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

Thematic (Sector/Industry)

<ul>
<li>The domestic provider business subsector fell sharply due to a document leaked out of the industry.Although rebounded, before the policy is clear, we do not recommend to buy the dips.</li>
<li>The reasonable market value of a biotech company in HKEX is the price that Big Pharma is willing to pay for it, or the valuation of its products.</li>
<li>Obtaining CE certificate is one of an important (or “easier”) ways for domestic medical device companies to enter global markets. However, the game rule changes.</li>
</ul>


The domestic provider business subsector fell sharply due to a document leaked out of the industry.Although rebounded, before the policy is clear, we do not recommend to buy the dips.
The reasonable market value of a biotech company in HKEX is the price that Big Pharma is willing to pay for it, or the valuation of its products.
Obtaining CE certificate is one of an important (or “easier”) ways for domestic medical device companies to enter global markets. However, the game rule changes.


China Healthcare Weekly (Mar18)-Leaked Document On Medical Service,Biotech Valuation,CE Mark Upgrade

Suzhou Zelgen Biopharmaceutica / Equity Bottom-Up

<ul>
<li>We analyzed <a href="https://www.smartkarma.com/entities/suzhou-zelgen-biopharmaceuticals-a" target="_blank" data-smartkarma-citation="entities:30375:1" rel="noopener">Suzhou Zelgen Biopharmaceuticals (688266 CH)</a>’s key products(Donafenib, recombinant human thrombin for topical use, Alkotinib, Jaktinib, etc.). They have to face fierce competition, VBP impact and small market size.</li>
<li>Through Gensun Biopharma, Zelgen has established the ability to develop advanced tumor immunotherapy drugs. Whether it can continue to launch new products is the key to test Zelgen's R&amp;D system.</li>
<li>We are cautious about Zelgen because uncertainties led to inaccurate prediction on market size and outlook.Investors can choose to “catch” a rebound, but Zelgen is far from a complete reversal.</li>
</ul>


We analyzed Suzhou Zelgen Biopharmaceuticals (688266 CH)’s key products(Donafenib, recombinant human thrombin for topical use, Alkotinib, Jaktinib, etc.). They have to face fierce competition, VBP impact and small market size.
Through Gensun Biopharma, Zelgen has established the ability to develop advanced tumor immunotherapy drugs. Whether it can continue to launch new products is the key to test Zelgen's R&amp;D system.
We are cautious about Zelgen because uncertainties led to inaccurate prediction on market size and outlook.Investors can choose to “catch” a rebound, but Zelgen is far from a complete reversal.


Suzhou Zelgen Biopharmaceuticals (688266.CH) - Uncertainty Leads to Inaccurate Prediction on Outlook

Equity Capital Markets

Biocytogen Pharmaceuticals (Beijing) / Equity Capital Markets

<ul>
<li>The candidates in Biocytogen’s pipeline do not have advantages in development progress and also have to face fierce competition, so continuous large R&amp;D investment in the future would be inevitable.</li>
<li>However, the development model of Biocytogen is very novel and special, which could make it a rare target in the market if it is successfully listed.  </li>
<li>Therefore, the certainty of Biocytogen’s future growth is expected to improve gradually, and the mid- and long-term investment value would continue to increase due to the high moat.</li>
</ul>


The candidates in Biocytogen’s pipeline do not have advantages in development progress and also have to face fierce competition, so continuous large R&amp;D investment in the future would be inevitable.
However, the development model of Biocytogen is very novel and special, which could make it a rare target in the market if it is successfully listed.  
Therefore, the certainty of Biocytogen’s future growth is expected to improve gradually, and the mid- and long-term investment value would continue to increase due to the high moat.


Pre-IPO Biocytogen Pharmaceuticals - The Novel Development Model Offset the Pipeline's Shortcomings

<ul>
<li>Recently, the “14th Five-year Plan” for the construction of China's medical beauty standard system was released. We analyzed the impact on related companies.</li>
<li>As <a href="https://www.smartkarma.com/entities/wuxi-apptec" target="_blank" data-smartkarma-citation="entities:23679:1" rel="noopener">Wuxi Biologics (2269 HK)</a> was included in "unverified list", its share price tumbled. So, it’s extremely urgent for China to realize autonomous control of important upstream raw materials and equipment. </li>
<li>
<a href="https://www.smartkarma.com/entities/innovent-biologics-inc" target="_blank" data-smartkarma-citation="entities:27452:1" rel="noopener">Innovent Biologics Inc (1801 HK)</a> should hold additional clinical trials to back its biologics application for Sintilimab (PD-1), indicating that the FDA’s attitude has changed.</li>
</ul>


Recently, the “14th Five-year Plan” for the construction of China's medical beauty standard system was released. We analyzed the impact on related companies.
As Wuxi Biologics (2269 HK) was included in "unverified list", its share price tumbled. So, it’s extremely urgent for China to realize autonomous control of important upstream raw materials and equipment. 

Innovent Biologics Inc (1801 HK) should hold additional clinical trials to back its biologics application for Sintilimab (PD-1), indicating that the FDA’s attitude has changed.


China Healthcare Weekly (Feb.11)- “14th Five-Year Plan” For Medical Beauty, Wuxi Biologics, Innovent

Hong Kong

CStone Pharmaceuticals operates as a biotechnology company. The Company develops immuno-oncology and molecularly targeted drugs to address unmet medical needs for cancer patients. CStone Pharmaceuticals serves customers worldwide.

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CStone Pharmaceuticals (2616 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

China Healthcare Weekly (Mar18)-Leaked Document On Medical Service,Biotech Valuation,CE Mark Upgrade

We analyzed the impact of leaked document on medical service. We also analyzed the logic of the reasonable market value of a biotech in HKEX. The...

Xinyao (Criss) Wang

Suzhou Zelgen Biopharmaceuticals (688266.CH) - Uncertainty Leads to Inaccurate Prediction on Outlook

Zelgen’s key products would face fierce competition, VBP and small market size, leading to inaccurate prediction on outlook. So we choose to be...

Xinyao (Criss) Wang

Pre-IPO Biocytogen Pharmaceuticals - The Novel Development Model Offset the Pipeline's Shortcomings

We analyzed the unique development strategy of Biocytogen, and also pointed out the concerns on its pipeline. However, its business model is hard...

Xinyao (Criss) Wang

China Healthcare Weekly (Feb.11)- “14th Five-Year Plan” For Medical Beauty, Wuxi Biologics, Innovent

We analyzed the “14th Five-year Plan” for medical beauty, the impact of WuXi Bio after being included in "unverified list" and the prospects of...

Xinyao (Criss) Wang

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