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>CSPC Pharmaceutical’s NDA for Anbenitamab injection has been accepted in China. Phase 2 trial of Lead candidate of TransThera Sciences, Tinengotinib in combination with Fulvestrant for breast cancer got approval.</li>
<li>Samsung Biologics signed CMO contract worth $1.3B with a U.S.-based pharmaceutical company. Daiichi Sankyo reported positive clinical trial result for ifinatamab deruxtecan in SCLC.</li>
<li>Sun Pharmaceutical’s Halol facility is under import alert, resulting in the refusal of shipments from the facility into the U.S. Biocon inaugurates its first U.S. manufacturing facility in New Jersey.</li>
</ul>


CSPC Pharmaceutical’s NDA for Anbenitamab injection has been accepted in China. Phase 2 trial of Lead candidate of TransThera Sciences, Tinengotinib in combination with Fulvestrant for breast cancer got approval.
Samsung Biologics signed CMO contract worth $1.3B with a U.S.-based pharmaceutical company. Daiichi Sankyo reported positive clinical trial result for ifinatamab deruxtecan in SCLC.
Sun Pharmaceutical’s Halol facility is under import alert, resulting in the refusal of shipments from the facility into the U.S. Biocon inaugurates its first U.S. manufacturing facility in New Jersey.


APAC Healthcare Weekly (September 14)–CSPC Pharm, TransThera, Samsung Bio, Daiichi Sankyo, Sun Pharm

<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>
<a href="https://www.smartkarma.com/entities/kissei-pharmaceutical-co-ltd" target="_blank" data-smartkarma-citation="entities:18303:1" rel="noopener">Kissei Pharmaceutical (4547 JP)</a> reported 4.9% YoY jump in revenue during Q1FY26 driven by Beova and Tavneos amidst price revision pressures and generic competition.</li>
<li>The company partially revised FY26 guidance down for ordinary profit and operating profit accounting for an anticipated in-licensing agreement coming their way.</li>
<li>The next trigger for the stock would be Linzagolix receiving approval for treatment of uterine fibroids in Japan and new in-licensing agreement.  </li>
</ul>



Kissei Pharmaceutical (4547 JP) reported 4.9% YoY jump in revenue during Q1FY26 driven by Beova and Tavneos amidst price revision pressures and generic competition.
The company partially revised FY26 guidance down for ordinary profit and operating profit accounting for an anticipated in-licensing agreement coming their way.
The next trigger for the stock would be Linzagolix receiving approval for treatment of uterine fibroids in Japan and new in-licensing agreement.  


Kissei Pharmaceutical (4547 JP): Beova & Tavneos Still Key, Linzagolix Japan Approval Next Trigger

<ul>
<li>Shanghai Henlius Biotech initiated Phase 3 U.S. clinical trial for HLX22 for gastroesophageal junction and gastric cancer. CanSino Biologics obtained clinical trial approval in China for polio vaccine.</li>
<li>FDA rejected Nippon Shinyaku’s new drug application for CAP-1002 for DMD. JCR Pharmaceuticals announced license agreement with Acumen Pharmaceuticals to develop Alzheimer’s disease drug using JCR’s BBB -penetrating technology platform.</li>
<li>Mesoblast recorded $13.2M revenue from Ryoncil post-launch March 28 through June 30. Sun Pharma launched Leqselvi in the U.S. for the treatment of adults with severe alopecia areata.</li>
</ul>


Shanghai Henlius Biotech initiated Phase 3 U.S. clinical trial for HLX22 for gastroesophageal junction and gastric cancer. CanSino Biologics obtained clinical trial approval in China for polio vaccine.
FDA rejected Nippon Shinyaku’s new drug application for CAP-1002 for DMD. JCR Pharmaceuticals announced license agreement with Acumen Pharmaceuticals to develop Alzheimer’s disease drug using JCR’s BBB -penetrating technology platform.
Mesoblast recorded $13.2M revenue from Ryoncil post-launch March 28 through June 30. Sun Pharma launched Leqselvi in the U.S. for the treatment of adults with severe alopecia areata.


APAC Healthcare Weekly (July 20) – Henlius Bio, CanSino, Nippon Shinyaku, JCR, Mesoblast, Sun Pharma

Japan

Nippon Shinyaku Co., Ltd. manufactures pharmaceutical and health foods products. The Company produces drugs for urinary, nerve, respiratory, and circulatory systems as well as analgesic and anti-inflammatory drugs.  Nippon Shinyaku also develops synthetic anti-bacterial agents.

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Nippon Shinyaku (4516 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 (September 14)–CSPC Pharm, TransThera, Samsung Bio, Daiichi Sankyo, Sun Pharm

CSPC Pharma’s NDA for Anbenitamab injection has been accepted in China. TransThera got trial approval for lead candidate. Samsung Bio signed $1.3B...

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

Kissei Pharmaceutical (4547 JP): Beova & Tavneos Still Key, Linzagolix Japan Approval Next Trigger

Kissei Pharmaceutical sees 5% sales growth in Q1FY26 despite price revision and competition. The company has revised FY26 guidance down due to in...

Tina Banerjee

APAC Healthcare Weekly (July 20) – Henlius Bio, CanSino, Nippon Shinyaku, JCR, Mesoblast, Sun Pharma

Henlius Bio initiates P3 U.S. trial for cancer drug. FDA rejected Nippon Shinyaku’s new drug filing. JCR partners with Acumen to develop...

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 (September 14)–CSPC Pharm, TransThera, Samsung Bio, Daiichi Sankyo, Sun Pharm

CSPC Pharma’s NDA for Anbenitamab injection has been accepted in China. TransThera got trial approval for lead candidate. Samsung Bio signed $1.3B...

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

Kissei Pharmaceutical (4547 JP): Beova & Tavneos Still Key, Linzagolix Japan Approval Next Trigger

​Kissei Pharmaceutical sees 5% sales growth in Q1FY26 despite price revision and competition. The company has revised FY26 guidance down due to in...

Tina Banerjee

APAC Healthcare Weekly (July 20) – Henlius Bio, CanSino, Nippon Shinyaku, JCR, Mesoblast, Sun Pharma

Henlius Bio initiates P3 U.S. trial for cancer drug. FDA rejected Nippon Shinyaku’s new drug filing. JCR partners with Acumen to develop...

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...

Kissei Pharmaceutical sees 5% sales growth in Q1FY26 despite price revision and competition. The company has revised FY26 guidance down due to in...