Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<ul>
<li>EMA’s human medicines committee (CHMP) recommended three new medicines for approval and adopted positive opinion for one generic medicine at its February 2025 meeting. </li>
<li>The committee recommended extending the therapeutic indications of 16 existing medicines, including two cystic fibrosis medicines, KAFTRIO and KALYDECO and oncology drugs CALQUENCE, DARZALEX, ENHERTU, and RINVOQ . </li>
<li>The CHMP concluded that its opinion recommending a marketing authorization for Eisai's Alzheimer’s disease drug Leqembi does not need to be updated.</li>
</ul>


EMA’s human medicines committee (CHMP) recommended three new medicines for approval and adopted positive opinion for one generic medicine at its February 2025 meeting. 
The committee recommended extending the therapeutic indications of 16 existing medicines, including two cystic fibrosis medicines, KAFTRIO and KALYDECO and oncology drugs CALQUENCE, DARZALEX, ENHERTU, and RINVOQ . 
The CHMP concluded that its opinion recommending a marketing authorization for Eisai's Alzheimer’s disease drug Leqembi does not need to be updated.


CHMP Meeting Update: 4 New Medicines Recommended For Approval, Reinstates Previous Leqembi Decision

Equity Bottom-Up

<ul>
<li>
<a href="https://www.smartkarma.com/entities/peptidream-inc" target="_blank" data-smartkarma-citation="entities:13514:1" rel="noopener">Peptidream Inc (4587 JP)</a> reported better-than-expected 2024 result, with all key parameters beating upwardly revised guidance. Both revenue and net profit hit record high.</li>
<li>Larger than anticipated upfront associated with the expanded Novartis collaboration and increased milestone revenue contributed to the stellar performance of 2024.</li>
<li>The company expects 2025 revenue to increase 5% YoY to ¥49B. Both core operating and operating profits are expected to increase 2% YoY and net profit by 1%.  </li>
</ul>



Peptidream Inc (4587 JP) reported better-than-expected 2024 result, with all key parameters beating upwardly revised guidance. Both revenue and net profit hit record high.
Larger than anticipated upfront associated with the expanded Novartis collaboration and increased milestone revenue contributed to the stellar performance of 2024.
The company expects 2025 revenue to increase 5% YoY to ¥49B. Both core operating and operating profits are expected to increase 2% YoY and net profit by 1%.  


Peptidream (4587 JP): 2024 Result Beats Guidance; Positive Outlook for 2025

<ul>
<li>In November 2024, <a href="https://www.smartkarma.com/entities/alteogen-inc" target="_blank" data-smartkarma-citation="entities:15886:1" rel="noopener">Alteogen Inc (196170 KS)</a> entered into an exclusive license agreement with Daiichi Sankyo for an upfront payment of $20M (KRW28B).</li>
<li>With increasing number of players developing ADC drugs mainly targeting various cancers, we can expect more big-ticket licensing deals for ALT-B4, going ahead.</li>
<li>On February 4, Alteogen has raised ~KRW155B through redeemable convertible preference shares. Over the last few months, Alteogen shares had a roller coaster ride due to fund raising rumors.</li>
</ul>


In November 2024, Alteogen Inc (196170 KS) entered into an exclusive license agreement with Daiichi Sankyo for an upfront payment of $20M (KRW28B).
With increasing number of players developing ADC drugs mainly targeting various cancers, we can expect more big-ticket licensing deals for ALT-B4, going ahead.
On February 4, Alteogen has raised ~KRW155B through redeemable convertible preference shares. Over the last few months, Alteogen shares had a roller coaster ride due to fund raising rumors.


Alteogen (196170 KS): More ALT-B4 Licensing Deal to Follow; Fund Raise Wipes Off Uncertainty

<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>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

United States

Merck & Co., Inc.  is a global health care company that delivers health solutions through its prescription medicines, vaccines, biologic therapies, animal health, and consumer care products, which it markets directly and through its joint ventures. The Company has operations in pharmaceutical, animal health, and consumer care.

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Merck & Co (MRK US)

CHMP Meeting Update: 4 New Medicines Recommended For Approval, Reinstates Previous Leqembi Decision

EMA’s CHMP recommended three new and one generic medicines for approval at its February 2025 meeting. The committee concluded that its positive...

Tina Banerjee

Peptidream (4587 JP): 2024 Result Beats Guidance; Positive Outlook for 2025

Peptidream surpasses expectations with record high revenue and net profit in 2024, fueled by expanded Novartis collaboration and milestone...

Tina Banerjee

Alteogen (196170 KS): More ALT-B4 Licensing Deal to Follow; Fund Raise Wipes Off Uncertainty

Alteogen secures $20M upfront payment in exclusive license deal with Daiichi Sankyo for using ALT-B4 in developing SC version of blockbuster ADC...

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 (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

Price Gauge

52-week Range

Market Cap (USDm)

P/E

Dividend (Yield)

CHMP Meeting Update: 4 New Medicines Recommended For Approval, Reinstates Previous Leqembi Decision

EMA’s CHMP recommended three new and one generic medicines for approval at its February 2025 meeting. The committee concluded that its positive...

Tina Banerjee

Peptidream (4587 JP): 2024 Result Beats Guidance; Positive Outlook for 2025

​Peptidream surpasses expectations with record high revenue and net profit in 2024, fueled by expanded Novartis collaboration and milestone...

Tina Banerjee

Alteogen (196170 KS): More ALT-B4 Licensing Deal to Follow; Fund Raise Wipes Off Uncertainty

​Alteogen secures $20M upfront payment in exclusive license deal with Daiichi Sankyo for using ALT-B4 in developing SC version of blockbuster ADC...

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 (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

Peptidream surpasses expectations with record high revenue and net profit in 2024, fueled by expanded Novartis collaboration and milestone...

Alteogen secures $20M upfront payment in exclusive license deal with Daiichi Sankyo for using ALT-B4 in developing SC version of blockbuster ADC...