Global Healthcare Analyst

Tina Banerjee

Equity Bottom-Up

<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>, during FY26, reported revenue of ¥515B, an increase of 6% YoY. Opdivo witnessed 5% decrease in revenue to ¥114.3B mainly due to increased competition.</li>
<li>The company revealed the guidance numbers for FY27. Revenue is expected to be ¥455B, a decrease of 11.8% YoY, mainly due to the absence of sales of Forxiga Tablets.</li>
<li>No near-term catalyst visible for the company at this moment but eventual indication expansions, approvals, new line of drugs may provide some impetus to share price from the present levels.</li>
</ul>



Ono Pharmaceutical (4528 JP), during FY26, reported revenue of ¥515B, an increase of 6% YoY. Opdivo witnessed 5% decrease in revenue to ¥114.3B mainly due to increased competition.
The company revealed the guidance numbers for FY27. Revenue is expected to be ¥455B, a decrease of 11.8% YoY, mainly due to the absence of sales of Forxiga Tablets.
No near-term catalyst visible for the company at this moment but eventual indication expansions, approvals, new line of drugs may provide some impetus to share price from the present levels.


Ono Pharma (4528 JP): Opdivo Conundrum Continues, FY27 Guidance Takes Forxiga Hit

Thematic (Sector/Industry)

<ul>
<li>Simcere inks outlicensing agreement with Roche for tri-specific antibody in total deal value of $2B+. Hutchmed enters outlicense agreement with GSK for first-in-class drug candidate for upfront payment of $110M.</li>
<li>Akeso’s ivonescimab demonstrates significant overall survival benefit in Keytruda head-to-head trial in NSCLC. Daiichi Sankyo’s Enhertu has been approved in EU for the first-line treatment of HER2 positive breast cancer.</li>
<li>Alteogen inked agreement with Novartis for the development and commercialization of subcutaneous products utilizing ALT-B4. Pharmaessentia secured FDA approval of Besremi for the treatment of essential thrombocythemia.</li>
</ul>


Simcere inks outlicensing agreement with Roche for tri-specific antibody in total deal value of $2B+. Hutchmed enters outlicense agreement with GSK for first-in-class drug candidate for upfront payment of $110M.
Akeso’s ivonescimab demonstrates significant overall survival benefit in Keytruda head-to-head trial in NSCLC. Daiichi Sankyo’s Enhertu has been approved in EU for the first-line treatment of HER2 positive breast cancer.
Alteogen inked agreement with Novartis for the development and commercialization of subcutaneous products utilizing ALT-B4. Pharmaessentia secured FDA approval of Besremi for the treatment of essential thrombocythemia.


APAC Healthcare Weekly (Sept 6) – Simcere, Hutchmed, Akeso, Daiichi Sankyo, Alteogen, Pharmaessentia

<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> , during 9MFY26, reported revenue of ¥397B, an increase of 6% YoY. Opdivo witnessed 6% decrease in revenue to ¥100B mainly due to increased competition.</li>
<li>In December 2025, Keytruda from Merck was the top selling cancer drug of Japan for 27 consecutive months, recording monthly prescription revenue of roughly ¥18B-22B, above Opdivo’s revenue of ¥10B-12B.</li>
<li>No near-term catalyst visible for the company at this moment but eventual indication expansions, approvals, new line of drugs may provide some impetus to share price from the present levels.</li>
</ul>



Ono Pharmaceutical (4528 JP) , during 9MFY26, reported revenue of ¥397B, an increase of 6% YoY. Opdivo witnessed 6% decrease in revenue to ¥100B mainly due to increased competition.
In December 2025, Keytruda from Merck was the top selling cancer drug of Japan for 27 consecutive months, recording monthly prescription revenue of roughly ¥18B-22B, above Opdivo’s revenue of ¥10B-12B.
No near-term catalyst visible for the company at this moment but eventual indication expansions, approvals, new line of drugs may provide some impetus to share price from the present levels.


