Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<ul>
<li>U.S. has implemented a universal baseline tariff of 10%, effective April 5. Japan faces 24% reciprocal tariff from April 9.</li>
<li>In 2023, Japan exported pharmaceutical products worth $6.34B (~43% of total exports) to the U.S.</li>
<li>Japanese pharma and medical devices companies have significant revenue exposure to the U.S.</li>
</ul>


U.S. has implemented a universal baseline tariff of 10%, effective April 5. Japan faces 24% reciprocal tariff from April 9.
In 2023, Japan exported pharmaceutical products worth $6.34B (~43% of total exports) to the U.S.
Japanese pharma and medical devices companies have significant revenue exposure to the U.S.


US Tariff Impact on APAC Healthcare: Focus Country- JAPAN

<ul>
<li>Shionogi is acquiring Torii Pharmaceutical and pharmaceutical business of Japan Tobacco. Daiichi Sankyo’s Enhertu meets main goal in the neoadjuvant setting (before surgery) in early-stage breast cancer trial.</li>
<li>HK inno.N received approval for the domestic phase 3 clinical trial of obesity drug candidate. Neuren Pharmaceuticals’ Daybue recorded $84.6M revenue in the U.S. in 1Q25, up 11% YoY.</li>
<li>Biocon secured multiple market access agreements for Yesintek, its biosimilar to Stelara. Lupin received FDA approval for antiretroviral agent raltegravir tablets for the treatment of human immunodeficiency virus (HIV-1) infection.</li>
</ul>


Shionogi is acquiring Torii Pharmaceutical and pharmaceutical business of Japan Tobacco. Daiichi Sankyo’s Enhertu meets main goal in the neoadjuvant setting (before surgery) in early-stage breast cancer trial.
HK inno.N received approval for the domestic phase 3 clinical trial of obesity drug candidate. Neuren Pharmaceuticals’ Daybue recorded $84.6M revenue in the U.S. in 1Q25, up 11% YoY.
Biocon secured multiple market access agreements for Yesintek, its biosimilar to Stelara. Lupin received FDA approval for antiretroviral agent raltegravir tablets for the treatment of human immunodeficiency virus (HIV-1) infection.


APAC Healthcare Weekly (May 11)- Shionogi, Daiichi Sankyo, HK Inno, Neuren, Biocon, Aster DM, Lupin

<ul>
<li>FDA has confirmed the primary endpoints for Neuren Pharmaceuticals’ planned Phase 3 pivotal clinical trial of NNZ-2591 in Phelan-McDermid syndrome. Eisai has ultimately received its long-waited European approval for Leqembi.</li>
<li>Chugai Pharmaceutical’s outlicensed oral GLP-1 drug candidate orforglipron has shown positive topline Phase 3 results. Telix announced preliminary results from the Phase 2 study of TLX101 in recurrent high-grade glioma.</li>
<li>Biocon secured market entry date for Yesafili, an interchangeable biosimilar to Eylea in the U.S. FDA has issued Form 483 with 11 observations for Aurobindo Pharma’s North Carolina inhaler plant.</li>
</ul>


FDA has confirmed the primary endpoints for Neuren Pharmaceuticals’ planned Phase 3 pivotal clinical trial of NNZ-2591 in Phelan-McDermid syndrome. Eisai has ultimately received its long-waited European approval for Leqembi.
Chugai Pharmaceutical’s outlicensed oral GLP-1 drug candidate orforglipron has shown positive topline Phase 3 results. Telix announced preliminary results from the Phase 2 study of TLX101 in recurrent high-grade glioma.
Biocon secured market entry date for Yesafili, an interchangeable biosimilar to Eylea in the U.S. FDA has issued Form 483 with 11 observations for Aurobindo Pharma’s North Carolina inhaler plant.


APAC Healthcare Weekly (April 20)- Neuren, Chugai, Eisai, Telix, Biocon, Aurobindo Pharma

<ul>
<li>Eisai is eyeing for Leqembi global revenue of ¥250–280B in FY28. Kaken Pharmaceutical inlicensed dermatology drug candidate from Alumis. Kaken’s onychomycosis drug got approval in Italy.</li>
<li>Mochida Pharmaceutical has applied for marketing approval of Actembra biosimilar in Japan. Shionogi has filed for indication expansion of Xocova for post-exposure prophylaxis of COVID-19 in Japan.</li>
<li>SK Bioscience got approval for Phase 3 clinical trial of 21-valent pneumococcal vaccine in European countries. PharmaEssential obtained approval for Phase 3 clinical trial of Ropeginterferon alfa-2b in China.</li>
</ul>


