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 Daiichi Sankyo and Merck have voluntarily withdrawn BLA seeking accelerated approval in the U.S. for patritumab deruxtecan for NSCLC.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 Daiichi Sankyo and Merck have voluntarily withdrawn BLA seeking accelerated approval in the U.S. for patritumab deruxtecan for NSCLC.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>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>SillaJen got FDA nod to expand clinical trial of BAL0891 for acute myeloid leukemia. Akeso received FDA approval for its PD-1 inhibitor penpulimab for the treatment of nasopharyngeal carcinoma.</li>
<li>Innovent Biologics got approval for limertinib in China for the first-line treatment of locally advanced or metastatic non-small cell lung cancer. CSL launches Andembry Pen for Hereditary Angioedema in Japan.</li>
<li>Daiichi Sankyo submitted indication expansion application in Japan for Enhertu for the treatment of HER2 positive advanced or recurrent solid tumors. Lupin received FDA approval for Tolvaptan Tablets.</li>
</ul>


SillaJen got FDA nod to expand clinical trial of BAL0891 for acute myeloid leukemia. Akeso received FDA approval for its PD-1 inhibitor penpulimab for the treatment of nasopharyngeal carcinoma.
Innovent Biologics got approval for limertinib in China for the first-line treatment of locally advanced or metastatic non-small cell lung cancer. CSL launches Andembry Pen for Hereditary Angioedema in Japan.
Daiichi Sankyo submitted indication expansion application in Japan for Enhertu for the treatment of HER2 positive advanced or recurrent solid tumors. Lupin received FDA approval for Tolvaptan Tablets.


APAC Healthcare Weekly (April 27)- Sillajen, Akeso, Innovent Biologics, CSL, Daiichi Sankyo, Lupin

<ul>
<li>Kissei Pharmaceutical initiates additional Phase III clinical trial for Rovatirelin (KPS-0373) for the treatment of spinocerebellar degeneration. Shanghai Junshi Biosciences received 11th indication approval for toripalimab in China.</li>
<li>AstraZeneca Entered into exclusive licensing agreement worth $1.35B with Alteogen to use latter’s hyaluronidase protein, ALT-B4, to develop subcutaneous versions of its “several oncology assets.”</li>
<li>Celltrion Has unveiled “Value-up Program,” whereby the company is targeting 30% revenue CAGR by 2027 to reach KRW5T revenue and 7% ROE. HLB faced another rejection from FDA for rivoceranib.</li>
</ul>


Kissei Pharmaceutical initiates additional Phase III clinical trial for Rovatirelin (KPS-0373) for the treatment of spinocerebellar degeneration. Shanghai Junshi Biosciences received 11th indication approval for toripalimab in China.
AstraZeneca Entered into exclusive licensing agreement worth $1.35B with Alteogen to use latter’s hyaluronidase protein, ALT-B4, to develop subcutaneous versions of its “several oncology assets.”
Celltrion Has unveiled “Value-up Program,” whereby the company is targeting 30% revenue CAGR by 2027 to reach KRW5T revenue and 7% ROE. HLB faced another rejection from FDA for rivoceranib.


APAC Healthcare Weekly (Mar 23)- Kissei, Alteogen, Junshi Biosciences, Celltrion, Lunit, HLB

<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

China

Junshi Biosciences is an innovation-driven biopharmaceutical company focused on the discovery, development, clinical research, and commercialization of innovative therapeutics. Its key products, including toripalimab injection, Etesevimab, and adalimumab injection, are used to treat malignant tumors, autoimmune diseases, chronic metabolic diseases, nervous system diseases, and infectious diseases. The company was founded in December 2012 and is headquartered in Shanghai, China.

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Junshi Biosciences (1877 HK)

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 (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 27)- Sillajen, Akeso, Innovent Biologics, CSL, Daiichi Sankyo, Lupin

SillaJen got FDA nod for clinical trial indication expansion. FDA approves Akeso’s first drug. Innovent’s cancer drug was approved in China....

Tina Banerjee

APAC Healthcare Weekly (Mar 23)- Kissei, Alteogen, Junshi Biosciences, Celltrion, Lunit, HLB

Kissei Pharma initiates additional P3 trial. Junshi Biosciences' drug got indication expansion. AstraZeneca partners with Alteogen. Celltrion aims...

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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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 (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 27)- Sillajen, Akeso, Innovent Biologics, CSL, Daiichi Sankyo, Lupin

SillaJen got FDA nod for clinical trial indication expansion. FDA approves Akeso’s first drug. Innovent’s cancer drug was approved in China....

Tina Banerjee

APAC Healthcare Weekly (Mar 23)- Kissei, Alteogen, Junshi Biosciences, Celltrion, Lunit, HLB

​Kissei Pharma initiates additional P3 trial. Junshi Biosciences' drug got indication expansion. AstraZeneca partners with Alteogen. Celltrion aims...

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

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

Kissei Pharma initiates additional P3 trial. Junshi Biosciences' drug got indication expansion. AstraZeneca partners with Alteogen. Celltrion aims...