Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<ul>
<li>Celltrion received FDA approval for Omlyclo, the first and only biosimilar designated as interchangeable with Xolair. Ono Pharmaceutical in-licensed drug candidate for polycythemia vera from Ionis Pharmaceuticals.</li>
<li>Sun Pharmaceutical will acquire Checkpoint Therapeutics for an upfront cash payment of $4.10 per share. Syngene is acquiring Emergent’s biologics facility in Baltimore for $36.5M.</li>
<li>Zydus Lifesciences is acquiring 85.6% stake in in Amplitude Surgical for €257M. Sichuan Kelun received China approval for sacituzumab tirumotecan for certain types of non-small cell lung cancer.</li>
</ul>


Celltrion received FDA approval for Omlyclo, the first and only biosimilar designated as interchangeable with Xolair. Ono Pharmaceutical in-licensed drug candidate for polycythemia vera from Ionis Pharmaceuticals.
Sun Pharmaceutical will acquire Checkpoint Therapeutics for an upfront cash payment of $4.10 per share. Syngene is acquiring Emergent’s biologics facility in Baltimore for $36.5M.
Zydus Lifesciences is acquiring 85.6% stake in in Amplitude Surgical for €257M. Sichuan Kelun received China approval for sacituzumab tirumotecan for certain types of non-small cell lung cancer.


APAC Healthcare Weekly (Mar 16)- Celltrion, Ono Pharma, Sun Pharma, Syngene, Zydus, Sichuan Kelun

<ul>
<li>Daiichi Sankyo has announced that Dato-DXd has been recommended for approval in EU. Astellas Pharma has submitted new drug application for conditional approval of Izervay for Geographic Atrophy in Japan.</li>
<li>SanBio has successfully secured the planned production yield for the second commercial production run to meet the approval conditions for the shipment of Akuugo suspension for intracranial implantation.</li>
<li>IHH Healthcare is seeking compensation of INR109.3B from Daiichi Sankyo for its stake buy in Fortis Healthcare. Dr. Reddy’s Laboratories entered licensing agreement with Shanghai Henlius Biotech for Darzalex biosimilar.</li>
</ul>


Daiichi Sankyo has announced that Dato-DXd has been recommended for approval in EU. Astellas Pharma has submitted new drug application for conditional approval of Izervay for Geographic Atrophy in Japan.
SanBio has successfully secured the planned production yield for the second commercial production run to meet the approval conditions for the shipment of Akuugo suspension for intracranial implantation.
IHH Healthcare is seeking compensation of INR109.3B from Daiichi Sankyo for its stake buy in Fortis Healthcare. Dr. Reddy’s Laboratories entered licensing agreement with Shanghai Henlius Biotech for Darzalex biosimilar.


APAC Healthcare Weekly (Feb 9)- Daiichi Sankyo, Astellas, SanBio, IHH, Henlius Biotech, Dr. Reddy’s

<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

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> 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

Japan

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

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SanBio Co Ltd (4592 JP)

APAC Healthcare Weekly (Mar 16)- Celltrion, Ono Pharma, Sun Pharma, Syngene, Zydus, Sichuan Kelun

APAC healthcare companies continued to get approvals for new products and initiates clinical trials. The companies continued with acquisitions and...

Tina Banerjee

APAC Healthcare Weekly (Feb 9)- Daiichi Sankyo, Astellas, SanBio, IHH, Henlius Biotech, Dr. Reddy’s

APAC healthcare companies continued to get approvals for new products and initiates clinical trials. The companies continued with acquisitions and...

Tina Banerjee

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

The insight covers key developments in prominent APAC healthcare companies. These developments are expected to impact the financials of the...

Tina Banerjee

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

The insight covers key developments in prominent APAC healthcare companies. These developments are expected to impact the financials of the...

Tina Banerjee