Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<ul>
<li>Hansoh’s risvutatug rezetecan for second-line treatment of SCLC has been included in NMPA’s Priority Review. InSilico completed first patient enrollment and dosing in Phase 3 trial evaluating rentosertib in IPF.</li>
<li>Shionogi received approval in Australia for cefiderocol for the treatment of carbapenem-resistant Gram-negative bacterial infections. Kyowa Kirin’s Phase 2 trial for ophthalmic drug candidate did not meet primary endpoint.</li>
<li>Samsung Biologics signed a new CMO contract worth $262M with a European pharmaceutical company. SK Biopharmaceutical received notification regarding FDA's partial clinical hold on its epilepsy drug candidate, opakalim.</li>
</ul>


Hansoh’s risvutatug rezetecan for second-line treatment of SCLC has been included in NMPA’s Priority Review. InSilico completed first patient enrollment and dosing in Phase 3 trial evaluating rentosertib in IPF.
Shionogi received approval in Australia for cefiderocol for the treatment of carbapenem-resistant Gram-negative bacterial infections. Kyowa Kirin’s Phase 2 trial for ophthalmic drug candidate did not meet primary endpoint.
Samsung Biologics signed a new CMO contract worth $262M with a European pharmaceutical company. SK Biopharmaceutical received notification regarding FDA's partial clinical hold on its epilepsy drug candidate, opakalim.


APAC Healthcare Weekly (Sept 13) – Hansoh, InSilico, Shionogi, Kyowa Kirin, Samsung Bio, SK Biopharm

<ul>
<li>Simcere inks outlicensing agreement with Roche for tri-specific antibody in total deal value of $2B+. Hutchmed enters outlicense agreement with GSK for first-in-class drug candidate for upfront payment of $110M.</li>
<li>Akeso’s ivonescimab demonstrates significant overall survival benefit in Keytruda head-to-head trial in NSCLC. Daiichi Sankyo’s Enhertu has been approved in EU for the first-line treatment of HER2 positive breast cancer.</li>
<li>Alteogen inked agreement with Novartis for the development and commercialization of subcutaneous products utilizing ALT-B4. Pharmaessentia secured FDA approval of Besremi for the treatment of essential thrombocythemia.</li>
</ul>


Simcere inks outlicensing agreement with Roche for tri-specific antibody in total deal value of $2B+. Hutchmed enters outlicense agreement with GSK for first-in-class drug candidate for upfront payment of $110M.
Akeso’s ivonescimab demonstrates significant overall survival benefit in Keytruda head-to-head trial in NSCLC. Daiichi Sankyo’s Enhertu has been approved in EU for the first-line treatment of HER2 positive breast cancer.
Alteogen inked agreement with Novartis for the development and commercialization of subcutaneous products utilizing ALT-B4. Pharmaessentia secured FDA approval of Besremi for the treatment of essential thrombocythemia.


APAC Healthcare Weekly (Sept 6) – Simcere, Hutchmed, Akeso, Daiichi Sankyo, Alteogen, Pharmaessentia

Equity Bottom-Up

<ul>
<li>
<a href="https://www.smartkarma.com/entities/shionogi-co-ltd" target="_blank" data-smartkarma-citation="entities:19535:1" rel="noopener">Shionogi &amp; Co (4507 JP)</a> has announced 9MFY26 result, with revenue, operating profit, and net profit reaching record highs, led by growth in core businesses.</li>
<li>Double-Digit growth in royalty income from HIV franchise, rebound in domestic prescription business led by Torii, and expanded sales of Cefiderocol in the U.S. and EU drove 9MFY26 performance.</li>
<li>With high base effect for Xocova ending, and new growth drivers remaining intact, Shionogi’s financial performance to improve from FY27. The company is expecting few new launches during FY28–32.</li>
</ul>



Shionogi &amp; Co (4507 JP) has announced 9MFY26 result, with revenue, operating profit, and net profit reaching record highs, led by growth in core businesses.
Double-Digit growth in royalty income from HIV franchise, rebound in domestic prescription business led by Torii, and expanded sales of Cefiderocol in the U.S. and EU drove 9MFY26 performance.
With high base effect for Xocova ending, and new growth drivers remaining intact, Shionogi’s financial performance to improve from FY27. The company is expecting few new launches during FY28–32.


