BioArctic and Eisai's Leqembi BLA Accepted in China for Subcutaneous Use
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 06 2026
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Should l Buy BIOA?
Source: Newsfilter
- Application Acceptance: BioArctic and Eisai's Biologics License Application for the subcutaneous formulation of Leqembi (lecanemab) has been accepted by China's NMPA, potentially making it the first at-home anti-amyloid treatment in the country, significantly enhancing patient convenience in medication administration.
- Market Potential: Eisai estimates that there were 17 million patients with mild cognitive impairment or mild dementia in China in 2024, a number expected to rise with the aging population, positioning Leqembi to meet the increasing market demand effectively.
- Innovative Treatment Method: The new 500mg subcutaneous injection allows for weekly home administration, replacing the current biweekly IV treatment in hospitals, which is anticipated to reduce healthcare resource consumption and streamline the overall Alzheimer's treatment pathway.
- International Collaboration: The long-term partnership between BioArctic and Eisai, established in 2005, not only highlights their combined R&D capabilities but also lays a solid foundation for BioArctic's commercialization efforts in the Nordic region, further strengthening its competitive position in the global Alzheimer's treatment landscape.
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Analyst Views on BIOA
Wall Street analysts forecast BIOA stock price to rise
4 Analyst Rating
2 Buy
2 Hold
0 Sell
Moderate Buy
Current: 19.940
Low
15.00
Averages
37.00
High
73.00
Current: 19.940
Low
15.00
Averages
37.00
High
73.00
About BIOA
BioAge Labs, Inc. is a clinical-stage biopharmaceutical company developing therapeutic product candidates for metabolic diseases, such as obesity, by targeting the biology of human aging. Its lead product is BGE-102, a structurally novel, orally available small molecule NLRP3 inhibitor with high potency and brain penetration. In preclinical obesity models, BGE-102 resulted in weight loss as both a monotherapy and in combination with a GLP-1R agonist. Its pipeline includes novel, orally available, brain-penetrant small-molecule NLRP3 inhibitors to treat metabolic diseases and conditions driven by neuroinflammation, as well as novel APJ agonists for metabolic disorders. In preclinical obesity models, APJ agonism has demonstrated the ability to more than double the weight loss induced by a GLP-1R agonist while also restoring healthy body composition and improving muscle function.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
BioArctic to Release Q4 2025 Report on February 18, 2026
- Report Release Schedule: BioArctic AB will publish its Q4 2025 report on February 18, 2026, at 08:00 CET, showcasing the company's latest advancements in neurodegenerative disease treatments.
- Investor Presentation: Following the report, CEO Gunilla Osswald and CFO Anders Martin-Löf will hold an investor presentation at 09:30 CET on the same day to interpret the report and engage in a Q&A session, enhancing interaction with investors.
- Diverse Participation Options: Investors can participate via webcast or teleconference, with the webcast allowing for written questions and the teleconference enabling verbal inquiries, thereby improving information transparency.
- Company Background: BioArctic focuses on innovative treatment solutions, particularly its Leqembi®, the world's first drug proven to slow the progression of early Alzheimer's disease, highlighting the company's leadership in the biopharmaceutical sector.
See More
Leqembi Receives Priority Review in China
- Priority Review Approval: Eisai announced that the Biologics License Application (BLA) for Leqembi (lecanemab) for early Alzheimer's disease has received Priority Review from China's National Medical Products Administration, which is expected to accelerate the drug's market entry to meet rising patient demand.
- Home Administration Option: The new subcutaneous autoinjector (SC-AI) allows for a once-weekly home administration, replacing the current biweekly IV treatment, which is anticipated to significantly enhance patient convenience and adherence, thereby improving quality of life.
- Significant Market Potential: Eisai estimates that there were approximately 17 million patients with Mild Cognitive Impairment or mild dementia in China in 2024, a number expected to rise with an aging population, indicating a growing demand for Leqembi in the market.
- Innovative Drug Insurance Coverage: Leqembi has been included in the
See More
Leqembi Receives Priority Review in China
- Priority Review Granted: Eisai announced that the Biologics License Application (BLA) for Leqembi has been designated for Priority Review by China's National Medical Products Administration, marking a significant advancement in the treatment of early Alzheimer's disease and is expected to expedite its market launch.
- New Home Administration Option: The subcutaneous autoinjector (SC-AI) allows for a once-weekly home administration, replacing the current biweekly intravenous method in hospitals, which is anticipated to significantly enhance patient convenience and adherence to treatment.
