Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<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

External broker reports(aggregated public sources), HDFC Securities

HDFC Securities

External broker reports(aggregated public sources)

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Content available is external broker reports authored by a third party outside the Smartkarma network and has been aggregated by an online aggregator through publicly available sources and is displayed by Smartkarma in this format for user's convenience and general informational purposes only. Content does not constitute investment or financial advice and Smartkarma makes no representation or warranty regarding its accuracy or contents. Original third party author retains all copyright and other proprietary rights in the content. Access or use of third party links not controlled by Smartkarma are at the user's own risk.

<ul><li>Lupin and Zydus received unfavourable opinion in Mirabegron (gMyrbetriq) patent litigation (against Astellas Pharma) from the District court of Delaware, US</li><li>The Court concludes that Lupin/Zydus did not meet their burden of showing, by clear and convincing evidence, that the ‘780 patent (patent expiry is in Sep’29) is invalid for lack of enablement, written description, or indefiniteness</li><li>The court finds evidence in Astellas’ favour on the validity issue</li></ul>Content is external broker report sourced from online content aggregator through publicly available sources and is displayed below for general informational purposes only. Refer full disclaimer below.

Lupin and Zydus received unfavourable opinion in Mirabegron (gMyrbetriq) patent litigation (against Astellas Pharma) from the District court of Delaware, USThe Court concludes that Lupin/Zydus did not meet their burden of showing, by clear and convincing evidence, that the ‘780 patent (patent expiry is in Sep’29) is invalid for lack of enablement, written description, or indefinitenessThe court finds evidence in Astellas’ favour on the validity issueContent is external broker report sourced from online content aggregator through publicly available sources and is displayed below for general informational purposes only. Refer full disclaimer below.

Pharmaceuticals: Lupin/Zydus lost Myrbetriq patent case in district court 

<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

External broker reports(aggregated public sources), Axis Direct

Axis Direct

Axis Direct is the flagship brand under Axis Securities Limited, a subsidiary of Axis Bank in India. 

Content available is external broker reports authored by a third party outside the Smartkarma network and has been aggregated by an online aggregator through publicly available sources and is displayed by Smartkarma in this format for user's convenience and general informational purposes only. Content does not constitute investment or financial advice and Smartkarma makes no representation or warranty regarding its accuracy or contents. Original third party author retains all copyright and other proprietary rights in the content. Access or use of third party links not controlled by Smartkarma are at the user's own risk.

<ul><li>We anticipate that pharmaceutical companies within our coverage will collectively demonstrate revenue growth of 10.9% YoY and 0.8% QoQ, along with EBITDA growth of 15.3% YoY and a decline of 1.7% QoQ.</li><li>Moreover, adjusted PAT is expected to grow by 8.7% YoY and decrease by 7.9% QoQ.</li><li>Domestic formulations and niche launches in the US market will likely drive this growth.</li></ul>Content is external broker report sourced from online content aggregator through publicly available sources and is displayed below for general informational purposes only. Refer full disclaimer below.

We anticipate that pharmaceutical companies within our coverage will collectively demonstrate revenue growth of 10.9% YoY and 0.8% QoQ, along with EBITDA growth of 15.3% YoY and a decline of 1.7% QoQ.Moreover, adjusted PAT is expected to grow by 8.7% YoY and decrease by 7.9% QoQ.Domestic formulations and niche launches in the US market will likely drive this growth.Content is external broker report sourced from online content aggregator through publicly available sources and is displayed below for general informational purposes only. Refer full disclaimer below.

Q4FY25 Earnings Preview - Pharma & Healthcare

<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 (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

Pharmaceuticals: Lupin/Zydus lost Myrbetriq patent case in district court

Lupin and Zydus received unfavourable opinion in Mirabegron (gMyrbetriq) patent litigation (against Astellas Pharma) from the District court of...

HDFC Securities

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

Q4FY25 Earnings Preview - Pharma & Healthcare

Moreover, adjusted PAT is expected to grow by 8.7% YoY and decrease by 7.9% QoQ. Domestic formulations and niche launches in the US market will...

Axis Direct

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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