Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<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>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

CEO, A. Stotz Investment Research

Dr. Andrew Stotz, CFA

Quantamental Investing to beat Benchmarks

A. Stotz Investment Research

We pick stocks. We construct portfolios. All our effort is focused on how to better pick stocks and construct portfolios. We serve fund management companies, family offices, and high net worth individuals.

<ul>
<li>We highlight 14 stocks in Asia that look interesting to us based on our FVMR methodology</li>
<li>Portfolio changes: Two stock remains, 12 stocks added into portfolio</li>
<li>Since its inception, it has generated a before-fee total return of 200% versus the MSCI Asia ex Japan of 77%</li>
</ul>


We highlight 14 stocks in Asia that look interesting to us based on our FVMR methodology
Portfolio changes: Two stock remains, 12 stocks added into portfolio
Since its inception, it has generated a before-fee total return of 200% versus the MSCI Asia ex Japan of 77%


<ul>
<li>Nippon Shinyaku filed NDA of tagraxofusp for a rare aggressive hematologic malignancy in Japan. Shionogi initiated rolling NDA submission to the FDA for Xocova for COVID-19 post-exposure prophylaxis.</li>
<li>Beigene is discontinuing clinical development program for ociperlimab, as a potential treatment for lung cancer. Celltrion received positive CHMP opinion for the addition of the Omlyclo autoinjector formulation.  </li>
<li>The first three children with SR-aGvHD will receive a course of Mesoblast’s Ryoncil commencing this week. Lupin is acquiring UK-based Renascience Pharma, a sole supplier of 4 specialty products.</li>
</ul>


Nippon Shinyaku filed NDA of tagraxofusp for a rare aggressive hematologic malignancy in Japan. Shionogi initiated rolling NDA submission to the FDA for Xocova for COVID-19 post-exposure prophylaxis.
Beigene is discontinuing clinical development program for ociperlimab, as a potential treatment for lung cancer. Celltrion received positive CHMP opinion for the addition of the Omlyclo autoinjector formulation.  
The first three children with SR-aGvHD will receive a course of Mesoblast’s Ryoncil commencing this week. Lupin is acquiring UK-based Renascience Pharma, a sole supplier of 4 specialty products.


APAC Healthcare Weekly (April 6)- Nippon Shinyaku, Shionogi, Beigene, Celltrion, Mesoblast, Lupin

<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

South Korea

Celltrion, Inc. produces and sells biosimilar products, as well as consignment processing services for other businesses.

Price Gauge
52-week Range	0.00 - 0.00
Market Cap (USDm)	0.00
P/E	0.00
Dividend (Yield)	0.00

Celltrion (068270 KP)

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

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

The Stocks to Own in Asia – Vol. 48

We highlight 14 stocks in Asia that look interesting to us based on our FVMR methodology. Since its inception, it has generated a before-fee total...

A. Stotz Investment Research

APAC Healthcare Weekly (April 6)- Nippon Shinyaku, Shionogi, Beigene, Celltrion, Mesoblast, Lupin

Nippon Shinyaku and Shionogi are filing for new drugs. Beigene dropped a phase 3 oncology asset. Mesoblast is about to start treatment with...

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

Price Gauge

52-week Range

Market Cap (USDm)

P/E

Dividend (Yield)

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

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

The Stocks to Own in Asia – Vol. 48

We highlight 14 stocks in Asia that look interesting to us based on our FVMR methodology. Since its inception, it has generated a before-fee total...

A. Stotz Investment Research

APAC Healthcare Weekly (April 6)- Nippon Shinyaku, Shionogi, Beigene, Celltrion, Mesoblast, Lupin

Nippon Shinyaku and Shionogi are filing for new drugs. Beigene dropped a phase 3 oncology asset. Mesoblast is about to start treatment with...

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

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