- Significant Market Potential: Eisai estimates that there were approximately 17 million patients with Mild Cognitive Impairment or mild dementia in China in 2024, a number expected to rise with an aging population, making Leqembi's approval crucial for providing better treatment options.
- Innovative Drug Insurance Coverage: Leqembi has been included in the
See More
Leqembi Receives Priority Review in China
- Priority Review Granted: Eisai announced that the Biologics License Application (BLA) for Leqembi (lecanemab) for early Alzheimer's disease has been designated for Priority Review by China's National Medical Products Administration, which is expected to accelerate the drug's market launch and provide faster treatment options for patients.
- Home Administration Convenience: The new subcutaneous autoinjector (SC-AI) allows for a once-weekly home administration, replacing the current biweekly IV injections, which is anticipated to significantly enhance patient adherence to treatment and alleviate healthcare resource burdens.
- Significant Market Potential: Eisai estimates that there were approximately 17 million patients with Mild Cognitive Impairment or mild dementia in China in 2024, a number expected to rise with the aging population, indicating a substantial increase in potential demand for Leqembi.
- Innovative Drug Insurance Coverage: Leqembi has been included in the
See More
BioArctic's Leqembi Sales Surge in Q4 2025
- Significant Sales Growth: In Q4 2025, global sales of Leqembi reached JPY 20.7 billion, representing a 21% increase compared to Q4 2024, resulting in SEK 127 million in royalties for BioArctic, highlighting its strong performance in the Alzheimer's treatment market.
- Currency Impact Notable: The strong appreciation of the Swedish krona in 2025 means that, at constant exchange rates, BioArctic's royalty increase would have been approximately 50%, indicating enhanced competitiveness in the global market.
- Positive Future Outlook: Eisai is set to release its Q3 FY2025 results on February 9, 2026, while BioArctic will publish its full-year 2025 report on February 18, 2026, which is expected to further reveal Leqembi's market potential and the company's financial health.
- Deepening Strategic Collaboration: The long-term partnership between BioArctic and Eisai, established in 2005 with key agreements in 2007 and 2015, has laid the groundwork for Leqembi's success, with BioArctic accelerating its commercialization preparations in the Nordic region.
See More
BioArctic and Eisai Submit New Drug Application for Lecanemab
- Drug Application Submission: Eisai has submitted a Marketing Authorisation Variation to the EMA for lecanemab, proposing to transition maintenance dosing from biweekly to every four weeks, aiming to enhance patient convenience and adherence, thereby strengthening market competitiveness.
- Indication Expansion: Lecanemab is currently indicated for patients with mild cognitive impairment and early Alzheimer's disease, particularly targeting ApoE ε4 non-carriers or heterozygotes, which is expected to further broaden its application in Alzheimer's treatment and increase the company's market share in this domain.
- Clinical Research Progress: Eisai's AHEAD 3-45 study is ongoing, focusing on individuals with preclinical Alzheimer's disease, which is anticipated to provide crucial data on the long-term efficacy of lecanemab, further solidifying its market position.
- Strategic Partnership: BioArctic has maintained a long-term collaboration with Eisai since 2005 for the development of lecanemab, with BioArctic holding commercialization rights in the Nordic region, and this application will facilitate their joint commercialization efforts in that area.
See More
BioArctic to Release Q4 2025 Report on February 18, 2026
- Report Release Schedule: BioArctic AB will publish its Q4 2025 report on February 18, 2026, at 08:00 CET, showcasing the company's latest advancements in neurodegenerative disease treatments.
- Investor Presentation: Following the report, CEO Gunilla Osswald and CFO Anders Martin-Löf will hold an investor presentation at 09:30 CET on the same day to interpret the report and engage in a Q&A session, enhancing interaction with investors.
- Diverse Participation Options: Investors can participate via webcast or teleconference, with the webcast allowing for written questions and the teleconference enabling verbal inquiries, thereby improving information transparency.
- Company Background: BioArctic focuses on innovative treatment solutions, particularly its Leqembi®, the world's first drug proven to slow the progression of early Alzheimer's disease, highlighting the company's leadership in the biopharmaceutical sector.
See More
Leqembi Receives Priority Review in China
- Priority Review Approval: Eisai announced that the Biologics License Application (BLA) for Leqembi (lecanemab) for early Alzheimer's disease has received Priority Review from China's National Medical Products Administration, which is expected to accelerate the drug's market entry to meet rising patient demand.
