Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<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>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>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>Daiichi Sankyo received seventh FDA approval for Enhertu in certain types of breast cancers. Eisai received FDA approval for Leqembi’s intravenous monthly maintenance dosing.</li>
<li>Nippon Shinyaku entered into an option agreement with AB2 BIO for the rights of commercialization of Tadekinig alfa in the U.S. for certain rare autoinflammatory diseases.</li>
<li>Shionogi announced positive results from Phase 2 trial of its novel investigational RSV oral antiviral candidate S-337395. Celltrion has received FDA approval for Actemra biosimilar.</li>
</ul>


Daiichi Sankyo received seventh FDA approval for Enhertu in certain types of breast cancers. Eisai received FDA approval for Leqembi’s intravenous monthly maintenance dosing.
Nippon Shinyaku entered into an option agreement with AB2 BIO for the rights of commercialization of Tadekinig alfa in the U.S. for certain rare autoinflammatory diseases.
Shionogi announced positive results from Phase 2 trial of its novel investigational RSV oral antiviral candidate S-337395. Celltrion has received FDA approval for Actemra biosimilar.


APAC Healthcare Weekly (Feb 2)- Daiichi Sankyo, Eisai, Nippon Shinyaku, Shionogi, Celltrion

<ul>
<li>Daiichi Sankyo received FDA approval for Datroway for the treatment of unresectable or metastatic hormone receptor (HR) positive, HER2 negative breast cancer who have received prior endocrine-based therapy and chemotherapy.</li>
<li>Sumitomo Pharma partnered with J&amp;J for co-promotion of the long-acting antipsychotic medication XEPLION. Shanghai Fosun Pharma’s proposed buyout of Shanghai Henlius Biotech for HK$5.4B (~$693M) failed to pass shareholders’ vote.</li>
<li>SK Bioscience signed a co-promotion and distribution agreement with Sanofi for RSV and hepatitis A vaccines. Hugel received approval for its botulinum toxin for five indications from the UAE.</li>
</ul>


Daiichi Sankyo received FDA approval for Datroway for the treatment of unresectable or metastatic hormone receptor (HR) positive, HER2 negative breast cancer who have received prior endocrine-based therapy and chemotherapy.
Sumitomo Pharma partnered with J&amp;J for co-promotion of the long-acting antipsychotic medication XEPLION. Shanghai Fosun Pharma’s proposed buyout of Shanghai Henlius Biotech for HK$5.4B (~$693M) failed to pass shareholders’ vote.
SK Bioscience signed a co-promotion and distribution agreement with Sanofi for RSV and hepatitis A vaccines. Hugel received approval for its botulinum toxin for five indications from the UAE.


APAC Healthcare Weekly (Jan 26)- Daiichi Sankyo, Sumitomo Pharma, Fosun Pharma, SK Bioscience, Hugel

Japan

Shionogi & Co., Ltd. is a pharmaceutical company. The Company develops prescription and over-the-counter drugs and diagnostics.

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Shionogi & (4507 JT)

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 (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 (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 (Feb 2)- Daiichi Sankyo, Eisai, Nippon Shinyaku, Shionogi, Celltrion

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 (Jan 26)- Daiichi Sankyo, Sumitomo Pharma, Fosun Pharma, SK Bioscience, Hugel

APAC healthcare companies got approvals for new products as well as clinical trials. The companies continued with acquisitions and collaborations...

Tina Banerjee

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