Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<ul>
<li>Daiichi Sankyo announced positive topline result from the phase 3 trial of Enhertu in gastric cancer. Kyorin Pharmaceutical outlicensed KRP-M223, a preclinical mast-cell-targeting candidate for chronic spontaneous urticaria, to Novartis.</li>
<li>Celltrion received FDA approval for Stoboclo and Osenvelt, biosimilars referencing Prolia and Xgeva, respectively. Zydus Lifesciences expects to start the development of world’s first combination vaccine against shigellosis and typhoid.</li>
<li>Biocon received FDA approval for lenalidomide capsules, indicated for types of multiple myeloma, and some other hematologic indications and dasatinib tablets for the treatment of chronic myeloid leukemia.</li>
</ul>


Daiichi Sankyo announced positive topline result from the phase 3 trial of Enhertu in gastric cancer. Kyorin Pharmaceutical outlicensed KRP-M223, a preclinical mast-cell-targeting candidate for chronic spontaneous urticaria, to Novartis.
Celltrion received FDA approval for Stoboclo and Osenvelt, biosimilars referencing Prolia and Xgeva, respectively. Zydus Lifesciences expects to start the development of world’s first combination vaccine against shigellosis and typhoid.
Biocon received FDA approval for lenalidomide capsules, indicated for types of multiple myeloma, and some other hematologic indications and dasatinib tablets for the treatment of chronic myeloid leukemia.


APAC Healthcare Weekly (Mar 9)- Daiichi Sankyo, Kyorin Pharma, Celltrion, Zydus Lifesciences, Biocon

Equity Bottom-Up

<ul>
<li>In 9MFY25, <a href="https://www.smartkarma.com/entities/eisai-co-ltd" target="_blank" data-smartkarma-citation="entities:21001:1" rel="noopener">Eisai Co Ltd (4523 JP)</a> reported 9% YoY growth in revenue, driven by 3Ls. Operating profit rose 48% YoY and net profit climbed 56% YoY to ¥45.5B.</li>
<li>Eisai kept its FY25 total revenue guidance unchanged, implying a weaker Q4FY25 with a probable loss on the cards.</li>
<li>Lenvima growth stabilizes on indication expansion, Leqembi awaiting approvals and untangling safety concerns in a bid to reach its full market potential.</li>
</ul>


In 9MFY25, Eisai Co Ltd (4523 JP) reported 9% YoY growth in revenue, driven by 3Ls. Operating profit rose 48% YoY and net profit climbed 56% YoY to ¥45.5B.
Eisai kept its FY25 total revenue guidance unchanged, implying a weaker Q4FY25 with a probable loss on the cards.
Lenvima growth stabilizes on indication expansion, Leqembi awaiting approvals and untangling safety concerns in a bid to reach its full market potential.


Eisai (4523 JP): 3L Drive 9MFY25 Result; FY25 Guidance Reaffirmed; Leqembi at an Inflection Point

<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>
<a href="https://www.smartkarma.com/entities/shionogi-co-ltd" target="_blank" data-smartkarma-citation="entities:19535:1" rel="noopener">Shionogi &amp; Co (4507 JP)</a> reported 1% YoY revenue decline during 9MFY25 as domestic sales of prescription drugs decreased 38% YoY.</li>
<li>Quviviq, a DORA treatment for insomnia was launched in December 2024. Shionogi acquired exclusive distribution rights for Quviviq in Japan and it is expected to be a significant revenue contributor.</li>
<li>Shionogi submitted NDA in Japan for zuranolone, a treatment in development for major depressive disorder (MDD). Approval is expected in H1FY26.</li>
</ul>



Shionogi &amp; Co (4507 JP) reported 1% YoY revenue decline during 9MFY25 as domestic sales of prescription drugs decreased 38% YoY.
Quviviq, a DORA treatment for insomnia was launched in December 2024. Shionogi acquired exclusive distribution rights for Quviviq in Japan and it is expected to be a significant revenue contributor.
Shionogi submitted NDA in Japan for zuranolone, a treatment in development for major depressive disorder (MDD). Approval is expected in H1FY26.


Shionogi & Co (4507 JP): 9MFY25 Revenue Flat; Insomnia Drug Launched; NDA Submission in Japan

<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

Japan

Otsuka Holdings Co Ltd is a pharmaceutical company. The Company manufactures, sells, imports and exports pharmaceuticals, clinical testing, and medical equipment for intractable diseases.

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Otsuka Holdings (4578 JP)

APAC Healthcare Weekly (Mar 9)- Daiichi Sankyo, Kyorin Pharma, Celltrion, Zydus Lifesciences, Biocon

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

Tina Banerjee

Eisai (4523 JP): 3L Drive 9MFY25 Result; FY25 Guidance Reaffirmed; Leqembi at an Inflection Point

Eisai sees strong revenue and profit growth in 9MFY25, but Q4FY25 outlook seems weaker with potential loss. Focus will be on addressing safety...

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

Shionogi & Co (4507 JP): 9MFY25 Revenue Flat; Insomnia Drug Launched; NDA Submission in Japan

Shionogi reported 1% revenue decline in 9MFY25. Despite of launching new insomnia drug in Japan and new drug application submission in Japan, near...

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

Price Gauge

52-week Range

Market Cap (USDm)

P/E

Dividend (Yield)

APAC Healthcare Weekly (Mar 9)- Daiichi Sankyo, Kyorin Pharma, Celltrion, Zydus Lifesciences, Biocon

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

Tina Banerjee

Eisai (4523 JP): 3L Drive 9MFY25 Result; FY25 Guidance Reaffirmed; Leqembi at an Inflection Point

​Eisai sees strong revenue and profit growth in 9MFY25, but Q4FY25 outlook seems weaker with potential loss. Focus will be on addressing safety...

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

Shionogi & Co (4507 JP): 9MFY25 Revenue Flat; Insomnia Drug Launched; NDA Submission in Japan

​Shionogi reported 1% revenue decline in 9MFY25. Despite of launching new insomnia drug in Japan and new drug application submission in Japan, near...

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

Eisai sees strong revenue and profit growth in 9MFY25, but Q4FY25 outlook seems weaker with potential loss. Focus will be on addressing safety...

Shionogi reported 1% revenue decline in 9MFY25. Despite of launching new insomnia drug in Japan and new drug application submission in Japan, near...