Global Healthcare Analyst

Tina Banerjee

Equity Bottom-Up

<ul>
<li>
<a href="https://www.smartkarma.com/entities/shionogi-co-ltd" target="_blank" data-smartkarma-citation="entities:19535:1" rel="noopener">Shionogi &amp; Co (4507 JP)</a> achieved YoY improvement in all key parameters. Moreover, Q1FY26 result shows a significant improvement compared to Q1FY25, when all key parameters recorded double-digit YoY decline.</li>
<li>During Q1FY26, revenue increased 2% YoY to ¥100B, driven by HIV franchise. Q1FY26 revenue records 19% progress, while operating and net profit advanced more than 20% of full-year target.</li>
<li>Shionogi has maintained H1FY26 and FY26 guidance. This indicates Q2FY26 revenue expectation of ¥133B, up 14% YoY. Acquisition of JT Group’s pharmaceutical business and Torii Pharmaceutical is progressing.</li>
</ul>



Shionogi &amp; Co (4507 JP) achieved YoY improvement in all key parameters. Moreover, Q1FY26 result shows a significant improvement compared to Q1FY25, when all key parameters recorded double-digit YoY decline.
During Q1FY26, revenue increased 2% YoY to ¥100B, driven by HIV franchise. Q1FY26 revenue records 19% progress, while operating and net profit advanced more than 20% of full-year target.
Shionogi has maintained H1FY26 and FY26 guidance. This indicates Q2FY26 revenue expectation of ¥133B, up 14% YoY. Acquisition of JT Group’s pharmaceutical business and Torii Pharmaceutical is progressing.


Shionogi & Co (4507 JP): High on HIV Royalty; FY Guidance Reaffirmed; New Launches to Drive Growth

Thematic (Sector/Industry)

<ul>
<li>Sino Biopharmaceutical initiated Phase 1 trial for innovative drug candidate TQB6411 targeting advanced malignant tumors in China. Wuxi Biologics announced that five manufacturing facilities passed the Pre-License Inspection by FDA.</li>
<li>FDA drug advisory committee voted against Otsuka’s indication expansion application for Rexulti. Telix Pharmaceutical received a subpoena from the SEC regarding the development of prostate cancer therapeutic candidates. </li>
<li>Lupin received FDA approval for generic versions of Liraglutide and Glucagon injections. Sun Pharmaceutical announced positive top-line results from two Phase 3 trials of Ilumya in active psoriatic arthritis.</li>
</ul>


Sino Biopharmaceutical initiated Phase 1 trial for innovative drug candidate TQB6411 targeting advanced malignant tumors in China. Wuxi Biologics announced that five manufacturing facilities passed the Pre-License Inspection by FDA.
FDA drug advisory committee voted against Otsuka’s indication expansion application for Rexulti. Telix Pharmaceutical received a subpoena from the SEC regarding the development of prostate cancer therapeutic candidates. 
Lupin received FDA approval for generic versions of Liraglutide and Glucagon injections. Sun Pharmaceutical announced positive top-line results from two Phase 3 trials of Ilumya in active psoriatic arthritis.


APAC Healthcare Weekly (July 27) – Sino Bio, Wuxi Bio, Otsuka, Telix, Lupin, Sun Pharma

<ul>
<li>
<a href="https://www.smartkarma.com/entities/ono-pharmaceutical-co-ltd" target="_blank" data-smartkarma-citation="entities:8979:1" rel="noopener">Ono Pharmaceutical (4528 JP)</a> guided Opdivo revenue in FY26 to be ¥138.5B (Japan: ¥125B, up 4% and Overseas: ¥13.5B, up 3%), up 4% YoY.</li>
<li>Opdivo in combination with Yervoy (from Bristol Myers Squibb) was approved in Europe, US, South Korea, and Japan for the first-line treatment of patients with unresectable or metastatic hepatocellular carcinoma.</li>
<li>In FY26, Opdivo’s revenue growth will come from indication expansion but smaller addressable patient population remains a concern for long term.</li>
</ul>



Ono Pharmaceutical (4528 JP) guided Opdivo revenue in FY26 to be ¥138.5B (Japan: ¥125B, up 4% and Overseas: ¥13.5B, up 3%), up 4% YoY.
Opdivo in combination with Yervoy (from Bristol Myers Squibb) was approved in Europe, US, South Korea, and Japan for the first-line treatment of patients with unresectable or metastatic hepatocellular carcinoma.
In FY26, Opdivo’s revenue growth will come from indication expansion but smaller addressable patient population remains a concern for long term.


