Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<ul>
<li>CHMP has recommended five medicines for approval at its March 2025 meeting, including two innovative drugs and three biosimilars.</li>
<li>The Committee Recommended not granting a marketing authorization for Eli Lilly’s Kisunla (donasemab), a medicine intended for the treatment of early Alzheimer’s disease.</li>
<li>The committee recommended extensions of indication for seven medicines that are already authorized in the EU, while recommended to refuse extending the marketing authorisation for Pemazyre for myeloid/lymphoid neoplasms.</li>
</ul>


CHMP has recommended five medicines for approval at its March 2025 meeting, including two innovative drugs and three biosimilars.
The Committee Recommended not granting a marketing authorization for Eli Lilly’s Kisunla (donasemab), a medicine intended for the treatment of early Alzheimer’s disease.
The committee recommended extensions of indication for seven medicines that are already authorized in the EU, while recommended to refuse extending the marketing authorisation for Pemazyre for myeloid/lymphoid neoplasms.


CHMP Meeting Update: Five New Medicines Recommended for Approval, Rejects Kisunla Application

<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

<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>GenScript Biotech established operations site and logistics center in Australia. Eisai has received positive opinion from CHMP recommending approval of lecanemab. Otsuka forms JV to boost IV supply in US.</li>
<li>Lunit formed strategic alliance in France to expand AI solution deployment. Daiichi Sankyo and AstraZeneca submitted a new BLA for accelerated approval in the U.S. for datopotamab deruxtecan for NSCLC.</li>
<li>Cellid has completed recruiting and dosing all participants in its Phase 3 clinical trial of COVID-19 vaccine targeting Omicron variant. Alembic Pharmaceutical received FDA approval for hypertension drug.</li>
</ul>


GenScript Biotech established operations site and logistics center in Australia. Eisai has received positive opinion from CHMP recommending approval of lecanemab. Otsuka forms JV to boost IV supply in US.
Lunit formed strategic alliance in France to expand AI solution deployment. Daiichi Sankyo and AstraZeneca submitted a new BLA for accelerated approval in the U.S. for datopotamab deruxtecan for NSCLC.
Cellid has completed recruiting and dosing all participants in its Phase 3 clinical trial of COVID-19 vaccine targeting Omicron variant. Alembic Pharmaceutical received FDA approval for hypertension drug.


APAC Healthcare Weekly (Nov 17)- GenScript Biotech, Eisai, Otsuka, Daiichi Sankyo, Cellid, and Lunit

<ul>
<li>
<a href="https://www.smartkarma.com/entities/samsung-biologics-co-ltd" target="_blank" data-smartkarma-citation="entities:22932:1" rel="noopener">Samsung Biologics (207940 KS)</a> signed a contract manufacturing agreement worth KRW1.7T ($1.2B) with an Asian pharmaceutical company. <a href="https://www.smartkarma.com/entities/celltrion-inc" target="_blank" data-smartkarma-citation="entities:991:1" rel="noopener">Celltrion Inc (068270 KS)</a> has announced KRW100B ($72M) share buyback, starting October 28.</li>
<li>
<a href="https://www.smartkarma.com/entities/astellas-pharma-inc" target="_blank" data-smartkarma-citation="entities:6091:1" rel="noopener">Astellas Pharma (4503 JP)</a> received FDA approval for Vyloy for gastric cancer. <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> received FDA Fast Track designation for its RSV drug candidate, S-337395.</li>
<li>
<a href="https://www.smartkarma.com/entities/zai-lab-ltd-94df40cf-c15e-462f-b3de-8d2d434ae935" target="_blank" data-smartkarma-citation="entities:36261:1" rel="noopener">Zai Lab (9688 HK)</a> announced positive topline data from global Phase 1a/1b study of ZL-1310 in small cell lung cancer. <a href="https://www.smartkarma.com/entities/legend-biotech-corp" target="_blank" data-smartkarma-citation="entities:28963:1" rel="noopener">Legend Biotech Corp (LEGN US)</a> sheds Genscript Biotech as its majority shareholder.</li>
</ul>



Samsung Biologics (207940 KS) signed a contract manufacturing agreement worth KRW1.7T ($1.2B) with an Asian pharmaceutical company. Celltrion Inc (068270 KS) has announced KRW100B ($72M) share buyback, starting October 28.

Astellas Pharma (4503 JP) received FDA approval for Vyloy for gastric cancer. Shionogi &amp; Co (4507 JP) received FDA Fast Track designation for its RSV drug candidate, S-337395.

Zai Lab (9688 HK) announced positive topline data from global Phase 1a/1b study of ZL-1310 in small cell lung cancer. Legend Biotech Corp (LEGN US) sheds Genscript Biotech as its majority shareholder.


APAC Healthcare Weekly (Oct 27)- Samsung Biologics, Celltrion, Astellas, Otsuka, Legend, and Zai Lab

United States

Pfizer Inc. operates as a pharmaceutical company. The Company offers medicines, vaccines, medical devices, and consumer healthcare products for oncology, inflammation, cardiovascular, and other therapeutic areas. Pfizer serves customers worldwide.

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CHMP Meeting Update: Five New Medicines Recommended for Approval, Rejects Kisunla Application

CHMP recommends approval for five medicines, but rejects marketing authorization for Eli Lilly's Kisunla for early Alzheimer's disease. It also...

Tina Banerjee

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

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 (Nov 17)- GenScript Biotech, Eisai, Otsuka, Daiichi Sankyo, Cellid, and Lunit

Biotech companies expand operations globally with new sites and drug approvals, advancing healthcare solutions and treatments. A phase 3 trial for...

Tina Banerjee

APAC Healthcare Weekly (Oct 27)- Samsung Biologics, Celltrion, Astellas, Otsuka, Legend, and Zai Lab

Samsung Biologics secures largest ever contract, Celltrion announced KRW100B buyback, Astellas Pharma got label expansion approval for Vyloy,...

Tina Banerjee

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CHMP Meeting Update: Five New Medicines Recommended for Approval, Rejects Kisunla Application

​CHMP recommends approval for five medicines, but rejects marketing authorization for Eli Lilly's Kisunla for early Alzheimer's disease. It also...

Tina Banerjee

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

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 (Nov 17)- GenScript Biotech, Eisai, Otsuka, Daiichi Sankyo, Cellid, and Lunit

​Biotech companies expand operations globally with new sites and drug approvals, advancing healthcare solutions and treatments. A phase 3 trial for...

Tina Banerjee

APAC Healthcare Weekly (Oct 27)- Samsung Biologics, Celltrion, Astellas, Otsuka, Legend, and Zai Lab

Samsung Biologics secures largest ever contract, Celltrion announced KRW100B buyback, Astellas Pharma got label expansion approval for Vyloy,...

Tina Banerjee

CHMP recommends approval for five medicines, but rejects marketing authorization for Eli Lilly's Kisunla for early Alzheimer's disease. It also...

Biotech companies expand operations globally with new sites and drug approvals, advancing healthcare solutions and treatments. A phase 3 trial for...