- Home Administration Option: The new subcutaneous autoinjector (SC-AI) allows for a once-weekly home administration, replacing the current biweekly IV treatment, which is anticipated to significantly enhance patient convenience and adherence, thereby improving quality of life.
- Significant Market Potential: Eisai estimates that there were approximately 17 million patients with Mild Cognitive Impairment or mild dementia in China in 2024, a number expected to rise with an aging population, indicating a growing demand for Leqembi in the market.
- Innovative Drug Insurance Coverage: Leqembi has been included in the
See More
Leqembi Receives Priority Review in China
- Priority Review Granted: Eisai announced that the Biologics License Application (BLA) for Leqembi has been designated for Priority Review by China's National Medical Products Administration, marking a significant advancement in the treatment of early Alzheimer's disease and is expected to expedite its market launch.
- New Home Administration Option: The subcutaneous autoinjector (SC-AI) allows for a once-weekly home administration, replacing the current biweekly intravenous method in hospitals, which is anticipated to significantly enhance patient convenience and adherence to treatment.
- Significant Market Potential: Eisai estimates that there were approximately 17 million patients with Mild Cognitive Impairment or mild dementia in China in 2024, a number expected to rise with an aging population, making Leqembi's approval crucial for providing better treatment options.
- Innovative Drug Insurance Coverage: Leqembi has been included in the
See More
Leqembi Receives Priority Review in China
- Priority Review Granted: Eisai announced that the Biologics License Application (BLA) for Leqembi (lecanemab) for early Alzheimer's disease has been designated for Priority Review by China's National Medical Products Administration, which is expected to accelerate the drug's market launch and provide faster treatment options for patients.
- Home Administration Convenience: The new subcutaneous autoinjector (SC-AI) allows for a once-weekly home administration, replacing the current biweekly IV injections, which is anticipated to significantly enhance patient adherence to treatment and alleviate healthcare resource burdens.
- Significant Market Potential: Eisai estimates that there were approximately 17 million patients with Mild Cognitive Impairment or mild dementia in China in 2024, a number expected to rise with the aging population, indicating a substantial increase in potential demand for Leqembi.
- Innovative Drug Insurance Coverage: Leqembi has been included in the
See More
BioArctic's Leqembi Sales Surge in Q4 2025
- Significant Sales Growth: In Q4 2025, global sales of Leqembi reached JPY 20.7 billion, representing a 21% increase compared to Q4 2024, resulting in SEK 127 million in royalties for BioArctic, highlighting its strong performance in the Alzheimer's treatment market.
- Currency Impact Notable: The strong appreciation of the Swedish krona in 2025 means that, at constant exchange rates, BioArctic's royalty increase would have been approximately 50%, indicating enhanced competitiveness in the global market.
- Positive Future Outlook: Eisai is set to release its Q3 FY2025 results on February 9, 2026, while BioArctic will publish its full-year 2025 report on February 18, 2026, which is expected to further reveal Leqembi's market potential and the company's financial health.
- Deepening Strategic Collaboration: The long-term partnership between BioArctic and Eisai, established in 2005 with key agreements in 2007 and 2015, has laid the groundwork for Leqembi's success, with BioArctic accelerating its commercialization preparations in the Nordic region.
See More
BioArctic and Eisai Submit New Drug Application for Lecanemab
- Drug Application Submission: Eisai has submitted a Marketing Authorisation Variation to the EMA for lecanemab, proposing to transition maintenance dosing from biweekly to every four weeks, aiming to enhance patient convenience and adherence, thereby strengthening market competitiveness.
- Indication Expansion: Lecanemab is currently indicated for patients with mild cognitive impairment and early Alzheimer's disease, particularly targeting ApoE ε4 non-carriers or heterozygotes, which is expected to further broaden its application in Alzheimer's treatment and increase the company's market share in this domain.
- Clinical Research Progress: Eisai's AHEAD 3-45 study is ongoing, focusing on individuals with preclinical Alzheimer's disease, which is anticipated to provide crucial data on the long-term efficacy of lecanemab, further solidifying its market position.
- Strategic Partnership: BioArctic has maintained a long-term collaboration with Eisai since 2005 for the development of lecanemab, with BioArctic holding commercialization rights in the Nordic region, and this application will facilitate their joint commercialization efforts in that area.
See More
