Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<ul>
<li>Hansoh’s fourth-generation EGFR TKI HS-10504 tablets secured Breakthrough Therapy Designation in China for NSCLC. Junshi Biosciences got 13th indication expansion approval for toripalimab for HER2-expressing locally advanced or metastatic UC.</li>
<li>Daiichi Sankyo secured FDA approval for Enhertu’s two new breast cancer indications. The company’s Datroway got U.S. approval for TNBC. Japan approved NHI price for SanBio’s Akuugo.</li>
<li>Hanmi Pharmaceutical initiated domestic Phase 3 trial to expand indication for efpeglenatide beyond obesity to include the treatment of diabetes. Yuhan Corp signed $140M API supply contract with Gilead Sciences.</li>
</ul>


Hansoh’s fourth-generation EGFR TKI HS-10504 tablets secured Breakthrough Therapy Designation in China for NSCLC. Junshi Biosciences got 13th indication expansion approval for toripalimab for HER2-expressing locally advanced or metastatic UC.
Daiichi Sankyo secured FDA approval for Enhertu’s two new breast cancer indications. The company’s Datroway got U.S. approval for TNBC. Japan approved NHI price for SanBio’s Akuugo.
Hanmi Pharmaceutical initiated domestic Phase 3 trial to expand indication for efpeglenatide beyond obesity to include the treatment of diabetes. Yuhan Corp signed $140M API supply contract with Gilead Sciences.


APAC Healthcare Weekly (May 24)– Hansoh, Junshi Bio, Daiichi Sankyo, SanBio, Hanmi Pharm, Yuhan Corp

<ul>
<li>China has published 2025 National Reimbursement Drug List, which will be officially implemented nationwide on January 1, 2026. The list added 114 new drugs, including 50 Class 1 innovative drugs.</li>
<li>Fosun Pharmaceutical subsidiary inked exclusive global collaboration and license agreement with Pfizer for weight loss drug candidate YP05002. SanBio obtained partial change approval to the marketing authorization for Akuugo.</li>
<li>PeptiDream achieved milestone of nominating a clinical development candidate from collaboration program with Asahi Kasei. Zydus Lifesciences entered strategic partnership with Formycon for exclusive licensing and supply of Keytruda biosimilar.</li>
</ul>


China has published 2025 National Reimbursement Drug List, which will be officially implemented nationwide on January 1, 2026. The list added 114 new drugs, including 50 Class 1 innovative drugs.
Fosun Pharmaceutical subsidiary inked exclusive global collaboration and license agreement with Pfizer for weight loss drug candidate YP05002. SanBio obtained partial change approval to the marketing authorization for Akuugo.
PeptiDream achieved milestone of nominating a clinical development candidate from collaboration program with Asahi Kasei. Zydus Lifesciences entered strategic partnership with Formycon for exclusive licensing and supply of Keytruda biosimilar.


APAC Healthcare Weekly (December 14) – China NRDL, Fosun Pharma, SanBio, Peptidream, Zydus Life

<ul>
<li>Hansoh Pharmaceutical entered outlicense agreement with Roche for upfront and milestone payments of $2B+. Leads Biolabs and Dianthus Therapeutics entered into exclusive global license agreement for pre-clinical asset.</li>
<li>Chugai Pharmaceutical’s partner Eli Lilly announced positive results from Phase 3 trials of orforglipron. SanBio Co announced that their partial change application for AKUUGO is one step ahead for approval.</li>
<li>Celltrion launched Actemra biosimilar, Aptozma in the U.S. at ~35% discount to original drug. Samsung Biologics shareholders approved biologics business spin-off plan to transform the company into a pure-play CDMO.</li>
</ul>


Hansoh Pharmaceutical entered outlicense agreement with Roche for upfront and milestone payments of $2B+. Leads Biolabs and Dianthus Therapeutics entered into exclusive global license agreement for pre-clinical asset.
Chugai Pharmaceutical’s partner Eli Lilly announced positive results from Phase 3 trials of orforglipron. SanBio Co announced that their partial change application for AKUUGO is one step ahead for approval.
Celltrion launched Actemra biosimilar, Aptozma in the U.S. at ~35% discount to original drug. Samsung Biologics shareholders approved biologics business spin-off plan to transform the company into a pure-play CDMO.


APAC Healthcare Weekly (October 19) – Hansoh, Leads Biolabs, Chugai, SanBio, Celltrion, Samsung Bio

<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

<ul>
<li>Eisai Initiated rolling submission of sBLA to the FDA for Leqembi subcutaneous autoinjector as a weekly starting dose. Hansoh Pharmaceutical’s innovative drug Xinyue got additional indication approval in China.</li>
<li>Jiangsu Hengrui received marketing approval of its self-developed Class 1 innovative drug, Zeprumetostat in China. Celltrion got approval in Europe to start Phase 3 trial of its Darzalex biosimilar.</li>
<li>SK Bioscience applied for Phase 3 clinical trial of SKYVaricella in South Korea to add the 2-dose indication. Lupin received FDA approval for risperidone extended-release injectable suspension.</li>
</ul>


Eisai Initiated rolling submission of sBLA to the FDA for Leqembi subcutaneous autoinjector as a weekly starting dose. Hansoh Pharmaceutical’s innovative drug Xinyue got additional indication approval in China.
Jiangsu Hengrui received marketing approval of its self-developed Class 1 innovative drug, Zeprumetostat in China. Celltrion got approval in Europe to start Phase 3 trial of its Darzalex biosimilar.
SK Bioscience applied for Phase 3 clinical trial of SKYVaricella in South Korea to add the 2-dose indication. Lupin received FDA approval for risperidone extended-release injectable suspension.


APAC Healthcare Weekly (September 7) – Eisai, Hansoh, Hengrui, Celltrion, SK Bioscience, Lupin

Japan

Sanbio Co Ltd researches, develops, manufactures, and sells regenerative cell re lated pharmaceutical products.

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SanBio Co Ltd (4592 JP)

APAC Healthcare Weekly (May 24)– Hansoh, Junshi Bio, Daiichi Sankyo, SanBio, Hanmi Pharm, Yuhan Corp

Hansoh’s HS-10504 tablets secured BTD in China. Junshi Bio secured 13th indication approval for toripalimab. Daiichi Sanyo’s Enhertu and Datroway...

Tina Banerjee

APAC Healthcare Weekly (December 14) – China NRDL, Fosun Pharma, SanBio, Peptidream, Zydus Life

China published 2025 NRDL, adding 114 new drugs. Fosun Pharma inked outlicensing deal with Pfizer for obesity drug candidate. PeptiDream achieved...

Tina Banerjee

APAC Healthcare Weekly (October 19) – Hansoh, Leads Biolabs, Chugai, SanBio, Celltrion, Samsung Bio

Hansoh and Leads Biolabs bag global outlicensing deals. Chugai’s partner Lilly announced positive P3 result for orforglipron. Celltrion launched...

Tina Banerjee

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

APAC Healthcare Weekly (September 7) – Eisai, Hansoh, Hengrui, Celltrion, SK Bioscience, Lupin

Eisai initiated FDA submission of Leqembi subcutaneous injection as starting dose. Hansoh and Hengrui got approvals for new drugs. Celltrion got...

Tina Banerjee

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