Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<ul>
<li>Sino Biopharmaceutical’s NDA for bispecific ADC, TQB2102, has been accepted by NMPA for breast cancer. CHMP recommended approval of Impact Therapeutics’ Sepalna for epithelial ovarian, fallopian tube, and peritoneal cancers.</li>
<li>FDA granted priority review to Takeda’s zasocitinib for moderate-to-severe plaque psoriasis. Daiichi Sankyo announced positive results from the Phase 3 trial evaluating Enhertu as a first-line treatment of NSCLC.</li>
<li>SK Biopharmaceuticals has signed a license and equity investment agreement with 1ST Biotherapeutics to secure global exclusive development and commercialization rights for a new drug candidate for Parkinson's disease.</li>
</ul>


Sino Biopharmaceutical’s NDA for bispecific ADC, TQB2102, has been accepted by NMPA for breast cancer. CHMP recommended approval of Impact Therapeutics’ Sepalna for epithelial ovarian, fallopian tube, and peritoneal cancers.
FDA granted priority review to Takeda’s zasocitinib for moderate-to-severe plaque psoriasis. Daiichi Sankyo announced positive results from the Phase 3 trial evaluating Enhertu as a first-line treatment of NSCLC.
SK Biopharmaceuticals has signed a license and equity investment agreement with 1ST Biotherapeutics to secure global exclusive development and commercialization rights for a new drug candidate for Parkinson's disease.


APAC Healthcare Weekly (Sept 20) –Sino Bio, Impact Therapeutics, Takeda, Daiichi Sankyo, SK Biopharm

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 strong 1Q26 result, with revenue increasing 58% YoY and 17% QoQ to KRW228B, with Xcopri U.S. revenue increasing 48% YoY and 16% QoQ to KRW198B.</li>
<li>This quarter is significant in that operating profit approached approximately KRW90B, reaching an all-time high despite increased research and development and marketing expenses compared to the previous year. </li>
<li>For full-year 2026, SKBP guided for Xcopri U.S. revenue of $550–580M, up 24–31% YoY. Considering 1Q26 momentum, the company is well-positioned to meet the guidance.</li>
</ul>



SK Biopharmaceuticals (326030 KS) announced strong 1Q26 result, with revenue increasing 58% YoY and 17% QoQ to KRW228B, with Xcopri U.S. revenue increasing 48% YoY and 16% QoQ to KRW198B.
This quarter is significant in that operating profit approached approximately KRW90B, reaching an all-time high despite increased research and development and marketing expenses compared to the previous year. 
For full-year 2026, SKBP guided for Xcopri U.S. revenue of $550–580M, up 24–31% YoY. Considering 1Q26 momentum, the company is well-positioned to meet the guidance.


SK Biopharmaceuticals (326030 KS): Record High Operating Profit in 1Q; Xcopri Guidance Maintained

<ul>
<li>Hansoh’s risvutatug rezetecan for second-line treatment of SCLC has been included in NMPA’s Priority Review. InSilico completed first patient enrollment and dosing in Phase 3 trial evaluating rentosertib in IPF.</li>
<li>Shionogi received approval in Australia for cefiderocol for the treatment of carbapenem-resistant Gram-negative bacterial infections. Kyowa Kirin’s Phase 2 trial for ophthalmic drug candidate did not meet primary endpoint.</li>
<li>Samsung Biologics signed a new CMO contract worth $262M with a European pharmaceutical company. SK Biopharmaceutical received notification regarding FDA's partial clinical hold on its epilepsy drug candidate, opakalim.</li>
</ul>


Hansoh’s risvutatug rezetecan for second-line treatment of SCLC has been included in NMPA’s Priority Review. InSilico completed first patient enrollment and dosing in Phase 3 trial evaluating rentosertib in IPF.
Shionogi received approval in Australia for cefiderocol for the treatment of carbapenem-resistant Gram-negative bacterial infections. Kyowa Kirin’s Phase 2 trial for ophthalmic drug candidate did not meet primary endpoint.
Samsung Biologics signed a new CMO contract worth $262M with a European pharmaceutical company. SK Biopharmaceutical received notification regarding FDA's partial clinical hold on its epilepsy drug candidate, opakalim.


