Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<ul>
<li>Henlius Biotech is collaborating with Sandoz for commercialization of up to 10 biosimilars in ~$322M deal. Wuxi XDC achieved GMP release of its antibody bioconjugates production line at Singapore site.</li>
<li>Chugai Pharmaceutical signed an exclusive license agreement with GSK for the anti-dengue virus antibody AID351. Daiichi Sankyo’s Enhertu demonstrated PFS improvement as first-line treatment of NSCLC in Phase 3 trial.</li>
<li>Celltrion has launched IV formulation of Steqeyma in Japan. Eubiologics submitted an IND to the MFDS for domestic Phase 1 trial for its Alzheimer’s disease vaccine candidate, Padivax.</li>
</ul>


Henlius Biotech is collaborating with Sandoz for commercialization of up to 10 biosimilars in ~$322M deal. Wuxi XDC achieved GMP release of its antibody bioconjugates production line at Singapore site.
Chugai Pharmaceutical signed an exclusive license agreement with GSK for the anti-dengue virus antibody AID351. Daiichi Sankyo’s Enhertu demonstrated PFS improvement as first-line treatment of NSCLC in Phase 3 trial.
Celltrion has launched IV formulation of Steqeyma in Japan. Eubiologics submitted an IND to the MFDS for domestic Phase 1 trial for its Alzheimer’s disease vaccine candidate, Padivax.


APAC Healthcare Weekly (August 23) – Henlius Bio, Wuxi XDC, Chugai Pharma, Daiichi Sankyo, Celltrion

<ul>
<li>CSPC Pharmaceutical’s Phase 3 trial of depression drug candidate HA1406 met pre-specified primary efficacy endpoint. Jiangsu Hengrui Pharmaceuticals received NMPA approval for long-acting basal insulin, sudelidec injection.</li>
<li>Otsuka Holdings secured FDA approval for Simtriyo, a once-daily extended-release capsule for ADHD. Nippon Shinyaku obtained exclusive commercialization rights for Tadekinig alfa in the U.S. for Hyperinflammatory Syndrome.</li>
<li>Pharmaessentia announced topline results from the Phase 1b clinical trial of P1101 (Besremi) and anti-PD1 in Chronic Hepatitis B or D. Cipla secured FDA approval for generic Advair Diskus.</li>
</ul>


CSPC Pharmaceutical’s Phase 3 trial of depression drug candidate HA1406 met pre-specified primary efficacy endpoint. Jiangsu Hengrui Pharmaceuticals received NMPA approval for long-acting basal insulin, sudelidec injection.
Otsuka Holdings secured FDA approval for Simtriyo, a once-daily extended-release capsule for ADHD. Nippon Shinyaku obtained exclusive commercialization rights for Tadekinig alfa in the U.S. for Hyperinflammatory Syndrome.
Pharmaessentia announced topline results from the Phase 1b clinical trial of P1101 (Besremi) and anti-PD1 in Chronic Hepatitis B or D. Cipla secured FDA approval for generic Advair Diskus.


APAC Healthcare Weekly (August 2) – CSPC, Hengrui, Otsuka, Nippon Shinyaku, PharmaEssnetia, Cipla

<ul>
<li>InSilico Medicine and SK Biopharmaceuticals entered R&amp;D collaboration to discover AI-enabled neuroimmune drug candidates. Abbisko Cayman entered into a strategic research collaboration and license agreement with Eli Lilly.</li>
<li>Nippon Shinyaku’s partner Regenxbio cleared path to resubmit Hunter syndrome gene therapy candidate RGX-121 to the FDA. Otsuka announced positive topline results in Phase 3b study evaluating centanafadine in ADHD.</li>
<li>Yuhan Corp received orphan drug designation from the EMA for its Gaucher disease therapy candidate YH35995. Medytox obtained approval for its hyaluronic acid filler Neuramis Deep Lidocaine in China.</li>
</ul>


InSilico Medicine and SK Biopharmaceuticals entered R&amp;D collaboration to discover AI-enabled neuroimmune drug candidates. Abbisko Cayman entered into a strategic research collaboration and license agreement with Eli Lilly.
Nippon Shinyaku’s partner Regenxbio cleared path to resubmit Hunter syndrome gene therapy candidate RGX-121 to the FDA. Otsuka announced positive topline results in Phase 3b study evaluating centanafadine in ADHD.
Yuhan Corp received orphan drug designation from the EMA for its Gaucher disease therapy candidate YH35995. Medytox obtained approval for its hyaluronic acid filler Neuramis Deep Lidocaine in China.


APAC Healthcare Weekly (June 28) – Insilico, Abbisko, Nippon Shinyaku, Otsuka, Yuhan Corp, Medytox

<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

Guangzhou Innogen Pharmaceutical Group Co Ltd is a China-based company primarily engaged in the research, development, and commercialization of pharmaceutical products. The company focuses on innovative therapies for diabetes and other metabolic diseases, with its core product being Efsubaglutide Alfa (Diabegone) for type 2 diabetes. It was founded in 2014 and is headquartered in Shanghai, China.

Guangzhou Innogen Pharmaceutical (2591 HK)

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Guangzhou Innogen Pharmaceutical (2591 HK)

APAC Healthcare Weekly (August 23) – Henlius Bio, Wuxi XDC, Chugai Pharma, Daiichi Sankyo, Celltrion

Henlius strikes biosimilar commercialization deal with Sandoz. Chugai signs exclusive license deal with GSK for anti-dengue virus antibody....

Tina Banerjee

APAC Healthcare Weekly (August 2) – CSPC, Hengrui, Otsuka, Nippon Shinyaku, PharmaEssnetia, Cipla

Hengrui got NMPA approval for long-acting insulin. FDA approves Otsuka’s new CNS drug. Pharmaessentia announced positive topline result from Phase...

Tina Banerjee

APAC Healthcare Weekly (June 28) – Insilico, Abbisko, Nippon Shinyaku, Otsuka, Yuhan Corp, Medytox

Few Chinese companies signed outlicensing deals. Nippon Shinyaku’s partner Regenxbio will resubmit gene therapy drug candidate to FDA. Otsuka...

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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