Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<ul>
<li>CSPC entered research collaboration with AstraZeneca for oral small molecule drug discovery utilizing CSPC’s AI-driven drug discovery platform. Wuxi Biologics kicked off construction of new microbial manufacturing site in China.</li>
<li>Samsung Biologics signed a CDMO contract worth more than KRW100B (~$73M) with an unnamed European pharmaceutical company. Daiichi Sankyo initiates Phase 3 trial of Enhertu in first-line breast cancer.</li>
<li>SanBio has completed filing a partial change application of marketing approval of Akuugo. Cochlear introduces Nucleus Nexa system, the world’s first and only smart cochlear implant system.</li>
</ul>


CSPC entered research collaboration with AstraZeneca for oral small molecule drug discovery utilizing CSPC’s AI-driven drug discovery platform. Wuxi Biologics kicked off construction of new microbial manufacturing site in China.
Samsung Biologics signed a CDMO contract worth more than KRW100B (~$73M) with an unnamed European pharmaceutical company. Daiichi Sankyo initiates Phase 3 trial of Enhertu in first-line breast cancer.
SanBio has completed filing a partial change application of marketing approval of Akuugo. Cochlear introduces Nucleus Nexa system, the world’s first and only smart cochlear implant system.


APAC Healthcare Weekly (June 15)- CSPC, Wuxi Bio, Samsung Bio, Daiichi Sankyo, SanBio, Cochlear

<ul>
<li>Jiangsu Hengrui Medicine launches Hong Kong IPO to raise ~$1.3B. Wuxi Biologics is selling its drug product plant in Germany to Terumo for €150M.</li>
<li>Chugai Pharmaceutical got conditional approval in Japan for gene therapy product, Elevidys for Duchenne muscular dystrophy. GC Biopharma dosed first patient in Fabry disease drug trial in Korea.</li>
<li>Mayne Pharma was hit hard as an ‘untitled letter’ from the FDA related to certain promotional claims used in a speaker presentation for oral contraceptive Nextstellis, was made public.  </li>
</ul>


Jiangsu Hengrui Medicine launches Hong Kong IPO to raise ~$1.3B. Wuxi Biologics is selling its drug product plant in Germany to Terumo for €150M.
Chugai Pharmaceutical got conditional approval in Japan for gene therapy product, Elevidys for Duchenne muscular dystrophy. GC Biopharma dosed first patient in Fabry disease drug trial in Korea.
Mayne Pharma was hit hard as an ‘untitled letter’ from the FDA related to certain promotional claims used in a speaker presentation for oral contraceptive Nextstellis, was made public.  


APAC Healthcare Weekly (May 18)-Hengrui Medicine, Wuxi Biologics, Chugai, GC Biopharma, Mayne Pharma

<ul>
<li>FDA has confirmed the primary endpoints for Neuren Pharmaceuticals’ planned Phase 3 pivotal clinical trial of NNZ-2591 in Phelan-McDermid syndrome. Eisai has ultimately received its long-waited European approval for Leqembi.</li>
<li>Chugai Pharmaceutical’s outlicensed oral GLP-1 drug candidate orforglipron has shown positive topline Phase 3 results. Telix announced preliminary results from the Phase 2 study of TLX101 in recurrent high-grade glioma.</li>
<li>Biocon secured market entry date for Yesafili, an interchangeable biosimilar to Eylea in the U.S. FDA has issued Form 483 with 11 observations for Aurobindo Pharma’s North Carolina inhaler plant.</li>
</ul>


FDA has confirmed the primary endpoints for Neuren Pharmaceuticals’ planned Phase 3 pivotal clinical trial of NNZ-2591 in Phelan-McDermid syndrome. Eisai has ultimately received its long-waited European approval for Leqembi.
Chugai Pharmaceutical’s outlicensed oral GLP-1 drug candidate orforglipron has shown positive topline Phase 3 results. Telix announced preliminary results from the Phase 2 study of TLX101 in recurrent high-grade glioma.
Biocon secured market entry date for Yesafili, an interchangeable biosimilar to Eylea in the U.S. FDA has issued Form 483 with 11 observations for Aurobindo Pharma’s North Carolina inhaler plant.


