Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<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 has announced that Dato-DXd has been recommended for approval in EU. Astellas Pharma has submitted new drug application for conditional approval of Izervay for Geographic Atrophy in Japan.</li>
<li>SanBio has successfully secured the planned production yield for the second commercial production run to meet the approval conditions for the shipment of Akuugo suspension for intracranial implantation.</li>
<li>IHH Healthcare is seeking compensation of INR109.3B from Daiichi Sankyo for its stake buy in Fortis Healthcare. Dr. Reddy’s Laboratories entered licensing agreement with Shanghai Henlius Biotech for Darzalex biosimilar.</li>
</ul>


Daiichi Sankyo has announced that Dato-DXd has been recommended for approval in EU. Astellas Pharma has submitted new drug application for conditional approval of Izervay for Geographic Atrophy in Japan.
SanBio has successfully secured the planned production yield for the second commercial production run to meet the approval conditions for the shipment of Akuugo suspension for intracranial implantation.
IHH Healthcare is seeking compensation of INR109.3B from Daiichi Sankyo for its stake buy in Fortis Healthcare. Dr. Reddy’s Laboratories entered licensing agreement with Shanghai Henlius Biotech for Darzalex biosimilar.


APAC Healthcare Weekly (Feb 9)- Daiichi Sankyo, Astellas, SanBio, IHH, Henlius Biotech, Dr. Reddy’s

<ul>
<li>In its January 2025 meeting, EMA’s human medicines committee (CHMP) recommended eight medicines for approval, including four innovative, three biosimilars, and one generic drugs.</li>
<li>The committee has also recommended extensions of indication for eight medicines that are already authorized in the EU.</li>
<li>Marketing applications for two medicines were withdrawn. Among them, withdrawal of Daiichi Sankyo’s datopotamab deruxtecan for non-squamous non-small cell lung cancer is noteworthy.</li>
</ul>


In its January 2025 meeting, EMA’s human medicines committee (CHMP) recommended eight medicines for approval, including four innovative, three biosimilars, and one generic drugs.
The committee has also recommended extensions of indication for eight medicines that are already authorized in the EU.
Marketing applications for two medicines were withdrawn. Among them, withdrawal of Daiichi Sankyo’s datopotamab deruxtecan for non-squamous non-small cell lung cancer is noteworthy.


CHMP Meeting Update: Eight New Medicines Recommended For Approval

<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

Daiichi Sankyo Co, Ltd is a holding company established through merger of Sankyo and Daiichi pharmaceutical. The Group manufactures pharmaceuticals for human/veterinary use and medical tools and equipment. It also researches and promotes products through related companies throughout the world. The Group also produces food, food additives, livestock feeds, and agrochemicals.

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Daiichi Sankyo (4568 JP)

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 9)- Daiichi Sankyo, Astellas, SanBio, IHH, Henlius Biotech, Dr. Reddy’s

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

Tina Banerjee

CHMP Meeting Update: Eight New Medicines Recommended For Approval

In its January 2025 meeting, CHMP recommended 8 drugs for approval, including 4 innovative, 3 biosimilars, and 1 generic drugs. The committee has...

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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