Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<ul>
<li>3SBio entered into an exclusive licensing agreement with Pfizer granting them exclusive license to develop, manufacture, commercialize, and otherwise exploit its breakthrough PD-1/VEGF bispecific antibody SSGJ-707 worldwide excluding mainland China.</li>
<li>CSPC Pharmaceutical Group Limited announced that CPO301, their first-in-class epidermal growth factor receptor (‘‘EGFR’’) antibody drug conjugate (ADC), has been granted the third Fast Track designation by the U.S. FDA.</li>
<li>Samsung Biologics Co. announced that it plans to spin off its biosimilar development business into separate new entity, Samsung Epis Holdings. Samsung Biologics will become a pure-play CDMO.</li>
</ul>


3SBio entered into an exclusive licensing agreement with Pfizer granting them exclusive license to develop, manufacture, commercialize, and otherwise exploit its breakthrough PD-1/VEGF bispecific antibody SSGJ-707 worldwide excluding mainland China.
CSPC Pharmaceutical Group Limited announced that CPO301, their first-in-class epidermal growth factor receptor (‘‘EGFR’’) antibody drug conjugate (ADC), has been granted the third Fast Track designation by the U.S. FDA.
Samsung Biologics Co. announced that it plans to spin off its biosimilar development business into separate new entity, Samsung Epis Holdings. Samsung Biologics will become a pure-play CDMO.


APAC Healthcare Weekly (May 25)- 3SBio, Samsung Biologics, Celltrion, CSPC Pharma, Chugai

<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

Equity Bottom-Up

SK Biopharmaceuticals   / Equity Bottom-Up

<ul>
<li>
<a href="https://www.smartkarma.com/entities/sk-biopharmaceuticals-co-ltd" target="_blank" data-smartkarma-citation="entities:28966:1" rel="noopener">SK Biopharmaceuticals (326030 KS)</a> announced muted 1Q25 result, with all key parameters, including revenue, operating profit, and net profit declining sequentially, as the Xcopri sales in the U.S. moderates.</li>
<li>Xcopri U.S. sales increased 3% QoQ, which is the lowest over the last one year, due to seasonal inventory drawdown, restructuring of major pharmacy chain, and high base effect.</li>
<li>SKBP considers Xcopri U.S. revenue moderation as ‘temporary’ and sees recovery in 2Q. However, high revenue exposure to the U.S. seems to be a serious headwind in current uncertain scenario.  </li>
</ul>



SK Biopharmaceuticals (326030 KS) announced muted 1Q25 result, with all key parameters, including revenue, operating profit, and net profit declining sequentially, as the Xcopri sales in the U.S. moderates.
Xcopri U.S. sales increased 3% QoQ, which is the lowest over the last one year, due to seasonal inventory drawdown, restructuring of major pharmacy chain, and high base effect.
SKBP considers Xcopri U.S. revenue moderation as ‘temporary’ and sees recovery in 2Q. However, high revenue exposure to the U.S. seems to be a serious headwind in current uncertain scenario.  


SK Biopharmaceuticals (326030 KS): Starts 2025 on Slower Note; Xcopri US Sales Growth Moderates

<ul>
<li>
<a href="https://www.smartkarma.com/entities/hk-inno-n-corp" target="_blank" data-smartkarma-citation="entities:33522:1" rel="noopener">HK inno.N (195940 KS)</a> announced positive topline result from the U.S. Phase 3 trial evaluating K-CAB in gastroesophageal reflux disease. U.S. filing is expected in 4Q25.</li>
<li>HK inno.N has reported strong 1Q25 result, with double-digit growth across all key parameters. Revenue increased 16% YoY, while operating profit grew at a faster pace of 47% YoY.</li>
<li>The U.S. filing and approval are the major catalysts. However, HK inno has other growth engines as well. Innovative pipeline is also progressing, ensuring long-term growth prospect.</li>
</ul>



HK inno.N (195940 KS) announced positive topline result from the U.S. Phase 3 trial evaluating K-CAB in gastroesophageal reflux disease. U.S. filing is expected in 4Q25.
HK inno.N has reported strong 1Q25 result, with double-digit growth across all key parameters. Revenue increased 16% YoY, while operating profit grew at a faster pace of 47% YoY.
The U.S. filing and approval are the major catalysts. However, HK inno has other growth engines as well. Innovative pipeline is also progressing, ensuring long-term growth prospect.


HK Inno. N (195940 KS): Promising US Trial Result for K-CAB Raises Hope; Starts 2025 on Strong Note

<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

South Korea

Hanmi Pharm. Company Ltd. produces pharmaceutical products, including antibiotics, vitamins, and intestinal tonics.  The Company also provides beverages and processes soft capsules for other pharmaceutical firms.

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Hanmi Pharm (128940 KS)

APAC Healthcare Weekly (May 25)- 3SBio, Samsung Biologics, Celltrion, CSPC Pharma, Chugai

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 (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

SK Biopharmaceuticals (326030 KS): Starts 2025 on Slower Note; Xcopri US Sales Growth Moderates

SK Biopharmaceuticals reports muted 1Q25 results with sequential decline in key parameters due to Xcopri sales moderation in the U.S. due to...

Tina Banerjee

HK Inno. N (195940 KS): Promising US Trial Result for K-CAB Raises Hope; Starts 2025 on Strong Note

HK inno.N reports positive Phase 3 trial results for K-CAB in GERD, with US filing expected in 4Q25. The company reported double-digit growth...

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

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APAC Healthcare Weekly (May 25)- 3SBio, Samsung Biologics, Celltrion, CSPC Pharma, Chugai

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 (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

SK Biopharmaceuticals (326030 KS): Starts 2025 on Slower Note; Xcopri US Sales Growth Moderates

​SK Biopharmaceuticals reports muted 1Q25 results with sequential decline in key parameters due to Xcopri sales moderation in the U.S. due to...

Tina Banerjee

HK Inno. N (195940 KS): Promising US Trial Result for K-CAB Raises Hope; Starts 2025 on Strong Note

​HK inno.N reports positive Phase 3 trial results for K-CAB in GERD, with US filing expected in 4Q25. The company reported double-digit growth...

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

SK Biopharmaceuticals reports muted 1Q25 results with sequential decline in key parameters due to Xcopri sales moderation in the U.S. due to...

HK inno.N reports positive Phase 3 trial results for K-CAB in GERD, with US filing expected in 4Q25. The company reported double-digit growth...