Global Healthcare Analyst

Tina Banerjee

Equity Bottom-Up

<ul>
<li>
<a href="https://www.smartkarma.com/entities/sanbio-co-ltd" target="_blank" data-smartkarma-citation="entities:24540:1" rel="noopener">SanBio Co Ltd (4592 JP)</a> reported marginally higher operating loss (~¥1909.9M) in H1FY27.  R&amp;D expenses decreased. Net loss witnessed narrowing too.</li>
<li>Integration of manufacturing at Minaris Japan’s Yokohama facility and contract manufacturing agreement with JCR Pharmaceuticals to strengthen the stable supply of Akuugo.</li>
<li>FY27 guidance reiterated with revenue expected to be ¥396M. FY27 would be an inflection point for SanBio and the stock still remains a moderately risky bet.</li>
</ul>



SanBio Co Ltd (4592 JP) reported marginally higher operating loss (~¥1909.9M) in H1FY27.  R&amp;D expenses decreased. Net loss witnessed narrowing too.
Integration of manufacturing at Minaris Japan’s Yokohama facility and contract manufacturing agreement with JCR Pharmaceuticals to strengthen the stable supply of Akuugo.
FY27 guidance reiterated with revenue expected to be ¥396M. FY27 would be an inflection point for SanBio and the stock still remains a moderately risky bet.


SanBio (4592 JP): FY27 Guidance Reiterated, All Eyes On How Akuugo Sales Fall Through

<ul>
<li>
<a href="https://www.smartkarma.com/entities/sanbio-co-ltd" target="_blank" data-smartkarma-citation="entities:24540:1" rel="noopener">SanBio Co Ltd (4592 JP)</a> reported lower operating loss (~¥953.3M) in Q1FY27 as R&amp;D expenses decreased. Net loss witnessed narrowing too.</li>
<li>Akuugo received the NHI price listing in May 2026, and was eventually launched in June. SanBio will accelerate a project to expand Akuugo’s current indication for traumatic brain injury globally.  </li>
<li>FY27 guidance reiterated with revenue expected to be ¥396M. SanBio remains a risky bet with probability of a high return going up with every milestone.</li>
</ul>



SanBio Co Ltd (4592 JP) reported lower operating loss (~¥953.3M) in Q1FY27 as R&amp;D expenses decreased. Net loss witnessed narrowing too.
Akuugo received the NHI price listing in May 2026, and was eventually launched in June. SanBio will accelerate a project to expand Akuugo’s current indication for traumatic brain injury globally.  
FY27 guidance reiterated with revenue expected to be ¥396M. SanBio remains a risky bet with probability of a high return going up with every milestone.


SanBio (4592 JP): Q1 Losses Narrow, NHI Price Listing and Akuugo Launch Done, Guidance Reiterated

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>
<a href="https://www.smartkarma.com/entities/sanbio-co-ltd" target="_blank" data-smartkarma-citation="entities:24540:1" rel="noopener">SanBio Co Ltd (4592 JP)</a> reported higher operating loss (~¥3.79B) in FY26 as R&amp;D expenses rose for partial changes approval of Akuugo. Net loss widened too.</li>
<li>SanBio currently anticipates the NHI price listing in May 2026, and the launch of Akuugo is also planned for the same month.</li>
<li>SanBio remains a risky bet with probability of a high return going up with every milestone, the launch of Akuugo being the next.</li>
</ul>



SanBio Co Ltd (4592 JP) reported higher operating loss (~¥3.79B) in FY26 as R&amp;D expenses rose for partial changes approval of Akuugo. Net loss widened too.
SanBio currently anticipates the NHI price listing in May 2026, and the launch of Akuugo is also planned for the same month.
SanBio remains a risky bet with probability of a high return going up with every milestone, the launch of Akuugo being the next.


