Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<ul>
<li>EMA’s human medicines committee (CHMP) recommended sixteen medicines for approval at its April 2025 meeting. CHMP also adopted positive opinion for nine biosimilar medicines.</li>
<li>Among the new medicines, Vertex’s triple combination cystic fibrosis drug Alyftrek, Amgen’s Thyroid eye disease drug Tepezza, and Jazz Pharmaceutical’s billiary tract cancer drug Ziihera have potential to become blockbusters.</li>
<li>The Agency has recommended the refusal of the marketing authorization for Eli Lilly’s Alzheimer’s Disease drug Kisunla. Eli Lilly may ask for a re-examination of the opinion within 15 days.</li>
</ul>


EMA’s human medicines committee (CHMP) recommended sixteen medicines for approval at its April 2025 meeting. CHMP also adopted positive opinion for nine biosimilar medicines.
Among the new medicines, Vertex’s triple combination cystic fibrosis drug Alyftrek, Amgen’s Thyroid eye disease drug Tepezza, and Jazz Pharmaceutical’s billiary tract cancer drug Ziihera have potential to become blockbusters.
The Agency has recommended the refusal of the marketing authorization for Eli Lilly’s Alzheimer’s Disease drug Kisunla. Eli Lilly may ask for a re-examination of the opinion within 15 days.


CHMP Meeting Update April 2025: Sixteen New Medicines Recommended For Approval

<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

HK/China Healthcare Analyst (ex-Fosun Pharma)

Xinyao (Criss) Wang

<ul>
<li>Although both Republicans and Democrats have policies related to supply chain security/lowering drug prices, they have taken different approaches. Harris is likely to be “a continuation of the Biden policy”. </li>
<li>Harris would continue Biden’s strategy of “wooing India to contain China” and developing a pro-US supply chain system that isolates China.Her future policy direction may be more "predictable" than Trump's.</li>
<li>Whether Trump or Harris is elected as President of the US, there's a high possibility that the US will continue to confront China in the fields of biosecurity and biotechnology.</li>
</ul>


Although both Republicans and Democrats have policies related to supply chain security/lowering drug prices, they have taken different approaches. Harris is likely to be “a continuation of the Biden policy”. 
Harris would continue Biden’s strategy of “wooing India to contain China” and developing a pro-US supply chain system that isolates China.Her future policy direction may be more "predictable" than Trump's.
Whether Trump or Harris is elected as President of the US, there's a high possibility that the US will continue to confront China in the fields of biosecurity and biotechnology.


What Does a Kamala Harris Presidency Mean for China Healthcare?

Equity Long-Short Analyst

Pyari Menon

<ul>
<li>The three companies we write about this week are <a href="https://www.smartkarma.com/entities/raytheon-technologies-corp" target="_blank" data-smartkarma-citation="entities:6453:1" rel="noopener">Raytheon Technologies (RTX US)</a><a href="https://www.smartkarma.com/entities/beiersdorf-ag" target="_blank" data-smartkarma-citation="entities:21588:1" rel="noopener">Beiersdorf AG (BEI GR)</a> and <a href="https://www.smartkarma.com/entities/king-slide-works-co-ltd" target="_blank" data-smartkarma-citation="entities:7130:1" rel="noopener">King Slide Works (2059 TT)</a> 
</li>
<li>For the twenty-six weeks since inception ended 19 May the combined innovation portfolio was +2.5%, versus DJIA-0.9%, S&amp;P500+5.7%, Nasdaq+13.6%, Russell2000 -4.1%, MSCI-ACWI-ETF+6.9%, S&amp;P midcap 400 -2.2%, all in US$ terms</li>
<li>Small-Cap (+4.1%) versus Russell2000 (-4.1%) and midcap (+1.9%) versus S&amp;P400 (-2.2%) continues to outperform benchmarks, but the omission of mega-tech names has hurt large-cap portfolio (+2.6%) versus S&amp;P500 (+5.7%) . </li>
</ul>


