Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<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>Daiichi Sankyo received FDA approval for Datroway for the treatment of unresectable or metastatic hormone receptor (HR) positive, HER2 negative breast cancer who have received prior endocrine-based therapy and chemotherapy.</li>
<li>Sumitomo Pharma partnered with J&amp;J for co-promotion of the long-acting antipsychotic medication XEPLION. Shanghai Fosun Pharma’s proposed buyout of Shanghai Henlius Biotech for HK$5.4B (~$693M) failed to pass shareholders’ vote.</li>
<li>SK Bioscience signed a co-promotion and distribution agreement with Sanofi for RSV and hepatitis A vaccines. Hugel received approval for its botulinum toxin for five indications from the UAE.</li>
</ul>


Daiichi Sankyo received FDA approval for Datroway for the treatment of unresectable or metastatic hormone receptor (HR) positive, HER2 negative breast cancer who have received prior endocrine-based therapy and chemotherapy.
Sumitomo Pharma partnered with J&amp;J for co-promotion of the long-acting antipsychotic medication XEPLION. Shanghai Fosun Pharma’s proposed buyout of Shanghai Henlius Biotech for HK$5.4B (~$693M) failed to pass shareholders’ vote.
SK Bioscience signed a co-promotion and distribution agreement with Sanofi for RSV and hepatitis A vaccines. Hugel received approval for its botulinum toxin for five indications from the UAE.


APAC Healthcare Weekly (Jan 26)- Daiichi Sankyo, Sumitomo Pharma, Fosun Pharma, SK Bioscience, Hugel

Australia

Recce Limited produces pharmaceutical products. The Company offers antibiotics to kill bacteria. Recce markets its products in Australia.

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Recce Ltd (RCE AU)

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 (Jan 26)- Daiichi Sankyo, Sumitomo Pharma, Fosun Pharma, SK Bioscience, Hugel

APAC healthcare companies got approvals for new products as well as clinical trials. The companies continued with acquisitions and collaborations...

Tina Banerjee

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