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>Akeso has a very high starting point, and was regarded as the leader of domestic second-tier biotech companies. However, in current unfavorable market sentiment, it’s necessary to re-examine the Company.</li>
<li>In Akeso’s pipeline, there are some valuable and differentiated candidates, especially in the field of bispecific antibodies. Its R&amp;D capability is also well recognized.</li>
<li>However, due to the rich pipeline, related clinical trials will drain money fast. So, investors are advised to be cautious until Akeso has ensured sustainable and stable cash flow.</li>
</ul>


Akeso has a very high starting point, and was regarded as the leader of domestic second-tier biotech companies. However, in current unfavorable market sentiment, it’s necessary to re-examine the Company.
In Akeso’s pipeline, there are some valuable and differentiated candidates, especially in the field of bispecific antibodies. Its R&amp;D capability is also well recognized.
However, due to the rich pipeline, related clinical trials will drain money fast. So, investors are advised to be cautious until Akeso has ensured sustainable and stable cash flow.


Akeso Biopharma Inc (9926.HK) - Caution Is Advised Until Sufficient Financing Is Secured

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>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

Asia Pac IPO & Placement Research, China biotech, Aequitas Research

Ke Yan, CFA, FRM

Asia Pac IPO & Placement Research, China biotech

IPOs and Placements coverage across Asia Pacific

Aequitas Research

We cover all listing across the Asia Pacific along with follow-up placements. As of Dec 2020, our team had covered 539 IPOs with a hit rate of 73.5% and 685 placements with a hit rate of 66.8%.

We combine fundamental bottom-up views with our proprietary quantitative framework to provide a holistic coverage across new listings and placements. Our coverage includes pre-IPO notes before the deal is launched, follow-up analysis once the deal is live and post-listing trading analysis as well.

Equity Capital Markets

<ul>
<li>Lepu Biopharma is a biotech spin-off of A-share listed Lepu Medical. The company launched book building to raise up to USD 120m via a Hong Kong listing.</li>
<li>In our previous note, we look at the company's core products, including HX008, LP002, MRG003 and MRG002. The products have their own differentiating factors to tackle the intense competition.</li>
<li>In this note, we provide an update for the book building. We will run the deal through our ECM framework and provide an update on the deal.</li>
</ul>


Lepu Biopharma is a biotech spin-off of A-share listed Lepu Medical. The company launched book building to raise up to USD 120m via a Hong Kong listing.
In our previous note, we look at the company's core products, including HX008, LP002, MRG003 and MRG002. The products have their own differentiating factors to tackle the intense competition.
In this note, we provide an update for the book building. We will run the deal through our ECM framework and provide an update on the deal.


Lepu Biopharma (乐普生物科技) IPO: Sentiment Cooled Down

China

Akeso Inc. operates operatesa s a biotech company. The compnay develops treatments and therapies for various types of diseases. Akeso serves cutomers worldwide

Price Gauge
52-week Range	0.00 - 0.00
Market Cap (USDm)	0.00
P/E	0.00
Dividend (Yield)	0.00

Akeso Biopharma Inc (9926 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