Ono Pharma (4528 JP): Opdivo Subdued, Recovers Some Lost Ground in NSCLC, FY26 Guidance Reiterated

<ul>
<li>Jiangsu Hengrui received NMPA approval for camrelizumab as a first-line treatment of recurrent or metastatic cervical cancer. BeOne Medicines announced $300M expansion of its New Jersey manufacturing and R&amp;D center.</li>
<li>Takeda Pharmaceutical got China approval for Orzeyful as a treatment of narcolepsy type 1. Nippon Shinyaku outlicences NS-025 to Aquelys Therapeutics for the treatment of xerostomia associated with Sjögren’s disease.</li>
<li>Samsung Biologics is acquiring PolyPeptide, a leading global CDMO specializing in peptide-based API, for CHF1.46B. Celltrion has applied to the EMA for marketing authorization for its Cosentyx biosimilar candidate, CT-P55. </li>
</ul>


Jiangsu Hengrui received NMPA approval for camrelizumab as a first-line treatment of recurrent or metastatic cervical cancer. BeOne Medicines announced $300M expansion of its New Jersey manufacturing and R&amp;D center.
Takeda Pharmaceutical got China approval for Orzeyful as a treatment of narcolepsy type 1. Nippon Shinyaku outlicences NS-025 to Aquelys Therapeutics for the treatment of xerostomia associated with Sjögren’s disease.
Samsung Biologics is acquiring PolyPeptide, a leading global CDMO specializing in peptide-based API, for CHF1.46B. Celltrion has applied to the EMA for marketing authorization for its Cosentyx biosimilar candidate, CT-P55. 


APAC Healthcare Weekly (July 26) – Hengrui, BeOne, Takeda, Nippon Shinyaku, Samsung Bio, Celltrion

<ul>
<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

Japan

ONO PHARMACEUTICAL CO., LTD. manufactures and sells pharmaceutical products. The Company mainly researches and develops prescription drugs.

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Ono Pharmaceutical (4528 JT)

Ono Pharma (4528 JP): Opdivo Conundrum Continues, FY27 Guidance Takes Forxiga Hit

Ono Pharma reported 6% increase in revenue during FY26, Opdivo revenue down 5%. FY27 guidance sees 12% revenue drop hit by Forxiga. No near term...

Tina Banerjee

APAC Healthcare Weekly (Sept 6) – Simcere, Hutchmed, Akeso, Daiichi Sankyo, Alteogen, Pharmaessentia

Simcere and Hutchmend inked outlicensing deals with Roche and GSK, respectively. Akeso’s ivonescimab extends lives vs Keytruda. Alteogen inked...

Tina Banerjee

Ono Pharma (4528 JP): Opdivo Subdued, Recovers Some Lost Ground in NSCLC, FY26 Guidance Reiterated

Ono Pharmaceutical reports 6% revenue increase in 9MFY26, Opdivo continue to face competition. No immediate catalysts for company, but indication...

Tina Banerjee

APAC Healthcare Weekly (July 26) – Hengrui, BeOne, Takeda, Nippon Shinyaku, Samsung Bio, Celltrion

Hengrui’s camrelizumab got indication expansion approval for cervical cancer. BeOne announced $300M expansion plan for US facility. Samsung...

Tina Banerjee

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

US DoD designated Wuxi AppTec as a “Chinese military company.” Takeda’s zasocitinib tops BMS’ Sotyktu in head-to-head trial. Alteogen secured...

Tina Banerjee

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Ono Pharma (4528 JP): Opdivo Conundrum Continues, FY27 Guidance Takes Forxiga Hit

​Ono Pharma reported 6% increase in revenue during FY26, Opdivo revenue down 5%. FY27 guidance sees 12% revenue drop hit by Forxiga. No near term...

Tina Banerjee

APAC Healthcare Weekly (Sept 6) – Simcere, Hutchmed, Akeso, Daiichi Sankyo, Alteogen, Pharmaessentia

Simcere and Hutchmend inked outlicensing deals with Roche and GSK, respectively. Akeso’s ivonescimab extends lives vs Keytruda. Alteogen inked...

Tina Banerjee

Ono Pharma (4528 JP): Opdivo Subdued, Recovers Some Lost Ground in NSCLC, FY26 Guidance Reiterated

​Ono Pharmaceutical reports 6% revenue increase in 9MFY26, Opdivo continue to face competition. No immediate catalysts for company, but indication...

Tina Banerjee

APAC Healthcare Weekly (July 26) – Hengrui, BeOne, Takeda, Nippon Shinyaku, Samsung Bio, Celltrion

Hengrui’s camrelizumab got indication expansion approval for cervical cancer. BeOne announced $300M expansion plan for US facility. Samsung...

Tina Banerjee

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

US DoD designated Wuxi AppTec as a “Chinese military company.” Takeda’s zasocitinib tops BMS’ Sotyktu in head-to-head trial. Alteogen secured...

Tina Banerjee

Ono Pharma reported 6% increase in revenue during FY26, Opdivo revenue down 5%. FY27 guidance sees 12% revenue drop hit by Forxiga. No near term...

Ono Pharmaceutical reports 6% revenue increase in 9MFY26, Opdivo continue to face competition. No immediate catalysts for company, but indication...