APAC Healthcare Weekly (Sept 13) – Hansoh, InSilico, Shionogi, Kyowa Kirin, Samsung Bio, SK Biopharm

Event-Driven

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<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> (SKBP) has announced that <a href="https://www.smartkarma.com/entities/sk-holdings-co-ltd" target="_blank" data-smartkarma-citation="entities:393:1" rel="noopener">SK Inc (034730 KS)</a> plans to offload ~11M shares of SKBP on March 30, 2026 at a price of KRW114,500 per share.</li>
<li>Although SK Inc is reducing its stake ~14% in SKBP, it will remain the majority shareholder, thereby retaining the control and management rights in the company.</li>
<li>SK Inc’s stake sale should not impact future growth prospect of SKBP, as the company has multiple growth drivers. FDA-approved epilepsy drug Xcopri is the main and near-term growth engine.</li>
</ul>



SK Biopharmaceuticals (326030 KS) (SKBP) has announced that SK Inc (034730 KS) plans to offload ~11M shares of SKBP on March 30, 2026 at a price of KRW114,500 per share.
Although SK Inc is reducing its stake ~14% in SKBP, it will remain the majority shareholder, thereby retaining the control and management rights in the company.
SK Inc’s stake sale should not impact future growth prospect of SKBP, as the company has multiple growth drivers. FDA-approved epilepsy drug Xcopri is the main and near-term growth engine.


SK Biopharmaceuticals (326030 KS): Parent’s Stake Sale Does Not Tarnish Future Growth Prospect

<ul>
<li>CSPC Pharmaceutical’s SYS6010 met primary endpoint in Phase 3 study as a monotherapy for NSCLC. Akeso’s ivonescimab demonstrates significant overall survival in Phase 3 trial for advanced biliary tract cancer.</li>
<li>Takeda Pharma secured FDA approval for Mimrylo (rusfertide) for the treatment of erythrocytosis in adults with polycythemia vera. Astellas Pharma initiates global Phase 3 study evaluating ASP2138 for gastric cancers.</li>
<li>Hanmi Pharm outlicenses obesity drug candidate HM1732 to Genentech for a total deal value of $2.3B. SK Biopharmaceuticals entered an agreement to in-license opakalim, an investigational antiseizure medication, from Biohaven.</li>
</ul>


CSPC Pharmaceutical’s SYS6010 met primary endpoint in Phase 3 study as a monotherapy for NSCLC. Akeso’s ivonescimab demonstrates significant overall survival in Phase 3 trial for advanced biliary tract cancer.
Takeda Pharma secured FDA approval for Mimrylo (rusfertide) for the treatment of erythrocytosis in adults with polycythemia vera. Astellas Pharma initiates global Phase 3 study evaluating ASP2138 for gastric cancers.
Hanmi Pharm outlicenses obesity drug candidate HM1732 to Genentech for a total deal value of $2.3B. SK Biopharmaceuticals entered an agreement to in-license opakalim, an investigational antiseizure medication, from Biohaven.


APAC Healthcare Weekly (August 30)– CSPC Pharma, Akeso, Takeda, Astellas, Hanmi Pharm, SK Biopharma

South Korea

SK Biopharmaceuticals Co., Ltd. researches and develops new drugs. The Company develops and markets brain disorders treatment drugs, central nervous system disorders treatment drugs, and other products. SK Biopharmaceuticals markets its products worldwide.

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SK Biopharmaceuticals (326030 KS)

APAC Healthcare Weekly (Sept 20) –Sino Bio, Impact Therapeutics, Takeda, Daiichi Sankyo, SK Biopharm

NMPA accepted Sino Bio’s NDA for bispecific ADC drug candidate. FDA granted priority review to Takeda’s zasocitinib for moderate-to-severe plaque...

Tina Banerjee