Global Healthcare Analyst

Tina Banerjee

Equity Bottom-Up

Shanghai Junshi Biosciences  / Equity Bottom-Up

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<a href="https://www.smartkarma.com/entities/shanghai-junshi-bioscience-h" target="_blank" data-smartkarma-citation="entities:27760:1" rel="noopener">Shanghai Junshi Bioscience Co. Ltd. (1877 HK)'s</a> oncology drug candidate toripalimab marketing application is currently under priority review by the FDA, with a target action date of April 30, 2022.</li>
<li>However, FDA may reject toripalimab application, as it is predominantly based on China clinical trial data. Toripalimab may also face delay in FDA decision due to delayed regulatory inspection.</li>
<li>PD-1 drug market in the U.S. is intensely competitive, making the commercialization prospect of a new drug quite difficult. Toripalimab reported muted performance in China due to pricing headwind.</li>
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Shanghai Junshi Bioscience Co. Ltd. (1877 HK)'s oncology drug candidate toripalimab marketing application is currently under priority review by the FDA, with a target action date of April 30, 2022.
However, FDA may reject toripalimab application, as it is predominantly based on China clinical trial data. Toripalimab may also face delay in FDA decision due to delayed regulatory inspection.
PD-1 drug market in the U.S. is intensely competitive, making the commercialization prospect of a new drug quite difficult. Toripalimab reported muted performance in China due to pricing headwind.


Shanghai Junshi Bioscience (1877 HK): Uncertainties Prevailing Ahead of First U.S. Drug Approval

HK/China Healthcare Analyst (ex-Fosun Pharma)

Xinyao (Criss) Wang

Thematic (Sector/Industry)

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<a href="https://www.smartkarma.com/entities/eli-lilly-co" target="_blank" data-smartkarma-citation="entities:19419:1" rel="noopener">Eli Lilly'</a>s development strategy is worth learning from, which explains the investment logic of a lot of “smart money” and can also be used for reference by domestic pharmaceutical companies.</li>
<li>For CGT, before detail policies on how to properly commercialize CGT in China released, CXO with related R&amp;D capabilities could be a better investment option at the current stage.</li>
<li>The overall sleep situation of Chinese people is not optimistic, leading to the rapid development of China's sleep economy. Meanwhile, we also recommend that investors pay attention to sleep quality.</li>
</ul>



Eli Lilly's development strategy is worth learning from, which explains the investment logic of a lot of “smart money” and can also be used for reference by domestic pharmaceutical companies.
For CGT, before detail policies on how to properly commercialize CGT in China released, CXO with related R&amp;D capabilities could be a better investment option at the current stage.
The overall sleep situation of Chinese people is not optimistic, leading to the rapid development of China's sleep economy. Meanwhile, we also recommend that investors pay attention to sleep quality.


China Healthcare Weekly (Mar.25)- Viable Business Model for Pharma, CXO for CGT, China Sleep Economy

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<a href="https://www.smartkarma.com/entities/abbvie-inc" target="_blank" data-smartkarma-citation="entities:1135:1" rel="noopener">Abbvie Inc (ABBV US)</a> shares remained rangebound in 2021, mainly due to Humira patent expiration overhang. Humira is the flagship drug of the company, accounting for 37% of total revenue.</li>
<li>Increasing label expansion of its two other drugs, Skyrizi and Rinvoq are now increasingly opening up new growth avenues for AbbVie. Together these drugs contributed 8% to total revenue.</li>
<li>Attractive valuation and healthy dividend yield make AbbVie a top value investment idea amid this turbulent time.</li>
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Abbvie Inc (ABBV US) shares remained rangebound in 2021, mainly due to Humira patent expiration overhang. Humira is the flagship drug of the company, accounting for 37% of total revenue.
Increasing label expansion of its two other drugs, Skyrizi and Rinvoq are now increasingly opening up new growth avenues for AbbVie. Together these drugs contributed 8% to total revenue.
Attractive valuation and healthy dividend yield make AbbVie a top value investment idea amid this turbulent time.


