Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<ul>
<li>Eisai Initiated rolling submission of sBLA to the FDA for Leqembi subcutaneous autoinjector as a weekly starting dose. Hansoh Pharmaceutical’s innovative drug Xinyue got additional indication approval in China.</li>
<li>Jiangsu Hengrui received marketing approval of its self-developed Class 1 innovative drug, Zeprumetostat in China. Celltrion got approval in Europe to start Phase 3 trial of its Darzalex biosimilar.</li>
<li>SK Bioscience applied for Phase 3 clinical trial of SKYVaricella in South Korea to add the 2-dose indication. Lupin received FDA approval for risperidone extended-release injectable suspension.</li>
</ul>


Eisai Initiated rolling submission of sBLA to the FDA for Leqembi subcutaneous autoinjector as a weekly starting dose. Hansoh Pharmaceutical’s innovative drug Xinyue got additional indication approval in China.
Jiangsu Hengrui received marketing approval of its self-developed Class 1 innovative drug, Zeprumetostat in China. Celltrion got approval in Europe to start Phase 3 trial of its Darzalex biosimilar.
SK Bioscience applied for Phase 3 clinical trial of SKYVaricella in South Korea to add the 2-dose indication. Lupin received FDA approval for risperidone extended-release injectable suspension.


APAC Healthcare Weekly (September 7) – Eisai, Hansoh, Hengrui, Celltrion, SK Bioscience, Lupin

<ul>
<li>Shanghai Henlius Biotech initiated Phase 3 U.S. clinical trial for HLX22 for gastroesophageal junction and gastric cancer. CanSino Biologics obtained clinical trial approval in China for polio vaccine.</li>
<li>FDA rejected Nippon Shinyaku’s new drug application for CAP-1002 for DMD. JCR Pharmaceuticals announced license agreement with Acumen Pharmaceuticals to develop Alzheimer’s disease drug using JCR’s BBB -penetrating technology platform.</li>
<li>Mesoblast recorded $13.2M revenue from Ryoncil post-launch March 28 through June 30. Sun Pharma launched Leqselvi in the U.S. for the treatment of adults with severe alopecia areata.</li>
</ul>


Shanghai Henlius Biotech initiated Phase 3 U.S. clinical trial for HLX22 for gastroesophageal junction and gastric cancer. CanSino Biologics obtained clinical trial approval in China for polio vaccine.
FDA rejected Nippon Shinyaku’s new drug application for CAP-1002 for DMD. JCR Pharmaceuticals announced license agreement with Acumen Pharmaceuticals to develop Alzheimer’s disease drug using JCR’s BBB -penetrating technology platform.
Mesoblast recorded $13.2M revenue from Ryoncil post-launch March 28 through June 30. Sun Pharma launched Leqselvi in the U.S. for the treatment of adults with severe alopecia areata.


APAC Healthcare Weekly (July 20) – Henlius Bio, CanSino, Nippon Shinyaku, JCR, Mesoblast, Sun Pharma

<ul>
<li>RemeGen granted exclusive rights to develop and commercialize Telitacicept worldwide (excluding Greater China) to Vor Biopharma for $125M. Innovent Biologics received a first-in-class weight loss drug approval in China.</li>
<li>Daiichi Sankyo received FDA approval for Datroway for the treatment of certain types of non-small cell lung cancer (NSCLC). SanBio now expects Akuugo approval in H2FY26, instead of Q2FY26.</li>
<li>Otsuka in-licensed HBM7020 from Harbour BioMed for an upfront payment of $47M and near-term milestones. Glenmark Pharmaceuticals has launched Beigene’s Tevimbra in India for NSCLC.</li>
</ul>


RemeGen granted exclusive rights to develop and commercialize Telitacicept worldwide (excluding Greater China) to Vor Biopharma for $125M. Innovent Biologics received a first-in-class weight loss drug approval in China.
Daiichi Sankyo received FDA approval for Datroway for the treatment of certain types of non-small cell lung cancer (NSCLC). SanBio now expects Akuugo approval in H2FY26, instead of Q2FY26.
Otsuka in-licensed HBM7020 from Harbour BioMed for an upfront payment of $47M and near-term milestones. Glenmark Pharmaceuticals has launched Beigene’s Tevimbra in India for NSCLC.