APAC Healthcare Weekly (April 20)- Neuren, Chugai, Eisai, Telix, Biocon, Aurobindo Pharma

<ul>
<li>Nippon Shinyaku filed NDA of tagraxofusp for a rare aggressive hematologic malignancy in Japan. Shionogi initiated rolling NDA submission to the FDA for Xocova for COVID-19 post-exposure prophylaxis.</li>
<li>Beigene is discontinuing clinical development program for ociperlimab, as a potential treatment for lung cancer. Celltrion received positive CHMP opinion for the addition of the Omlyclo autoinjector formulation.  </li>
<li>The first three children with SR-aGvHD will receive a course of Mesoblast’s Ryoncil commencing this week. Lupin is acquiring UK-based Renascience Pharma, a sole supplier of 4 specialty products.</li>
</ul>


Nippon Shinyaku filed NDA of tagraxofusp for a rare aggressive hematologic malignancy in Japan. Shionogi initiated rolling NDA submission to the FDA for Xocova for COVID-19 post-exposure prophylaxis.
Beigene is discontinuing clinical development program for ociperlimab, as a potential treatment for lung cancer. Celltrion received positive CHMP opinion for the addition of the Omlyclo autoinjector formulation.  
The first three children with SR-aGvHD will receive a course of Mesoblast’s Ryoncil commencing this week. Lupin is acquiring UK-based Renascience Pharma, a sole supplier of 4 specialty products.


APAC Healthcare Weekly (April 6)- Nippon Shinyaku, Shionogi, Beigene, Celltrion, Mesoblast, Lupin

<ul>
<li>Eisai is eyeing for Leqembi global revenue of ¥250–280B in FY28. Kaken Pharmaceutical inlicensed dermatology drug candidate from Alumis. Kaken’s onychomycosis drug got approval in Italy.</li>
<li>Mochida Pharmaceutical has applied for marketing approval of Actembra biosimilar in Japan. Shionogi has filed for indication expansion of Xocova for post-exposure prophylaxis of COVID-19 in Japan.</li>
<li>SK Bioscience got approval for Phase 3 clinical trial of 21-valent pneumococcal vaccine in European countries. PharmaEssential obtained approval for Phase 3 clinical trial of Ropeginterferon alfa-2b in China.</li>
</ul>


Eisai is eyeing for Leqembi global revenue of ¥250–280B in FY28. Kaken Pharmaceutical inlicensed dermatology drug candidate from Alumis. Kaken’s onychomycosis drug got approval in Italy.
Mochida Pharmaceutical has applied for marketing approval of Actembra biosimilar in Japan. Shionogi has filed for indication expansion of Xocova for post-exposure prophylaxis of COVID-19 in Japan.
SK Bioscience got approval for Phase 3 clinical trial of 21-valent pneumococcal vaccine in European countries. PharmaEssential obtained approval for Phase 3 clinical trial of Ropeginterferon alfa-2b in China.


APAC Healthcare Weekly (Mar 30)- Eisai, Kaken, Mochida, Shionogi, SK Bioscience, PharmaEssentia

Australia

Mesoblast Limited provides biomedical services. The Company develops drugs for cardiovascular diseases, oncology, hematology, and spine orthopedic disorders treatment. Mesoblast conducts its business worldwide.

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Mesoblast Ltd (MSB AU)

APAC Healthcare Weekly (June 15)- CSPC, Wuxi Bio, Samsung Bio, Daiichi Sankyo, SanBio, Cochlear

CSPC entered research collaboration with AstraZeneca. Wuxi Bio is constructing new plant in China. Samsung Bio signed new CDMO contract. Daiichi...

Tina Banerjee

APAC Healthcare Weekly (May 18)-Hengrui Medicine, Wuxi Biologics, Chugai, GC Biopharma, Mayne Pharma

Jiangsu Hengrui launches HK IPO. Wuxi Biologics to sell Germany plant. Chugai got Japan approval for gene therapy. Mayne Pharma was hit as FDA...

Tina Banerjee

APAC Healthcare Weekly (April 20)- Neuren, Chugai, Eisai, Telix, Biocon, Aurobindo Pharma

Neuren is a step closer to P3 trial in PMS. Chugai’s oral GLP-1 drug candidate shows promise in P3 trial. Eisai got Leqembi approval in EU. Biocon...

Tina Banerjee

APAC Healthcare Weekly (April 6)- Nippon Shinyaku, Shionogi, Beigene, Celltrion, Mesoblast, Lupin

Nippon Shinyaku and Shionogi are filing for new drugs. Beigene dropped a phase 3 oncology asset. Mesoblast is about to start treatment with...

Tina Banerjee

APAC Healthcare Weekly (Mar 30)- Eisai, Kaken, Mochida, Shionogi, SK Bioscience, PharmaEssentia

Eisai outlined Leqembi sales target. Kaken inlicensed drug candidate. Mochida filed for Actembra biosimilar. Shionogi applied for label expansion...

Tina Banerjee

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