Global Healthcare Analyst

Tina Banerjee

Equity Bottom-Up

<ul>
<li>
<a href="https://www.smartkarma.com/entities/kaken-pharmaceutical-co-ltd" target="_blank" data-smartkarma-citation="entities:18819:1" rel="noopener">Kaken Pharmaceutical (4521 JP)</a> reported rather underwhelming earnings in H1FY26, with revenue, operating profit and net profit witnessing significant drop as upfront payments received last fiscal put pressure.</li>
<li>Kaken’s major drug Clenafin saw revenue rise 1.5% to ¥9.3B on AG launch, while Ecclock helped drive revenue growing 12% YoY to ¥1.5B.</li>
<li>FY26 guidance revised downwards to ¥86.3B (down 8% YoY). Kaken needs an immediate strong revenue driver to rescue it from pangs of drug price revision and generic competition.</li>
</ul>



Kaken Pharmaceutical (4521 JP) reported rather underwhelming earnings in H1FY26, with revenue, operating profit and net profit witnessing significant drop as upfront payments received last fiscal put pressure.
Kaken’s major drug Clenafin saw revenue rise 1.5% to ¥9.3B on AG launch, while Ecclock helped drive revenue growing 12% YoY to ¥1.5B.
FY26 guidance revised downwards to ¥86.3B (down 8% YoY). Kaken needs an immediate strong revenue driver to rescue it from pangs of drug price revision and generic competition.


Kaken Pharma (4521 JP): Bleaker FY26 Ahead, Growth Pangs to Continue for Now

Thematic (Sector/Industry)

<ul>
<li>Takeda has dropped AstraZeneca-partnered antibody drug candidate from its pipeline. Eisai and Merck are closing late-stage trial of Lenvima plus Keytruda in hepatocellular carcinoma on disappointing result.</li>
<li>Wuxi AppTec sharpens CRDMO business by selling its China-based clinical research subsidiaries. FDA has designated Celltrion’s Stoboclo and Osenvelt as interchangeable biosimilars to the reference products Prolia and Xgeva, respectively.</li>
<li>CSL is delaying demerger of CSL Seqirus ‘to maximise shareholder value.’ PharmaEssentia has filed for the additional indication of Besremi for Essential Thrombocythemia (ET) with the FDA.</li>
</ul>


Takeda has dropped AstraZeneca-partnered antibody drug candidate from its pipeline. Eisai and Merck are closing late-stage trial of Lenvima plus Keytruda in hepatocellular carcinoma on disappointing result.
Wuxi AppTec sharpens CRDMO business by selling its China-based clinical research subsidiaries. FDA has designated Celltrion’s Stoboclo and Osenvelt as interchangeable biosimilars to the reference products Prolia and Xgeva, respectively.
CSL is delaying demerger of CSL Seqirus ‘to maximise shareholder value.’ PharmaEssentia has filed for the additional indication of Besremi for Essential Thrombocythemia (ET) with the FDA.


APAC Healthcare Weekly (November 2) – Takeda, Eisai, Wuxi AppTec, Celltrion, CSL, PharmaEssentia

<ul>
<li>InnoCare Pharma granted global rights to Zenas BioPharm to develop and commercialize an experimental drug, orelabrutinib for multiple sclerosis and other autoimmune conditions. The deal is worth of $2B+.</li>
<li>Daiichi Sankyo submitted application for additional indication of Enhertu as first-line therapy for HER2 positive breast cancer in Japan. Celltrion got FDA clearance for its Eylea biosimilar, Eydenzelt.</li>
<li>Mesoblast announced gross revenue of $22M from Ryoncil for the quarter ended September 30, 2025, up 66% QoQ. Lupin will invest $250M for new pharmaceutical manufacturing plant in Florida.</li>
</ul>


InnoCare Pharma granted global rights to Zenas BioPharm to develop and commercialize an experimental drug, orelabrutinib for multiple sclerosis and other autoimmune conditions. The deal is worth of $2B+.
Daiichi Sankyo submitted application for additional indication of Enhertu as first-line therapy for HER2 positive breast cancer in Japan. Celltrion got FDA clearance for its Eylea biosimilar, Eydenzelt.
Mesoblast announced gross revenue of $22M from Ryoncil for the quarter ended September 30, 2025, up 66% QoQ. Lupin will invest $250M for new pharmaceutical manufacturing plant in Florida.


APAC Healthcare Weekly (October 12) – InnoCare, Daiichi Sankyo, Celltrion, Mesoblast, Lupin

<ul>
<li>
<a href="https://www.smartkarma.com/entities/kaken-pharmaceutical-co-ltd" target="_blank" data-smartkarma-citation="entities:18819:1" rel="noopener">Kaken Pharmaceutical (4521 JP)</a> witnessed 3% YoY revenue growth in 1QFY26 to ¥18.9B as overseas pharmaceutical and crop protection sales while domestic market remained under pressure.</li>
<li>Kaken’s major drug Clenafin saw revenue drop 3% to ¥4.4B on patent cliff, while Ecclock helped drive revenue growing 18% YoY to ¥803M.</li>
<li>Kaken reiterated FY26 guidance where it expects revenue to fall 6% YoY to ¥88 billion. No respite from immediate pangs in the form of drug price revision and generic competition.</li>
</ul>



Kaken Pharmaceutical (4521 JP) witnessed 3% YoY revenue growth in 1QFY26 to ¥18.9B as overseas pharmaceutical and crop protection sales while domestic market remained under pressure.
Kaken’s major drug Clenafin saw revenue drop 3% to ¥4.4B on patent cliff, while Ecclock helped drive revenue growing 18% YoY to ¥803M.
Kaken reiterated FY26 guidance where it expects revenue to fall 6% YoY to ¥88 billion. No respite from immediate pangs in the form of drug price revision and generic competition.


