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>FDA has confirmed the primary endpoints for Neuren Pharmaceuticals’ planned Phase 3 pivotal clinical trial of NNZ-2591 in Phelan-McDermid syndrome. Eisai has ultimately received its long-waited European approval for Leqembi.</li>
<li>Chugai Pharmaceutical’s outlicensed oral GLP-1 drug candidate orforglipron has shown positive topline Phase 3 results. Telix announced preliminary results from the Phase 2 study of TLX101 in recurrent high-grade glioma.</li>
<li>Biocon secured market entry date for Yesafili, an interchangeable biosimilar to Eylea in the U.S. FDA has issued Form 483 with 11 observations for Aurobindo Pharma’s North Carolina inhaler plant.</li>
</ul>


FDA has confirmed the primary endpoints for Neuren Pharmaceuticals’ planned Phase 3 pivotal clinical trial of NNZ-2591 in Phelan-McDermid syndrome. Eisai has ultimately received its long-waited European approval for Leqembi.
Chugai Pharmaceutical’s outlicensed oral GLP-1 drug candidate orforglipron has shown positive topline Phase 3 results. Telix announced preliminary results from the Phase 2 study of TLX101 in recurrent high-grade glioma.
Biocon secured market entry date for Yesafili, an interchangeable biosimilar to Eylea in the U.S. FDA has issued Form 483 with 11 observations for Aurobindo Pharma’s North Carolina inhaler plant.


APAC Healthcare Weekly (April 20)- Neuren, Chugai, Eisai, Telix, Biocon, Aurobindo Pharma

<ul>
<li>The U.S. has started collecting baseline tariff of 10% from April 5. Reciprocal tariff has been temporarily halted but Indian Pharma companies remain vulnerable to possible tariff threat.</li>
<li>During 9MFY25, the U.S. has been the top exporting destination for Indian pharmaceutical products, with 33% share in the exports.</li>
<li>With negotiations on, India might opt for “zero for zero” tariff approach specifically in the case of Pharmaceutical and Medical devices.</li>
</ul>


The U.S. has started collecting baseline tariff of 10% from April 5. Reciprocal tariff has been temporarily halted but Indian Pharma companies remain vulnerable to possible tariff threat.
During 9MFY25, the U.S. has been the top exporting destination for Indian pharmaceutical products, with 33% share in the exports.
With negotiations on, India might opt for “zero for zero” tariff approach specifically in the case of Pharmaceutical and Medical devices.


US Tariff Impact on APAC Healthcare: Focus Country- INDIA

External broker reports(aggregated public sources), HDFC Securities

HDFC Securities

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<ul><li>The US government under Trump 2.0 has announced reciprocal tariffs across countries, including ~26% tariff on imports from India</li><li>However, pharmaceutical products were exempted from the first round of tariffs</li><li>This is a positive for the sector, which has been under a tariff overhang since the last 2-3 months</li></ul><p><em>Content is external broker report sourced from online content aggregator through publicly available sources and is displayed below for general informational purposes only. Refer full disclaimer below.</em></p>

The US government under Trump 2.0 has announced reciprocal tariffs across countries, including ~26% tariff on imports from IndiaHowever, pharmaceutical products were exempted from the first round of tariffsThis is a positive for the sector, which has been under a tariff overhang since the last 2-3 monthsContent is external broker report sourced from online content aggregator through publicly available sources and is displayed below for general informational purposes only. Refer full disclaimer below.

Pharmaceuticals: Pharma dodges first round of US tariff risk

Equity Bottom-Up

<ul>
<li>
<a href="https://www.smartkarma.com/entities/lupin-ltd" target="_blank" data-smartkarma-citation="entities:17910:1" rel="noopener">Lupin Ltd (LPC IN)</a> has reported solid set of numbers for Q3FY23, with revenue increasing 11% YoY, EBITDA growing 32% YoY, and net profit improving 39% YoY.</li>
<li>North America revenue increased 12% YoY and 8% QoQ to record high of INR21B. Strong momentum in complex portfolio and continued cost optimization are driving consistent profitable growth in U.S.</li>
<li>Complex generics are expected to contribute 50%+ of revenue in the next couple of years. This calls for accelerated growth and better margin.</li>
</ul>



Lupin Ltd (LPC IN) has reported solid set of numbers for Q3FY23, with revenue increasing 11% YoY, EBITDA growing 32% YoY, and net profit improving 39% YoY.
North America revenue increased 12% YoY and 8% QoQ to record high of INR21B. Strong momentum in complex portfolio and continued cost optimization are driving consistent profitable growth in U.S.
Complex generics are expected to contribute 50%+ of revenue in the next couple of years. This calls for accelerated growth and better margin.


Lupin Ltd (LPC IN): Differentiated Portfolio Drives Solid Q3FY25 Performance; Momentum to Continue

India

Aurobindo Pharma Limited manufactures and markets oral and sterile antibiotics, antibacterials, anti-ulcerants and other generic basic drugs. Products include semi-synthetic penicillin drugs like ampicillin and amoxycillinas well as antibiotics, which include cloxacillin and dicloxacillin. The Company also manufactures formulations like astemizole, domeperidone and omeprazole.

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Aurobindo Pharma (ARBP IN)

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

APAC Healthcare Weekly (April 20)- Neuren, Chugai, Eisai, Telix, Biocon, Aurobindo Pharma

Neuren is a step closer to P3 trial in PMS. Chugai’s oral GLP-1 drug candidate shows promise in P3 trial. Eisai got Leqembi approval in EU. Biocon...

Tina Banerjee

US Tariff Impact on APAC Healthcare: Focus Country- INDIA

US imposed baseline tariff from April 5. Reciprocal tariff has been temporarily halted but Indian Pharma companies remain vulnerable. U.S. has been...

Tina Banerjee

Pharmaceuticals: Pharma dodges first round of US tariff risk

The US government under Trump 2.0 has announced reciprocal tariffs across countries, including ~26% tariff on imports from India

HDFC Securities

Lupin Ltd (LPC IN): Differentiated Portfolio Drives Solid Q3FY25 Performance; Momentum to Continue

Lupin reports strong Q3FY23 result with revenue up 11% YoY, EBITDA up 32% YoY, and PAT up 39% YoY. North America revenue hits record high, driven...

Tina Banerjee

Price Gauge

52-week Range

Market Cap (USDm)

P/E

Dividend (Yield)

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

APAC Healthcare Weekly (April 20)- Neuren, Chugai, Eisai, Telix, Biocon, Aurobindo Pharma

Neuren is a step closer to P3 trial in PMS. Chugai’s oral GLP-1 drug candidate shows promise in P3 trial. Eisai got Leqembi approval in EU. Biocon...

Tina Banerjee

US Tariff Impact on APAC Healthcare: Focus Country- INDIA

US imposed baseline tariff from April 5. Reciprocal tariff has been temporarily halted but Indian Pharma companies remain vulnerable. U.S. has been...

Tina Banerjee

Pharmaceuticals: Pharma dodges first round of US tariff risk

The US government under Trump 2.0 has announced reciprocal tariffs across countries, including ~26% tariff on imports from India

HDFC Securities

Lupin Ltd (LPC IN): Differentiated Portfolio Drives Solid Q3FY25 Performance; Momentum to Continue

​Lupin reports strong Q3FY23 result with revenue up 11% YoY, EBITDA up 32% YoY, and PAT up 39% YoY. North America revenue hits record high, driven...

Tina Banerjee

Lupin reports strong Q3FY23 result with revenue up 11% YoY, EBITDA up 32% YoY, and PAT up 39% YoY. North America revenue hits record high, driven...