Global Healthcare Analyst

Tina Banerjee

Equity Bottom-Up

<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> received a conditional approval of IZERVAY (avacincaptad pegol intravitreal solution) in Japan for the suppression of geographic atrophy (GA) growth in atrophic age-related macular degeneration (AMD).</li>
<li>In Q1FY26, with 25% YoY revenue growth, Izervay reported record high quarterly sales of ¥16B. The drug continues to be preferred treatment for new patient start (market share of ~55%).</li>
<li>For FY26, Astellas projects revenue of ¥470B from strategic brands, of which Izervay is expected to around ~¥105B. This will gradually accelerate in coming fiscals with Japan sales falling in.</li>
</ul>



Astellas Pharma (4503 JP) received a conditional approval of IZERVAY (avacincaptad pegol intravitreal solution) in Japan for the suppression of geographic atrophy (GA) growth in atrophic age-related macular degeneration (AMD).
In Q1FY26, with 25% YoY revenue growth, Izervay reported record high quarterly sales of ¥16B. The drug continues to be preferred treatment for new patient start (market share of ~55%).
For FY26, Astellas projects revenue of ¥470B from strategic brands, of which Izervay is expected to around ~¥105B. This will gradually accelerate in coming fiscals with Japan sales falling in.


Astellas Pharma (4503 JP): Izervay Approved In Japan, Strategic Brands Will Be Key In Near Future

Thematic (Sector/Industry)

<ul>
<li>Eisai Initiated rolling submission of sBLA to the FDA for Leqembi subcutaneous autoinjector as a weekly starting dose. Hansoh Pharmaceutical’s innovative drug Xinyue got additional indication approval in China.</li>
<li>Jiangsu Hengrui received marketing approval of its self-developed Class 1 innovative drug, Zeprumetostat in China. Celltrion got approval in Europe to start Phase 3 trial of its Darzalex biosimilar.</li>
<li>SK Bioscience applied for Phase 3 clinical trial of SKYVaricella in South Korea to add the 2-dose indication. Lupin received FDA approval for risperidone extended-release injectable suspension.</li>
</ul>


Eisai Initiated rolling submission of sBLA to the FDA for Leqembi subcutaneous autoinjector as a weekly starting dose. Hansoh Pharmaceutical’s innovative drug Xinyue got additional indication approval in China.
Jiangsu Hengrui received marketing approval of its self-developed Class 1 innovative drug, Zeprumetostat in China. Celltrion got approval in Europe to start Phase 3 trial of its Darzalex biosimilar.
SK Bioscience applied for Phase 3 clinical trial of SKYVaricella in South Korea to add the 2-dose indication. Lupin received FDA approval for risperidone extended-release injectable suspension.


APAC Healthcare Weekly (September 7) – Eisai, Hansoh, Hengrui, Celltrion, SK Bioscience, Lupin

<ul>
<li>During Q1FY26, <a href="https://www.smartkarma.com/entities/eisai-co-ltd" target="_blank" data-smartkarma-citation="entities:21001:1" rel="noopener">Eisai Co Ltd (4523 JP)</a> reported 55% YoY increase in operating profit to ¥21B, on just 7% YoY growth in revenue to ¥203B. The company reiterated FY guidance.</li>
<li>During Q1FY26, Leqembi revenue increased 269% YoY and 57% QoQ to ¥23B, driven by growth across all the regions. Eisai has guided for FY26 Leqembi revenue of ¥77B (+73% YoY).</li>
<li>The U.S. approval of Leqembi SC-AI maintenance dosing and the drug’s European launch are the key near-term triggers.</li>
</ul>


During Q1FY26, Eisai Co Ltd (4523 JP) reported 55% YoY increase in operating profit to ¥21B, on just 7% YoY growth in revenue to ¥203B. The company reiterated FY guidance.
During Q1FY26, Leqembi revenue increased 269% YoY and 57% QoQ to ¥23B, driven by growth across all the regions. Eisai has guided for FY26 Leqembi revenue of ¥77B (+73% YoY).
The U.S. approval of Leqembi SC-AI maintenance dosing and the drug’s European launch are the key near-term triggers.


Eisai Co Ltd (4523 JP): Impressive 1Q Result; Subcutaneous Leqembi Is Key for Future Growth

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<li>
<a href="https://www.smartkarma.com/entities/kyowa-kirin-co-ltd" target="_blank" data-smartkarma-citation="entities:18055:1" rel="noopener">Kyowa Kirin Co Ltd (4151 JP)</a> revenue declined 1% YoY to ¥230.7B, impacted by APAC business restructuring, reduced drug prices in Japan, despite the growth in North America and EMEA.</li>
<li>The company remains heavily dependent on Crysvita generating almost 43% of the total revenue of the company. Crysvita sales rose 10% YoY to ¥99.8B in 1H25.</li>
<li>The next big trigger to the stock price would be the FDA decision on approval of ziftomenib, due in November.</li>
</ul>



Kyowa Kirin Co Ltd (4151 JP) revenue declined 1% YoY to ¥230.7B, impacted by APAC business restructuring, reduced drug prices in Japan, despite the growth in North America and EMEA.
The company remains heavily dependent on Crysvita generating almost 43% of the total revenue of the company. Crysvita sales rose 10% YoY to ¥99.8B in 1H25.
The next big trigger to the stock price would be the FDA decision on approval of ziftomenib, due in November.


