Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<ul>
<li>Hansoh Pharmaceutical announced that a new indication of Xinyue has been included in the Priority Review. Astellas Pharma announced positive update from the Phase 3 EV-302 clinical trial.</li>
<li>CSL has received EU approval for HAE drug, Andemry. Imugene announce more positive results from its Phase 1b trial of azer-cel, an allogenic therapy in relapsed/refractory diffuse large B-cell lymphoma.</li>
<li>LigaChem Bio signed technology transfer agreement for a new anticancer target antibody for the development of ADC candidates with Daan Biotherapeutics. Lupin received FDA approval for generic Atrovent Nasal Spray.</li>
</ul>


Hansoh Pharmaceutical announced that a new indication of Xinyue has been included in the Priority Review. Astellas Pharma announced positive update from the Phase 3 EV-302 clinical trial.
CSL has received EU approval for HAE drug, Andemry. Imugene announce more positive results from its Phase 1b trial of azer-cel, an allogenic therapy in relapsed/refractory diffuse large B-cell lymphoma.
LigaChem Bio signed technology transfer agreement for a new anticancer target antibody for the development of ADC candidates with Daan Biotherapeutics. Lupin received FDA approval for generic Atrovent Nasal Spray.


APAC Healthcare Weekly (Feb 16)- Hansoh Pharma, Astellas Pharma, CSL, Imugene, LigaChem Bio, Lupin

Equity Bottom-Up

SK Biopharmaceuticals   / Equity Bottom-Up

<ul>
<li>
<a href="https://www.smartkarma.com/entities/sk-biopharmaceuticals-co-ltd" target="_blank" data-smartkarma-citation="entities:28966:1" rel="noopener">SK Biopharmaceuticals (326030 KS)</a> reported first-ever annual operating and net profit of KRW96B and KRW227B, respectively in 2024. In 2023, operating and net loss stood at KRW38B and KRW35B, respectively.</li>
<li>The company has turned profitable in 2024 driven by continued momentum of Xcopri in U.S. For 2024, Xcopri recorded revenue of $321.6M in the U.S., exceeding guidance of $300–320M.</li>
<li>For 2025, SKBP has guided for Xcopri U.S. revenue of $420–450M (~KRW570–610B), up 31–40% YoY. The company expects 2025 SG&amp;A expenses will be KRW490B, up 20% YoY.</li>
</ul>



SK Biopharmaceuticals (326030 KS) reported first-ever annual operating and net profit of KRW96B and KRW227B, respectively in 2024. In 2023, operating and net loss stood at KRW38B and KRW35B, respectively.
The company has turned profitable in 2024 driven by continued momentum of Xcopri in U.S. For 2024, Xcopri recorded revenue of $321.6M in the U.S., exceeding guidance of $300–320M.
For 2025, SKBP has guided for Xcopri U.S. revenue of $420–450M (~KRW570–610B), up 31–40% YoY. The company expects 2025 SG&amp;A expenses will be KRW490B, up 20% YoY.


SK Biopharmaceuticals (326030 KS): Records Maiden Profit in 2024; Momentum to Continue

<ul>
<li>
<a href="https://www.smartkarma.com/entities/sumitomo-pharma-co" target="_blank" data-smartkarma-citation="entities:1935:1" rel="noopener">Sumitomo Pharma (4506 JP)</a> reported 25% YoY revenue growth during 9MFY25, driven by North America.</li>
<li>Restructuring and streamlining efforts help curb expenses and post a core operating profit of ¥21B during 9MFY25 compared to an operating loss of ¥96B in same period last year.</li>
<li>Sumitomo is now expecting FY25 revenue to be ¥381B, up by ¥43B from the previous forecast and a core net profit of ¥16B.</li>
</ul>



Sumitomo Pharma (4506 JP) reported 25% YoY revenue growth during 9MFY25, driven by North America.
Restructuring and streamlining efforts help curb expenses and post a core operating profit of ¥21B during 9MFY25 compared to an operating loss of ¥96B in same period last year.
Sumitomo is now expecting FY25 revenue to be ¥381B, up by ¥43B from the previous forecast and a core net profit of ¥16B.


Sumitomo Pharma (4506 JP): Robust 9MFY25 Revenues; Back in Black; Guidance Revised

<ul>
<li>In its January 2025 meeting, EMA’s human medicines committee (CHMP) recommended eight medicines for approval, including four innovative, three biosimilars, and one generic drugs.</li>
<li>The committee has also recommended extensions of indication for eight medicines that are already authorized in the EU.</li>
<li>Marketing applications for two medicines were withdrawn. Among them, withdrawal of Daiichi Sankyo’s datopotamab deruxtecan for non-squamous non-small cell lung cancer is noteworthy.</li>
</ul>


In its January 2025 meeting, EMA’s human medicines committee (CHMP) recommended eight medicines for approval, including four innovative, three biosimilars, and one generic drugs.
The committee has also recommended extensions of indication for eight medicines that are already authorized in the EU.
Marketing applications for two medicines were withdrawn. Among them, withdrawal of Daiichi Sankyo’s datopotamab deruxtecan for non-squamous non-small cell lung cancer is noteworthy.


