Global Healthcare Analyst

Tina Banerjee

Equity Bottom-Up

<ul>
<li>In FY26, <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> revenue grew 7% YoY to ¥170B driven by growth in etical drugs revenue, higher licensing fees and operating profit stood at ¥35.5B (flat YoY).</li>
<li>Viltepso witnessed slowing in US. Licensing income increased on higher overseas sales of Uptravi. Newly launched drugs like Vyxeos and Fintepla continue to show promise.</li>
<li>Company expects FY27 revenue to be ¥200B (up 17% YoY) taking into account Uptravi’s royalty income, U.S. launch of CAP-1002 (deramiocel) and growth in the domestic products.</li>
</ul>


In FY26, Nippon Shinyaku (4516 JP) revenue grew 7% YoY to ¥170B driven by growth in etical drugs revenue, higher licensing fees and operating profit stood at ¥35.5B (flat YoY).
Viltepso witnessed slowing in US. Licensing income increased on higher overseas sales of Uptravi. Newly launched drugs like Vyxeos and Fintepla continue to show promise.
Company expects FY27 revenue to be ¥200B (up 17% YoY) taking into account Uptravi’s royalty income, U.S. launch of CAP-1002 (deramiocel) and growth in the domestic products.


Nippon Shinyaku (4516 JP): FY27 Guidance Signals Recovery, Speed Bumps Remain

Thematic (Sector/Industry)

<ul>
<li>Hansoh’s fourth-generation EGFR TKI HS-10504 tablets secured Breakthrough Therapy Designation in China for NSCLC. Junshi Biosciences got 13th indication expansion approval for toripalimab for HER2-expressing locally advanced or metastatic UC.</li>
<li>Daiichi Sankyo secured FDA approval for Enhertu’s two new breast cancer indications. The company’s Datroway got U.S. approval for TNBC. Japan approved NHI price for SanBio’s Akuugo.</li>
<li>Hanmi Pharmaceutical initiated domestic Phase 3 trial to expand indication for efpeglenatide beyond obesity to include the treatment of diabetes. Yuhan Corp signed $140M API supply contract with Gilead Sciences.</li>
</ul>


Hansoh’s fourth-generation EGFR TKI HS-10504 tablets secured Breakthrough Therapy Designation in China for NSCLC. Junshi Biosciences got 13th indication expansion approval for toripalimab for HER2-expressing locally advanced or metastatic UC.
Daiichi Sankyo secured FDA approval for Enhertu’s two new breast cancer indications. The company’s Datroway got U.S. approval for TNBC. Japan approved NHI price for SanBio’s Akuugo.
Hanmi Pharmaceutical initiated domestic Phase 3 trial to expand indication for efpeglenatide beyond obesity to include the treatment of diabetes. Yuhan Corp signed $140M API supply contract with Gilead Sciences.


APAC Healthcare Weekly (May 24)– Hansoh, Junshi Bio, Daiichi Sankyo, SanBio, Hanmi Pharm, Yuhan Corp

<ul>
<li>In 9MFY26, <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> revenue grew 5% YoY to ¥127.1B driven by higher licensing fees and operating profit stood at ¥32.3B (down 1% YoY).</li>
<li>Viltepso witnessed slowing in US. Licensing income increased on higher overseas sales of Uptravi. Newly launched drugs like Vyxeos and Fintepla continue to show promise.</li>
<li>FY26 revenue guidance revised slightly upwards (¥170B from previous ¥168B) on Uptravi’s royalty income strength. Operating profit and net profit guidance remain unchanged.</li>
</ul>


In 9MFY26, Nippon Shinyaku (4516 JP) revenue grew 5% YoY to ¥127.1B driven by higher licensing fees and operating profit stood at ¥32.3B (down 1% YoY).
Viltepso witnessed slowing in US. Licensing income increased on higher overseas sales of Uptravi. Newly launched drugs like Vyxeos and Fintepla continue to show promise.
FY26 revenue guidance revised slightly upwards (¥170B from previous ¥168B) on Uptravi’s royalty income strength. Operating profit and net profit guidance remain unchanged.


Nippon Shinyaku (4516 JP): Viltepso Concerns Deepen in 9MFY26, Guidance Marginally Revised

<ul>
<li>
<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> and <a href="https://www.smartkarma.com/entities/capricor-therapeutics-inc" target="_blank" data-smartkarma-citation="entities:37671:1" rel="noopener">Capricor Therapeutics (CAPR US)</a> announced positive topline results from its pivotal Phase 3 HOPE-3 trial evaluating Deramiocel.  </li>
<li>Capricor plans to submit its response to the Complete Response Letter incorporating HOPE-3 data, following prior alignment with FDA.</li>
<li>The next big trigger for the stock would be the approval of Deramiocel and RGX-121 by FDA followed by their commercialization.</li>
</ul>



Nippon Shinyaku (4516 JP) and Capricor Therapeutics (CAPR US) announced positive topline results from its pivotal Phase 3 HOPE-3 trial evaluating Deramiocel.  
Capricor plans to submit its response to the Complete Response Letter incorporating HOPE-3 data, following prior alignment with FDA.
The next big trigger for the stock would be the approval of Deramiocel and RGX-121 by FDA followed by their commercialization.


Nippon Shinyaku (4516 JP): Deramiocel Data Positive, Approval and Commercialization Next Big Trigger

<ul>
<li>Fosun Pharmaceutical received NMPA approval for Phase I/II clinical trial of CAR-T cell drug candidate FKC289. RemeGen received $650M upfront payment from AbbVie under the exclusive license agreement for RC148.</li>
<li>FDA has granted Priority Review to Daiichi Sankyo’s Biologics License Application for ifinatamab deruxtecan. Astellas Pharma initiates Phase 3 registrational study evaluating setidegrasib as first-line treatment for pancreatic ductal adenocarcinoma.</li>
<li>Telix and Regeneron Pharmaceuticals is collaborating to jointly develop and commercialize radiopharmaceutical therapies. Telix will receive upfront cash payment of $40M from Regeneron for access to its radiopharmaceutical manufacturing platform.</li>
</ul>


Fosun Pharmaceutical received NMPA approval for Phase I/II clinical trial of CAR-T cell drug candidate FKC289. RemeGen received $650M upfront payment from AbbVie under the exclusive license agreement for RC148.
FDA has granted Priority Review to Daiichi Sankyo’s Biologics License Application for ifinatamab deruxtecan. Astellas Pharma initiates Phase 3 registrational study evaluating setidegrasib as first-line treatment for pancreatic ductal adenocarcinoma.
Telix and Regeneron Pharmaceuticals is collaborating to jointly develop and commercialize radiopharmaceutical therapies. Telix will receive upfront cash payment of $40M from Regeneron for access to its radiopharmaceutical manufacturing platform.


APAC Healthcare Weekly (April 19) – Fosun Pharma, Remegen, Daiichi Sankyo, Astellas Pharma, Telix

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)