Kyowa Kirin (4151 JP): 1H25 Stay Muted, Guidance Reaffirmed, Ziftomenib Approval Decision Awaited

<ul>
<li>
<a href="https://www.smartkarma.com/entities/sumitomo-pharma-co" target="_blank" data-smartkarma-citation="entities:1935:1" rel="noopener">Sumitomo Pharma (4506 JP)</a> reported 19% YoY (negative Fx impact of 7%) revenue growth during Q1FY26 to ¥108B, mainly driven by North America.</li>
<li>Orgovyx witnessed growth in medicare patients due to reduction in out-of-pocket caps and Gemtesa on the other hand improved market share employing price focussed strategy.</li>
<li>Sumitomo Pharma is well on track moving ahead of the significant losses suffered in FY23 and FY24, focusing on expanding revenue, reducing costs, and securing future business drivers.</li>
</ul>



Sumitomo Pharma (4506 JP) reported 19% YoY (negative Fx impact of 7%) revenue growth during Q1FY26 to ¥108B, mainly driven by North America.
Orgovyx witnessed growth in medicare patients due to reduction in out-of-pocket caps and Gemtesa on the other hand improved market share employing price focussed strategy.
Sumitomo Pharma is well on track moving ahead of the significant losses suffered in FY23 and FY24, focusing on expanding revenue, reducing costs, and securing future business drivers.


Sumitomo Pharma (4506 JP): Orgovyx, Gemtesa Strong; Promise in Oncology and Regenerative Line Up

Japan

Shionogi & Company Ltd., is a pharmaceutical company. The Company develops prescription & over-the-counter drugs and diagnostics.

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Shionogi & Co (4507 JP)

Astellas Pharma (4503 JP): Izervay Approved In Japan, Strategic Brands Will Be Key In Near Future

Astellas Pharma's Izervay receives conditional approval in Japan for age-related macular degeneration. Izervay witnessed record high sales in...

Tina Banerjee

APAC Healthcare Weekly (September 7) – Eisai, Hansoh, Hengrui, Celltrion, SK Bioscience, Lupin

Eisai initiated FDA submission of Leqembi subcutaneous injection as starting dose. Hansoh and Hengrui got approvals for new drugs. Celltrion got...

Tina Banerjee

Eisai Co Ltd (4523 JP): Impressive 1Q Result; Subcutaneous Leqembi Is Key for Future Growth

Eisai gets FDA nod for once weekly Leqembi subcutaneous autoinjector for maintenance dosing. The introduction of easy-to-use SC-AI will allow for...

Tina Banerjee

Kyowa Kirin (4151 JP): 1H25 Stay Muted, Guidance Reaffirmed, Ziftomenib Approval Decision Awaited

Kyowa Kirin 1H revenue declines 1% YoY to ¥230.7B, impacted by APAC restructuring and reduced drug prices in Japan. FDA decision on ziftomenib in...

Tina Banerjee

Sumitomo Pharma (4506 JP): Orgovyx, Gemtesa Strong; Promise in Oncology and Regenerative Line Up

Sumitomo Pharma sees 19% YoY revenue growth in Q1FY26 driven by North America. The company is well on track for moving ahead of the significant...

Tina Banerjee

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Astellas Pharma (4503 JP): Izervay Approved In Japan, Strategic Brands Will Be Key In Near Future

​Astellas Pharma's Izervay receives conditional approval in Japan for age-related macular degeneration. Izervay witnessed record high sales in...

Tina Banerjee

APAC Healthcare Weekly (September 7) – Eisai, Hansoh, Hengrui, Celltrion, SK Bioscience, Lupin

Eisai initiated FDA submission of Leqembi subcutaneous injection as starting dose. Hansoh and Hengrui got approvals for new drugs. Celltrion got...

Tina Banerjee

Eisai Co Ltd (4523 JP): Impressive 1Q Result; Subcutaneous Leqembi Is Key for Future Growth

Eisai gets FDA nod for once weekly Leqembi subcutaneous autoinjector for maintenance dosing. The introduction of easy-to-use SC-AI will allow for...

Tina Banerjee

Kyowa Kirin (4151 JP): 1H25 Stay Muted, Guidance Reaffirmed, Ziftomenib Approval Decision Awaited

​Kyowa Kirin 1H revenue declines 1% YoY to ¥230.7B, impacted by APAC restructuring and reduced drug prices in Japan. FDA decision on ziftomenib in...

Tina Banerjee

Sumitomo Pharma (4506 JP): Orgovyx, Gemtesa Strong; Promise in Oncology and Regenerative Line Up

​Sumitomo Pharma sees 19% YoY revenue growth in Q1FY26 driven by North America. The company is well on track for moving ahead of the significant...

Tina Banerjee

Astellas Pharma's Izervay receives conditional approval in Japan for age-related macular degeneration. Izervay witnessed record high sales in...

Kyowa Kirin 1H revenue declines 1% YoY to ¥230.7B, impacted by APAC restructuring and reduced drug prices in Japan. FDA decision on ziftomenib in...

Sumitomo Pharma sees 19% YoY revenue growth in Q1FY26 driven by North America. The company is well on track for moving ahead of the significant...