AbbVie Inc (ABBV US): Great Value Stock to Buy in Choppy Market

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<a href="https://www.smartkarma.com/entities/mesoblast-ltd" target="_blank" data-smartkarma-citation="entities:769:1" rel="noopener">Mesoblast Ltd (MSB AU)</a> has developed a range of late-stage product candidates derived from its first and second generation proprietary mesenchymal lineage cell therapy technology platforms.</li>
<li>BLA resubmission of remestemcel-L and formal BLA submission of rexlemestrocel-L to the FDA are two near-term catalysts for Mesoblast. Latest clinical trial results should support efficacy of both the candidates.</li>
<li>In November, Mesoblast completed a refinancing of its senior secured debt facility with a new $90 million five-year facility. Current funding is available for an estimated seven quarters.</li>
</ul>



Mesoblast Ltd (MSB AU) has developed a range of late-stage product candidates derived from its first and second generation proprietary mesenchymal lineage cell therapy technology platforms.
BLA resubmission of remestemcel-L and formal BLA submission of rexlemestrocel-L to the FDA are two near-term catalysts for Mesoblast. Latest clinical trial results should support efficacy of both the candidates.
In November, Mesoblast completed a refinancing of its senior secured debt facility with a new $90 million five-year facility. Current funding is available for an estimated seven quarters.


Mesoblast (MSB AU): Preparing for Re-Submission of Biologics License Application for Ryoncil

Paradigm Biopharmaceuticals / Equity Bottom-Up

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<a href="https://www.smartkarma.com/entities/paradigm-biopharmaceuticals" target="_blank" data-smartkarma-citation="entities:26140:1" rel="noopener">Paradigm Biopharmaceuticals (PAR AU)</a> is re-pioneering patent expired, existing drug molecule pentosan polysulfate sodium as a potential treatment of osteoarthritis, under the brand name Zilosul.</li>
<li>With a current addressable patient population of 72 million people, Zilosul has an annual revenue potential of more than $10 billion, if approved.</li>
<li>Inherent safety concern on the existing FDA-approved indication and Paradigm’s financial capability are the near-term overhangs on the commercialization prospect of the drug.</li>
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Paradigm Biopharmaceuticals (PAR AU) is re-pioneering patent expired, existing drug molecule pentosan polysulfate sodium as a potential treatment of osteoarthritis, under the brand name Zilosul.
With a current addressable patient population of 72 million people, Zilosul has an annual revenue potential of more than $10 billion, if approved.
Inherent safety concern on the existing FDA-approved indication and Paradigm’s financial capability are the near-term overhangs on the commercialization prospect of the drug.


Paradigm Biopharmaceuticals (PAR AU): Concerns on First Potentially Commercialized Product

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)

Shanghai Junshi Bioscience (1877 HK): Uncertainties Prevailing Ahead of First U.S. Drug Approval

Going by the FDA’s recent action, Junshi Bioscience’s toripalimab has a chance to get rejected by the FDA. It may miss the approval timeline....

Tina Banerjee

China Healthcare Weekly (Mar.25)- Viable Business Model for Pharma, CXO for CGT, China Sleep Economy

The strategy of Eli Lilly could be a good reference for domestic pharmaceutical companies.CXO for CGT is a better investment option.The sleep...

Xinyao (Criss) Wang

AbbVie Inc (ABBV US): Great Value Stock to Buy in Choppy Market

Abbvie’s reducing dependence on Humira, visibility on non-Humira portfolio, coupled with high dividend yield and attractive valuation make it a top...

Tina Banerjee

Mesoblast (MSB AU): Preparing for Re-Submission of Biologics License Application for Ryoncil

Mesoblast is preparing for biologics license application for two of its pipeline candidates. The company believes it has generated substantial new...

Tina Banerjee

Paradigm Biopharmaceuticals (PAR AU): Concerns on First Potentially Commercialized Product

The company's dependence on a single molecule makes it a risky bet. Moreover, the inherent safety concern of the lead candidate may limit its...

Tina Banerjee

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