Shionogi & Co (4507 JP): Decent 9MFY26 Result; No Revision in FY Forecast; Accelerate Growth Ahead

<ul>
<li>
<a href="https://www.smartkarma.com/entities/shionogi-co-ltd" target="_blank" data-smartkarma-citation="entities:19535:1" rel="noopener">Shionogi &amp; Co (4507 JP)</a> is acquiring rare neurodegenerative disease drug Radicava for $2.5B. The transaction is expected to be immediately accretive in FY27, adding ~$700M in annual global sales.</li>
<li>This acquisition will solidify Shionogi’s strategic focus in rare disease and immediately establish a strong rare disease commercial platform in the U.S. market.</li>
<li>Shionogi has received approval in Japan for inlicensed drug Zurzuvae for the indication of depression and depressive state.</li>
</ul>



Shionogi &amp; Co (4507 JP) is acquiring rare neurodegenerative disease drug Radicava for $2.5B. The transaction is expected to be immediately accretive in FY27, adding ~$700M in annual global sales.
This acquisition will solidify Shionogi’s strategic focus in rare disease and immediately establish a strong rare disease commercial platform in the U.S. market.
Shionogi has received approval in Japan for inlicensed drug Zurzuvae for the indication of depression and depressive state.


Shionogi (4507 JP): $2.5B ALS Drug Buyout and New Approval To Accelerate Portfolio Diversification

<ul>
<li>During H1FY26, <a href="https://www.smartkarma.com/entities/shionogi-co-ltd" target="_blank" data-smartkarma-citation="entities:19535:1" rel="noopener">Shionogi &amp; Co (4507 JP)</a> maintained revenue, operating profit, and net profit at the same level as previous year. None of the key parameters achieved their respective targets.</li>
<li>Better-Than-Expected contribution from Torii, additional revenue generation from Quviviq, double-digit revenue growth of cefiderocol in the U.S. and EU, and stable growth in HIV royalty drove overall performance.</li>
<li>Shionogi has reduced FY26 revenue guidance (due to weak prescription drug sales) and raised operating and net profit guidance, driven by strong growth in royalty income and cost optimization initiatives.</li>
</ul>


During H1FY26, Shionogi &amp; Co (4507 JP) maintained revenue, operating profit, and net profit at the same level as previous year. None of the key parameters achieved their respective targets.
Better-Than-Expected contribution from Torii, additional revenue generation from Quviviq, double-digit revenue growth of cefiderocol in the U.S. and EU, and stable growth in HIV royalty drove overall performance.
Shionogi has reduced FY26 revenue guidance (due to weak prescription drug sales) and raised operating and net profit guidance, driven by strong growth in royalty income and cost optimization initiatives.


Shionogi & Co (4507 JP): Muted 1H Result; Solid HIV Business Leads FY Profit Guidance Raise

Japan

Shionogi & Company Ltd., is a pharmaceutical company. The Company develops prescription & over-the-counter drugs and diagnostics.

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Shionogi & Co (4507 JP)

APAC Healthcare Weekly (Sept 13) – Hansoh, InSilico, Shionogi, Kyowa Kirin, Samsung Bio, SK Biopharm

Hansoh’s risvutatug rezetecan has been included in NMPA’s Priority Review. InSilico initiates rentosertib Phase 3 trial in IPF. Samsung Biologics...

Tina Banerjee

APAC Healthcare Weekly (Sept 6) – Simcere, Hutchmed, Akeso, Daiichi Sankyo, Alteogen, Pharmaessentia

Simcere and Hutchmend inked outlicensing deals with Roche and GSK, respectively. Akeso’s ivonescimab extends lives vs Keytruda. Alteogen inked...

Tina Banerjee