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Caixin Global

Articles from Caixin Global

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<ul><li>Trump / Cover Story: Trump’s first 100 days back in office is breaking world order </li><li>Tariffs /: Trump’s tariffs are the talk of the Canton Fair</li><li>Hospitals /: Beijing hospital scandal sparks debate about pilot medical degree program</li></ul>

Trump / Cover Story: Trump’s first 100 days back in office is breaking world order Tariffs /: Trump’s tariffs are the talk of the Canton FairHospitals /: Beijing hospital scandal sparks debate about pilot medical degree program

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

Research from Water Tower Research, Water Tower Research

Water Tower Research

Research from Water Tower Research

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.

Equity Research Firm

Thematic (Sector/Industry)

<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

Global Healthcare Analyst

Tina Banerjee

<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

<ul>
<li>Kissei Pharmaceutical initiates additional Phase III clinical trial for Rovatirelin (KPS-0373) for the treatment of spinocerebellar degeneration. Shanghai Junshi Biosciences received 11th indication approval for toripalimab in China.</li>
<li>AstraZeneca Entered into exclusive licensing agreement worth $1.35B with Alteogen to use latter’s hyaluronidase protein, ALT-B4, to develop subcutaneous versions of its “several oncology assets.”</li>
<li>Celltrion Has unveiled “Value-up Program,” whereby the company is targeting 30% revenue CAGR by 2027 to reach KRW5T revenue and 7% ROE. HLB faced another rejection from FDA for rivoceranib.</li>
</ul>


Kissei Pharmaceutical initiates additional Phase III clinical trial for Rovatirelin (KPS-0373) for the treatment of spinocerebellar degeneration. Shanghai Junshi Biosciences received 11th indication approval for toripalimab in China.
AstraZeneca Entered into exclusive licensing agreement worth $1.35B with Alteogen to use latter’s hyaluronidase protein, ALT-B4, to develop subcutaneous versions of its “several oncology assets.”
Celltrion Has unveiled “Value-up Program,” whereby the company is targeting 30% revenue CAGR by 2027 to reach KRW5T revenue and 7% ROE. HLB faced another rejection from FDA for rivoceranib.


APAC Healthcare Weekly (Mar 23)- Kissei, Alteogen, Junshi Biosciences, Celltrion, Lunit, HLB

United Kingdom

AstraZeneca is a Swedish-British multinational pharmaceutical and biotechnology company focused on the discovery, development, and commercialization of prescription medicines. Its portfolio spans oncology, rare diseases, and biopharmaceuticals, including cardiovascular, renal & metabolism, and respiratory & immunology. The company was formed in 1999 through the merger of Astra AB and Zeneca Group PLC and is headquartered in Cambridge, UK.

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AstraZeneca (AZN LN)

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

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

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

APAC Healthcare Weekly (Mar 23)- Kissei, Alteogen, Junshi Biosciences, Celltrion, Lunit, HLB

Kissei Pharma initiates additional P3 trial. Junshi Biosciences' drug got indication expansion. AstraZeneca partners with Alteogen. Celltrion aims...

Tina Banerjee

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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

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

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

APAC Healthcare Weekly (Mar 23)- Kissei, Alteogen, Junshi Biosciences, Celltrion, Lunit, HLB

​Kissei Pharma initiates additional P3 trial. Junshi Biosciences' drug got indication expansion. AstraZeneca partners with Alteogen. Celltrion aims...

Tina Banerjee

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

Kissei Pharma initiates additional P3 trial. Junshi Biosciences' drug got indication expansion. AstraZeneca partners with Alteogen. Celltrion aims...