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>Shionogi is acquiring Torii Pharmaceutical and pharmaceutical business of Japan Tobacco. Daiichi Sankyo’s Enhertu meets main goal in the neoadjuvant setting (before surgery) in early-stage breast cancer trial.</li>
<li>HK inno.N received approval for the domestic phase 3 clinical trial of obesity drug candidate. Neuren Pharmaceuticals’ Daybue recorded $84.6M revenue in the U.S. in 1Q25, up 11% YoY.</li>
<li>Biocon secured multiple market access agreements for Yesintek, its biosimilar to Stelara. Lupin received FDA approval for antiretroviral agent raltegravir tablets for the treatment of human immunodeficiency virus (HIV-1) infection.</li>
</ul>


Shionogi is acquiring Torii Pharmaceutical and pharmaceutical business of Japan Tobacco. Daiichi Sankyo’s Enhertu meets main goal in the neoadjuvant setting (before surgery) in early-stage breast cancer trial.
HK inno.N received approval for the domestic phase 3 clinical trial of obesity drug candidate. Neuren Pharmaceuticals’ Daybue recorded $84.6M revenue in the U.S. in 1Q25, up 11% YoY.
Biocon secured multiple market access agreements for Yesintek, its biosimilar to Stelara. Lupin received FDA approval for antiretroviral agent raltegravir tablets for the treatment of human immunodeficiency virus (HIV-1) infection.


APAC Healthcare Weekly (May 11)- Shionogi, Daiichi Sankyo, HK Inno, Neuren, Biocon, Aster DM, Lupin

<ul>
<li>SillaJen got FDA nod to expand clinical trial of BAL0891 for acute myeloid leukemia. Akeso received FDA approval for its PD-1 inhibitor penpulimab for the treatment of nasopharyngeal carcinoma.</li>
<li>Innovent Biologics got approval for limertinib in China for the first-line treatment of locally advanced or metastatic non-small cell lung cancer. CSL launches Andembry Pen for Hereditary Angioedema in Japan.</li>
<li>Daiichi Sankyo submitted indication expansion application in Japan for Enhertu for the treatment of HER2 positive advanced or recurrent solid tumors. Lupin received FDA approval for Tolvaptan Tablets.</li>
</ul>


SillaJen got FDA nod to expand clinical trial of BAL0891 for acute myeloid leukemia. Akeso received FDA approval for its PD-1 inhibitor penpulimab for the treatment of nasopharyngeal carcinoma.
Innovent Biologics got approval for limertinib in China for the first-line treatment of locally advanced or metastatic non-small cell lung cancer. CSL launches Andembry Pen for Hereditary Angioedema in Japan.
Daiichi Sankyo submitted indication expansion application in Japan for Enhertu for the treatment of HER2 positive advanced or recurrent solid tumors. Lupin received FDA approval for Tolvaptan Tablets.


APAC Healthcare Weekly (April 27)- Sillajen, Akeso, Innovent Biologics, CSL, Daiichi Sankyo, Lupin

<ul>
<li>The U.S. has started collecting baseline tariff of 10% from April 5. Reciprocal tariff has been temporarily halted but Indian Pharma companies remain vulnerable to possible tariff threat.</li>
<li>During 9MFY25, the U.S. has been the top exporting destination for Indian pharmaceutical products, with 33% share in the exports.</li>
<li>With negotiations on, India might opt for “zero for zero” tariff approach specifically in the case of Pharmaceutical and Medical devices.</li>
</ul>


The U.S. has started collecting baseline tariff of 10% from April 5. Reciprocal tariff has been temporarily halted but Indian Pharma companies remain vulnerable to possible tariff threat.
During 9MFY25, the U.S. has been the top exporting destination for Indian pharmaceutical products, with 33% share in the exports.
With negotiations on, India might opt for “zero for zero” tariff approach specifically in the case of Pharmaceutical and Medical devices.


US Tariff Impact on APAC Healthcare: Focus Country- INDIA

<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

India

Lupin is an Indian multinational pharmaceutical company that develops, manufactures, and markets a diverse range of branded and generic formulations, biotechnology products, and active pharmaceutical ingredients (APIs). The company specializes in therapeutic areas such as cardiovascular, anti-diabetic, respiratory, anti-infective, and women's health. Lupin Limited was founded in 1968 and is headquartered in Mumbai, India.

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Lupin (LPC IN)

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 (May 11)- Shionogi, Daiichi Sankyo, HK Inno, Neuren, Biocon, Aster DM, Lupin

Shionogi is acquiring Torii Pharma. Daiichi Sankyo’s Enhertu meets key goal in breast cancer trial. HK inno got domestic approval for P3 trial of...

Tina Banerjee

APAC Healthcare Weekly (April 27)- Sillajen, Akeso, Innovent Biologics, CSL, Daiichi Sankyo, Lupin

SillaJen got FDA nod for clinical trial indication expansion. FDA approves Akeso’s first drug. Innovent’s cancer drug was approved in China....

Tina Banerjee

US Tariff Impact on APAC Healthcare: Focus Country- INDIA

US imposed baseline tariff from April 5. Reciprocal tariff has been temporarily halted but Indian Pharma companies remain vulnerable. U.S. has been...

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

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