Global Healthcare Analyst

Tina Banerjee

Equity Bottom-Up

Jiangsu Hengrui Medicine / Equity Bottom-Up

<ul>
<li>
<a href="https://www.smartkarma.com/entities/jiangsu-hengrui-medicine-co-ltd" target="_blank" data-smartkarma-citation="entities:14128:1" rel="noopener">Jiangsu Hengrui Medicine (600276 CH)</a> received conditional marketing approval for its self-developed Class 1 innovative drug, Trastuzumab Rezetecan for Injection (SHR-A1811).</li>
<li>In 1Q25, Jiangsu Hengrui reported revenue growth of 20% YoY to RMB 7.2B. Innovative drugs and Licensing should help keep this momentum in near future.</li>
<li>The near-term trigger for the stock would be a further marketing approval from the US FDA.</li>
</ul>



Jiangsu Hengrui Medicine (600276 CH) received conditional marketing approval for its self-developed Class 1 innovative drug, Trastuzumab Rezetecan for Injection (SHR-A1811).
In 1Q25, Jiangsu Hengrui reported revenue growth of 20% YoY to RMB 7.2B. Innovative drugs and Licensing should help keep this momentum in near future.
The near-term trigger for the stock would be a further marketing approval from the US FDA.


Jiangsu Hengrui Medicine (600276 CH): ADC Drug Approval Presents Long-Term Opportunity

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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.

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<ul><li>FDA Commissioner Martin Makary injected some regulatory optimism with his first public comments, advocating for accelerated drug approval pathways.</li><li>While biopharma headlines were a roller coaster, investors appeared ready to grasp any positive news, despite more signs of FDA dysfunction.</li><li>In an E&amp;Y report reviewed by Reuters, 25% pharma tariffs would increase drug costs by $51 billion, leading to either 12.9% higher prices or reductions in R&amp;D efforts and workforce. </li></ul>

FDA Commissioner Martin Makary injected some regulatory optimism with his first public comments, advocating for accelerated drug approval pathways.While biopharma headlines were a roller coaster, investors appeared ready to grasp any positive news, despite more signs of FDA dysfunction.In an E&amp;Y report reviewed by Reuters, 25% pharma tariffs would increase drug costs by $51 billion, leading to either 12.9% higher prices or reductions in R&amp;D efforts and workforce. 

Biopharma Week in Review: Makary Sparked FDA Optimism; Growing Pushback on HHS Changes

<ul>
<li>EMA’s human medicines committee (CHMP) recommended sixteen medicines for approval at its April 2025 meeting. CHMP also adopted positive opinion for nine biosimilar medicines.</li>
<li>Among the new medicines, Vertex’s triple combination cystic fibrosis drug Alyftrek, Amgen’s Thyroid eye disease drug Tepezza, and Jazz Pharmaceutical’s billiary tract cancer drug Ziihera have potential to become blockbusters.</li>
<li>The Agency has recommended the refusal of the marketing authorization for Eli Lilly’s Alzheimer’s Disease drug Kisunla. Eli Lilly may ask for a re-examination of the opinion within 15 days.</li>
</ul>


EMA’s human medicines committee (CHMP) recommended sixteen medicines for approval at its April 2025 meeting. CHMP also adopted positive opinion for nine biosimilar medicines.
Among the new medicines, Vertex’s triple combination cystic fibrosis drug Alyftrek, Amgen’s Thyroid eye disease drug Tepezza, and Jazz Pharmaceutical’s billiary tract cancer drug Ziihera have potential to become blockbusters.
The Agency has recommended the refusal of the marketing authorization for Eli Lilly’s Alzheimer’s Disease drug Kisunla. Eli Lilly may ask for a re-examination of the opinion within 15 days.


CHMP Meeting Update April 2025: Sixteen New Medicines Recommended For Approval

<ul>
<li>CHMP has recommended five medicines for approval at its March 2025 meeting, including two innovative drugs and three biosimilars.</li>
<li>The Committee Recommended not granting a marketing authorization for Eli Lilly’s Kisunla (donasemab), a medicine intended for the treatment of early Alzheimer’s disease.</li>
<li>The committee recommended extensions of indication for seven medicines that are already authorized in the EU, while recommended to refuse extending the marketing authorisation for Pemazyre for myeloid/lymphoid neoplasms.</li>
</ul>


CHMP has recommended five medicines for approval at its March 2025 meeting, including two innovative drugs and three biosimilars.
The Committee Recommended not granting a marketing authorization for Eli Lilly’s Kisunla (donasemab), a medicine intended for the treatment of early Alzheimer’s disease.
The committee recommended extensions of indication for seven medicines that are already authorized in the EU, while recommended to refuse extending the marketing authorisation for Pemazyre for myeloid/lymphoid neoplasms.


CHMP Meeting Update: Five New Medicines Recommended for Approval, Rejects Kisunla Application

United Kingdom

AstraZeneca PLC operates as a holding company. The Company, through its subsidiaries, researches, manufactures, and sells pharmaceutical and medical products. AstraZeneca focuses its operations on eight therapeutic areas, including gastrointestinal, oncology, cardiovascular, respiratory, central nervous system, pain control, anaesthesia, and infection.

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Jiangsu Hengrui Medicine (600276 CH): ADC Drug Approval Presents Long-Term Opportunity

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Among the new medicines, Vertex’s triple combination CF drug Alyftrek, Amgen’s Thyroid eye disease drug Tepezza, and Jazz Pharmaceutical’s cancer...

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CHMP Meeting Update: Five New Medicines Recommended for Approval, Rejects Kisunla Application

CHMP recommends approval for five medicines, but rejects marketing authorization for Eli Lilly's Kisunla for early Alzheimer's disease. It also...

Tina Banerjee

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Jiangsu Hengrui Medicine (600276 CH): ADC Drug Approval Presents Long-Term Opportunity

​Jiangsu Hengrui receives conditional approval for Trastuzumab Rezetecan for NSCLC. In 1Q25, the company reported sales growth of 20%. Innovative...

Tina Banerjee

CX Daily: Trump’s First 100 Days Back in Office Is Breaking World Order

TOP STORIES Trump / Cover Story: Trump’s first 100 days back in office is breaking world order One-hundred days into Donald Trump’s second...

Caixin Global

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FDA Commissioner Martin Makary injected some regulatory optimism with his first public comments, advocating for accelerated drug approval pathways.

Water Tower Research

CHMP Meeting Update April 2025: Sixteen New Medicines Recommended For Approval

Among the new medicines, Vertex’s triple combination CF drug Alyftrek, Amgen’s Thyroid eye disease drug Tepezza, and Jazz Pharmaceutical’s cancer...

Tina Banerjee

CHMP Meeting Update: Five New Medicines Recommended for Approval, Rejects Kisunla Application

​CHMP recommends approval for five medicines, but rejects marketing authorization for Eli Lilly's Kisunla for early Alzheimer's disease. It also...

Tina Banerjee

Jiangsu Hengrui receives conditional approval for Trastuzumab Rezetecan for NSCLC. In 1Q25, the company reported sales growth of 20%. Innovative...

CHMP recommends approval for five medicines, but rejects marketing authorization for Eli Lilly's Kisunla for early Alzheimer's disease. It also...