Global Healthcare Analyst

Tina Banerjee

Equity Bottom-Up

<ul>
<li>
<a href="https://www.smartkarma.com/entities/kyowa-kirin-co-ltd" target="_blank" data-smartkarma-citation="entities:18055:1" rel="noopener">Kyowa Kirin Co Ltd (4151 JP)</a> announced top-line results of the Phase 3 trial of rocatinlimab targeting moderate to severe Atopic Dermatitis (eczema), which affects 6.6M patients in the U.S.</li>
<li>The trial met co-primary endpoints and reached statistically significant differences from placebo for all key secondary endpoints. However, efficacy data was less compelling compared to current standard of care.</li>
<li>Kyowa Kirin shares nosedived mainly on the concern over competitive strength of rocatinlimab. Amid gloomy outlook, Kyowa Kirin shares will need time to recover.</li>
</ul>



Kyowa Kirin Co Ltd (4151 JP) announced top-line results of the Phase 3 trial of rocatinlimab targeting moderate to severe Atopic Dermatitis (eczema), which affects 6.6M patients in the U.S.
The trial met co-primary endpoints and reached statistically significant differences from placebo for all key secondary endpoints. However, efficacy data was less compelling compared to current standard of care.
Kyowa Kirin shares nosedived mainly on the concern over competitive strength of rocatinlimab. Amid gloomy outlook, Kyowa Kirin shares will need time to recover.


Kyowa Kirin (4151 JP): Reports Phase 3 Trial Result in Atopic Dermatitis; Rivalry Remains Doubtful

HK/China Healthcare Analyst (ex-Fosun Pharma)

Xinyao (Criss) Wang

Thematic (Sector/Industry)

<ul>
<li>Although both Republicans and Democrats have policies related to supply chain security/lowering drug prices, they have taken different approaches. Harris is likely to be “a continuation of the Biden policy”. </li>
<li>Harris would continue Biden’s strategy of “wooing India to contain China” and developing a pro-US supply chain system that isolates China.Her future policy direction may be more "predictable" than Trump's.</li>
<li>Whether Trump or Harris is elected as President of the US, there's a high possibility that the US will continue to confront China in the fields of biosecurity and biotechnology.</li>
</ul>


Although both Republicans and Democrats have policies related to supply chain security/lowering drug prices, they have taken different approaches. Harris is likely to be “a continuation of the Biden policy”. 
Harris would continue Biden’s strategy of “wooing India to contain China” and developing a pro-US supply chain system that isolates China.Her future policy direction may be more "predictable" than Trump's.
Whether Trump or Harris is elected as President of the US, there's a high possibility that the US will continue to confront China in the fields of biosecurity and biotechnology.


What Does a Kamala Harris Presidency Mean for China Healthcare?

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<li>
<a href="https://www.smartkarma.com/entities/samsung-biologics-co-ltd" target="_blank" data-smartkarma-citation="entities:22932:1" rel="noopener">Samsung Biologics (207940 KS)</a> signed a contract manufacturing agreement worth KRW1.7T ($1.2B) with an Asian pharmaceutical company. <a href="https://www.smartkarma.com/entities/celltrion-inc" target="_blank" data-smartkarma-citation="entities:991:1" rel="noopener">Celltrion Inc (068270 KS)</a> has announced KRW100B ($72M) share buyback, starting October 28.</li>
<li>
<a href="https://www.smartkarma.com/entities/astellas-pharma-inc" target="_blank" data-smartkarma-citation="entities:6091:1" rel="noopener">Astellas Pharma (4503 JP)</a> received FDA approval for Vyloy for gastric cancer. <a href="https://www.smartkarma.com/entities/shionogi-co-ltd" target="_blank" data-smartkarma-citation="entities:19535:1" rel="noopener">Shionogi &amp; Co (4507 JP)</a> received FDA Fast Track designation for its RSV drug candidate, S-337395.</li>
<li>
<a href="https://www.smartkarma.com/entities/zai-lab-ltd-94df40cf-c15e-462f-b3de-8d2d434ae935" target="_blank" data-smartkarma-citation="entities:36261:1" rel="noopener">Zai Lab (9688 HK)</a> announced positive topline data from global Phase 1a/1b study of ZL-1310 in small cell lung cancer. <a href="https://www.smartkarma.com/entities/legend-biotech-corp" target="_blank" data-smartkarma-citation="entities:28963:1" rel="noopener">Legend Biotech Corp (LEGN US)</a> sheds Genscript Biotech as its majority shareholder.</li>
</ul>



Samsung Biologics (207940 KS) signed a contract manufacturing agreement worth KRW1.7T ($1.2B) with an Asian pharmaceutical company. Celltrion Inc (068270 KS) has announced KRW100B ($72M) share buyback, starting October 28.

Astellas Pharma (4503 JP) received FDA approval for Vyloy for gastric cancer. Shionogi &amp; Co (4507 JP) received FDA Fast Track designation for its RSV drug candidate, S-337395.

Zai Lab (9688 HK) announced positive topline data from global Phase 1a/1b study of ZL-1310 in small cell lung cancer. Legend Biotech Corp (LEGN US) sheds Genscript Biotech as its majority shareholder.


APAC Healthcare Weekly (Oct 27)- Samsung Biologics, Celltrion, Astellas, Otsuka, Legend, and Zai Lab

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Water Tower Research

Research from Water Tower Research

Water Tower Research is a leading equity research firm that provides research on micro, small and mid cap companies.

