Global Healthcare Analyst

Tina Banerjee

Equity Bottom-Up

<ul>
<li>During FY25, <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> did not generate any revenue and incurred an operating expense of ¥3.5B, down 23% YoY.</li>
<li>The company successfully completed two commercial production runs to accumulate inventories in preparation for launch of Akuugo. The earliest possible timing for shipment is assumed to be Q2FY26.</li>
<li>SanBio has a cash runway through FY26. Further, in March, the company has raised funds of ¥2.1B through third party placement.</li>
</ul>


During FY25, SanBio Co Ltd (4592 JP) did not generate any revenue and incurred an operating expense of ¥3.5B, down 23% YoY.
The company successfully completed two commercial production runs to accumulate inventories in preparation for launch of Akuugo. The earliest possible timing for shipment is assumed to be Q2FY26.
SanBio has a cash runway through FY26. Further, in March, the company has raised funds of ¥2.1B through third party placement.


SanBio Co Ltd (4592 JP): Losses Narrow; AKUUGO Upbeat on Successful Commercial Runs; FY26 Key

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<ul><li>SanBio reported no operating revenue for FY01/25, with an operating loss of JPY3.5bn, narrowing from JPY4.5bn.</li><li>Non-operating income was JPY628mn, primarily from foreign-exchange gains, while non-operating expenses totaled JPY134mn.</li><li>The company expects no operating revenue for FY01/26, forecasting operating expenses of JPY3.5bn, focusing on AKUUGO® approval.</li></ul>

SanBio reported no operating revenue for FY01/25, with an operating loss of JPY3.5bn, narrowing from JPY4.5bn.Non-operating income was JPY628mn, primarily from foreign-exchange gains, while non-operating expenses totaled JPY134mn.The company expects no operating revenue for FY01/26, forecasting operating expenses of JPY3.5bn, focusing on AKUUGO® approval.

SanBio Co Ltd (4592 JP): Full-year FY01/25 flash update

Thematic (Sector/Industry)

<ul>
<li>China has published 2025 National Reimbursement Drug List, which will be officially implemented nationwide on January 1, 2026. The list added 114 new drugs, including 50 Class 1 innovative drugs.</li>
<li>Fosun Pharmaceutical subsidiary inked exclusive global collaboration and license agreement with Pfizer for weight loss drug candidate YP05002. SanBio obtained partial change approval to the marketing authorization for Akuugo.</li>
<li>PeptiDream achieved milestone of nominating a clinical development candidate from collaboration program with Asahi Kasei. Zydus Lifesciences entered strategic partnership with Formycon for exclusive licensing and supply of Keytruda biosimilar.</li>
</ul>


China has published 2025 National Reimbursement Drug List, which will be officially implemented nationwide on January 1, 2026. The list added 114 new drugs, including 50 Class 1 innovative drugs.
Fosun Pharmaceutical subsidiary inked exclusive global collaboration and license agreement with Pfizer for weight loss drug candidate YP05002. SanBio obtained partial change approval to the marketing authorization for Akuugo.
PeptiDream achieved milestone of nominating a clinical development candidate from collaboration program with Asahi Kasei. Zydus Lifesciences entered strategic partnership with Formycon for exclusive licensing and supply of Keytruda biosimilar.


APAC Healthcare Weekly (December 14) – China NRDL, Fosun Pharma, SanBio, Peptidream, Zydus Life

<ul>
<li>Hansoh Pharmaceutical entered outlicense agreement with Roche for upfront and milestone payments of $2B+. Leads Biolabs and Dianthus Therapeutics entered into exclusive global license agreement for pre-clinical asset.</li>
<li>Chugai Pharmaceutical’s partner Eli Lilly announced positive results from Phase 3 trials of orforglipron. SanBio Co announced that their partial change application for AKUUGO is one step ahead for approval.</li>
<li>Celltrion launched Actemra biosimilar, Aptozma in the U.S. at ~35% discount to original drug. Samsung Biologics shareholders approved biologics business spin-off plan to transform the company into a pure-play CDMO.</li>
</ul>


Hansoh Pharmaceutical entered outlicense agreement with Roche for upfront and milestone payments of $2B+. Leads Biolabs and Dianthus Therapeutics entered into exclusive global license agreement for pre-clinical asset.
Chugai Pharmaceutical’s partner Eli Lilly announced positive results from Phase 3 trials of orforglipron. SanBio Co announced that their partial change application for AKUUGO is one step ahead for approval.
Celltrion launched Actemra biosimilar, Aptozma in the U.S. at ~35% discount to original drug. Samsung Biologics shareholders approved biologics business spin-off plan to transform the company into a pure-play CDMO.


APAC Healthcare Weekly (October 19) – Hansoh, Leads Biolabs, Chugai, SanBio, Celltrion, Samsung Bio

<ul>
<li>Daiichi Sankyo’s indication expansion application for Enhertu has been accepted for review by FDA for certain types of breast cancers. Santen’s new drug application has been accepted in China.  </li>
<li>Hanmi Pharm entered into a global licensing agreement with Gilead Sciences granting Gilead the exclusive rights to develop and commercialize encequidar. Boryung is acquiring Sanofi’s cytotoxic anti-cancer drug Taxotere.</li>
<li>IHH Healthcare received SEBI approval for mandatory open offer for 26% stake in Fortis Healthcare. Lupin has launched Liraglutide prefilled pen, bioequivalent to Victoza, in the U.S.</li>
</ul>


Daiichi Sankyo’s indication expansion application for Enhertu has been accepted for review by FDA for certain types of breast cancers. Santen’s new drug application has been accepted in China.  
Hanmi Pharm entered into a global licensing agreement with Gilead Sciences granting Gilead the exclusive rights to develop and commercialize encequidar. Boryung is acquiring Sanofi’s cytotoxic anti-cancer drug Taxotere.
IHH Healthcare received SEBI approval for mandatory open offer for 26% stake in Fortis Healthcare. Lupin has launched Liraglutide prefilled pen, bioequivalent to Victoza, in the U.S.


APAC Healthcare Weekly (October 5) – Daiichi Sankyo, Santen, Hanmi Pharm, Boryung, IHH Health, Lupin

Japan

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

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SanBio Co Ltd (4592 JP)