The three companies we write about this week are Raytheon Technologies (RTX US)Beiersdorf AG (BEI GR) and King Slide Works (2059 TT) 

For the twenty-six weeks since inception ended 19 May the combined innovation portfolio was +2.5%, versus DJIA-0.9%, S&amp;P500+5.7%, Nasdaq+13.6%, Russell2000 -4.1%, MSCI-ACWI-ETF+6.9%, S&amp;P midcap 400 -2.2%, all in US$ terms
Small-Cap (+4.1%) versus Russell2000 (-4.1%) and midcap (+1.9%) versus S&amp;P400 (-2.2%) continues to outperform benchmarks, but the omission of mega-tech names has hurt large-cap portfolio (+2.6%) versus S&amp;P500 (+5.7%) . 


The Innovations Portfolios - Week Twenty Six

<ul>
<li>The three companies we write about this week are <a href="https://www.smartkarma.com/entities/contemporary-amperex-techn-a" target="_blank" data-smartkarma-citation="entities:24404:1" rel="noopener">CATL (A) (300750 CH)</a> , <a href="https://www.smartkarma.com/entities/kimberly-clark-corp" target="_blank" data-smartkarma-citation="entities:2292:1" rel="noopener">Kimberly Clark (KMB US)</a> and <a href="https://www.smartkarma.com/entities/blackberry-ltd" target="_blank" data-smartkarma-citation="entities:25472:1" rel="noopener">BlackBerry Ltd (BB CN)</a> </li>
<li>For the twenty-one weeks since inception ended 14 April the combined innovation portfolio was +3.6%, versus DJIA +0.4%, S&amp;P500 +4.3%, Nasdaq +8.8%, Russell2000 -3.7%, MSCI-ACWI-ETF +6.2%, all in US$ terms</li>
<li>For the same period the small cap innovation portfolio was up +5.9%, the mid cap portfolio was up +4.4% and the large cap portfolio was up +3.4%</li>
</ul>


The three companies we write about this week are CATL (A) (300750 CH) , Kimberly Clark (KMB US) and BlackBerry Ltd (BB CN) 
For the twenty-one weeks since inception ended 14 April the combined innovation portfolio was +3.6%, versus DJIA +0.4%, S&amp;P500 +4.3%, Nasdaq +8.8%, Russell2000 -3.7%, MSCI-ACWI-ETF +6.2%, all in US$ terms
For the same period the small cap innovation portfolio was up +5.9%, the mid cap portfolio was up +4.4% and the large cap portfolio was up +3.4%


The Innovations Portfolios - Week Twenty One

United States

Vertex Pharmaceuticals Incorporated discovers, develops, and commercializes novel, small molecule pharmaceuticals for the treatment of diseases for which there are currently limited or no effective treatments.  The Company develops drugs for the treatment of cystic fibrosis, autoimmune diseases, cancer, inflammatory bowel disease, and neurological disorders.

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Vertex Pharmaceuticals (VRTX US)

CHMP Meeting Update April 2025: Sixteen New Medicines Recommended For Approval

Among the new medicines, Vertex’s triple combination CF drug Alyftrek, Amgen’s Thyroid eye disease drug Tepezza, and Jazz Pharmaceutical’s cancer...

Tina Banerjee

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

What Does a Kamala Harris Presidency Mean for China Healthcare?

Harris could be “a continuation of Biden's policy” , making her future policy direction more "predictable" .But the US will continue to confront...

Xinyao (Criss) Wang

The Innovations Portfolios - Week Twenty Six

The small-Cap (+4.1%) and midcap (+1.9%) portfolios continues to outperform respective benchmarks, but the willful omission of mega-tech names has...

Pyari Menon

The Innovations Portfolios - Week Twenty One

For the twenty-one weeks since inception ended 14 April the innovation small cap portfolio was up 5.9%, mid cap portfolio was up 4.4% and the large...

Pyari Menon

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