Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<ul>
<li>Nippon Shinyaku filed NDA of tagraxofusp for a rare aggressive hematologic malignancy in Japan. Shionogi initiated rolling NDA submission to the FDA for Xocova for COVID-19 post-exposure prophylaxis.</li>
<li>Beigene is discontinuing clinical development program for ociperlimab, as a potential treatment for lung cancer. Celltrion received positive CHMP opinion for the addition of the Omlyclo autoinjector formulation.  </li>
<li>The first three children with SR-aGvHD will receive a course of Mesoblast’s Ryoncil commencing this week. Lupin is acquiring UK-based Renascience Pharma, a sole supplier of 4 specialty products.</li>
</ul>


Nippon Shinyaku filed NDA of tagraxofusp for a rare aggressive hematologic malignancy in Japan. Shionogi initiated rolling NDA submission to the FDA for Xocova for COVID-19 post-exposure prophylaxis.
Beigene is discontinuing clinical development program for ociperlimab, as a potential treatment for lung cancer. Celltrion received positive CHMP opinion for the addition of the Omlyclo autoinjector formulation.  
The first three children with SR-aGvHD will receive a course of Mesoblast’s Ryoncil commencing this week. Lupin is acquiring UK-based Renascience Pharma, a sole supplier of 4 specialty products.


APAC Healthcare Weekly (April 6)- Nippon Shinyaku, Shionogi, Beigene, Celltrion, Mesoblast, Lupin

Equity Bottom-Up

<ul>
<li>During 9MFY25, <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> reported revenue growth of 8% YoY to ¥121B, while operating profit stood at ¥33B, up 8% YoY.</li>
<li>Viltepso witnessed growth both in Japan and the U.S. and licensing income also increased on higher overseas sales of Uptravi.</li>
<li>Guidance for FY25 have been raised with sales now expected to be ¥160B, up 8% YoY.</li>
</ul>


During 9MFY25, Nippon Shinyaku (4516 JP) reported revenue growth of 8% YoY to ¥121B, while operating profit stood at ¥33B, up 8% YoY.
Viltepso witnessed growth both in Japan and the U.S. and licensing income also increased on higher overseas sales of Uptravi.
Guidance for FY25 have been raised with sales now expected to be ¥160B, up 8% YoY.


Nippon Shinyaku (4516 JP): Strong 9MFY25 Numbers; FY25 Guidance Raised; Regular Launches Remain Key

Japan Specialist

Mark Chadwick

<ul>
<li>The Nikkei Stock Average declined 738 yen (1.9%) in the second week of January as heavy-weight stocks sell-off</li>
<li>Nintendo (7974 JP) ended the trading week marginally higher by 0.7% after a partial unveiling of its new Swich 2 Console. Less earnings cyclicality, but less upside?</li>
<li>The BoJ looks set to lift interest rates again next week, unless market turbulence following Trump's  inauguration, delays the inevitable</li>
</ul>


The Nikkei Stock Average declined 738 yen (1.9%) in the second week of January as heavy-weight stocks sell-off
Nintendo (7974 JP) ended the trading week marginally higher by 0.7% after a partial unveiling of its new Swich 2 Console. Less earnings cyclicality, but less upside?
The BoJ looks set to lift interest rates again next week, unless market turbulence following Trump's  inauguration, delays the inevitable


Japan Strategy Weekly | Nintendo’s Switch and Trump’s Return

<ul>
<li>BeiGene has received FDA approved for Tevimbra for the first-line treatment of certain types of gastric cancers. Innovent announced a collaboration and exclusive license agreement with Roche for an ADC.</li>
<li>CSPC Pharmaceutical got clinical trial approval in China for Leuprorelin extended-release Injection. Sichuan Kelun-Biotech received China approval for tagitanlimab in nasopharyngeal cancer.</li>
<li>Hutchmed China is divesting its 45% equity interest in joint venture for $608M. Yuhan Corp has received European approval for its lung cancer drug Leclaza.</li>
</ul>


BeiGene has received FDA approved for Tevimbra for the first-line treatment of certain types of gastric cancers. Innovent announced a collaboration and exclusive license agreement with Roche for an ADC.
CSPC Pharmaceutical got clinical trial approval in China for Leuprorelin extended-release Injection. Sichuan Kelun-Biotech received China approval for tagitanlimab in nasopharyngeal cancer.
Hutchmed China is divesting its 45% equity interest in joint venture for $608M. Yuhan Corp has received European approval for its lung cancer drug Leclaza.


