease and reduce cognitive impairment in early Alzheimer's disease. Leqembi has been developed together with BioArctic's partner Eisai, who are responsible for regulatory interactions and commercialization globally. In addition to Leqembi, BioArctic has a broad research portfolio with antibodies against Parkinson's disease and ALS as well as additional projects against Alzheimer's disease. Several of the projects utilize the company's proprietary BrainTransporter™ technology, which has the potential to actively transport antibodies across the blood-brain barrier to enhance the efficacy of the treatment. BioArctic's B share (BIOA B) is listed on Nasdaq Stockholm Large Cap. For further information, please visit www.bioarctic.com.

This information was brought to you by Cision http://news.cision.com

https://news.cision.com/bioarctic/r/leqembi-included-in-china-s-commercial-insurance-innovative-drug-list,c4278794

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SOURCE BioArctic

FAQ

What does Leqembi inclusion on China's Commercial Insurance Innovative Drug List mean for patients and insurers?

Inclusion allows commercial insurers to negotiate coverage products for Leqembi, potentially expanding patient access starting January 1, 2026.

When does Leqembi’s coverage under China’s Commercial Insurance Innovative Drug List take effect for Eisai (B partner)?

January 1, 2026 is the scheduled effective date for the Commercial Insurance Innovative Drug List.

How many Chinese patients did Eisai estimate could be affected by wider Leqembi access in 2024?

Eisai estimated about 17 million patients with MCI or mild dementia due to Alzheimer’s in China in 2024.

When did Eisai launch Leqembi in China and who handles commercialization?

Eisai launched Leqembi in China in June 2024 and is responsible for clinical development, approval filings, and commercialization there.

What are BioArctic’s commercialization rights for Leqembi (symbol B)?

BioArctic holds the right to commercialize Leqembi in the Nordic region together with Eisai and is preparing joint commercialization efforts.

Will inclusion on the list automatically put Leqembi on China’s basic reimbursement list (NRDL)?

No; the Commercial Insurance Innovative Drug List is separate and enables commercial insurance coverage discussions rather than automatic NRDL inclusion.