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

<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>Ono Pharmaceutical received FDA approval for Romvimza for the treatment of symptomatic tenosynovial giant cell tumor. Shionogi obtains domestic approval for digital therapeutic app, Endeavorride for ADHD.</li>
<li>Samsung Biologics received FDA and European Commission approval for Prolia biosimilar. Celltrion received European approval for Prolia and Eylea biosimilars. Cosette Pharmaceuticals is acquiring Mayne Pharma for A$7.40 per share.</li>
<li>CSPC Pharmaceutical granted an exclusive license to Radiance Biopharma to develop and commercialize antibody drug conjugates SYS6005 in selected geographies. Cipla received FDA approval for anti-cancer drug Nilotinib capsules.</li>
</ul>


Ono Pharmaceutical received FDA approval for Romvimza for the treatment of symptomatic tenosynovial giant cell tumor. Shionogi obtains domestic approval for digital therapeutic app, Endeavorride for ADHD.
Samsung Biologics received FDA and European Commission approval for Prolia biosimilar. Celltrion received European approval for Prolia and Eylea biosimilars. Cosette Pharmaceuticals is acquiring Mayne Pharma for A$7.40 per share.
CSPC Pharmaceutical granted an exclusive license to Radiance Biopharma to develop and commercialize antibody drug conjugates SYS6005 in selected geographies. Cipla received FDA approval for anti-cancer drug Nilotinib capsules.


APAC Healthcare Weekly (Feb 23)- Ono Pharma, Shionogi, Samsung Biologics, Celltrion, CSPC, Mayne

<ul>
<li>Alteogen has signed an exclusive license agreement with Daiichi Sankyo to develop and commercialize a subcutaneous version of Enhertu. Volpara won $7.3M contract from the U.S. Defense Health Agency.</li>
<li>Santen Pharmaceutical has rolled out Rhopressa ophthalmic solution in South Korea for the treatment of open-angle glaucoma or ocular hypertension.</li>
<li>Sun Pharmaceutical’s launch of alopecia drug Leqselvi in the U.S. will be delayed due to litigation with Incyte. Recently, a U.S. District Court decided to grant a preliminary injunction.</li>
</ul>


Alteogen has signed an exclusive license agreement with Daiichi Sankyo to develop and commercialize a subcutaneous version of Enhertu. Volpara won $7.3M contract from the U.S. Defense Health Agency.
Santen Pharmaceutical has rolled out Rhopressa ophthalmic solution in South Korea for the treatment of open-angle glaucoma or ocular hypertension.
Sun Pharmaceutical’s launch of alopecia drug Leqselvi in the U.S. will be delayed due to litigation with Incyte. Recently, a U.S. District Court decided to grant a preliminary injunction.


APAC Healthcare Weekly (Nov 10)- Alteogen, Santen Pharmaceutical, Beigene, Sun Pharmaceutical

Taiwan

Oneness Biotech Co Ltd develops botanical new drugs and several biological-active new chemical entities that are purified and molecularly modified from these botanical sources.

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Oneness Biotech (4743 TT)

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

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

APAC Healthcare Weekly (Feb 23)- Ono Pharma, Shionogi, Samsung Biologics, Celltrion, CSPC, Mayne

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

Tina Banerjee

APAC Healthcare Weekly (Nov 10)- Alteogen, Santen Pharmaceutical, Beigene, Sun Pharmaceutical

Alteogen partners with Daiichi Sankyo for Enhertu, Volpara secures $7.3M contract, Santen launches Rhopressa in South Korea, Sun Pharma's Leqselvi...

Tina Banerjee

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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

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

APAC Healthcare Weekly (Feb 23)- Ono Pharma, Shionogi, Samsung Biologics, Celltrion, CSPC, Mayne

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

Tina Banerjee

APAC Healthcare Weekly (Nov 10)- Alteogen, Santen Pharmaceutical, Beigene, Sun Pharmaceutical

​Alteogen partners with Daiichi Sankyo for Enhertu, Volpara secures $7.3M contract, Santen launches Rhopressa in South Korea, Sun Pharma's Leqselvi...

Tina Banerjee

Alteogen partners with Daiichi Sankyo for Enhertu, Volpara secures $7.3M contract, Santen launches Rhopressa in South Korea, Sun Pharma's Leqselvi...