Global Healthcare Analyst

Tina Banerjee

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

<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>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

<ul>
<li>Daiichi Sankyo announced positive topline result from the phase 3 trial of Enhertu in gastric cancer. Kyorin Pharmaceutical outlicensed KRP-M223, a preclinical mast-cell-targeting candidate for chronic spontaneous urticaria, to Novartis.</li>
<li>Celltrion received FDA approval for Stoboclo and Osenvelt, biosimilars referencing Prolia and Xgeva, respectively. Zydus Lifesciences expects to start the development of world’s first combination vaccine against shigellosis and typhoid.</li>
<li>Biocon received FDA approval for lenalidomide capsules, indicated for types of multiple myeloma, and some other hematologic indications and dasatinib tablets for the treatment of chronic myeloid leukemia.</li>
</ul>


Daiichi Sankyo announced positive topline result from the phase 3 trial of Enhertu in gastric cancer. Kyorin Pharmaceutical outlicensed KRP-M223, a preclinical mast-cell-targeting candidate for chronic spontaneous urticaria, to Novartis.
Celltrion received FDA approval for Stoboclo and Osenvelt, biosimilars referencing Prolia and Xgeva, respectively. Zydus Lifesciences expects to start the development of world’s first combination vaccine against shigellosis and typhoid.
Biocon received FDA approval for lenalidomide capsules, indicated for types of multiple myeloma, and some other hematologic indications and dasatinib tablets for the treatment of chronic myeloid leukemia.


APAC Healthcare Weekly (Mar 9)- Daiichi Sankyo, Kyorin Pharma, Celltrion, Zydus Lifesciences, Biocon

<ul>
<li>Hansoh Pharmaceutical announced that a new indication of Xinyue has been included in the Priority Review. Astellas Pharma announced positive update from the Phase 3 EV-302 clinical trial.</li>
<li>CSL has received EU approval for HAE drug, Andemry. Imugene announce more positive results from its Phase 1b trial of azer-cel, an allogenic therapy in relapsed/refractory diffuse large B-cell lymphoma.</li>
<li>LigaChem Bio signed technology transfer agreement for a new anticancer target antibody for the development of ADC candidates with Daan Biotherapeutics. Lupin received FDA approval for generic Atrovent Nasal Spray.</li>
</ul>


Hansoh Pharmaceutical announced that a new indication of Xinyue has been included in the Priority Review. Astellas Pharma announced positive update from the Phase 3 EV-302 clinical trial.
CSL has received EU approval for HAE drug, Andemry. Imugene announce more positive results from its Phase 1b trial of azer-cel, an allogenic therapy in relapsed/refractory diffuse large B-cell lymphoma.
LigaChem Bio signed technology transfer agreement for a new anticancer target antibody for the development of ADC candidates with Daan Biotherapeutics. Lupin received FDA approval for generic Atrovent Nasal Spray.


APAC Healthcare Weekly (Feb 16)- Hansoh Pharma, Astellas Pharma, CSL, Imugene, LigaChem Bio, Lupin

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)