Global Healthcare Analyst

Tina Banerjee

Equity Bottom-Up

SK Biopharmaceuticals   / Equity Bottom-Up

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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> reported record high quarterly earnings in 3Q25 on surging U.S. sales of Xcopri, which surpassed quarterly revenue of $100M for the second time.</li>
<li>Revenue from Xcopri in the U.S. increased 52% YoY (accelerated from 47% YoY reported in 2Q25) and 12% QoQ to record high of KRW172B, on enhanced marketing efforts.</li>
<li>For full-year 2025, SKBP guided for Xcopri U.S. revenue of $420–450M (~KRW570–610B), up 31–40% YoY. During first nine months of 2025, Xcopri U.S. revenue reached $325M (KRW460M).</li>
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SK Biopharmaceuticals (326030 KS) reported record high quarterly earnings in 3Q25 on surging U.S. sales of Xcopri, which surpassed quarterly revenue of $100M for the second time.
Revenue from Xcopri in the U.S. increased 52% YoY (accelerated from 47% YoY reported in 2Q25) and 12% QoQ to record high of KRW172B, on enhanced marketing efforts.
For full-year 2025, SKBP guided for Xcopri U.S. revenue of $420–450M (~KRW570–610B), up 31–40% YoY. During first nine months of 2025, Xcopri U.S. revenue reached $325M (KRW460M).


SK Biopharmaceuticals (326030 KS): Swelling Xcopri Sales in US Drives Record High 3Q Earnings

Thematic (Sector/Industry)

<ul>
<li>CSPC Pharmaceutical’s Phase 3 trial of depression drug candidate HA1406 met pre-specified primary efficacy endpoint. Jiangsu Hengrui Pharmaceuticals received NMPA approval for long-acting basal insulin, sudelidec injection.</li>
<li>Otsuka Holdings secured FDA approval for Simtriyo, a once-daily extended-release capsule for ADHD. Nippon Shinyaku obtained exclusive commercialization rights for Tadekinig alfa in the U.S. for Hyperinflammatory Syndrome.</li>
<li>Pharmaessentia announced topline results from the Phase 1b clinical trial of P1101 (Besremi) and anti-PD1 in Chronic Hepatitis B or D. Cipla secured FDA approval for generic Advair Diskus.</li>
</ul>


CSPC Pharmaceutical’s Phase 3 trial of depression drug candidate HA1406 met pre-specified primary efficacy endpoint. Jiangsu Hengrui Pharmaceuticals received NMPA approval for long-acting basal insulin, sudelidec injection.
Otsuka Holdings secured FDA approval for Simtriyo, a once-daily extended-release capsule for ADHD. Nippon Shinyaku obtained exclusive commercialization rights for Tadekinig alfa in the U.S. for Hyperinflammatory Syndrome.
Pharmaessentia announced topline results from the Phase 1b clinical trial of P1101 (Besremi) and anti-PD1 in Chronic Hepatitis B or D. Cipla secured FDA approval for generic Advair Diskus.


APAC Healthcare Weekly (August 2) – CSPC, Hengrui, Otsuka, Nippon Shinyaku, PharmaEssnetia, Cipla

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<li>InSilico Medicine and SK Biopharmaceuticals entered R&amp;D collaboration to discover AI-enabled neuroimmune drug candidates. Abbisko Cayman entered into a strategic research collaboration and license agreement with Eli Lilly.</li>
<li>Nippon Shinyaku’s partner Regenxbio cleared path to resubmit Hunter syndrome gene therapy candidate RGX-121 to the FDA. Otsuka announced positive topline results in Phase 3b study evaluating centanafadine in ADHD.</li>
<li>Yuhan Corp received orphan drug designation from the EMA for its Gaucher disease therapy candidate YH35995. Medytox obtained approval for its hyaluronic acid filler Neuramis Deep Lidocaine in China.</li>
</ul>


InSilico Medicine and SK Biopharmaceuticals entered R&amp;D collaboration to discover AI-enabled neuroimmune drug candidates. Abbisko Cayman entered into a strategic research collaboration and license agreement with Eli Lilly.
Nippon Shinyaku’s partner Regenxbio cleared path to resubmit Hunter syndrome gene therapy candidate RGX-121 to the FDA. Otsuka announced positive topline results in Phase 3b study evaluating centanafadine in ADHD.
Yuhan Corp received orphan drug designation from the EMA for its Gaucher disease therapy candidate YH35995. Medytox obtained approval for its hyaluronic acid filler Neuramis Deep Lidocaine in China.


APAC Healthcare Weekly (June 28) – Insilico, Abbisko, Nippon Shinyaku, Otsuka, Yuhan Corp, Medytox

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<li>Last week, the U.S. DoD designated Wuxi AppTec as a “Chinese military company.” In response, Wuxi AppTec has filed a complaint at the U.S. District Court.</li>
<li>CSPC Pharmaceutical received trial approval for semaglutide long-acting injection in U.S. Takeda’s TYK2 inhibitor zasocitinib tops BMS’ Sotyktu in head-to-head trial for clearing skin in patients with moderate-to-severe plaque psoriasis.</li>
<li>SK Bioscience initiated process development for injectable rotavirus vaccine candidate after entering license agreement with the U.S. CDC. Alteogen’s ALT-B4 received an Intention to Grant decision from European Patent Office.</li>
</ul>


Last week, the U.S. DoD designated Wuxi AppTec as a “Chinese military company.” In response, Wuxi AppTec has filed a complaint at the U.S. District Court.
CSPC Pharmaceutical received trial approval for semaglutide long-acting injection in U.S. Takeda’s TYK2 inhibitor zasocitinib tops BMS’ Sotyktu in head-to-head trial for clearing skin in patients with moderate-to-severe plaque psoriasis.
SK Bioscience initiated process development for injectable rotavirus vaccine candidate after entering license agreement with the U.S. CDC. Alteogen’s ALT-B4 received an Intention to Grant decision from European Patent Office.


APAC Healthcare Weekly (June 14) – Wuxi AppTec, Remegen, CSPC Pharma, Takeda, SK Bioscience Alteogen

<ul>
<li>Henlius Biotech’s serplulimab is a step ahead for EU approval for two indications. InSilico Medicine inked a licensing and drug discovery collaboration with Eli Lilly for $115M upfront payment.</li>
<li>Shionogi completes acquisition of Radicava and stake increase in ViiV Healthcare. Mochida Pharmaceutical inked licensing deal with LG Chem for marketing of Dinagest in South Korea and Thailand.</li>
<li>Samsung Biologics has completed its acquisition of a manufacturing facility in Rockville, Maryland from GSK. SK Biopharmaceuticals has submitted NDA to the FDA for the oral suspension formulation of Xcopri.  </li>
</ul>


Henlius Biotech’s serplulimab is a step ahead for EU approval for two indications. InSilico Medicine inked a licensing and drug discovery collaboration with Eli Lilly for $115M upfront payment.
Shionogi completes acquisition of Radicava and stake increase in ViiV Healthcare. Mochida Pharmaceutical inked licensing deal with LG Chem for marketing of Dinagest in South Korea and Thailand.
Samsung Biologics has completed its acquisition of a manufacturing facility in Rockville, Maryland from GSK. SK Biopharmaceuticals has submitted NDA to the FDA for the oral suspension formulation of Xcopri.  


APAC Healthcare Weekly (April 5) – Henlius Biotech, InSilico, Shionogi, Samsung Bio, 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)