APAC Healthcare Weekly (June 29)- RemeGen, Innovent, Daiichi, SanBio, Otsuka, Chugai, Glenmark

<ul>
<li>CSPC entered research collaboration with AstraZeneca for oral small molecule drug discovery utilizing CSPC’s AI-driven drug discovery platform. Wuxi Biologics kicked off construction of new microbial manufacturing site in China.</li>
<li>Samsung Biologics signed a CDMO contract worth more than KRW100B (~$73M) with an unnamed European pharmaceutical company. Daiichi Sankyo initiates Phase 3 trial of Enhertu in first-line breast cancer.</li>
<li>SanBio has completed filing a partial change application of marketing approval of Akuugo. Cochlear introduces Nucleus Nexa system, the world’s first and only smart cochlear implant system.</li>
</ul>


CSPC entered research collaboration with AstraZeneca for oral small molecule drug discovery utilizing CSPC’s AI-driven drug discovery platform. Wuxi Biologics kicked off construction of new microbial manufacturing site in China.
Samsung Biologics signed a CDMO contract worth more than KRW100B (~$73M) with an unnamed European pharmaceutical company. Daiichi Sankyo initiates Phase 3 trial of Enhertu in first-line breast cancer.
SanBio has completed filing a partial change application of marketing approval of Akuugo. Cochlear introduces Nucleus Nexa system, the world’s first and only smart cochlear implant system.


APAC Healthcare Weekly (June 15)- CSPC, Wuxi Bio, Samsung Bio, Daiichi Sankyo, SanBio, Cochlear

<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

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 (September 7) – Eisai, Hansoh, Hengrui, Celltrion, SK Bioscience, Lupin

Eisai initiated FDA submission of Leqembi subcutaneous injection as starting dose. Hansoh and Hengrui got approvals for new drugs. Celltrion got...

Tina Banerjee

APAC Healthcare Weekly (July 20) – Henlius Bio, CanSino, Nippon Shinyaku, JCR, Mesoblast, Sun Pharma

Henlius Bio initiates P3 U.S. trial for cancer drug. FDA rejected Nippon Shinyaku’s new drug filing. JCR partners with Acumen to develop...

Tina Banerjee

APAC Healthcare Weekly (June 29)- RemeGen, Innovent, Daiichi, SanBio, Otsuka, Chugai, Glenmark

Last week couple of Chinese companies signed outlicensing deals with international players. Innovent got weight loss drug approval in China....

Tina Banerjee

APAC Healthcare Weekly (June 15)- CSPC, Wuxi Bio, Samsung Bio, Daiichi Sankyo, SanBio, Cochlear

CSPC entered research collaboration with AstraZeneca. Wuxi Bio is constructing new plant in China. Samsung Bio signed new CDMO contract. Daiichi...

Tina Banerjee

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

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APAC Healthcare Weekly (September 7) – Eisai, Hansoh, Hengrui, Celltrion, SK Bioscience, Lupin

Eisai initiated FDA submission of Leqembi subcutaneous injection as starting dose. Hansoh and Hengrui got approvals for new drugs. Celltrion got...

Tina Banerjee

APAC Healthcare Weekly (July 20) – Henlius Bio, CanSino, Nippon Shinyaku, JCR, Mesoblast, Sun Pharma

Henlius Bio initiates P3 U.S. trial for cancer drug. FDA rejected Nippon Shinyaku’s new drug filing. JCR partners with Acumen to develop...

Tina Banerjee

APAC Healthcare Weekly (June 29)- RemeGen, Innovent, Daiichi, SanBio, Otsuka, Chugai, Glenmark

Last week couple of Chinese companies signed outlicensing deals with international players. Innovent got weight loss drug approval in China....

Tina Banerjee

APAC Healthcare Weekly (June 15)- CSPC, Wuxi Bio, Samsung Bio, Daiichi Sankyo, SanBio, Cochlear

CSPC entered research collaboration with AstraZeneca. Wuxi Bio is constructing new plant in China. Samsung Bio signed new CDMO contract. Daiichi...

Tina Banerjee

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

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