Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<ul>
<li>Eisai received approval for its insomnia drug, Dayvigo in China. Daiichi Sankyo and Merck have voluntarily withdrawn BLA seeking accelerated approval in the U.S. for patritumab deruxtecan for NSCLC.</li>
<li>Samsung Biologics secured two CMO contract worth KRW441B from unnamed pharmaceutical companies in Asia and Europe. SK Bioscience has completed a major expansion of its vaccine production facility in Andong.</li>
<li>CSPC Pharmaceutical is in negotiations regarding three potential outlicensing deals. Jiangsu Hengrui Pharmaceuticals received approvals for three drugs in China. Hansoh’s third BLA for Xinyue has been accepted by NMPA.</li>
</ul>


Eisai received approval for its insomnia drug, Dayvigo in China. Daiichi Sankyo and Merck have voluntarily withdrawn BLA seeking accelerated approval in the U.S. for patritumab deruxtecan for NSCLC.
Samsung Biologics secured two CMO contract worth KRW441B from unnamed pharmaceutical companies in Asia and Europe. SK Bioscience has completed a major expansion of its vaccine production facility in Andong.
CSPC Pharmaceutical is in negotiations regarding three potential outlicensing deals. Jiangsu Hengrui Pharmaceuticals received approvals for three drugs in China. Hansoh’s third BLA for Xinyue has been accepted by NMPA.


APAC Healthcare Weekly (June 1)- Eisai, Daiichi, Samsung Bio, SK Bioscience, CSPC, Hengrui Pharma

<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>Celltrion received FDA approval for Omlyclo, the first and only biosimilar designated as interchangeable with Xolair. Ono Pharmaceutical in-licensed drug candidate for polycythemia vera from Ionis Pharmaceuticals.</li>
<li>Sun Pharmaceutical will acquire Checkpoint Therapeutics for an upfront cash payment of $4.10 per share. Syngene is acquiring Emergent’s biologics facility in Baltimore for $36.5M.</li>
<li>Zydus Lifesciences is acquiring 85.6% stake in in Amplitude Surgical for €257M. Sichuan Kelun received China approval for sacituzumab tirumotecan for certain types of non-small cell lung cancer.</li>
</ul>


Celltrion received FDA approval for Omlyclo, the first and only biosimilar designated as interchangeable with Xolair. Ono Pharmaceutical in-licensed drug candidate for polycythemia vera from Ionis Pharmaceuticals.
Sun Pharmaceutical will acquire Checkpoint Therapeutics for an upfront cash payment of $4.10 per share. Syngene is acquiring Emergent’s biologics facility in Baltimore for $36.5M.
Zydus Lifesciences is acquiring 85.6% stake in in Amplitude Surgical for €257M. Sichuan Kelun received China approval for sacituzumab tirumotecan for certain types of non-small cell lung cancer.


APAC Healthcare Weekly (Mar 16)- Celltrion, Ono Pharma, Sun Pharma, Syngene, Zydus, Sichuan Kelun

<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>Daiichi Sankyo is investing $152M for building a new ADC manufacturing facility in Shanghai. Eisai has received approval for Urece in China as a treatment for gout patients with hyperuricemia.</li>
<li>Celltrion has announced its largest-ever dividend of KRW750 per share and 1:20 bonus shares. The record date for dividend payment and bonus share is December 31.</li>
<li>Metropolis Healthcare is acquiring Core Diagnostics, a prominent player in India’s specialized diagnostics sector for INR2.5B. CSPC Pharmaceutical has granted an exclusive license to Beigene for a clinical-stage drug candidate.</li>
</ul>


Daiichi Sankyo is investing $152M for building a new ADC manufacturing facility in Shanghai. Eisai has received approval for Urece in China as a treatment for gout patients with hyperuricemia.
Celltrion has announced its largest-ever dividend of KRW750 per share and 1:20 bonus shares. The record date for dividend payment and bonus share is December 31.
Metropolis Healthcare is acquiring Core Diagnostics, a prominent player in India’s specialized diagnostics sector for INR2.5B. CSPC Pharmaceutical has granted an exclusive license to Beigene for a clinical-stage drug candidate.


APAC Healthcare Weekly (Dec 15)-Daiichi Sankyo, Eisai, Celltrion, Metropolis Healthcare, CSPC Pharma

Japan

Sanbio Co Ltd researches, develops, manufactures, and sells regenerative cell re lated pharmaceutical products.

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SanBio Co Ltd (4592 JP)

APAC Healthcare Weekly (June 1)- Eisai, Daiichi, Samsung Bio, SK Bioscience, CSPC, Hengrui Pharma

Eisai's Dayvigo approved in China. Daiichi Sankyo withdrew BLA in US. Samsung Bio secures CMO contracts. SK Bioscience expands vaccine...

Tina Banerjee

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 (Mar 16)- Celltrion, Ono Pharma, Sun Pharma, Syngene, Zydus, Sichuan Kelun

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

APAC Healthcare Weekly (Dec 15)-Daiichi Sankyo, Eisai, Celltrion, Metropolis Healthcare, CSPC Pharma

The insight covers key developments in prominent APAC healthcare companies. These developments are expected to impact the financials of the...

Tina Banerjee

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APAC Healthcare Weekly (June 1)- Eisai, Daiichi, Samsung Bio, SK Bioscience, CSPC, Hengrui Pharma

​Eisai's Dayvigo approved in China. Daiichi Sankyo withdrew BLA in US. Samsung Bio secures CMO contracts. SK Bioscience expands vaccine...

Tina Banerjee

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 (Mar 16)- Celltrion, Ono Pharma, Sun Pharma, Syngene, Zydus, Sichuan Kelun

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

APAC Healthcare Weekly (Dec 15)-Daiichi Sankyo, Eisai, Celltrion, Metropolis Healthcare, CSPC Pharma

The insight covers key developments in prominent APAC healthcare companies. These developments are expected to impact the financials of the...

Tina Banerjee

Eisai's Dayvigo approved in China. Daiichi Sankyo withdrew BLA in US. Samsung Bio secures CMO contracts. SK Bioscience expands vaccine...