Research Coverage of Japanese Listed Companies, Shared Research Inc

Shared Research

Research Coverage of Japanese Listed Companies

Shared Research Inc

Pioneering research coverage of Japanese listed companies. Now customizable and interactive for global institutional investors. Corporate access reimagined.

Equity Bottom-Up

<ul><li>In cumulative Q3 FY01/25, SanBio reported no operating revenue, with an operating loss of JPY2.5bn, narrowing YoY.</li><li>Non-operating income was JPY504mn, primarily from foreign-exchange gains; recurring loss was JPY2.0bn, increasing YoY.</li><li>Net loss attributable to owners was JPY2.2bn; deferred tax liabilities and extraordinary gains impacted financial results.</li></ul>

In cumulative Q3 FY01/25, SanBio reported no operating revenue, with an operating loss of JPY2.5bn, narrowing YoY.Non-operating income was JPY504mn, primarily from foreign-exchange gains; recurring loss was JPY2.0bn, increasing YoY.Net loss attributable to owners was JPY2.2bn; deferred tax liabilities and extraordinary gains impacted financial results.

SanBio Co Ltd (4592 JP): Q3 FY01/25 flash update

Global Healthcare Analyst

Tina Banerjee

<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> received conditional and time-limited marketing approval for Akuugo suspension for intracranial implantation in Japan, for improving chronic motor paralysis resulting from traumatic brain injury.</li>
<li>The company will run two or so rounds of commercial production to accumulate inventories in preparation for launch. The earliest possible timing for shipment is assumed to be Q1FY26.</li>
<li>SanBio has a cash runway through H1FY26. However, operating expenses will decrease and Akuugo will start generating revenue by H1FY26, thereby providing some more cushion to cash runway.</li>
</ul>



SanBio Co Ltd (4592 JP) received conditional and time-limited marketing approval for Akuugo suspension for intracranial implantation in Japan, for improving chronic motor paralysis resulting from traumatic brain injury.
The company will run two or so rounds of commercial production to accumulate inventories in preparation for launch. The earliest possible timing for shipment is assumed to be Q1FY26.
SanBio has a cash runway through H1FY26. However, operating expenses will decrease and Akuugo will start generating revenue by H1FY26, thereby providing some more cushion to cash runway.


SanBio Co Ltd (4592 JP): Conditional Approval for First Drug; Still a Long Way to Go

<ul><li>In 1H FY01/25, the company reported no operating revenue, an operating loss of JPY1.6bn, and R&D expenses of JPY1.0bn.</li><li>Non-operating income was JPY401mn, primarily from foreign-exchange gains, while non-operating expenses totaled JPY16mn, resulting in a recurring loss of JPY1.2bn.</li><li>The company received conditional marketing approval for SB623 in July 2024, with expected sales to begin in Q1 FY01/26.</li></ul>

In 1H FY01/25, the company reported no operating revenue, an operating loss of JPY1.6bn, and R&D expenses of JPY1.0bn.Non-operating income was JPY401mn, primarily from foreign-exchange gains, while non-operating expenses totaled JPY16mn, resulting in a recurring loss of JPY1.2bn.The company received conditional marketing approval for SB623 in July 2024, with expected sales to begin in Q1 FY01/26.

SanBio Co Ltd (4592 JP): 1H FY01/25 flash update

Thematic (Sector/Industry)

<ul>
<li>Daiichi Sankyo is investing $152M for building a new ADC manufacturing facility in Shanghai. Eisai has received approval for Urece in China as a treatment for gout patients with hyperuricemia.</li>
<li>Celltrion has announced its largest-ever dividend of KRW750 per share and 1:20 bonus shares. The record date for dividend payment and bonus share is December 31.</li>
<li>Metropolis Healthcare is acquiring Core Diagnostics, a prominent player in India’s specialized diagnostics sector for INR2.5B. CSPC Pharmaceutical has granted an exclusive license to Beigene for a clinical-stage drug candidate.</li>
</ul>


Daiichi Sankyo is investing $152M for building a new ADC manufacturing facility in Shanghai. Eisai has received approval for Urece in China as a treatment for gout patients with hyperuricemia.
Celltrion has announced its largest-ever dividend of KRW750 per share and 1:20 bonus shares. The record date for dividend payment and bonus share is December 31.
Metropolis Healthcare is acquiring Core Diagnostics, a prominent player in India’s specialized diagnostics sector for INR2.5B. CSPC Pharmaceutical has granted an exclusive license to Beigene for a clinical-stage drug candidate.


APAC Healthcare Weekly (Dec 15)-Daiichi Sankyo, Eisai, Celltrion, Metropolis Healthcare, CSPC Pharma

<ul>
<li>Eoflow Has been ordered by the U.S. Court to pay $452M as damages. Celltrion has submitted clinical trial application for CT-P44 (Darzalex biosimilar) to the FDA.</li>
<li>Takeda Pharmaceutical entered into an exclusive licensing agreement to develop and commercialize a late-stage oncology drug candidate. Medipal and JCR Pharmaceuticals initiated the Phase I/II trial of JR-446 in Japan.</li>
<li>SanBio has completed second production run for Akuugo suspension for intracranial implantation. Aurobindo Pharma’s U.S. arm Eugia has received final approval from the FDA to manufacture and market Pazopanib Tablets.</li>
</ul>


Eoflow Has been ordered by the U.S. Court to pay $452M as damages. Celltrion has submitted clinical trial application for CT-P44 (Darzalex biosimilar) to the FDA.
Takeda Pharmaceutical entered into an exclusive licensing agreement to develop and commercialize a late-stage oncology drug candidate. Medipal and JCR Pharmaceuticals initiated the Phase I/II trial of JR-446 in Japan.
SanBio has completed second production run for Akuugo suspension for intracranial implantation. Aurobindo Pharma’s U.S. arm Eugia has received final approval from the FDA to manufacture and market Pazopanib Tablets.


APAC Healthcare Weekly (Dec 8)- Eoflow, Celltrion, Takeda, Medipal, SanBio, Aurobindo Pharma

Japan

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

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SanBio Co Ltd (4592 JP)