Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<ul>
<li>Hansoh Pharmaceutical’s risvutatug rezetecan has been included in the Priority Review and Approval Procedure of NMPA. Innocare entered research collaboration and license agreement with Eli Lilly to develop new medicines.</li>
<li>Astellas Pharma initiated Phase 3 trial evaluating setidegrasib for NSCLC. Otsuka announced positive topline results from the Phase 3 trial evaluating ulefnersen in a genetic subtype of amyotrophic lateral sclerosis.</li>
<li>Elevar Therapeutics won FDA approval for Lyrfigtu for bile duct cancer. Telix Pharmaceuticals will acquire ITM Isotope Technologies, a global leader in radioisotope production and radiopharmaceutical development, for $1.65B upfront.</li>
</ul>


Hansoh Pharmaceutical’s risvutatug rezetecan has been included in the Priority Review and Approval Procedure of NMPA. Innocare entered research collaboration and license agreement with Eli Lilly to develop new medicines.
Astellas Pharma initiated Phase 3 trial evaluating setidegrasib for NSCLC. Otsuka announced positive topline results from the Phase 3 trial evaluating ulefnersen in a genetic subtype of amyotrophic lateral sclerosis.
Elevar Therapeutics won FDA approval for Lyrfigtu for bile duct cancer. Telix Pharmaceuticals will acquire ITM Isotope Technologies, a global leader in radioisotope production and radiopharmaceutical development, for $1.65B upfront.


APAC Healthcare Weekly (Sept 27) – Hansoh Pharma, Innocare, Astellas, Otsuka, Telix Pharmaceuticals

<ul>
<li>Simcere inks outlicensing agreement with Roche for tri-specific antibody in total deal value of $2B+. Hutchmed enters outlicense agreement with GSK for first-in-class drug candidate for upfront payment of $110M.</li>
<li>Akeso’s ivonescimab demonstrates significant overall survival benefit in Keytruda head-to-head trial in NSCLC. Daiichi Sankyo’s Enhertu has been approved in EU for the first-line treatment of HER2 positive breast cancer.</li>
<li>Alteogen inked agreement with Novartis for the development and commercialization of subcutaneous products utilizing ALT-B4. Pharmaessentia secured FDA approval of Besremi for the treatment of essential thrombocythemia.</li>
</ul>


Simcere inks outlicensing agreement with Roche for tri-specific antibody in total deal value of $2B+. Hutchmed enters outlicense agreement with GSK for first-in-class drug candidate for upfront payment of $110M.
Akeso’s ivonescimab demonstrates significant overall survival benefit in Keytruda head-to-head trial in NSCLC. Daiichi Sankyo’s Enhertu has been approved in EU for the first-line treatment of HER2 positive breast cancer.
Alteogen inked agreement with Novartis for the development and commercialization of subcutaneous products utilizing ALT-B4. Pharmaessentia secured FDA approval of Besremi for the treatment of essential thrombocythemia.


APAC Healthcare Weekly (Sept 6) – Simcere, Hutchmed, Akeso, Daiichi Sankyo, Alteogen, Pharmaessentia

<ul>
<li>Sichuan Kelub Biotech’s sac-TMT in combination with Keytruda as a first-line treatment for PD-L1-negative non-squamous NSCL) met primary endpoint. NMPA accepted CSPC Pharma’s NDA for Trastuzumab Envedotin (HER2-targeted ADC).</li>
<li>InSilico Medicine announced a multi-target strategic alliance with Bora Pharmaceuticals. Eisai secured FDA approval for a once-weekly Leqembi subcutaneous autoinjector as an initiation dose for Alzheimer’s disease.</li>
<li>Celltrion obtained domestic approval for Phase 1 clinical trials for its Tremfya biosimilar candidate, CT-P68. Mesoblast achieved target of 300 patients treated in Phase 3 trial of rexlemestrocel-L for CLBP.</li>
</ul>


Sichuan Kelub Biotech’s sac-TMT in combination with Keytruda as a first-line treatment for PD-L1-negative non-squamous NSCL) met primary endpoint. NMPA accepted CSPC Pharma’s NDA for Trastuzumab Envedotin (HER2-targeted ADC).
InSilico Medicine announced a multi-target strategic alliance with Bora Pharmaceuticals. Eisai secured FDA approval for a once-weekly Leqembi subcutaneous autoinjector as an initiation dose for Alzheimer’s disease.
Celltrion obtained domestic approval for Phase 1 clinical trials for its Tremfya biosimilar candidate, CT-P68. Mesoblast achieved target of 300 patients treated in Phase 3 trial of rexlemestrocel-L for CLBP.


APAC Healthcare Weekly (July 19) – Kelun Bio, CSPC Pharma, Insilico, Eisai, Celltrion, Mesoblast

<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>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

China

Jenscare Scientific develops, produces, sells, and services minimally invasive interventional therapies for structural heart diseases. Key products include LuX-Valve and LuX-Valve Plus for tricuspid valve replacement, Ken-Valve for aortic valve replacement, and JensClip for mitral valve repair. The company is headquartered in Ningbo, Zhejiang, PRC, and was founded in 2011.

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Jenscare Scientific (9877 HK)

APAC Healthcare Weekly (Sept 27) – Hansoh Pharma, Innocare, Astellas, Otsuka, Telix Pharmaceuticals

Hansoh’s risvutatug rezetecan has been included in NMPA’s Priority Review list. Elevar Therapeutics won FDA approval for Lyrfigtu for bile duct...

Tina Banerjee

APAC Healthcare Weekly (Sept 6) – Simcere, Hutchmed, Akeso, Daiichi Sankyo, Alteogen, Pharmaessentia

Simcere and Hutchmend inked outlicensing deals with Roche and GSK, respectively. Akeso’s ivonescimab extends lives vs Keytruda. Alteogen inked...

Tina Banerjee

APAC Healthcare Weekly (July 19) – Kelun Bio, CSPC Pharma, Insilico, Eisai, Celltrion, Mesoblast

Kelun Biotech’s sac-TMT met primary endpoint in Phase 3 trial. FDA approves Eisai’s Leqembi Iqlik for Alzheimer’s starting therapy. Mesoblast met...

Tina Banerjee

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 (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

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