Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<ul>
<li>Fosun Pharmaceutical received NMPA approval for Phase I/II clinical trial of CAR-T cell drug candidate FKC289. RemeGen received $650M upfront payment from AbbVie under the exclusive license agreement for RC148.</li>
<li>FDA has granted Priority Review to Daiichi Sankyo’s Biologics License Application for ifinatamab deruxtecan. Astellas Pharma initiates Phase 3 registrational study evaluating setidegrasib as first-line treatment for pancreatic ductal adenocarcinoma.</li>
<li>Telix and Regeneron Pharmaceuticals is collaborating to jointly develop and commercialize radiopharmaceutical therapies. Telix will receive upfront cash payment of $40M from Regeneron for access to its radiopharmaceutical manufacturing platform.</li>
</ul>


Fosun Pharmaceutical received NMPA approval for Phase I/II clinical trial of CAR-T cell drug candidate FKC289. RemeGen received $650M upfront payment from AbbVie under the exclusive license agreement for RC148.
FDA has granted Priority Review to Daiichi Sankyo’s Biologics License Application for ifinatamab deruxtecan. Astellas Pharma initiates Phase 3 registrational study evaluating setidegrasib as first-line treatment for pancreatic ductal adenocarcinoma.
Telix and Regeneron Pharmaceuticals is collaborating to jointly develop and commercialize radiopharmaceutical therapies. Telix will receive upfront cash payment of $40M from Regeneron for access to its radiopharmaceutical manufacturing platform.


APAC Healthcare Weekly (April 19) – Fosun Pharma, Remegen, Daiichi Sankyo, Astellas Pharma, Telix

<ul>
<li>Wuxi XDC partnered with Akari Therapeutics to accelerate IND filing for Akari’s ADC program. Xuanzhu Biopharmaceutical entered licensing agreement with Boston Oncology for upfront and milestone payments of $100M+.</li>
<li>Shionogi secured $119M BARDA contract for manufacturing, procurement, and expanded development of Fetroja for biothreat-related infections. ABL Bio’s partner has received Orphan Drug Designation from the FDA for tovecimig.</li>
<li>PharmaEssentia signed an investment agreement for a new manufacturing facility in Puerto Rico. Max Healthcare Institute is acquiring 58.4% stake in 250-bedded Kalinga Hospital for INR3B.</li>
</ul>


Wuxi XDC partnered with Akari Therapeutics to accelerate IND filing for Akari’s ADC program. Xuanzhu Biopharmaceutical entered licensing agreement with Boston Oncology for upfront and milestone payments of $100M+.
Shionogi secured $119M BARDA contract for manufacturing, procurement, and expanded development of Fetroja for biothreat-related infections. ABL Bio’s partner has received Orphan Drug Designation from the FDA for tovecimig.
PharmaEssentia signed an investment agreement for a new manufacturing facility in Puerto Rico. Max Healthcare Institute is acquiring 58.4% stake in 250-bedded Kalinga Hospital for INR3B.


APAC Healthcare Weekly (April 12) – Wuxi XDC, Xuanzhu Biopharma, Shionogi, ABL Bio, PharmaEssentia

<ul>
<li>Henlius Biotech’s serplulimab is a step ahead for EU approval for two indications. InSilico Medicine inked a licensing and drug discovery collaboration with Eli Lilly for $115M upfront payment.</li>
<li>Shionogi completes acquisition of Radicava and stake increase in ViiV Healthcare. Mochida Pharmaceutical inked licensing deal with LG Chem for marketing of Dinagest in South Korea and Thailand.</li>
<li>Samsung Biologics has completed its acquisition of a manufacturing facility in Rockville, Maryland from GSK. SK Biopharmaceuticals has submitted NDA to the FDA for the oral suspension formulation of Xcopri.  </li>
</ul>


Henlius Biotech’s serplulimab is a step ahead for EU approval for two indications. InSilico Medicine inked a licensing and drug discovery collaboration with Eli Lilly for $115M upfront payment.
Shionogi completes acquisition of Radicava and stake increase in ViiV Healthcare. Mochida Pharmaceutical inked licensing deal with LG Chem for marketing of Dinagest in South Korea and Thailand.
Samsung Biologics has completed its acquisition of a manufacturing facility in Rockville, Maryland from GSK. SK Biopharmaceuticals has submitted NDA to the FDA for the oral suspension formulation of Xcopri.  


