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>Daiichi Sankyo received EU approval for Enhertu in breast cancer. Kaken Pharmaceutical in-licensed hereditary angioedema drug candidate sebetralstat for Japan from KalVista Pharmaceuticals for an upfront payment of $11M.</li>
<li>ABL Bio signed £2B+ outlicensing licensing deal with GSK to develop novel medicines for neurodegenerative diseases. Samsung Biologics launched Epysqli, a biosimilar referencing Soliris in the U.S.</li>
<li>U.S. court ruled in favor of Sun Pharma regarding the launch of alopecia areata drug Leqselvi. Mayne Pharma has been involved in a legal proceeding in U.S., brought by TherapeuticsMD.</li>
</ul>


Daiichi Sankyo received EU approval for Enhertu in breast cancer. Kaken Pharmaceutical in-licensed hereditary angioedema drug candidate sebetralstat for Japan from KalVista Pharmaceuticals for an upfront payment of $11M.
ABL Bio signed £2B+ outlicensing licensing deal with GSK to develop novel medicines for neurodegenerative diseases. Samsung Biologics launched Epysqli, a biosimilar referencing Soliris in the U.S.
U.S. court ruled in favor of Sun Pharma regarding the launch of alopecia areata drug Leqselvi. Mayne Pharma has been involved in a legal proceeding in U.S., brought by TherapeuticsMD.


APAC Healthcare Weekly (April 13)- Daiichi Sankyo, Kaken, ABL Bio, Samsung Biologics, Sun Pharma

<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

<ul>
<li>Eisai is eyeing for Leqembi global revenue of ¥250–280B in FY28. Kaken Pharmaceutical inlicensed dermatology drug candidate from Alumis. Kaken’s onychomycosis drug got approval in Italy.</li>
<li>Mochida Pharmaceutical has applied for marketing approval of Actembra biosimilar in Japan. Shionogi has filed for indication expansion of Xocova for post-exposure prophylaxis of COVID-19 in Japan.</li>
<li>SK Bioscience got approval for Phase 3 clinical trial of 21-valent pneumococcal vaccine in European countries. PharmaEssential obtained approval for Phase 3 clinical trial of Ropeginterferon alfa-2b in China.</li>
</ul>


Eisai is eyeing for Leqembi global revenue of ¥250–280B in FY28. Kaken Pharmaceutical inlicensed dermatology drug candidate from Alumis. Kaken’s onychomycosis drug got approval in Italy.
Mochida Pharmaceutical has applied for marketing approval of Actembra biosimilar in Japan. Shionogi has filed for indication expansion of Xocova for post-exposure prophylaxis of COVID-19 in Japan.
SK Bioscience got approval for Phase 3 clinical trial of 21-valent pneumococcal vaccine in European countries. PharmaEssential obtained approval for Phase 3 clinical trial of Ropeginterferon alfa-2b in China.


APAC Healthcare Weekly (Mar 30)- Eisai, Kaken, Mochida, Shionogi, SK Bioscience, PharmaEssentia

<ul>
<li>Daiichi Sankyo announced positive topline result from the phase 3 trial of Enhertu in gastric cancer. Kyorin Pharmaceutical outlicensed KRP-M223, a preclinical mast-cell-targeting candidate for chronic spontaneous urticaria, to Novartis.</li>
<li>Celltrion received FDA approval for Stoboclo and Osenvelt, biosimilars referencing Prolia and Xgeva, respectively. Zydus Lifesciences expects to start the development of world’s first combination vaccine against shigellosis and typhoid.</li>
<li>Biocon received FDA approval for lenalidomide capsules, indicated for types of multiple myeloma, and some other hematologic indications and dasatinib tablets for the treatment of chronic myeloid leukemia.</li>
</ul>


Daiichi Sankyo announced positive topline result from the phase 3 trial of Enhertu in gastric cancer. Kyorin Pharmaceutical outlicensed KRP-M223, a preclinical mast-cell-targeting candidate for chronic spontaneous urticaria, to Novartis.
Celltrion received FDA approval for Stoboclo and Osenvelt, biosimilars referencing Prolia and Xgeva, respectively. Zydus Lifesciences expects to start the development of world’s first combination vaccine against shigellosis and typhoid.
Biocon received FDA approval for lenalidomide capsules, indicated for types of multiple myeloma, and some other hematologic indications and dasatinib tablets for the treatment of chronic myeloid leukemia.


APAC Healthcare Weekly (Mar 9)- Daiichi Sankyo, Kyorin Pharma, Celltrion, Zydus Lifesciences, Biocon

Japan

Takeda Pharmaceutical Co Ltd focuses on the Research & Development, Manufacturing, Sales and Marketing and Import/Export of Pharmaceutical Drugs. The Company focuses on the following core therapeutic areas: Cardiovascular & Metabolic, Oncology, Central Nervous System, Respiratory & Immunology, General Medicine (Gastrointestinal & Genitourinary) and Vaccine.

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Takeda Pharmaceutical (4502 JP)

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 13)- Daiichi Sankyo, Kaken, ABL Bio, Samsung Biologics, Sun Pharma

Daiichi got EU approval for Enhertu. Kaken Pharma signed inlicensing deal, while ABL stuck outlicensing deal. Sun Pharma's Leqselvi is now free to...

Tina Banerjee

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

APAC Healthcare Weekly (Mar 30)- Eisai, Kaken, Mochida, Shionogi, SK Bioscience, PharmaEssentia

Eisai outlined Leqembi sales target. Kaken inlicensed drug candidate. Mochida filed for Actembra biosimilar. Shionogi applied for label expansion...

Tina Banerjee

APAC Healthcare Weekly (Mar 9)- Daiichi Sankyo, Kyorin Pharma, Celltrion, Zydus Lifesciences, Biocon

APAC healthcare companies continued to get approvals for new products and initiates clinical trials. The companies continued with acquisitions and...

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 13)- Daiichi Sankyo, Kaken, ABL Bio, Samsung Biologics, Sun Pharma

Daiichi got EU approval for Enhertu. Kaken Pharma signed inlicensing deal, while ABL stuck outlicensing deal. Sun Pharma's Leqselvi is now free to...

Tina Banerjee

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

APAC Healthcare Weekly (Mar 30)- Eisai, Kaken, Mochida, Shionogi, SK Bioscience, PharmaEssentia

Eisai outlined Leqembi sales target. Kaken inlicensed drug candidate. Mochida filed for Actembra biosimilar. Shionogi applied for label expansion...

Tina Banerjee

APAC Healthcare Weekly (Mar 9)- Daiichi Sankyo, Kyorin Pharma, Celltrion, Zydus Lifesciences, Biocon

APAC healthcare companies continued to get approvals for new products and initiates clinical trials. The companies continued with acquisitions and...

Tina Banerjee

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