Global Healthcare Analyst

Tina Banerjee

Equity Bottom-Up

Shanghai Junshi Biosciences  / Equity Bottom-Up

<ul>
<li>
<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>
</ul>



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

<ul>
<li>After raising over RMB70 billion,investors have much higher expectation on BeiGene than other biotech/biopharma, because BeiGene is “different”,but the real pressure will come over the next two or three years.</li>
<li>Will BeiGene become China's first truly international pharmaceutical company, or be dragged into mediocrity by the failure of key trials or the failure of commercialization to meet the market’s expectations?</li>
<li>It is attractive if the market value is below US$20 billion. However, considering the Russia-Ukraine war and other potential external uncertainties, we advise investors to keep alert.</li>
</ul>


After raising over RMB70 billion,investors have much higher expectation on BeiGene than other biotech/biopharma, because BeiGene is “different”,but the real pressure will come over the next two or three years.
Will BeiGene become China's first truly international pharmaceutical company, or be dragged into mediocrity by the failure of key trials or the failure of commercialization to meet the market’s expectations?
It is attractive if the market value is below US$20 billion. However, considering the Russia-Ukraine war and other potential external uncertainties, we advise investors to keep alert.


BeiGene Ltd (6160.HK/688235.CH) - There Is No Way to Retreat

Thematic (Sector/Industry)

<ul>
<li>The successful approval of Legend Biotech's CAR-T therapy indicates the FDA is objective. But we can judge FDA's attitude and globalization logic more clearly through Junshi’s PD-1 result in April.</li>
<li>Let's talk about the cyclical nature of innovative drugs. Humans, they repeat history all the time.</li>
<li>The current pet vaccine market in China is in the blue ocean, with a huge space for growth. This market has become an investment option that cannot be ignored.</li>
</ul>


The successful approval of Legend Biotech's CAR-T therapy indicates the FDA is objective. But we can judge FDA's attitude and globalization logic more clearly through Junshi’s PD-1 result in April.
Let's talk about the cyclical nature of innovative drugs. Humans, they repeat history all the time.
The current pet vaccine market in China is in the blue ocean, with a huge space for growth. This market has become an investment option that cannot be ignored.


China Healthcare Weekly (Mar.4)-Innovative Drug Cyclical Nature, Pet Vaccine Mkt, Legend Bio, Junshi

<ul>
<li>The Beijing municipality has added fertility treatment in its medical insurance program. We analyzed related impact.</li>
<li>If we hope to have more companies entering global TOP50 during “14th Five-Year Plan” period, domestic medical device companies need at least 25% annualized revenue growth to make it happen.</li>
<li>Actually, the national medical insurance doesn't determine market size directly but adjust the “distribution”. There's no need to focus solely on anti-tumor field, but rare diseases and central nervous system diseases.</li>
</ul>


The Beijing municipality has added fertility treatment in its medical insurance program. We analyzed related impact.
If we hope to have more companies entering global TOP50 during “14th Five-Year Plan” period, domestic medical device companies need at least 25% annualized revenue growth to make it happen.
Actually, the national medical insurance doesn't determine market size directly but adjust the “distribution”. There's no need to focus solely on anti-tumor field, but rare diseases and central nervous system diseases.


China Healthcare Weekly (Feb.25)-Assisted Reproduction, Medical Device Co. Globalization, New Growth

<ul>
<li>The executive meeting of State Council has indicated the future direction of China healthcare industry- With the expansion of the VBP scope, the traditional sales mode will be hit hard.</li>
<li>The pricing system of innovative drugs in national medical insurance negotiation has its logic actually. It could provide enterprises with reasonable profits, but not significant profits or exponential growth.</li>
<li>The approval results of FDA on products of <a href="https://www.smartkarma.com/entities/legend-biotech-corp" target="_blank" data-smartkarma-citation="entities:28963:1" rel="noopener">Legend Biotech (LEGN US)</a> and Junshi could allow investors to have a better judgment on the logic of internationalization of domestic innovative drugs.</li>
</ul>


The executive meeting of State Council has indicated the future direction of China healthcare industry- With the expansion of the VBP scope, the traditional sales mode will be hit hard.
The pricing system of innovative drugs in national medical insurance negotiation has its logic actually. It could provide enterprises with reasonable profits, but not significant profits or exponential growth.
The approval results of FDA on products of Legend Biotech (LEGN US) and Junshi could allow investors to have a better judgment on the logic of internationalization of domestic innovative drugs.


China Healthcare Weekly (Feb.18)-VBP Expansion, China Drug Pricing System,FDA Approval,Junshi/Legend

China

Innovent Biologics, Inc. operates as a biopharmaceutical company. The Company develops, manufactures, and distributes monoclonal antibody drug candidates for the treatment of oncology, ophthalmology, autoimmune, cardiovascular, and other diseases. Innovent Biologics serves customers in China.

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Innovent Biologics Inc (1801 HK)

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

BeiGene Ltd (6160.HK/688235.CH) - There Is No Way to Retreat

BeiGene’s cash flow can't keep up with the cash burn rate in long term.So BeiGene has to deliver solid commercialization results,...

Xinyao (Criss) Wang

China Healthcare Weekly (Mar.4)-Innovative Drug Cyclical Nature, Pet Vaccine Mkt, Legend Bio, Junshi

Junshi’s PD-1 result in April is more representative to judge FDA's attitude and globalization logic. We probably are at the tail end of mab drug...

Xinyao (Criss) Wang

China Healthcare Weekly (Feb.25)-Assisted Reproduction, Medical Device Co. Globalization, New Growth

Assisted reproduction is covered by medical insurance; We analyzed the benchmark of medical device companies' globalization, clarify the...

Xinyao (Criss) Wang

China Healthcare Weekly (Feb.18)-VBP Expansion, China Drug Pricing System,FDA Approval,Junshi/Legend

We analyzed the VBP scope expansion and logic of drug pricing system in medical insurance negotiation.FDA's attitude on Legend Bio&Junshi's...

Xinyao (Criss) Wang

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