Kaken Pharma (4521 JP): FY26 Starts on a Bleak Note as Expected, Growth Pangs to Stay for Now

<ul>
<li>Celltrion is acquiring a biopharmaceutical production plant in the U.S. capable of producing key biopharmaceuticals. Alteogen received positive opinion from European Medicines Agency for its Eylea biosimilar.</li>
<li>Wuxi Biologics has begun construction for new modular Drug Product facility in Singapore. CSPC Pharmaceutical entered into an exclusive license agreement with Madrigal Pharmaceuticals, for its oral GLP-1 drug candidate.</li>
<li>Jiangsu Hengrui Pharmaceuticals has entered into agreements with GlaxoSmithKline, to grant GSK an exclusive worldwide right (excluding China) of HRS-9821 and up to 11 other programs.</li>
</ul>


Celltrion is acquiring a biopharmaceutical production plant in the U.S. capable of producing key biopharmaceuticals. Alteogen received positive opinion from European Medicines Agency for its Eylea biosimilar.
Wuxi Biologics has begun construction for new modular Drug Product facility in Singapore. CSPC Pharmaceutical entered into an exclusive license agreement with Madrigal Pharmaceuticals, for its oral GLP-1 drug candidate.
Jiangsu Hengrui Pharmaceuticals has entered into agreements with GlaxoSmithKline, to grant GSK an exclusive worldwide right (excluding China) of HRS-9821 and up to 11 other programs.


APAC Healthcare Weekly (Aug 3)– Celltrion, Alteogen, Wuxi Bio, CSPC, Jiangsu Hengrui, Eisai, Kissei

Japan

KISSEI PHARMACEUTICAL CO., LTD. manufactures and sells a variety of prescription drugs.  The Company's main products are for cholesterol, high blood pressure, digestion, allergy, circulatory and respiratory diseases, and Parkinson's disease.

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Kissei Pharmaceutical (4547 JP)

Kaken Pharma (4521 JP): Bleaker FY26 Ahead, Growth Pangs to Continue for Now

Kaken Pharmaceutical (4521 JP) reports underwhelming H1FY26 earnings with significant drops in revenue and profit. Needs strong revenue driver to...

Tina Banerjee

APAC Healthcare Weekly (November 2) – Takeda, Eisai, Wuxi AppTec, Celltrion, CSL, PharmaEssentia

Takeda and Eisai witnessed clinical trials setback. Wuxi AppTec is selling China-based CRO subsidiaries. CSL is delaying demerger of CSL Seqirus....

Tina Banerjee

APAC Healthcare Weekly (October 12) – InnoCare, Daiichi Sankyo, Celltrion, Mesoblast, Lupin

InnoCare stuck outlicensing deal with Zenas Bio. Daiichi Sankyo filed for label expansion of Enhertu in Japan. Celltrion got FDA nod for Eylea...

Tina Banerjee

Kaken Pharma (4521 JP): FY26 Starts on a Bleak Note as Expected, Growth Pangs to Stay for Now

Kaken Pharmaceutical saw 3% revenue growth in 1QFY26 supported by overseas sales. Major drug revenue dropped. Growth pangs are here to stay. FY26...

Tina Banerjee

APAC Healthcare Weekly (Aug 3)– Celltrion, Alteogen, Wuxi Bio, CSPC, Jiangsu Hengrui, Eisai, Kissei

Celltrion is acquiring a biopharmaceutical production plant in US. Wuxi Bio starts construction of new facility. CSPC and Jiangsu Hengrui stuck...

Tina Banerjee

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Kaken Pharma (4521 JP): Bleaker FY26 Ahead, Growth Pangs to Continue for Now

​Kaken Pharmaceutical (4521 JP) reports underwhelming H1FY26 earnings with significant drops in revenue and profit. Needs strong revenue driver to...

Tina Banerjee

APAC Healthcare Weekly (November 2) – Takeda, Eisai, Wuxi AppTec, Celltrion, CSL, PharmaEssentia

Takeda and Eisai witnessed clinical trials setback. Wuxi AppTec is selling China-based CRO subsidiaries. CSL is delaying demerger of CSL Seqirus....

Tina Banerjee

APAC Healthcare Weekly (October 12) – InnoCare, Daiichi Sankyo, Celltrion, Mesoblast, Lupin

InnoCare stuck outlicensing deal with Zenas Bio. Daiichi Sankyo filed for label expansion of Enhertu in Japan. Celltrion got FDA nod for Eylea...

Tina Banerjee

Kaken Pharma (4521 JP): FY26 Starts on a Bleak Note as Expected, Growth Pangs to Stay for Now

​Kaken Pharmaceutical saw 3% revenue growth in 1QFY26 supported by overseas sales. Major drug revenue dropped. Growth pangs are here to stay. FY26...

Tina Banerjee

APAC Healthcare Weekly (Aug 3)– Celltrion, Alteogen, Wuxi Bio, CSPC, Jiangsu Hengrui, Eisai, Kissei

Celltrion is acquiring a biopharmaceutical production plant in US. Wuxi Bio starts construction of new facility. CSPC and Jiangsu Hengrui stuck...

Tina Banerjee

Kaken Pharmaceutical (4521 JP) reports underwhelming H1FY26 earnings with significant drops in revenue and profit. Needs strong revenue driver to...

Kaken Pharmaceutical saw 3% revenue growth in 1QFY26 supported by overseas sales. Major drug revenue dropped. Growth pangs are here to stay. FY26...