Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<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Marketing applications for two medicines were withdrawn.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Marketing applications for two medicines were withdrawn.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

<ul>
<li>Wuxi Biologics is selling its Ireland vaccine manufacturing facility to Merck for $500M. Astellas Pharma received approval for Vyloy in China for the first-line treatment of gastric cancer.</li>
<li>FDA decision for Otsuka’s label expansion application for brexpiprazole for the treatment of post-traumatic stress disorder will be delayed. EMA has accepted Otsuka’s marketing application for HAE drug candidate donidalorsen.</li>
<li>Samsung Biologics has extended collaboration with LigaChem Biosciences to provide ADC services. Pharmaessentia has announced positive topline results from phase 3 clinical trial of P1101 for Essential Thrombocythemia (ET).</li>
</ul>


Wuxi Biologics is selling its Ireland vaccine manufacturing facility to Merck for $500M. Astellas Pharma received approval for Vyloy in China for the first-line treatment of gastric cancer.
FDA decision for Otsuka’s label expansion application for brexpiprazole for the treatment of post-traumatic stress disorder will be delayed. EMA has accepted Otsuka’s marketing application for HAE drug candidate donidalorsen.
Samsung Biologics has extended collaboration with LigaChem Biosciences to provide ADC services. Pharmaessentia has announced positive topline results from phase 3 clinical trial of P1101 for Essential Thrombocythemia (ET).


APAC Healthcare Weekly (Jan 12)- Wuxi Biologics, Astellas, Otsuka, Samsung Biologics, Pharmaessentia

Equity Bottom-Up

<ul>
<li>
<a href="https://www.smartkarma.com/entities/kyowa-kirin-co-ltd" target="_blank" data-smartkarma-citation="entities:18055:1" rel="noopener">Kyowa Kirin Co Ltd (4151 JP)</a> posted 14% revenue growth in 1H26. Core operating margin expands expanded on lower SG&amp;A and R&amp;D expense.</li>
<li>Kyowa Kirin reiterated 2026 guidance. They expect revenue to be ¥520B and core operating profit to be ¥130B. Company expects to end the year with a core profit of ¥103B.</li>
<li>Kyowa Kirin needs new drugs to augment growth. It remains highly dependent on Crysvita. Ziftomenib, infigratinib will drive revenue numbers in medium to long term.</li>
</ul>



Kyowa Kirin Co Ltd (4151 JP) posted 14% revenue growth in 1H26. Core operating margin expands expanded on lower SG&amp;A and R&amp;D expense.
Kyowa Kirin reiterated 2026 guidance. They expect revenue to be ¥520B and core operating profit to be ¥130B. Company expects to end the year with a core profit of ¥103B.
Kyowa Kirin needs new drugs to augment growth. It remains highly dependent on Crysvita. Ziftomenib, infigratinib will drive revenue numbers in medium to long term.


Kyowa Kirin (4151 JP): 1H26 Revenue Grow on North America, EMEA; Guidance Reiterated

<ul>
<li>CSPC Pharmaceutical entered into an exclusive license agreement with AstraZeneca for the global development, manufacture, and commercialization bad cholesterol lowering drug candidate YS2302018.</li>
<li>Ono Pharmaceutical entered into a license agreement with LigaChem Biosciences for LCB97, a pre-clinical stage antibody-drug conjugate (ADC) aimed at being a first-in-class drug in the field of solid tumors.</li>
<li>The U.S. International Trade Commission (ITC) has issued final ruling in favor of Hugel. This should accelerate Hugel’s business expansion in the U.S.</li>
</ul>


CSPC Pharmaceutical entered into an exclusive license agreement with AstraZeneca for the global development, manufacture, and commercialization bad cholesterol lowering drug candidate YS2302018.
Ono Pharmaceutical entered into a license agreement with LigaChem Biosciences for LCB97, a pre-clinical stage antibody-drug conjugate (ADC) aimed at being a first-in-class drug in the field of solid tumors.
The U.S. International Trade Commission (ITC) has issued final ruling in favor of Hugel. This should accelerate Hugel’s business expansion in the U.S.


APAC Healthcare Weekly (Oct 13)- CSPC Pharma, Hugel, Astellas, Ono Pharma, and Hanmi Pharm

Japan

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

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Ono Pharmaceutical (4528 JT)

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

APAC Healthcare Weekly (Jan 12)- Wuxi Biologics, Astellas, Otsuka, Samsung Biologics, Pharmaessentia

APAC healthcare companies got approvals for new products as well as clinical trials. The companies continued with acquisitions and collaborations...

Tina Banerjee

Kyowa Kirin (4151 JP): 1H26 Revenue Grow on North America, EMEA; Guidance Reiterated

Kyowa Kirin posted 14% revenue growth in 1H26, margin expanded and the company reiterated 2026 guidance. Company needs new drugs to augment growth....

Tina Banerjee

APAC Healthcare Weekly (Oct 13)- CSPC Pharma, Hugel, Astellas, Ono Pharma, and Hanmi Pharm

Nobel Peace prize comes in the backdrop of a series of conflicts in the Middle East, Ukraine, and Sudan. However, far away from the conflict zones,...

Tina Banerjee

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