Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<ul>
<li>Daiichi Sankyo’s indication expansion application for Enhertu has been accepted for review by FDA for certain types of breast cancers. Santen’s new drug application has been accepted in China.  </li>
<li>Hanmi Pharm entered into a global licensing agreement with Gilead Sciences granting Gilead the exclusive rights to develop and commercialize encequidar. Boryung is acquiring Sanofi’s cytotoxic anti-cancer drug Taxotere.</li>
<li>IHH Healthcare received SEBI approval for mandatory open offer for 26% stake in Fortis Healthcare. Lupin has launched Liraglutide prefilled pen, bioequivalent to Victoza, in the U.S.</li>
</ul>


Daiichi Sankyo’s indication expansion application for Enhertu has been accepted for review by FDA for certain types of breast cancers. Santen’s new drug application has been accepted in China.  
Hanmi Pharm entered into a global licensing agreement with Gilead Sciences granting Gilead the exclusive rights to develop and commercialize encequidar. Boryung is acquiring Sanofi’s cytotoxic anti-cancer drug Taxotere.
IHH Healthcare received SEBI approval for mandatory open offer for 26% stake in Fortis Healthcare. Lupin has launched Liraglutide prefilled pen, bioequivalent to Victoza, in the U.S.


APAC Healthcare Weekly (October 5) – Daiichi Sankyo, Santen, Hanmi Pharm, Boryung, IHH Health, Lupin

Equity Bottom-Up

<ul>
<li>In 1QFY26, <a href="https://www.smartkarma.com/entities/nippon-shinyaku-co-ltd" target="_blank" data-smartkarma-citation="entities:6634:1" rel="noopener">Nippon Shinyaku (4516 JP)</a> revenue grew 1% YoY to ¥39.5B and operating profit stood at ¥10.1B (down 9% YoY) as company incurred forex losses.</li>
<li>Viltepso witnessed slowing in US. Licensing income increased on higher overseas sales of Uptravi. Newly launched drugs like Vyxeos and Fintepla showed promise.</li>
<li>FY26 guidance revised downwards taking into account FDA’s rejection of BLA for CAP-1002. The company reduced FY26 revenue guidance to ¥166B from ¥173B.</li>
</ul>


In 1QFY26, Nippon Shinyaku (4516 JP) revenue grew 1% YoY to ¥39.5B and operating profit stood at ¥10.1B (down 9% YoY) as company incurred forex losses.
Viltepso witnessed slowing in US. Licensing income increased on higher overseas sales of Uptravi. Newly launched drugs like Vyxeos and Fintepla showed promise.
FY26 guidance revised downwards taking into account FDA’s rejection of BLA for CAP-1002. The company reduced FY26 revenue guidance to ¥166B from ¥173B.


Nippon Shinyaku (4516 JP): Flurry of Concerns Going Ahead; Revenue Steady for Now; Guidance Revised

<ul>
<li>Eli Lilly announced positive topline results from Phase 3 trial, evaluating orforglipron, discovered by Chugai. Hisamitsu Pharmaceutical initiated Phase 3 trial of HP-6050, a transdermal formulation for sedation in Japan.</li>
<li>WuXi XDC completed GMP release of its new drug product facility in China. CSPC Pharmaceutical’s application for marketing approval of Semaglutide Injection has been accepted by the NMPA of China.</li>
<li>Junshi Biosciences’s indication expansion application for toripalimab for treatment of urothelial carcinoma has been accepted in China. Hanmi Pharma advances HM17321, a first-in-class obesity therapy, into global Phase 1 trials.</li>
</ul>


Eli Lilly announced positive topline results from Phase 3 trial, evaluating orforglipron, discovered by Chugai. Hisamitsu Pharmaceutical initiated Phase 3 trial of HP-6050, a transdermal formulation for sedation in Japan.
WuXi XDC completed GMP release of its new drug product facility in China. CSPC Pharmaceutical’s application for marketing approval of Semaglutide Injection has been accepted by the NMPA of China.
Junshi Biosciences’s indication expansion application for toripalimab for treatment of urothelial carcinoma has been accepted in China. Hanmi Pharma advances HM17321, a first-in-class obesity therapy, into global Phase 1 trials.


APAC Healthcare Weekly (Aug 10) – Chugai, Hisamitsu, Wuxi XDC, CSPC Pharma, Junshi Bio, Hanmi Pharma

<ul>
<li>Shionogi applied for indication expansion of its oral COVID-19 drug for pediatric patients. Simcere Pharmaceutical received approval of Enzeshu for the treatment of ovarian cancer in China.</li>
<li>WuXi XDC has completed its manufacturing site in Singapore. The site to commence operation this year. Sino Biopharma got marketing approval in China for its inhouse congenital hemophilia drug Anqixin.</li>
<li>Apollo Hospitals is demerging its omni-channel pharmacy and digital health business. Torrent Pharmaceuticals is acquiring controlling stake in J. B. Chemicals at an equity valuation of INR 257B.</li>
</ul>


Shionogi applied for indication expansion of its oral COVID-19 drug for pediatric patients. Simcere Pharmaceutical received approval of Enzeshu for the treatment of ovarian cancer in China.
WuXi XDC has completed its manufacturing site in Singapore. The site to commence operation this year. Sino Biopharma got marketing approval in China for its inhouse congenital hemophilia drug Anqixin.
Apollo Hospitals is demerging its omni-channel pharmacy and digital health business. Torrent Pharmaceuticals is acquiring controlling stake in J. B. Chemicals at an equity valuation of INR 257B.