SanBio (4592 JP): Akuugo Awaiting NHI Price Listing and Launch, SB623 Trial Progressing Well In US

<ul>
<li>
<a href="https://www.smartkarma.com/entities/sanbio-co-ltd" target="_blank" data-smartkarma-citation="entities:24540:1" rel="noopener">SanBio Co Ltd (4592 JP)</a> reported higher operating loss (~¥2.7B) in 9MFY26 as R&amp;D expenses rose for partial changes approval of Akuugo. Net loss widened too.</li>
<li>MHLW approved the partial change to the marketing approval and revised the associated approval conditions. Going forward, after the NHI price listing, the company plans to launch Akuugo.</li>
<li>The approval and international offering augur well. SanBio remains a risky bet with probability of a high return going up with every milestone, the launch of Akuugo being the next.</li>
</ul>



SanBio Co Ltd (4592 JP) reported higher operating loss (~¥2.7B) in 9MFY26 as R&amp;D expenses rose for partial changes approval of Akuugo. Net loss widened too.
MHLW approved the partial change to the marketing approval and revised the associated approval conditions. Going forward, after the NHI price listing, the company plans to launch Akuugo.
The approval and international offering augur well. SanBio remains a risky bet with probability of a high return going up with every milestone, the launch of Akuugo being the next.


SanBio Co (4592 JP): Akuugo Launch Awaited, Groundwork Being Laid for New Indications & Geographies

Japan

Sanbio Co Ltd researches, develops, manufactures, and sells regenerative cell re lated pharmaceutical products.

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SanBio Co Ltd (4592 JP)

SanBio (4592 JP): FY27 Guidance Reiterated, All Eyes On How Akuugo Sales Fall Through

SanBio's R&D expenses decreased. H1FY27 Net loss narrowed. Guidance was reiterated. We feel FY27 would be an inflection point for SanBio, but it...

Tina Banerjee

SanBio (4592 JP): Q1 Losses Narrow, NHI Price Listing and Akuugo Launch Done, Guidance Reiterated

SanBio reported lower loss in Q1FY27 on R&D expenses decreased and forex gains. Akuugo received NHI price listing and was eventually launched....

Tina Banerjee

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

SanBio (4592 JP): Akuugo Awaiting NHI Price Listing and Launch, SB623 Trial Progressing Well In US

SanBio Co Ltd (4592 JP) reports higher operating loss in FY26 due to increased R&D expenses. Akuugo NHI price listing and launch planned for May...

Tina Banerjee

SanBio Co (4592 JP): Akuugo Launch Awaited, Groundwork Being Laid for New Indications & Geographies

Management expects the 2025 revenue of the company will achieve a growth of approximately 110%-120% YoY, mainly attributable to the core product...

Tina Banerjee

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SanBio (4592 JP): FY27 Guidance Reiterated, All Eyes On How Akuugo Sales Fall Through

SanBio's R&D expenses decreased. H1FY27 Net loss narrowed. Guidance was reiterated. We feel FY27 would be an inflection point for SanBio, but it...

Tina Banerjee

SanBio (4592 JP): Q1 Losses Narrow, NHI Price Listing and Akuugo Launch Done, Guidance Reiterated

​SanBio reported lower loss in Q1FY27 on R&D expenses decreased and forex gains. Akuugo received NHI price listing and was eventually launched....

Tina Banerjee

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

SanBio (4592 JP): Akuugo Awaiting NHI Price Listing and Launch, SB623 Trial Progressing Well In US

​SanBio Co Ltd (4592 JP) reports higher operating loss in FY26 due to increased R&D expenses. Akuugo NHI price listing and launch planned for May...

Tina Banerjee

SanBio Co (4592 JP): Akuugo Launch Awaited, Groundwork Being Laid for New Indications & Geographies

Management expects the 2025 revenue of the company will achieve a growth of approximately 110%-120% YoY, mainly attributable to the core product...

Tina Banerjee

SanBio reported lower loss in Q1FY27 on R&D expenses decreased and forex gains. Akuugo received NHI price listing and was eventually launched....

SanBio Co Ltd (4592 JP) reports higher operating loss in FY26 due to increased R&D expenses. Akuugo NHI price listing and launch planned for May...