Water Tower Research was founded by Wall Street veterans after witnessing a fundamental shift in the investment research industry with the result being a declining knowledge base among investors, a lack of awareness and a shrinking pool of fundamental research being conducted on companies across the small-cap and micro-cap spectrum. The same issues are now increasingly occurring in the mid-cap space. This sea change within the investment community is impacting not only the companies themselves but also current shareholders and potential investors. With significantly less active sell-side sponsorship by Wall Street, a substantial information gap has developed between companies and various constituents in the financial community. The net result is fewer channels for insight and information to flow between companies and investors.

Equity Research Firm

<ul><li>We review last week’s biopharma news for meaningful clinical data, regulatory updates, research innovation, and M&amp;A.</li><li>Last week, SRRK gained from muscle-building data in SMA, with positive read-through for obesity and BHVN.</li><li>WW joined HIMS in selling NVO GLP-1 copies, while the FDA backed off on LLY copiers after a lawsuit.</li></ul>

We review last week’s biopharma news for meaningful clinical data, regulatory updates, research innovation, and M&amp;A.Last week, SRRK gained from muscle-building data in SMA, with positive read-through for obesity and BHVN.WW joined HIMS in selling NVO GLP-1 copies, while the FDA backed off on LLY copiers after a lawsuit.

Biopharma Week in Review - October 14, 2024

<ul>
<li>
<a href="https://www.smartkarma.com/entities/shionogi-co-ltd" target="_blank" data-smartkarma-citation="entities:19535:1" rel="noopener">Shionogi &amp; Co (4507 JP)</a> has reiterated FY25 guidance, indicating sequentially better financial performance in Q2FY25 as well as H2FY25. Overseas business and royalty income are on strong footing.</li>
<li>Shionogi has acquired the exclusive distribution rights for Quviviq in Japan. With better efficacy and safety profile, and sizable patient population, Quviviq should be a significant revenue contributor.</li>
<li>Shionogi submitted NDA in Japan for zuranolone, a treatment in development for major depressive disorder (MDD). Approval is expected in H1FY26.</li>
</ul>



Shionogi &amp; Co (4507 JP) has reiterated FY25 guidance, indicating sequentially better financial performance in Q2FY25 as well as H2FY25. Overseas business and royalty income are on strong footing.
Shionogi has acquired the exclusive distribution rights for Quviviq in Japan. With better efficacy and safety profile, and sizable patient population, Quviviq should be a significant revenue contributor.
Shionogi submitted NDA in Japan for zuranolone, a treatment in development for major depressive disorder (MDD). Approval is expected in H1FY26.


Shionogi & Co (4507 JP): Performance to Improve in H2; Upcoming Drugs to Accelerate Growth

United States

Eli Lilly and Company discovers, develops, manufactures, and sells pharmaceutical products for humans and animals.  The Company's products are sold in countries around the world.  Eli Lilly's products include neuroscience products, endocrine products, anti-infectives, cardiovascular agents, oncology products, and animal health products.

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Eli Lilly & Co (LLY US)

Kyowa Kirin (4151 JP): Reports Phase 3 Trial Result in Atopic Dermatitis; Rivalry Remains Doubtful

Kyowa Kirin maintained 2024 guidance, which calls for 5% decline in operating profit and 16% decrease in net profit. The company is expected to...

Tina Banerjee

What Does a Kamala Harris Presidency Mean for China Healthcare?

Harris could be “a continuation of Biden's policy” , making her future policy direction more "predictable" .But the US will continue to confront...

Xinyao (Criss) Wang

APAC Healthcare Weekly (Oct 27)- Samsung Biologics, Celltrion, Astellas, Otsuka, Legend, and Zai Lab

Samsung Biologics secures largest ever contract, Celltrion announced KRW100B buyback, Astellas Pharma got label expansion approval for Vyloy,...

Tina Banerjee

Biopharma Week in Review - October 14, 2024

We review last week’s biopharma news for meaningful clinical data, regulatory updates, research innovation, and M&A. Last week, SRRK gained from...

Water Tower Research

Shionogi & Co (4507 JP): Performance to Improve in H2; Upcoming Drugs to Accelerate Growth

Shionogi reiterates FY25 guidance, showing improved financial performance in Q2FY25 and H2FY25. The company has acquired distribution rights for...

Tina Banerjee

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Kyowa Kirin (4151 JP): Reports Phase 3 Trial Result in Atopic Dermatitis; Rivalry Remains Doubtful

Kyowa Kirin maintained 2024 guidance, which calls for 5% decline in operating profit and 16% decrease in net profit. The company is expected to...

Tina Banerjee

What Does a Kamala Harris Presidency Mean for China Healthcare?

Harris could be “a continuation of Biden's policy” , making her future policy direction more "predictable" .But the US will continue to confront...

Xinyao (Criss) Wang

APAC Healthcare Weekly (Oct 27)- Samsung Biologics, Celltrion, Astellas, Otsuka, Legend, and Zai Lab

Samsung Biologics secures largest ever contract, Celltrion announced KRW100B buyback, Astellas Pharma got label expansion approval for Vyloy,...

Tina Banerjee

Biopharma Week in Review - October 14, 2024

We review last week’s biopharma news for meaningful clinical data, regulatory updates, research innovation, and M&A. Last week, SRRK gained from...

Water Tower Research

Shionogi & Co (4507 JP): Performance to Improve in H2; Upcoming Drugs to Accelerate Growth

​Shionogi reiterates FY25 guidance, showing improved financial performance in Q2FY25 and H2FY25. The company has acquired distribution rights for...

Tina Banerjee

Shionogi reiterates FY25 guidance, showing improved financial performance in Q2FY25 and H2FY25. The company has acquired distribution rights for...