APAC Healthcare Weekly (April 5) – Henlius Biotech, InSilico, Shionogi, Samsung Bio, SK Biopharma

<ul>
<li>Hengrui Pharma received indication expansion approval for trastuzumab rezetecan in China. MicroPort NeuroScientific’s Apollo Dream Rapamycin Target Eluting Stent has been granted the Breakthrough Device Designation by the FDA.</li>
<li>Celltrion signed KRW375B CMO agreement with a global pharmaceutical company for the supply of drug substance. Samsung Bioepis entered global commercialization agreement with Sandoz for five biosimilar candidates under development.</li>
<li>FDA accepted Sun Pharma’s indication expansion application for Ilumya for active psoriatic arthritis. Zydus Lifesciences entered licensing and supply agreements with Torrent Pharmaceuticals and Lupin to co-market Semaglutide in India.</li>
</ul>


Hengrui Pharma received indication expansion approval for trastuzumab rezetecan in China. MicroPort NeuroScientific’s Apollo Dream Rapamycin Target Eluting Stent has been granted the Breakthrough Device Designation by the FDA.
Celltrion signed KRW375B CMO agreement with a global pharmaceutical company for the supply of drug substance. Samsung Bioepis entered global commercialization agreement with Sandoz for five biosimilar candidates under development.
FDA accepted Sun Pharma’s indication expansion application for Ilumya for active psoriatic arthritis. Zydus Lifesciences entered licensing and supply agreements with Torrent Pharmaceuticals and Lupin to co-market Semaglutide in India.


APAC Healthcare Weekly (March 22) – Hengrui, Microport Neuro, Celltrion, Samsung Bio, Sun Pharma

<ul>
<li>Sino Biopharmaceutical’s pan-KRAS inhibitor TQB3205 got clinical trial approval in China for advanced malignant tumors. Jiangsu Hengrui Pharmaceuticals got indication expansion approval for Hetrombopag Olamine Tablets in China.</li>
<li>Astellas Pharma’s Phase3 study investigating Xospata in AML did not meet primary endpoint. Daiichi Sankyo’s indication expansion application for Enhertu has been accepted and granted Priority Review in the U.S.</li>
<li>HK inno.N  signed joint promotion contract with Tanabe Pharma for renal anemia drug Vadanem. CSL announces expansion of manufacturing facility in Illinois to expand its U.S. production presence.</li>
</ul>


Sino Biopharmaceutical’s pan-KRAS inhibitor TQB3205 got clinical trial approval in China for advanced malignant tumors. Jiangsu Hengrui Pharmaceuticals got indication expansion approval for Hetrombopag Olamine Tablets in China.
Astellas Pharma’s Phase3 study investigating Xospata in AML did not meet primary endpoint. Daiichi Sankyo’s indication expansion application for Enhertu has been accepted and granted Priority Review in the U.S.
HK inno.N  signed joint promotion contract with Tanabe Pharma for renal anemia drug Vadanem. CSL announces expansion of manufacturing facility in Illinois to expand its U.S. production presence.


APAC Healthcare Weekly (March 15) – Sino Bio, Hengrui, Astellas, Daiichi Sankyo, HK Inno, CSL

China

Shanghai Henlius Biotech is a global, innovation-driven biopharmaceutical company focused on delivering high-quality, affordable biologic therapies for oncology, autoimmune diseases, and ophthalmic diseases. The company is engaged in biopharmaceutical research and development, manufacturing, and commercialization, offering products such as the biosimilars HANLIKANG (rituximab), HANQUYOU (trastuzumab), HANDAYUAN (adalimumab), and HANBEITAI (bevacizumab), as well as the innovative biologic HANSIZHUANG (serplulimab). Headquartered in Shanghai, China, the company was founded in 2010.

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Shanghai Henlius Biotech (2696 HK)

APAC Healthcare Weekly (April 19) – Fosun Pharma, Remegen, Daiichi Sankyo, Astellas Pharma, Telix

FDA granted Priority Review to Daiichi Sankyo’s I-DXd. Astellas Pharma initiates Phase 3 study for setidegrasib. Telix and Regeneron...

Tina Banerjee

APAC Healthcare Weekly (April 12) – Wuxi XDC, Xuanzhu Biopharma, Shionogi, ABL Bio, PharmaEssentia

Wuxi XDC inked deal with Akari Therapeutics. Xuanzhu Bio entered licensing deal with Boston Oncology. Shionogi secured $119M BARDA contract for...

Tina Banerjee

APAC Healthcare Weekly (April 5) – Henlius Biotech, InSilico, Shionogi, Samsung Bio, SK Biopharma

Henlius’ serplulimab is a step ahead for EU approval for two indications. InSilico inked $2.75B deal with Lilly. SK Biopharmaceuticals applied for...

Tina Banerjee

APAC Healthcare Weekly (March 22) – Hengrui, Microport Neuro, Celltrion, Samsung Bio, Sun Pharma

Celltrion signed KRW375B biologics CMO deal with a global pharma company. Samsung Bioepis expands biosimilar collaboration with Sandoz. 40+ Indian...

Tina Banerjee

APAC Healthcare Weekly (March 15) – Sino Bio, Hengrui, Astellas, Daiichi Sankyo, HK Inno, CSL

Couple of Chinese companies got clinical trials approvals for their respective drug candidates. Astellas’ Phase 3 trial failed to meet primary...

Tina Banerjee

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