CHMP Meeting Update: Eight New Medicines Recommended For Approval

<ul>
<li>Daiichi Sankyo received seventh FDA approval for Enhertu in certain types of breast cancers. Eisai received FDA approval for Leqembi’s intravenous monthly maintenance dosing.</li>
<li>Nippon Shinyaku entered into an option agreement with AB2 BIO for the rights of commercialization of Tadekinig alfa in the U.S. for certain rare autoinflammatory diseases.</li>
<li>Shionogi announced positive results from Phase 2 trial of its novel investigational RSV oral antiviral candidate S-337395. Celltrion has received FDA approval for Actemra biosimilar.</li>
</ul>


Daiichi Sankyo received seventh FDA approval for Enhertu in certain types of breast cancers. Eisai received FDA approval for Leqembi’s intravenous monthly maintenance dosing.
Nippon Shinyaku entered into an option agreement with AB2 BIO for the rights of commercialization of Tadekinig alfa in the U.S. for certain rare autoinflammatory diseases.
Shionogi announced positive results from Phase 2 trial of its novel investigational RSV oral antiviral candidate S-337395. Celltrion has received FDA approval for Actemra biosimilar.


APAC Healthcare Weekly (Feb 2)- Daiichi Sankyo, Eisai, Nippon Shinyaku, Shionogi, Celltrion

Japan

ONO PHARMACEUTICAL CO., LTD. manufactures and sells pharmaceuticals.  The Company mainly researches and develops prescription drugs.

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Ono Pharmaceutical (4528 JP)

APAC Healthcare Weekly (Feb 16)- Hansoh Pharma, Astellas Pharma, CSL, Imugene, LigaChem Bio, Lupin

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

Tina Banerjee

SK Biopharmaceuticals (326030 KS): Records Maiden Profit in 2024; Momentum to Continue

SKBP reported 2024 operating and net profit of KRW96B and KRW227B, respectively, driven by Xcopri's U.S. revenue. The company guided for Xcopri...

Tina Banerjee

Sumitomo Pharma (4506 JP): Robust 9MFY25 Revenues; Back in Black; Guidance Revised

Sumitomo Pharma sees 25% revenue growth, with restructuring efforts leading to a turnaround in operating profit for 9MFY25. Updated forecast...

Tina Banerjee

CHMP Meeting Update: Eight New Medicines Recommended For Approval

In its January 2025 meeting, CHMP recommended 8 drugs for approval, including 4 innovative, 3 biosimilars, and 1 generic drugs. The committee has...

Tina Banerjee

APAC Healthcare Weekly (Feb 2)- Daiichi Sankyo, Eisai, Nippon Shinyaku, Shionogi, Celltrion

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

Tina Banerjee

Price Gauge

52-week Range

Market Cap (USDm)

P/E

Dividend (Yield)

APAC Healthcare Weekly (Feb 16)- Hansoh Pharma, Astellas Pharma, CSL, Imugene, LigaChem Bio, Lupin

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

Tina Banerjee

SK Biopharmaceuticals (326030 KS): Records Maiden Profit in 2024; Momentum to Continue

​SKBP reported 2024 operating and net profit of KRW96B and KRW227B, respectively, driven by Xcopri's U.S. revenue. The company guided for Xcopri...

Tina Banerjee

Sumitomo Pharma (4506 JP): Robust 9MFY25 Revenues; Back in Black; Guidance Revised

​Sumitomo Pharma sees 25% revenue growth, with restructuring efforts leading to a turnaround in operating profit for 9MFY25. Updated forecast...

Tina Banerjee

CHMP Meeting Update: Eight New Medicines Recommended For Approval

In its January 2025 meeting, CHMP recommended 8 drugs for approval, including 4 innovative, 3 biosimilars, and 1 generic drugs. The committee has...

Tina Banerjee

APAC Healthcare Weekly (Feb 2)- Daiichi Sankyo, Eisai, Nippon Shinyaku, Shionogi, Celltrion

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

Tina Banerjee

SKBP reported 2024 operating and net profit of KRW96B and KRW227B, respectively, driven by Xcopri's U.S. revenue. The company guided for Xcopri...

Sumitomo Pharma sees 25% revenue growth, with restructuring efforts leading to a turnaround in operating profit for 9MFY25. Updated forecast...