APAC Healthcare Weekly (Jan 5)- Beigene, Innovent Biologics, CSPC Pharma, Hutchmed, Yuhan, Lupin

<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

Japan

HISAMITSU PHARMACEUTICAL CO., INC. produces and sells pharmaceutical products. The Company's main product is anti-inflammatory analgesic plasters and poultices sold under the brand name Salonpas.  Hisamitsu Pharmaceutical exports its products to North America and Southeast Asia.  The Company also researches and develops antibacterial products through its related company, RRF.

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Hisamitsu Pharmaceutical Co (4530 JP)

APAC Healthcare Weekly (April 6)- Nippon Shinyaku, Shionogi, Beigene, Celltrion, Mesoblast, Lupin

Nippon Shinyaku and Shionogi are filing for new drugs. Beigene dropped a phase 3 oncology asset. Mesoblast is about to start treatment with...

Tina Banerjee

Nippon Shinyaku (4516 JP): Strong 9MFY25 Numbers; FY25 Guidance Raised; Regular Launches Remain Key

Nippon Shinyaku sees high single-digit revenue and profit growth in 9MFY25, with Viltepso and Uptravi driving sales increase. FY25 sales guidance...

Tina Banerjee

Japan Strategy Weekly | Nintendo’s Switch and Trump’s Return

Nikkei Stock Average drops due to heavy-weight stock sell-off, Nintendo sees slight gain with new console unveiling, BoJ likely to raise interest...

Mark Chadwick

APAC Healthcare Weekly (Jan 5)- Beigene, Innovent Biologics, CSPC Pharma, Hutchmed, Yuhan, Lupin

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

Tina Banerjee

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

US court orders Nippon Shinyaku to pay $115M for patent infringement on Sarepta Therapeutics' DMD drug Vyondys 53. This will significantly impact...

Tina Banerjee

Price Gauge

52-week Range

Market Cap (USDm)

P/E

Dividend (Yield)

APAC Healthcare Weekly (April 6)- Nippon Shinyaku, Shionogi, Beigene, Celltrion, Mesoblast, Lupin

Nippon Shinyaku and Shionogi are filing for new drugs. Beigene dropped a phase 3 oncology asset. Mesoblast is about to start treatment with...

Tina Banerjee

Nippon Shinyaku (4516 JP): Strong 9MFY25 Numbers; FY25 Guidance Raised; Regular Launches Remain Key

​Nippon Shinyaku sees high single-digit revenue and profit growth in 9MFY25, with Viltepso and Uptravi driving sales increase. FY25 sales guidance...

Tina Banerjee

Japan Strategy Weekly | Nintendo’s Switch and Trump’s Return

​Nikkei Stock Average drops due to heavy-weight stock sell-off, Nintendo sees slight gain with new console unveiling, BoJ likely to raise interest...

Mark Chadwick

APAC Healthcare Weekly (Jan 5)- Beigene, Innovent Biologics, CSPC Pharma, Hutchmed, Yuhan, Lupin

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

Tina Banerjee

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

​US court orders Nippon Shinyaku to pay $115M for patent infringement on Sarepta Therapeutics' DMD drug Vyondys 53. This will significantly impact...

Tina Banerjee

Nippon Shinyaku sees high single-digit revenue and profit growth in 9MFY25, with Viltepso and Uptravi driving sales increase. FY25 sales guidance...

Nikkei Stock Average drops due to heavy-weight stock sell-off, Nintendo sees slight gain with new console unveiling, BoJ likely to raise interest...

US court orders Nippon Shinyaku to pay $115M for patent infringement on Sarepta Therapeutics' DMD drug Vyondys 53. This will significantly impact...