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Marketing applications for two medicines were withdrawn.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Marketing applications for two medicines were withdrawn.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>Samsung Biologics secured highest ever contract manufacturing order worth KRW2.07T ($1.4B) from a European pharmaceutical company. The cumulative order volume has now surpassed $17.6B.</li>
<li>FDA has accepted Daiichi Sankyo’s revised filing for Dato-DXd for certain types of non-small cell lung cancer (NSCLC) and Eisai’s BLA for Leqembi subcutaneous autoinjector for weekly maintenance dosing.</li>
<li>Sun Pharma is acquiring Canada-based Antibe Therapeutics, a clinical-stage biotechnological company developing novel drugs primarily focusing on reducing pain and inflammation. Biocon got FDA clearance for insulin facility in Malaysia.</li>
</ul>


Samsung Biologics secured highest ever contract manufacturing order worth KRW2.07T ($1.4B) from a European pharmaceutical company. The cumulative order volume has now surpassed $17.6B.
FDA has accepted Daiichi Sankyo’s revised filing for Dato-DXd for certain types of non-small cell lung cancer (NSCLC) and Eisai’s BLA for Leqembi subcutaneous autoinjector for weekly maintenance dosing.
Sun Pharma is acquiring Canada-based Antibe Therapeutics, a clinical-stage biotechnological company developing novel drugs primarily focusing on reducing pain and inflammation. Biocon got FDA clearance for insulin facility in Malaysia.


APAC Healthcare Weekly (Jan 19)- Samsung Biologics, Daiichi Sankyo, Eisai, Sun Pharma, Biocon

<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

Japan

Eisai Co., Ltd. produces prescription drugs and medical equipment and sells mainly to sales agents and subsidiaries.  Through its subsidiary, Sanko Junyaku, the Company produces and sells diagnostic drugs.  Eisai also markets its products through related companies in the US, Europe, and Asia.  The Company also manufactures and sells foods, livestock feeds, chemical, and agrochemicals.

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Eisai Co Ltd (4523 JP)

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 19)- Samsung Biologics, Daiichi Sankyo, Eisai, Sun Pharma, Biocon

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

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

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