Ono Pharmaceutical (4528 JP): Label Expansion Helps, But Long-Term Growth Momentum Calls for More

<ul>
<li>
<a href="https://www.smartkarma.com/entities/otsuka-holdings-co-ltd" target="_blank" data-smartkarma-citation="entities:12292:1" rel="noopener">Otsuka Holdings (4578 JP)</a> reported 12% YoY growth in revenue in 1Q25, as pharmaceuticals sales grew backed by a 35% YoY growth in Rexulti revenue to ¥75.7B.</li>
<li>The company reiterated 2025 guidance. Higher costs to dent margins with subdued sales of Lonsurf, Jynarque.</li>
<li>Indication expansion of Rexulti and Araris acquisition augur well for the company from a mid to long term perspective.</li>
</ul>



Otsuka Holdings (4578 JP) reported 12% YoY growth in revenue in 1Q25, as pharmaceuticals sales grew backed by a 35% YoY growth in Rexulti revenue to ¥75.7B.
The company reiterated 2025 guidance. Higher costs to dent margins with subdued sales of Lonsurf, Jynarque.
Indication expansion of Rexulti and Araris acquisition augur well for the company from a mid to long term perspective.


Otsuka Holdings (4578 JP): Rexulti Drives 1Q25 Result; Label Expansion And Acquisition Augur Well

<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

Astellas Pharma Inc. is a pharmaceutical company committed to the therapeutic fields of Urology, Immunology including Transplantation and Infectious Diseases, Oncology, Neuroscience and DM Complications and Metabolic Diseases. With over 17,000 global employees, Astellas researches, develops, manufactures, and promotes its prescription drugs through subsidiaries in the US, Europe, and Asia

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Astellas Pharma (4503 JP)

Shionogi & Co (4507 JP): High on HIV Royalty; FY Guidance Reaffirmed; New Launches to Drive Growth

Shionogi sees 2% revenue growth in Q1FY26 revenue, driven by HIV franchise royalty. The company maintained FY guidance. Acquisition of JT Group's...

Tina Banerjee

APAC Healthcare Weekly (July 27) – Sino Bio, Wuxi Bio, Otsuka, Telix, Lupin, Sun Pharma

Wuxi Bio’s manufacturing facilities passed FDA inspection. Otsuka’s label expansion plan for Rexulti is in jeopardy. Telix got SEC subpoena. Lupin...

Tina Banerjee

Ono Pharmaceutical (4528 JP): Label Expansion Helps, But Long-Term Growth Momentum Calls for More

Ono Pharmaceutical expects 4% YoY growth in Opdivo revenue for FY26, driven by indication expansion but faces long-term concerns due to smaller...

Tina Banerjee

Otsuka Holdings (4578 JP): Rexulti Drives 1Q25 Result; Label Expansion And Acquisition Augur Well

Otsuka presented results from an interim analysis of Phase 3 study evaluating sibeprenlimab, for immunoglobulin A nephropathy (IgAN). The study,...

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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Shionogi & Co (4507 JP): High on HIV Royalty; FY Guidance Reaffirmed; New Launches to Drive Growth

​Shionogi sees 2% revenue growth in Q1FY26 revenue, driven by HIV franchise royalty. The company maintained FY guidance. Acquisition of JT Group's...

Tina Banerjee

APAC Healthcare Weekly (July 27) – Sino Bio, Wuxi Bio, Otsuka, Telix, Lupin, Sun Pharma

Wuxi Bio’s manufacturing facilities passed FDA inspection. Otsuka’s label expansion plan for Rexulti is in jeopardy. Telix got SEC subpoena. Lupin...

Tina Banerjee

Ono Pharmaceutical (4528 JP): Label Expansion Helps, But Long-Term Growth Momentum Calls for More

​Ono Pharmaceutical expects 4% YoY growth in Opdivo revenue for FY26, driven by indication expansion but faces long-term concerns due to smaller...

Tina Banerjee

Otsuka Holdings (4578 JP): Rexulti Drives 1Q25 Result; Label Expansion And Acquisition Augur Well

Otsuka presented results from an interim analysis of Phase 3 study evaluating sibeprenlimab, for immunoglobulin A nephropathy (IgAN). The study,...

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

Shionogi sees 2% revenue growth in Q1FY26 revenue, driven by HIV franchise royalty. The company maintained FY guidance. Acquisition of JT Group's...

Ono Pharmaceutical expects 4% YoY growth in Opdivo revenue for FY26, driven by indication expansion but faces long-term concerns due to smaller...

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