Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<ul>
<li>WuXi Biologics’ Ireland facility has been approved by EMA as a commercial manufacturing site for a global client’s innovative biologic. Ab&amp;B Bio-Tech received approval for RSV vaccine in Chian.</li>
<li>Ascletis Pharma announced encouraging preclinical efficacy results for ASC47, a first-in-class muscle-preserving weight loss drug candidate. Remegen entered outlicensing agreement with Santen Pharmaceutical for a proprietary intravitreal injection.</li>
<li>Daiichi Sankyo’s Ifinatamab deruxtecan has been granted Breakthrough Therapy Designation by the FDA for small cell lung cancer. CSL intends to lay off 15% workforce and demerge CSL Seqirus.</li>
</ul>


WuXi Biologics’ Ireland facility has been approved by EMA as a commercial manufacturing site for a global client’s innovative biologic. Ab&amp;B Bio-Tech received approval for RSV vaccine in Chian.
Ascletis Pharma announced encouraging preclinical efficacy results for ASC47, a first-in-class muscle-preserving weight loss drug candidate. Remegen entered outlicensing agreement with Santen Pharmaceutical for a proprietary intravitreal injection.
Daiichi Sankyo’s Ifinatamab deruxtecan has been granted Breakthrough Therapy Designation by the FDA for small cell lung cancer. CSL intends to lay off 15% workforce and demerge CSL Seqirus.


APAC Healthcare Weekly (Aug 24) – Wuxi Bio, Ab&B Bio, Ascletis Pharma, Remegen, Daiichi Sankyo, CSL

<ul>
<li>Hansoh Pharmaceutical stuck outlicense agreement with Regeneron Pharmaceuticals for GLP-1 drug candidate for an upfront payment of $80M. Daiichi Sankyo unveiled positive phase 3 trial result in first-line breast cancer.</li>
<li>Takeda received European approval for Adcetris as a chemotherapy regimen in Hodgkin lymphoma. Zydus Lifesciences is acquiring 5.9% stake in Agenus and commercial right for its lead candidate for India.</li>
<li>Mayne Pharma has filed a complaint in the U.S. Court against TherapeuticsMD. Cosette Pharmaceuticals indicated an intention to terminate the acquisition over “material adverse clause claims.”</li>
</ul>


Hansoh Pharmaceutical stuck outlicense agreement with Regeneron Pharmaceuticals for GLP-1 drug candidate for an upfront payment of $80M. Daiichi Sankyo unveiled positive phase 3 trial result in first-line breast cancer.
Takeda received European approval for Adcetris as a chemotherapy regimen in Hodgkin lymphoma. Zydus Lifesciences is acquiring 5.9% stake in Agenus and commercial right for its lead candidate for India.
Mayne Pharma has filed a complaint in the U.S. Court against TherapeuticsMD. Cosette Pharmaceuticals indicated an intention to terminate the acquisition over “material adverse clause claims.”


APAC Healthcare Weekly (June 8)- Hansoh Pharma, Daiichi Sankyo, Takeda, Mayne Pharma, Zydus Life

<ul>
<li>Jiangsu Hengrui Medicine launches Hong Kong IPO to raise ~$1.3B. Wuxi Biologics is selling its drug product plant in Germany to Terumo for €150M.</li>
<li>Chugai Pharmaceutical got conditional approval in Japan for gene therapy product, Elevidys for Duchenne muscular dystrophy. GC Biopharma dosed first patient in Fabry disease drug trial in Korea.</li>
<li>Mayne Pharma was hit hard as an ‘untitled letter’ from the FDA related to certain promotional claims used in a speaker presentation for oral contraceptive Nextstellis, was made public.  </li>
</ul>


Jiangsu Hengrui Medicine launches Hong Kong IPO to raise ~$1.3B. Wuxi Biologics is selling its drug product plant in Germany to Terumo for €150M.
Chugai Pharmaceutical got conditional approval in Japan for gene therapy product, Elevidys for Duchenne muscular dystrophy. GC Biopharma dosed first patient in Fabry disease drug trial in Korea.
Mayne Pharma was hit hard as an ‘untitled letter’ from the FDA related to certain promotional claims used in a speaker presentation for oral contraceptive Nextstellis, was made public.  


APAC Healthcare Weekly (May 18)-Hengrui Medicine, Wuxi Biologics, Chugai, GC Biopharma, Mayne 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>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

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Mayne Pharma Group Ltd. develops and manufactures oral pharmaceuticals.  The Company produces branded generics, specialty generics, and active pharmaceutical ingredients.

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Mayne Pharma (MYX AU)

APAC Healthcare Weekly (Aug 24) – Wuxi Bio, Ab&B Bio, Ascletis Pharma, Remegen, Daiichi Sankyo, CSL

Wuxi Bio got EMA nod for Ireland manufacturing facility. Daiichi Sankyo got breakthrough therapy designation for its drug candidate in US. CSL...

Tina Banerjee

APAC Healthcare Weekly (June 8)- Hansoh Pharma, Daiichi Sankyo, Takeda, Mayne Pharma, Zydus Life

Hansoh stuck deal with Regeneron for obesity drug candidate. Daiichi Sankyo unveiled positive phase 3 trial result in first-line breast cancer....

Tina Banerjee

APAC Healthcare Weekly (May 18)-Hengrui Medicine, Wuxi Biologics, Chugai, GC Biopharma, Mayne Pharma

Jiangsu Hengrui launches HK IPO. Wuxi Biologics to sell Germany plant. Chugai got Japan approval for gene therapy. Mayne Pharma was hit as FDA...

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 (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

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