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>NMPA accepted Simcere’s resubmitted NDA for Rademikibart for the treatment of atopic dermatitis. FDA has granted Priority Review to Beigene’s indication expansion application for Tevimra in first-line gastroesophageal adenocarcinoma.</li>
<li>FDA has accepted Taiho Pharmaceutical’s NDA for NSCLC drug candidate zipalertinib. Kyowa Kirin and Kura Oncology initiated Japanese Phase 2 registrational clinical trial studying ziftomenib, for acute myeloid leukemia.</li>
<li>Sun Pharmaceutical is acquiring Organon for $14 per share in an all‑cash transaction with an enterprise valuation of $12B. The transaction is expected to close in early 2027.</li>
</ul>


NMPA accepted Simcere’s resubmitted NDA for Rademikibart for the treatment of atopic dermatitis. FDA has granted Priority Review to Beigene’s indication expansion application for Tevimra in first-line gastroesophageal adenocarcinoma.
FDA has accepted Taiho Pharmaceutical’s NDA for NSCLC drug candidate zipalertinib. Kyowa Kirin and Kura Oncology initiated Japanese Phase 2 registrational clinical trial studying ziftomenib, for acute myeloid leukemia.
Sun Pharmaceutical is acquiring Organon for $14 per share in an all‑cash transaction with an enterprise valuation of $12B. The transaction is expected to close in early 2027.


APAC Healthcare Weekly (May 3) – Simcere, Beigene, Otsuka, Kyowa Kirin, Sun Pharma

<ul>
<li>Sino Biopharmaceutical got indication expansion approval for benmelstobart in stage III NSCLC in China. Hansoh Pharmaceutical got EU approval for Ameile as first-line treatment of advanced NSCLC.</li>
<li>EMA validated Daiichi Sankyo’s marketing authorization application for Enhertu as a monotherapy for HER2+ breast cancer. FDA accepted Ono Pharmaceutical’s NDA for primary central nervous system lymphoma drug candidate tirabrutinib.</li>
<li>ABL Bio initiates global phase 2 trial evaluating ABL111 as first-line treatment for metastatic gastric cancer. CSL entered an exclusive outlicensing agreement with Eli Lilly to develop and commercialise clazakizumab.</li>
</ul>


Sino Biopharmaceutical got indication expansion approval for benmelstobart in stage III NSCLC in China. Hansoh Pharmaceutical got EU approval for Ameile as first-line treatment of advanced NSCLC.
EMA validated Daiichi Sankyo’s marketing authorization application for Enhertu as a monotherapy for HER2+ breast cancer. FDA accepted Ono Pharmaceutical’s NDA for primary central nervous system lymphoma drug candidate tirabrutinib.
ABL Bio initiates global phase 2 trial evaluating ABL111 as first-line treatment for metastatic gastric cancer. CSL entered an exclusive outlicensing agreement with Eli Lilly to develop and commercialise clazakizumab.


APAC Healthcare Weekly (February 22) – Sino Bio, Hansoh Pharma, Daiichi Sankyo, Ono, ABL Bio, CSL

<ul>
<li>Takeda has dropped AstraZeneca-partnered antibody drug candidate from its pipeline. Eisai and Merck are closing late-stage trial of Lenvima plus Keytruda in hepatocellular carcinoma on disappointing result.</li>
<li>Wuxi AppTec sharpens CRDMO business by selling its China-based clinical research subsidiaries. FDA has designated Celltrion’s Stoboclo and Osenvelt as interchangeable biosimilars to the reference products Prolia and Xgeva, respectively.</li>
<li>CSL is delaying demerger of CSL Seqirus ‘to maximise shareholder value.’ PharmaEssentia has filed for the additional indication of Besremi for Essential Thrombocythemia (ET) with the FDA.</li>
</ul>


Takeda has dropped AstraZeneca-partnered antibody drug candidate from its pipeline. Eisai and Merck are closing late-stage trial of Lenvima plus Keytruda in hepatocellular carcinoma on disappointing result.
Wuxi AppTec sharpens CRDMO business by selling its China-based clinical research subsidiaries. FDA has designated Celltrion’s Stoboclo and Osenvelt as interchangeable biosimilars to the reference products Prolia and Xgeva, respectively.
CSL is delaying demerger of CSL Seqirus ‘to maximise shareholder value.’ PharmaEssentia has filed for the additional indication of Besremi for Essential Thrombocythemia (ET) with the FDA.


APAC Healthcare Weekly (November 2) – Takeda, Eisai, Wuxi AppTec, Celltrion, CSL, PharmaEssentia

<ul>
<li>Celltrion is acquiring a biopharmaceutical production plant in the U.S. capable of producing key biopharmaceuticals. Alteogen received positive opinion from European Medicines Agency for its Eylea biosimilar.</li>
<li>Wuxi Biologics has begun construction for new modular Drug Product facility in Singapore. CSPC Pharmaceutical entered into an exclusive license agreement with Madrigal Pharmaceuticals, for its oral GLP-1 drug candidate.</li>
<li>Jiangsu Hengrui Pharmaceuticals has entered into agreements with GlaxoSmithKline, to grant GSK an exclusive worldwide right (excluding China) of HRS-9821 and up to 11 other programs.</li>
</ul>


Celltrion is acquiring a biopharmaceutical production plant in the U.S. capable of producing key biopharmaceuticals. Alteogen received positive opinion from European Medicines Agency for its Eylea biosimilar.
Wuxi Biologics has begun construction for new modular Drug Product facility in Singapore. CSPC Pharmaceutical entered into an exclusive license agreement with Madrigal Pharmaceuticals, for its oral GLP-1 drug candidate.
Jiangsu Hengrui Pharmaceuticals has entered into agreements with GlaxoSmithKline, to grant GSK an exclusive worldwide right (excluding China) of HRS-9821 and up to 11 other programs.


APAC Healthcare Weekly (Aug 3)– Celltrion, Alteogen, Wuxi Bio, CSPC, Jiangsu Hengrui, Eisai, Kissei

South Korea

Seegene, Inc. manufactures In Vitro Diagnostic (IVD) products mainly through molecular diagnostic method.  The Company provides diagnostic & screening products for cancer, sepsis, influenza and virus infection.

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Seegene Inc (096530 KS)

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 (May 3) – Simcere, Beigene, Otsuka, Kyowa Kirin, Sun Pharma

NMPA accepted Simcere’s resubmitted NDA for Rademikibart. Beigene got FDA’s priority review for label expansion of Tevimra. Sun Pharma is acquiring...

Tina Banerjee

APAC Healthcare Weekly (February 22) – Sino Bio, Hansoh Pharma, Daiichi Sankyo, Ono, ABL Bio, CSL

Hansoh Pharma got EU approval for Ameile. EMA validated Daiichi Sankyo’s Enhertu in breast cancer. FDA accepted Ono Pharmaceutical’s tirabrutinib....

Tina Banerjee

APAC Healthcare Weekly (November 2) – Takeda, Eisai, Wuxi AppTec, Celltrion, CSL, PharmaEssentia

Takeda and Eisai witnessed clinical trials setback. Wuxi AppTec is selling China-based CRO subsidiaries. CSL is delaying demerger of CSL Seqirus....

Tina Banerjee

APAC Healthcare Weekly (Aug 3)– Celltrion, Alteogen, Wuxi Bio, CSPC, Jiangsu Hengrui, Eisai, Kissei

Celltrion is acquiring a biopharmaceutical production plant in US. Wuxi Bio starts construction of new facility. CSPC and Jiangsu Hengrui stuck...

Tina Banerjee

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