Global Healthcare Analyst

Tina Banerjee

Equity Bottom-Up

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<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>
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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

Research Coverage of Japanese Listed Companies, Shared Research Inc

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<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

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<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> recorded operating loss of ¥7.9B for FY23, better than guidance of ¥8.1B. For FY24, the company guided for operating loss of ¥4.6B, in-line with consensus.</li>
<li>SanBio’s cash position improved with cash and cash equivalents of ¥6.7B at the end of FY23, up from ¥4.6B at the end of the previous fiscal year.</li>
<li>The company aims to obtain approval of its lead candidate SB623 as a treatment for chronic motor deficit from traumatic brain injury during the current fiscal year.</li>
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SanBio Co Ltd (4592 JP) recorded operating loss of ¥7.9B for FY23, better than guidance of ¥8.1B. For FY24, the company guided for operating loss of ¥4.6B, in-line with consensus.
SanBio’s cash position improved with cash and cash equivalents of ¥6.7B at the end of FY23, up from ¥4.6B at the end of the previous fiscal year.
The company aims to obtain approval of its lead candidate SB623 as a treatment for chronic motor deficit from traumatic brain injury during the current fiscal year.


SanBio (4592 JP): Better-Than-Expected Operating Loss in FY23; Product Approval Expected in FY24

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<li>In March, <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> completed the application filing for approval for its investigational product SB623, as a treatment for chronic motor deficit from traumatic brain injury.</li>
<li>With a priority review designation, SB623 approval was expected in September. SanBio is expecting a delay in the approval. SB623 is now expected to be approved next year. </li>
<li>For FY23, the company is now expecting operating expenses of ¥8.1 billion, which exceeds the earlier expectations by ¥2.2 billion due to an anticipated increase in manufacturing-related expenses.</li>
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In March, SanBio Co Ltd (4592 JP) completed the application filing for approval for its investigational product SB623, as a treatment for chronic motor deficit from traumatic brain injury.
With a priority review designation, SB623 approval was expected in September. SanBio is expecting a delay in the approval. SB623 is now expected to be approved next year. 
For FY23, the company is now expecting operating expenses of ¥8.1 billion, which exceeds the earlier expectations by ¥2.2 billion due to an anticipated increase in manufacturing-related expenses.


SanBio (4592 JP): Remains Unlucky for Second-Time; Delay in First Product Approval Weighs Heavily

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<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> is expected to receive approval for its first regenerative cell medicine SB623 for treating chronic motor deficit from traumatic brain injury in Japan this year.</li>
<li>SB623, with current and future indication approvals, is targeting a large patient population of more than 50 million in major pharmaceutical markets globally. The indications have large unmet need.</li>
<li>SanBio has a pipeline of five other pre-clinical drug candidates, entailing visibility beyond SB623.</li>
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SanBio Co Ltd (4592 JP) is expected to receive approval for its first regenerative cell medicine SB623 for treating chronic motor deficit from traumatic brain injury in Japan this year.
SB623, with current and future indication approvals, is targeting a large patient population of more than 50 million in major pharmaceutical markets globally. The indications have large unmet need.
SanBio has a pipeline of five other pre-clinical drug candidates, entailing visibility beyond SB623.


SanBio (4592 JP): Marketing Approval of First Product Expected This Year in Japan

Japan

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

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SanBio Co Ltd (4592 JP)