Global Healthcare Analyst

Tina Banerjee

Equity Bottom-Up

<ul>
<li>In 4Q24, <a href="https://www.smartkarma.com/entities/beigene-ltd" target="_blank" data-smartkarma-citation="entities:27352:1" rel="noopener">BeiGene (6160 HK)</a> reported U.S. sales of Brukinsa of $616M, up 97% YoY and 22% QoQ, with 60%+ of demand growth coming from expanded use in CLL. </li>
<li>Brukinsa holds 25% market share in new patient starts in the U.S. in CLL, followed by Calquence (20%). For the first time, Brukinsa’s quarterly U.S. revenue outpaced that of Calquence.</li>
<li>Beigene has guided for 2025 revenue of $4.9–5.3B (up 29–39% YoY), driven by Brukinsa’s U.S. leadership position and continued global expansion in both Europe and other markets.</li>
</ul>


In 4Q24, BeiGene (6160 HK) reported U.S. sales of Brukinsa of $616M, up 97% YoY and 22% QoQ, with 60%+ of demand growth coming from expanded use in CLL. 
Brukinsa holds 25% market share in new patient starts in the U.S. in CLL, followed by Calquence (20%). For the first time, Brukinsa’s quarterly U.S. revenue outpaced that of Calquence.
Beigene has guided for 2025 revenue of $4.9–5.3B (up 29–39% YoY), driven by Brukinsa’s U.S. leadership position and continued global expansion in both Europe and other markets.


BeiGene (6160 HK): Brukinsa Outpaces Competitor in 4Q US Sales; Solid Guidance for 2025

Thematic (Sector/Industry)

<ul>
<li>Daiichi Sankyo received seventh FDA approval for Enhertu in certain types of breast cancers. Eisai received FDA approval for Leqembi’s intravenous monthly maintenance dosing.</li>
<li>Nippon Shinyaku entered into an option agreement with AB2 BIO for the rights of commercialization of Tadekinig alfa in the U.S. for certain rare autoinflammatory diseases.</li>
<li>Shionogi announced positive results from Phase 2 trial of its novel investigational RSV oral antiviral candidate S-337395. Celltrion has received FDA approval for Actemra biosimilar.</li>
</ul>


Daiichi Sankyo received seventh FDA approval for Enhertu in certain types of breast cancers. Eisai received FDA approval for Leqembi’s intravenous monthly maintenance dosing.
Nippon Shinyaku entered into an option agreement with AB2 BIO for the rights of commercialization of Tadekinig alfa in the U.S. for certain rare autoinflammatory diseases.
Shionogi announced positive results from Phase 2 trial of its novel investigational RSV oral antiviral candidate S-337395. Celltrion has received FDA approval for Actemra biosimilar.


APAC Healthcare Weekly (Feb 2)- Daiichi Sankyo, Eisai, Nippon Shinyaku, Shionogi, Celltrion

<ul>
<li>Wuxi Biologics is selling its Ireland vaccine manufacturing facility to Merck for $500M. Astellas Pharma received approval for Vyloy in China for the first-line treatment of gastric cancer.</li>
<li>FDA decision for Otsuka’s label expansion application for brexpiprazole for the treatment of post-traumatic stress disorder will be delayed. EMA has accepted Otsuka’s marketing application for HAE drug candidate donidalorsen.</li>
<li>Samsung Biologics has extended collaboration with LigaChem Biosciences to provide ADC services. Pharmaessentia has announced positive topline results from phase 3 clinical trial of P1101 for Essential Thrombocythemia (ET).</li>
</ul>


Wuxi Biologics is selling its Ireland vaccine manufacturing facility to Merck for $500M. Astellas Pharma received approval for Vyloy in China for the first-line treatment of gastric cancer.
FDA decision for Otsuka’s label expansion application for brexpiprazole for the treatment of post-traumatic stress disorder will be delayed. EMA has accepted Otsuka’s marketing application for HAE drug candidate donidalorsen.
Samsung Biologics has extended collaboration with LigaChem Biosciences to provide ADC services. Pharmaessentia has announced positive topline results from phase 3 clinical trial of P1101 for Essential Thrombocythemia (ET).


APAC Healthcare Weekly (Jan 12)- Wuxi Biologics, Astellas, Otsuka, Samsung Biologics, Pharmaessentia

<ul>
<li>Eoflow Has been ordered by the U.S. Court to pay $452M as damages. Celltrion has submitted clinical trial application for CT-P44 (Darzalex biosimilar) to the FDA.</li>
<li>Takeda Pharmaceutical entered into an exclusive licensing agreement to develop and commercialize a late-stage oncology drug candidate. Medipal and JCR Pharmaceuticals initiated the Phase I/II trial of JR-446 in Japan.</li>
<li>SanBio has completed second production run for Akuugo suspension for intracranial implantation. Aurobindo Pharma’s U.S. arm Eugia has received final approval from the FDA to manufacture and market Pazopanib Tablets.</li>
</ul>


Eoflow Has been ordered by the U.S. Court to pay $452M as damages. Celltrion has submitted clinical trial application for CT-P44 (Darzalex biosimilar) to the FDA.
Takeda Pharmaceutical entered into an exclusive licensing agreement to develop and commercialize a late-stage oncology drug candidate. Medipal and JCR Pharmaceuticals initiated the Phase I/II trial of JR-446 in Japan.
SanBio has completed second production run for Akuugo suspension for intracranial implantation. Aurobindo Pharma’s U.S. arm Eugia has received final approval from the FDA to manufacture and market Pazopanib Tablets.