APAC Healthcare Weekly (July 6)- Shionogi, Simcere, Wuxi XDC, Sino Bio, Apollo Hosp, Torrent Pharma

<ul>
<li>In FY25, <a href="https://www.smartkarma.com/entities/nippon-shinyaku-co-ltd" target="_blank" data-smartkarma-citation="entities:6634:1" rel="noopener">Nippon Shinyaku (4516 JP)</a> revenue grew 8% YoY to ¥160B and operating profit stood at ¥35.5B, up 6.5%.</li>
<li>Viltepso witnessed growth both in Japan and the U.S., licensing income also increased on higher overseas sales of Uptravi. Newly launched drugs like Vyxeos and Fintepla showed promise.</li>
<li>FY26 guidance indicate forex headwinds as higher costs will dent margins.</li>
</ul>


In FY25, Nippon Shinyaku (4516 JP) revenue grew 8% YoY to ¥160B and operating profit stood at ¥35.5B, up 6.5%.
Viltepso witnessed growth both in Japan and the U.S., licensing income also increased on higher overseas sales of Uptravi. Newly launched drugs like Vyxeos and Fintepla showed promise.
FY26 guidance indicate forex headwinds as higher costs will dent margins.


Nippon Shinyaku (4516 JP): Stable FY25; New Launches Key; Guidance Indicates A Forex Wary FY26

Japan

HISAMITSU PHARMACEUTICAL CO., INC. produces and sells pharmaceutical products. The Company's main product is anti-inflammatory analgesic plasters and poultices sold under the brand name Salonpas.  Hisamitsu Pharmaceutical exports its products to North America and Southeast Asia.  The Company also researches and develops antibacterial products through its related company, RRF.

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Hisamitsu Pharmaceutical Co (4530 JP)

APAC Healthcare Weekly (October 5) – Daiichi Sankyo, Santen, Hanmi Pharm, Boryung, IHH Health, Lupin

Daiichi Sankyo’s label expansion application for Enhertu has been accepted by FDA. Hanmi Pharm entered into global licensing agreement with Gilead...

Tina Banerjee

Nippon Shinyaku (4516 JP): Flurry of Concerns Going Ahead; Revenue Steady for Now; Guidance Revised

Nippon Shinyaku reports mixed 1QFY26 result, with revenue growing 1% YoY and operating profit decreasing 9% YoY due to forex losses. The company...

Tina Banerjee

APAC Healthcare Weekly (Aug 10) – Chugai, Hisamitsu, Wuxi XDC, CSPC Pharma, Junshi Bio, Hanmi Pharma

Obesity treatment related development dominated the week, with Chugai’s drug candidate meeting Phase 3 trial goals, CSPC is a step ahead for...

Tina Banerjee

APAC Healthcare Weekly (July 6)- Shionogi, Simcere, Wuxi XDC, Sino Bio, Apollo Hosp, Torrent Pharma

Simcere, CSPC, and Sino Bio got approvals for their new drugs in China. Apollo Hospital announced a demerger. Torrent is acquiring controlling...

Tina Banerjee

Nippon Shinyaku (4516 JP): Stable FY25; New Launches Key; Guidance Indicates A Forex Wary FY26

Nippon Shinyaku sees 8% revenue growth in FY25 on continued strength of Viltepso. Newly launched drugs showed promise. However, FY26 guidance...

Tina Banerjee

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52-week Range

Market Cap (USDm)

P/E

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APAC Healthcare Weekly (October 5) – Daiichi Sankyo, Santen, Hanmi Pharm, Boryung, IHH Health, Lupin

Daiichi Sankyo’s label expansion application for Enhertu has been accepted by FDA. Hanmi Pharm entered into global licensing agreement with Gilead...

Tina Banerjee

Nippon Shinyaku (4516 JP): Flurry of Concerns Going Ahead; Revenue Steady for Now; Guidance Revised

​Nippon Shinyaku reports mixed 1QFY26 result, with revenue growing 1% YoY and operating profit decreasing 9% YoY due to forex losses. The company...

Tina Banerjee

APAC Healthcare Weekly (Aug 10) – Chugai, Hisamitsu, Wuxi XDC, CSPC Pharma, Junshi Bio, Hanmi Pharma

Obesity treatment related development dominated the week, with Chugai’s drug candidate meeting Phase 3 trial goals, CSPC is a step ahead for...

Tina Banerjee

APAC Healthcare Weekly (July 6)- Shionogi, Simcere, Wuxi XDC, Sino Bio, Apollo Hosp, Torrent Pharma

Simcere, CSPC, and Sino Bio got approvals for their new drugs in China. Apollo Hospital announced a demerger. Torrent is acquiring controlling...

Tina Banerjee

Nippon Shinyaku (4516 JP): Stable FY25; New Launches Key; Guidance Indicates A Forex Wary FY26

​Nippon Shinyaku sees 8% revenue growth in FY25 on continued strength of Viltepso. Newly launched drugs showed promise. However, FY26 guidance...

Tina Banerjee

Nippon Shinyaku reports mixed 1QFY26 result, with revenue growing 1% YoY and operating profit decreasing 9% YoY due to forex losses. The company...

Nippon Shinyaku sees 8% revenue growth in FY25 on continued strength of Viltepso. Newly launched drugs showed promise. However, FY26 guidance...