Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<ul>
<li>Hengrui outlicenses once-weekly oral obesity drug candidate HRS-1596, to Novo for total deal value of $2.6B. EC revoked the EU marketing authorization for Hansoh’s lung cancer drug aumolertinib.</li>
<li>Roche halts development of obesity drug candidate emugrobart and returns all rights to Chugai. Daiichi Sankyo has withdrawn the BLA seeking accelerated approval in the U.S. for I-DXd for ES-SCLC.</li>
<li>Otsuka initiates NDA submission to the FDA for zipalertinib for the treatment of NSCLC. Sun Pharma inlicenses hypercholesterolaemia and dyslipidaemia drug lerodalcibep from LIB Therapeutics.</li>
</ul>


Hengrui outlicenses once-weekly oral obesity drug candidate HRS-1596, to Novo for total deal value of $2.6B. EC revoked the EU marketing authorization for Hansoh’s lung cancer drug aumolertinib.
Roche halts development of obesity drug candidate emugrobart and returns all rights to Chugai. Daiichi Sankyo has withdrawn the BLA seeking accelerated approval in the U.S. for I-DXd for ES-SCLC.
Otsuka initiates NDA submission to the FDA for zipalertinib for the treatment of NSCLC. Sun Pharma inlicenses hypercholesterolaemia and dyslipidaemia drug lerodalcibep from LIB Therapeutics.


APAC Healthcare Weekly (Oct 4) – Hengrui, Hansoh, Chugai Pharma, Daiichi Sankyo, Otsuka, Sun Pharma

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

<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>CSPC Pharmaceutical’s Phase 3 trial of depression drug candidate HA1406 met pre-specified primary efficacy endpoint. Jiangsu Hengrui Pharmaceuticals received NMPA approval for long-acting basal insulin, sudelidec injection.</li>
<li>Otsuka Holdings secured FDA approval for Simtriyo, a once-daily extended-release capsule for ADHD. Nippon Shinyaku obtained exclusive commercialization rights for Tadekinig alfa in the U.S. for Hyperinflammatory Syndrome.</li>
<li>Pharmaessentia announced topline results from the Phase 1b clinical trial of P1101 (Besremi) and anti-PD1 in Chronic Hepatitis B or D. Cipla secured FDA approval for generic Advair Diskus.</li>
</ul>


CSPC Pharmaceutical’s Phase 3 trial of depression drug candidate HA1406 met pre-specified primary efficacy endpoint. Jiangsu Hengrui Pharmaceuticals received NMPA approval for long-acting basal insulin, sudelidec injection.
Otsuka Holdings secured FDA approval for Simtriyo, a once-daily extended-release capsule for ADHD. Nippon Shinyaku obtained exclusive commercialization rights for Tadekinig alfa in the U.S. for Hyperinflammatory Syndrome.
Pharmaessentia announced topline results from the Phase 1b clinical trial of P1101 (Besremi) and anti-PD1 in Chronic Hepatitis B or D. Cipla secured FDA approval for generic Advair Diskus.


APAC Healthcare Weekly (August 2) – CSPC, Hengrui, Otsuka, Nippon Shinyaku, PharmaEssnetia, Cipla

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)

APAC Healthcare Weekly (Oct 4) – Hengrui, Hansoh, Chugai Pharma, Daiichi Sankyo, Otsuka, Sun Pharma

Hengrui stuck $2.6B outlicensing deal with Novo. EC revoked EU marketing authorization of Hansoh’s aumolertinib. Otsuka initiates NDA submission to...

Tina Banerjee