Global Healthcare Analyst

Tina Banerjee

Equity Bottom-Up

<ul>
<li>A US court found <a href="https://www.smartkarma.com/entities/nippon-shinyaku-co-ltd" target="_blank" data-smartkarma-citation="entities:6634:1" rel="noopener">Nippon Shinyaku (4516 JP)</a> guilty of patent infringement related to competitor <a href="https://www.smartkarma.com/entities/sarepta-therapeutics-inc" target="_blank" data-smartkarma-citation="entities:17729:1" rel="noopener">Sarepta Therapeutics (SRPT US)</a>'s DMD drug Vyondys 53 and asked to pay $115M as compensation.  </li>
<li>The jury verdict will have no bearing on Viltepso sales. Nippon Shinyaku disagreed with the verdict, and is considering all options including post jury motions and appeals.</li>
<li>An additional expense to the tune of $115M would surely be a huge drag on the profitability of the company which is already under pressure because of rising costs.</li>
</ul>


A US court found Nippon Shinyaku (4516 JP) guilty of patent infringement related to competitor Sarepta Therapeutics (SRPT US)'s DMD drug Vyondys 53 and asked to pay $115M as compensation.  
The jury verdict will have no bearing on Viltepso sales. Nippon Shinyaku disagreed with the verdict, and is considering all options including post jury motions and appeals.
An additional expense to the tune of $115M would surely be a huge drag on the profitability of the company which is already under pressure because of rising costs.


Nippon Shinyaku (4516 JP): Unfavorable Patent Verdict; Company Vows to Fight Back

Thematic (Sector/Industry)

<ul>
<li>Simcere entered into license agreement with Vigonvita for new indications of Deuterated Remdesivir Hydrobromide. Kelun Biotech inked partnership with Crescent Biopharma to develop and commercialize oncology therapeutics, including novel combinations.</li>
<li>Samsung Biologics is acquiring land for third campus in Songdo, Icheon for KRW249B. SK Biopharmaceutical signed supply agreement with Eckert &amp; Ziegler for actinium-225 for the development of next-generation radiopharmaceutical.</li>
<li>Daiichi Sankyo won a court appeal for its long-running legal battle with Seagen. Biocon made settlement agreement with Amgen clearing commercialization path for its Denosumab biosimilars in Europe and RoW.</li>
</ul>


Simcere entered into license agreement with Vigonvita for new indications of Deuterated Remdesivir Hydrobromide. Kelun Biotech inked partnership with Crescent Biopharma to develop and commercialize oncology therapeutics, including novel combinations.
Samsung Biologics is acquiring land for third campus in Songdo, Icheon for KRW249B. SK Biopharmaceutical signed supply agreement with Eckert &amp; Ziegler for actinium-225 for the development of next-generation radiopharmaceutical.
Daiichi Sankyo won a court appeal for its long-running legal battle with Seagen. Biocon made settlement agreement with Amgen clearing commercialization path for its Denosumab biosimilars in Europe and RoW.


APAC Healthcare Weekly (December 7) – Simcere, Kelun Bio, Samsung Biologics, Daiichi Sankyo, Biocon

<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 7.9% YoY jump in revenue during H1FY26 driven by Beova, Tavneos and IT services amidst price revision pressures and generic competition.</li>
<li>Kissei beat their H1FY26 guidance numbers. This compelled the company to revise their FY26 guidance numbers upwards.</li>
<li>An NDA application was submitted in Japan in February 2025 for Linzagolix. The next big trigger would be Linzagolix receiving the approval for treatment of uterine fibroids in Japan.  </li>
</ul>



Kissei Pharmaceutical (4547 JP) reported 7.9% YoY jump in revenue during H1FY26 driven by Beova, Tavneos and IT services amidst price revision pressures and generic competition.
Kissei beat their H1FY26 guidance numbers. This compelled the company to revise their FY26 guidance numbers upwards.
An NDA application was submitted in Japan in February 2025 for Linzagolix. The next big trigger would be Linzagolix receiving the approval for treatment of uterine fibroids in Japan.  


Kissei Pharmaceutical (4547 JP): Guidance Upward Revision a Positive; Beova & Tavneos Still Key

<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

<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

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.

Price Gauge
52-week Range	0.00 - 0.00
Market Cap (USDm)	0.00
P/E	0.00
Dividend (Yield)	0.00

Nippon Shinyaku (4516 JP)