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

Equity Bottom-Up

Jiangsu Hengrui Medicine / Equity Bottom-Up

<ul>
<li>
<a href="https://www.smartkarma.com/entities/jiangsu-hengrui-medicine-co-ltd" target="_blank" data-smartkarma-citation="entities:14128:1" rel="noopener">Jiangsu Hengrui Medicine (600276 CH)</a> and Merck entered into an exclusive license agreement for HRS-5346, an investigational oral small-molecule drug. The collaboration positions Merck to challenge two other pharma giants.</li>
<li>Hengrui has granted Merck exclusive rights to develop, manufacture, and commercialize HRS-5346 worldwide for an upfront payment of $200M. Hengrui is also eligible to receive milestone payments up to $1.77B.</li>
<li>Hengrui reported strong 19% YoY revenue growth during 9MFY25 to RMB 20B, while profits rose 6% YoY to RMB 5B. The company will report full-year 2024 result on March 31.</li>
</ul>



Jiangsu Hengrui Medicine (600276 CH) and Merck entered into an exclusive license agreement for HRS-5346, an investigational oral small-molecule drug. The collaboration positions Merck to challenge two other pharma giants.
Hengrui has granted Merck exclusive rights to develop, manufacture, and commercialize HRS-5346 worldwide for an upfront payment of $200M. Hengrui is also eligible to receive milestone payments up to $1.77B.
Hengrui reported strong 19% YoY revenue growth during 9MFY25 to RMB 20B, while profits rose 6% YoY to RMB 5B. The company will report full-year 2024 result on March 31.


Jiangsu Hengrui Medicine (600276 CH) Signs Deal With Merck For a New Class of Cardiovascular Drug

<ul>
<li>Celltrion received FDA approval for Omlyclo, the first and only biosimilar designated as interchangeable with Xolair. Ono Pharmaceutical in-licensed drug candidate for polycythemia vera from Ionis Pharmaceuticals.</li>
<li>Sun Pharmaceutical will acquire Checkpoint Therapeutics for an upfront cash payment of $4.10 per share. Syngene is acquiring Emergent’s biologics facility in Baltimore for $36.5M.</li>
<li>Zydus Lifesciences is acquiring 85.6% stake in in Amplitude Surgical for €257M. Sichuan Kelun received China approval for sacituzumab tirumotecan for certain types of non-small cell lung cancer.</li>
</ul>


Celltrion received FDA approval for Omlyclo, the first and only biosimilar designated as interchangeable with Xolair. Ono Pharmaceutical in-licensed drug candidate for polycythemia vera from Ionis Pharmaceuticals.
Sun Pharmaceutical will acquire Checkpoint Therapeutics for an upfront cash payment of $4.10 per share. Syngene is acquiring Emergent’s biologics facility in Baltimore for $36.5M.
Zydus Lifesciences is acquiring 85.6% stake in in Amplitude Surgical for €257M. Sichuan Kelun received China approval for sacituzumab tirumotecan for certain types of non-small cell lung cancer.


APAC Healthcare Weekly (Mar 16)- Celltrion, Ono Pharma, Sun Pharma, Syngene, Zydus, Sichuan Kelun

<ul>
<li>Ono Pharmaceutical received FDA approval for Romvimza for the treatment of symptomatic tenosynovial giant cell tumor. Shionogi obtains domestic approval for digital therapeutic app, Endeavorride for ADHD.</li>
<li>Samsung Biologics received FDA and European Commission approval for Prolia biosimilar. Celltrion received European approval for Prolia and Eylea biosimilars. Cosette Pharmaceuticals is acquiring Mayne Pharma for A$7.40 per share.</li>
<li>CSPC Pharmaceutical granted an exclusive license to Radiance Biopharma to develop and commercialize antibody drug conjugates SYS6005 in selected geographies. Cipla received FDA approval for anti-cancer drug Nilotinib capsules.</li>
</ul>


Ono Pharmaceutical received FDA approval for Romvimza for the treatment of symptomatic tenosynovial giant cell tumor. Shionogi obtains domestic approval for digital therapeutic app, Endeavorride for ADHD.
Samsung Biologics received FDA and European Commission approval for Prolia biosimilar. Celltrion received European approval for Prolia and Eylea biosimilars. Cosette Pharmaceuticals is acquiring Mayne Pharma for A$7.40 per share.
CSPC Pharmaceutical granted an exclusive license to Radiance Biopharma to develop and commercialize antibody drug conjugates SYS6005 in selected geographies. Cipla received FDA approval for anti-cancer drug Nilotinib capsules.


APAC Healthcare Weekly (Feb 23)- Ono Pharma, Shionogi, Samsung Biologics, Celltrion, CSPC, Mayne

<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

United States

Amgen Inc. is an independent biotechnology medicines company that discovers, develops, manufactures and markets medicines for grievous illnesses. The Company focuses solely on human therapeutics and concentrates on innovating novel medicines based on advances in cellular and molecular biology.

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Amgen Inc (AMGN US)

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

Jiangsu Hengrui Medicine (600276 CH) Signs Deal With Merck For a New Class of Cardiovascular Drug

Hengrui and Merck strike exclusive deal for HRS-5346, with upfront payment of $200M and potential milestone payments up to $1.77B. HRS-5346 is...

Tina Banerjee

APAC Healthcare Weekly (Mar 16)- Celltrion, Ono Pharma, Sun Pharma, Syngene, Zydus, Sichuan Kelun

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 (Feb 23)- Ono Pharma, Shionogi, Samsung Biologics, Celltrion, CSPC, Mayne

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

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52-week Range

Market Cap (USDm)

P/E

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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

Jiangsu Hengrui Medicine (600276 CH) Signs Deal With Merck For a New Class of Cardiovascular Drug

​Hengrui and Merck strike exclusive deal for HRS-5346, with upfront payment of $200M and potential milestone payments up to $1.77B. HRS-5346 is...

Tina Banerjee

APAC Healthcare Weekly (Mar 16)- Celltrion, Ono Pharma, Sun Pharma, Syngene, Zydus, Sichuan Kelun

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 (Feb 23)- Ono Pharma, Shionogi, Samsung Biologics, Celltrion, CSPC, Mayne

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

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

Hengrui and Merck strike exclusive deal for HRS-5346, with upfront payment of $200M and potential milestone payments up to $1.77B. HRS-5346 is...