Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<ul>
<li>In its January 2025 meeting, EMA’s human medicines committee (CHMP) recommended eight medicines for approval, including four innovative, three biosimilars, and one generic drugs.</li>
<li>The committee has also recommended extensions of indication for eight medicines that are already authorized in the EU.</li>
<li>Marketing applications for two medicines were withdrawn. Among them, withdrawal of Daiichi Sankyo’s datopotamab deruxtecan for non-squamous non-small cell lung cancer is noteworthy.</li>
</ul>


In its January 2025 meeting, EMA’s human medicines committee (CHMP) recommended eight medicines for approval, including four innovative, three biosimilars, and one generic drugs.
The committee has also recommended extensions of indication for eight medicines that are already authorized in the EU.
Marketing applications for two medicines were withdrawn. Among them, withdrawal of Daiichi Sankyo’s datopotamab deruxtecan for non-squamous non-small cell lung cancer is noteworthy.


CHMP Meeting Update: Eight New Medicines Recommended For Approval

<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

Equity Bottom-Up

<ul>
<li>
<a href="https://www.smartkarma.com/entities/chugai-pharmaceutical-co-ltd" target="_blank" data-smartkarma-citation="entities:4489:1" rel="noopener">Chugai Pharmaceutical (4519 JP)</a> announced stellar performance in 2024, with revenue, operating profit, and net income exceeded revised forecasts, all reaching record highs.</li>
<li>Export of Hemlibra to Roche increased 45% YoY to ¥304B. Roche is seeing strong uptake of Hemlibra in Europe, where the drug reported double-digit growth.</li>
<li>Chugai guided for 2% revenue growth in 2025. Domestic sales are expected to remain flat, while overseas sales are expected to increase 4%. Bottomline to outpace revenue growth.</li>
</ul>



Chugai Pharmaceutical (4519 JP) announced stellar performance in 2024, with revenue, operating profit, and net income exceeded revised forecasts, all reaching record highs.
Export of Hemlibra to Roche increased 45% YoY to ¥304B. Roche is seeing strong uptake of Hemlibra in Europe, where the drug reported double-digit growth.
Chugai guided for 2% revenue growth in 2025. Domestic sales are expected to remain flat, while overseas sales are expected to increase 4%. Bottomline to outpace revenue growth.


Chugai Pharmaceutical (4519 JP): Export Drives 2024 Result; Slower Growth Expected In 2025

<ul>
<li>
<a href="https://www.smartkarma.com/entities/astellas-pharma-inc" target="_blank" data-smartkarma-citation="entities:6091:1" rel="noopener">Astellas Pharma (4503 JP)</a> revised FY25 revenue guidance upward to ¥1900B on robust Xtandi performance and favourable forex movement. Core profits and margins will also see upward revisions and expansions.</li>
<li>The company will record an impairment charge of ¥176B for intangible assets this fiscal. As a result, FY25 operating profit on reported basis will come down to ¥11B from ¥80B.</li>
<li>Recently, Astellas has received approval for Vyloy and label expansion approval for Padcev in China. Label expansion application for Izervay in the U.S. has been accepted by the FDA.</li>
</ul>



Astellas Pharma (4503 JP) revised FY25 revenue guidance upward to ¥1900B on robust Xtandi performance and favourable forex movement. Core profits and margins will also see upward revisions and expansions.
The company will record an impairment charge of ¥176B for intangible assets this fiscal. As a result, FY25 operating profit on reported basis will come down to ¥11B from ¥80B.
Recently, Astellas has received approval for Vyloy and label expansion approval for Padcev in China. Label expansion application for Izervay in the U.S. has been accepted by the FDA.