APAC Healthcare Weekly (Dec 8)- Eoflow, Celltrion, Takeda, Medipal, SanBio, Aurobindo Pharma

<ul>
<li>GenScript Biotech established operations site and logistics center in Australia. Eisai has received positive opinion from CHMP recommending approval of lecanemab. Otsuka forms JV to boost IV supply in US.</li>
<li>Lunit formed strategic alliance in France to expand AI solution deployment. Daiichi Sankyo and AstraZeneca submitted a new BLA for accelerated approval in the U.S. for datopotamab deruxtecan for NSCLC.</li>
<li>Cellid has completed recruiting and dosing all participants in its Phase 3 clinical trial of COVID-19 vaccine targeting Omicron variant. Alembic Pharmaceutical received FDA approval for hypertension drug.</li>
</ul>


GenScript Biotech established operations site and logistics center in Australia. Eisai has received positive opinion from CHMP recommending approval of lecanemab. Otsuka forms JV to boost IV supply in US.
Lunit formed strategic alliance in France to expand AI solution deployment. Daiichi Sankyo and AstraZeneca submitted a new BLA for accelerated approval in the U.S. for datopotamab deruxtecan for NSCLC.
Cellid has completed recruiting and dosing all participants in its Phase 3 clinical trial of COVID-19 vaccine targeting Omicron variant. Alembic Pharmaceutical received FDA approval for hypertension drug.


APAC Healthcare Weekly (Nov 17)- GenScript Biotech, Eisai, Otsuka, Daiichi Sankyo, Cellid, and Lunit

United Kingdom

GlaxoSmithKline PLC operates as a research-based pharmaceutical company. The Company develops, manufactures, and markets vaccines, prescription, and over-the-counter medicines, as well as health-related consumer products. GlaxoSmithKline provides products for infections, depression, skin conditions, asthma, heart and circulatory disease, and cancer.

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GlaxoSmithKline PLC (GSK LN)

BeiGene (6160 HK): Brukinsa Outpaces Competitor in 4Q US Sales; Solid Guidance for 2025

BeiGene's Brukinsa sees significant growth in U.S. sales, surpassing Calquence for the first time, with 60%+ demand growth from expanded use in...

Tina Banerjee

APAC Healthcare Weekly (Feb 2)- Daiichi Sankyo, Eisai, Nippon Shinyaku, Shionogi, Celltrion

APAC healthcare companies continued to get approvals for new products and initiates clinical trials. The companies continued with acquisitions and...

Tina Banerjee

APAC Healthcare Weekly (Jan 12)- Wuxi Biologics, Astellas, Otsuka, Samsung Biologics, Pharmaessentia

APAC healthcare companies got approvals for new products as well as clinical trials. The companies continued with acquisitions and collaborations...

Tina Banerjee

APAC Healthcare Weekly (Dec 8)- Eoflow, Celltrion, Takeda, Medipal, SanBio, Aurobindo Pharma

The insight covers key developments in prominent APAC healthcare companies. These developments are expected to impact the financials of the...

Tina Banerjee

APAC Healthcare Weekly (Nov 17)- GenScript Biotech, Eisai, Otsuka, Daiichi Sankyo, Cellid, and Lunit

Biotech companies expand operations globally with new sites and drug approvals, advancing healthcare solutions and treatments. A phase 3 trial for...

Tina Banerjee

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52-week Range

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BeiGene (6160 HK): Brukinsa Outpaces Competitor in 4Q US Sales; Solid Guidance for 2025

​BeiGene's Brukinsa sees significant growth in U.S. sales, surpassing Calquence for the first time, with 60%+ demand growth from expanded use in...

Tina Banerjee

APAC Healthcare Weekly (Feb 2)- Daiichi Sankyo, Eisai, Nippon Shinyaku, Shionogi, Celltrion

APAC healthcare companies continued to get approvals for new products and initiates clinical trials. The companies continued with acquisitions and...

Tina Banerjee

APAC Healthcare Weekly (Jan 12)- Wuxi Biologics, Astellas, Otsuka, Samsung Biologics, Pharmaessentia

APAC healthcare companies got approvals for new products as well as clinical trials. The companies continued with acquisitions and collaborations...

Tina Banerjee

APAC Healthcare Weekly (Dec 8)- Eoflow, Celltrion, Takeda, Medipal, SanBio, Aurobindo Pharma

The insight covers key developments in prominent APAC healthcare companies. These developments are expected to impact the financials of the...

Tina Banerjee

APAC Healthcare Weekly (Nov 17)- GenScript Biotech, Eisai, Otsuka, Daiichi Sankyo, Cellid, and Lunit

​Biotech companies expand operations globally with new sites and drug approvals, advancing healthcare solutions and treatments. A phase 3 trial for...

Tina Banerjee

BeiGene's Brukinsa sees significant growth in U.S. sales, surpassing Calquence for the first time, with 60%+ demand growth from expanded use in...

Biotech companies expand operations globally with new sites and drug approvals, advancing healthcare solutions and treatments. A phase 3 trial for...