Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<ul>
<li>Hengrui Pharma received indication expansion approval for trastuzumab rezetecan in China. MicroPort NeuroScientific’s Apollo Dream Rapamycin Target Eluting Stent has been granted the Breakthrough Device Designation by the FDA.</li>
<li>Celltrion signed KRW375B CMO agreement with a global pharmaceutical company for the supply of drug substance. Samsung Bioepis entered global commercialization agreement with Sandoz for five biosimilar candidates under development.</li>
<li>FDA accepted Sun Pharma’s indication expansion application for Ilumya for active psoriatic arthritis. Zydus Lifesciences entered licensing and supply agreements with Torrent Pharmaceuticals and Lupin to co-market Semaglutide in India.</li>
</ul>


Hengrui Pharma received indication expansion approval for trastuzumab rezetecan in China. MicroPort NeuroScientific’s Apollo Dream Rapamycin Target Eluting Stent has been granted the Breakthrough Device Designation by the FDA.
Celltrion signed KRW375B CMO agreement with a global pharmaceutical company for the supply of drug substance. Samsung Bioepis entered global commercialization agreement with Sandoz for five biosimilar candidates under development.
FDA accepted Sun Pharma’s indication expansion application for Ilumya for active psoriatic arthritis. Zydus Lifesciences entered licensing and supply agreements with Torrent Pharmaceuticals and Lupin to co-market Semaglutide in India.


APAC Healthcare Weekly (March 22) – Hengrui, Microport Neuro, Celltrion, Samsung Bio, Sun Pharma

<ul>
<li>Sino Biopharmaceutical entered outlicensing agreement with Sanofi for rovadicitinib for upfront payment of $135M. Antengene entered outlicensing agreement with UCB for ATG-201 for upfront and near-term milestone payment of $80M.</li>
<li>FDA accepted Takeda’s NDA for polycythemia vera drug rusfertide and granted Priority Review.  Sumitomo Pharma received conditional and time‑limited approval in Japan for the allogeneic cell product Amchepry.</li>
<li>FDA has cleared ABL Bio’s application for a Phase 1 clinical trial of ABL209. Glenmark Pharmaceuticals received FDA approval for generic Flovent with 180-day CGT exclusivity.</li>
</ul>


Sino Biopharmaceutical entered outlicensing agreement with Sanofi for rovadicitinib for upfront payment of $135M. Antengene entered outlicensing agreement with UCB for ATG-201 for upfront and near-term milestone payment of $80M.
FDA accepted Takeda’s NDA for polycythemia vera drug rusfertide and granted Priority Review.  Sumitomo Pharma received conditional and time‑limited approval in Japan for the allogeneic cell product Amchepry.
FDA has cleared ABL Bio’s application for a Phase 1 clinical trial of ABL209. Glenmark Pharmaceuticals received FDA approval for generic Flovent with 180-day CGT exclusivity.


APAC Healthcare Weekly (March 8) – Sino Bio, Antengene, Takeda, Sumitomo Pharma, ABL Bio, Glenmark

<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>Shanghai Henlius Biotech entered outlicensing agreement with Eisai for serplulimab for upfront payment of $75M. Wuxi Biologics has signed a license and research service agreement with Vertex Pharmaceuticals. </li>
<li>Daiichi Sankyo’s indication expansion application for Datroway in TNBC has been accepted and granted Priority Review in the U.S. PeptiDream has initiated registrational Phase 2 clinical trial of radiotherapeutic candidate.</li>
<li>ABL Bio submitted clinical trial application to the FDA for a Phase 1 clinical trial of ADC candidate ABL209. SK Bioscience is in-licensing a clinical-stage RSV vaccine candidate.</li>
</ul>


Shanghai Henlius Biotech entered outlicensing agreement with Eisai for serplulimab for upfront payment of $75M. Wuxi Biologics has signed a license and research service agreement with Vertex Pharmaceuticals. 
Daiichi Sankyo’s indication expansion application for Datroway in TNBC has been accepted and granted Priority Review in the U.S. PeptiDream has initiated registrational Phase 2 clinical trial of radiotherapeutic candidate.
ABL Bio submitted clinical trial application to the FDA for a Phase 1 clinical trial of ADC candidate ABL209. SK Bioscience is in-licensing a clinical-stage RSV vaccine candidate.


APAC Healthcare Weekly (February 8) – Henlius Bio, Wuxi Bio, Daiichi Sankyo, Peptidream, ABL Bio

<ul>
<li>Leads Biolabs initiated Phase 2 clinical study evaluating LBL-024 for the first-line treatment of HCC. Henlius Biotech got FDA approval for Poherdy, as the first interchangeable biosimilar to Roche’s Perjeta.</li>
<li>Otsuka announced positive Phase 3 interim analysis of sibeprenlimab for immunoglobulin A nephropathy. ABL Bio signed technology transfer and joint R&amp;D agreement with Eli Lilly for upfront payment of $40M.</li>
<li>Boryung Pharmaceutical began construction to double its oral penicillin production capacity. Eubiologics published positive result from Phase 3 clinical trial evaluating EuTYPH-C, a typhoid conjugate vaccine.</li>
</ul>


Leads Biolabs initiated Phase 2 clinical study evaluating LBL-024 for the first-line treatment of HCC. Henlius Biotech got FDA approval for Poherdy, as the first interchangeable biosimilar to Roche’s Perjeta.
Otsuka announced positive Phase 3 interim analysis of sibeprenlimab for immunoglobulin A nephropathy. ABL Bio signed technology transfer and joint R&amp;D agreement with Eli Lilly for upfront payment of $40M.
Boryung Pharmaceutical began construction to double its oral penicillin production capacity. Eubiologics published positive result from Phase 3 clinical trial evaluating EuTYPH-C, a typhoid conjugate vaccine.


APAC Healthcare Weekly (November 16) – Leads Bio, Henlius Bio, Otsuka, ABL Bio, Boryung, Eubiologics

South Korea

ABLBio, Inc. operates as a drugs development company. The Company develops and manufactures neurodegenerative diseases therapeutic drugs, oncology therapeutic drugs, and other products. ABLBio markets its products throughout Korea.

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ABLBio (298380 KS)

APAC Healthcare Weekly (March 22) – Hengrui, Microport Neuro, Celltrion, Samsung Bio, Sun Pharma

Celltrion signed KRW375B biologics CMO deal with a global pharma company. Samsung Bioepis expands biosimilar collaboration with Sandoz. 40+ Indian...

Tina Banerjee

APAC Healthcare Weekly (March 8) – Sino Bio, Antengene, Takeda, Sumitomo Pharma, ABL Bio, Glenmark

Sino Bio and Anetengene stuck outlicensing deals with Sanofi and UCB, respectively. FDA accepted Takeda’s NDA for rusfertide. Sumitomo Pharma got...

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 (February 8) – Henlius Bio, Wuxi Bio, Daiichi Sankyo, Peptidream, ABL Bio

Henlius stuck outlicensing deal with Eisai. Wuxi Bio signs deal with Vertex. Daiichi’s Datroway got priority review in U.S. for TNBC. PeptiDream...

Tina Banerjee

APAC Healthcare Weekly (November 16) – Leads Bio, Henlius Bio, Otsuka, ABL Bio, Boryung, Eubiologics

Henlius got FDA approval for Perjeta biosimilar. Otsuka reports positive Phase 3 trial result for sibepernlimab. ABL Bio signed deal with Lilly....

Tina Banerjee

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