Astellas Pharma (4503 JP): Xtandi & Forex Lead To Guidance Revision, Impairment Losses One Off Burnt

<ul>
<li>Samsung Biologics secured highest ever contract manufacturing order worth KRW2.07T ($1.4B) from a European pharmaceutical company. The cumulative order volume has now surpassed $17.6B.</li>
<li>FDA has accepted Daiichi Sankyo’s revised filing for Dato-DXd for certain types of non-small cell lung cancer (NSCLC) and Eisai’s BLA for Leqembi subcutaneous autoinjector for weekly maintenance dosing.</li>
<li>Sun Pharma is acquiring Canada-based Antibe Therapeutics, a clinical-stage biotechnological company developing novel drugs primarily focusing on reducing pain and inflammation. Biocon got FDA clearance for insulin facility in Malaysia.</li>
</ul>


Samsung Biologics secured highest ever contract manufacturing order worth KRW2.07T ($1.4B) from a European pharmaceutical company. The cumulative order volume has now surpassed $17.6B.
FDA has accepted Daiichi Sankyo’s revised filing for Dato-DXd for certain types of non-small cell lung cancer (NSCLC) and Eisai’s BLA for Leqembi subcutaneous autoinjector for weekly maintenance dosing.
Sun Pharma is acquiring Canada-based Antibe Therapeutics, a clinical-stage biotechnological company developing novel drugs primarily focusing on reducing pain and inflammation. Biocon got FDA clearance for insulin facility in Malaysia.


APAC Healthcare Weekly (Jan 19)- Samsung Biologics, Daiichi Sankyo, Eisai, Sun Pharma, Biocon

Japan

Eisai Co., Ltd. produces prescription drugs and medical equipment and sells mainly to sales agents and subsidiaries.  Through its subsidiary, Sanko Junyaku, the Company produces and sells diagnostic drugs.  Eisai also markets its products through related companies in the US, Europe, and Asia.  The Company also manufactures and sells foods, livestock feeds, chemical, and agrochemicals.

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Eisai Co Ltd (4523 JP)

CHMP Meeting Update: Eight New Medicines Recommended For Approval

In its January 2025 meeting, CHMP recommended 8 drugs for approval, including 4 innovative, 3 biosimilars, and 1 generic drugs. The committee has...

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

Chugai Pharmaceutical (4519 JP): Export Drives 2024 Result; Slower Growth Expected In 2025

Chugai reports record-breaking performance in 2024, driven by strong Hemlibra exports to Roche. Chugai guided for 2% revenue growth in 2025,...

Tina Banerjee

Astellas Pharma (4503 JP): Xtandi & Forex Lead To Guidance Revision, Impairment Losses One Off Burnt

Astellas Pharma raises FY25 revenue guidance to ¥1900B from ¥1,800B. The company is recording ¥176B impairment charge for intangible assets, which...

Tina Banerjee

APAC Healthcare Weekly (Jan 19)- Samsung Biologics, Daiichi Sankyo, Eisai, Sun Pharma, Biocon

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

Tina Banerjee

Price Gauge

52-week Range

Market Cap (USDm)

P/E

Dividend (Yield)

CHMP Meeting Update: Eight New Medicines Recommended For Approval

In its January 2025 meeting, CHMP recommended 8 drugs for approval, including 4 innovative, 3 biosimilars, and 1 generic drugs. The committee has...

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

Chugai Pharmaceutical (4519 JP): Export Drives 2024 Result; Slower Growth Expected In 2025

​Chugai reports record-breaking performance in 2024, driven by strong Hemlibra exports to Roche. Chugai guided for 2% revenue growth in 2025,...

Tina Banerjee

Astellas Pharma (4503 JP): Xtandi & Forex Lead To Guidance Revision, Impairment Losses One Off Burnt

​Astellas Pharma raises FY25 revenue guidance to ¥1900B from ¥1,800B. The company is recording ¥176B impairment charge for intangible assets, which...

Tina Banerjee

APAC Healthcare Weekly (Jan 19)- Samsung Biologics, Daiichi Sankyo, Eisai, Sun Pharma, Biocon

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

Tina Banerjee

Chugai reports record-breaking performance in 2024, driven by strong Hemlibra exports to Roche. Chugai guided for 2% revenue growth in 2025,...

Astellas Pharma raises FY25 revenue guidance to ¥1900B from ¥1,800B. The company is recording ¥176B impairment charge for intangible assets, which...