Eisai is eyeing for Leqembi global revenue of ¥250–280B in FY28. Kaken Pharmaceutical inlicensed dermatology drug candidate from Alumis. Kaken’s onychomycosis drug got approval in Italy.
Mochida Pharmaceutical has applied for marketing approval of Actembra biosimilar in Japan. Shionogi has filed for indication expansion of Xocova for post-exposure prophylaxis of COVID-19 in Japan.
SK Bioscience got approval for Phase 3 clinical trial of 21-valent pneumococcal vaccine in European countries. PharmaEssential obtained approval for Phase 3 clinical trial of Ropeginterferon alfa-2b in China.


APAC Healthcare Weekly (Mar 30)- Eisai, Kaken, Mochida, Shionogi, SK Bioscience, PharmaEssentia

<ul>
<li>Daiichi Sankyo announced positive topline result from the phase 3 trial of Enhertu in gastric cancer. Kyorin Pharmaceutical outlicensed KRP-M223, a preclinical mast-cell-targeting candidate for chronic spontaneous urticaria, to Novartis.</li>
<li>Celltrion received FDA approval for Stoboclo and Osenvelt, biosimilars referencing Prolia and Xgeva, respectively. Zydus Lifesciences expects to start the development of world’s first combination vaccine against shigellosis and typhoid.</li>
<li>Biocon received FDA approval for lenalidomide capsules, indicated for types of multiple myeloma, and some other hematologic indications and dasatinib tablets for the treatment of chronic myeloid leukemia.</li>
</ul>


Daiichi Sankyo announced positive topline result from the phase 3 trial of Enhertu in gastric cancer. Kyorin Pharmaceutical outlicensed KRP-M223, a preclinical mast-cell-targeting candidate for chronic spontaneous urticaria, to Novartis.
Celltrion received FDA approval for Stoboclo and Osenvelt, biosimilars referencing Prolia and Xgeva, respectively. Zydus Lifesciences expects to start the development of world’s first combination vaccine against shigellosis and typhoid.
Biocon received FDA approval for lenalidomide capsules, indicated for types of multiple myeloma, and some other hematologic indications and dasatinib tablets for the treatment of chronic myeloid leukemia.


APAC Healthcare Weekly (Mar 9)- Daiichi Sankyo, Kyorin Pharma, Celltrion, Zydus Lifesciences, Biocon

Japan

Eisai Co., Ltd. produces prescription drugs and medical equipment and sells mainly to sales agents and subsidiaries.  Through its subsidiary, Sanko Junyaku, the Company produces and sells diagnostic drugs.  Eisai also markets its products through related companies in the US, Europe, and Asia.  The Company also manufactures and sells foods, livestock feeds, chemical, and agrochemicals.

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Eisai Co Ltd (4523 JP)

US Tariff Impact on APAC Healthcare: Focus Country- JAPAN

Trump is expected to sign an executive order to lower prescription drug prices. The question about the feasibility of implementation of Trump’s...

Tina Banerjee

APAC Healthcare Weekly (May 11)- Shionogi, Daiichi Sankyo, HK Inno, Neuren, Biocon, Aster DM, Lupin

Shionogi is acquiring Torii Pharma. Daiichi Sankyo’s Enhertu meets key goal in breast cancer trial. HK inno got domestic approval for P3 trial of...

Tina Banerjee

APAC Healthcare Weekly (April 20)- Neuren, Chugai, Eisai, Telix, Biocon, Aurobindo Pharma

Neuren is a step closer to P3 trial in PMS. Chugai’s oral GLP-1 drug candidate shows promise in P3 trial. Eisai got Leqembi approval in EU. Biocon...

Tina Banerjee

APAC Healthcare Weekly (Mar 30)- Eisai, Kaken, Mochida, Shionogi, SK Bioscience, PharmaEssentia

Eisai outlined Leqembi sales target. Kaken inlicensed drug candidate. Mochida filed for Actembra biosimilar. Shionogi applied for label expansion...

Tina Banerjee

APAC Healthcare Weekly (Mar 9)- Daiichi Sankyo, Kyorin Pharma, Celltrion, Zydus Lifesciences, Biocon

APAC healthcare companies continued to get approvals for new products and initiates clinical trials. The companies continued with acquisitions and...

Tina Banerjee

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