Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<ul>
<li>Hansoh’s fourth-generation EGFR TKI HS-10504 tablets secured Breakthrough Therapy Designation in China for NSCLC. Junshi Biosciences got 13th indication expansion approval for toripalimab for HER2-expressing locally advanced or metastatic UC.</li>
<li>Daiichi Sankyo secured FDA approval for Enhertu’s two new breast cancer indications. The company’s Datroway got U.S. approval for TNBC. Japan approved NHI price for SanBio’s Akuugo.</li>
<li>Hanmi Pharmaceutical initiated domestic Phase 3 trial to expand indication for efpeglenatide beyond obesity to include the treatment of diabetes. Yuhan Corp signed $140M API supply contract with Gilead Sciences.</li>
</ul>


Hansoh’s fourth-generation EGFR TKI HS-10504 tablets secured Breakthrough Therapy Designation in China for NSCLC. Junshi Biosciences got 13th indication expansion approval for toripalimab for HER2-expressing locally advanced or metastatic UC.
Daiichi Sankyo secured FDA approval for Enhertu’s two new breast cancer indications. The company’s Datroway got U.S. approval for TNBC. Japan approved NHI price for SanBio’s Akuugo.
Hanmi Pharmaceutical initiated domestic Phase 3 trial to expand indication for efpeglenatide beyond obesity to include the treatment of diabetes. Yuhan Corp signed $140M API supply contract with Gilead Sciences.


APAC Healthcare Weekly (May 24)– Hansoh, Junshi Bio, Daiichi Sankyo, SanBio, Hanmi Pharm, Yuhan Corp

<ul>
<li>Shanghai Henlius Biotech announced that PMDA of Japan approved phase 2/3 clinical trial of HLX43 for injection (an anti-PD-L1 antibody-drug conjugate) for advanced squamous non-small cell lung cancer (NSCLC).</li>
<li>Simcere Pharmaceutical announced that, SIM0613 for Injection, an antibody-drug conjugate, received the clinical trial approval in China, and is intended for commencing the clinical trial for advanced solid tumors.</li>
<li>Olympus has signed an exclusive global distribution agreement with EndoRobotics. Under this agreement, robot-assisted technologies manufactured by EndoRobotics will be distributed globally by Olympus exclusively.</li>
</ul>


Shanghai Henlius Biotech announced that PMDA of Japan approved phase 2/3 clinical trial of HLX43 for injection (an anti-PD-L1 antibody-drug conjugate) for advanced squamous non-small cell lung cancer (NSCLC).
Simcere Pharmaceutical announced that, SIM0613 for Injection, an antibody-drug conjugate, received the clinical trial approval in China, and is intended for commencing the clinical trial for advanced solid tumors.
Olympus has signed an exclusive global distribution agreement with EndoRobotics. Under this agreement, robot-assisted technologies manufactured by EndoRobotics will be distributed globally by Olympus exclusively.


APAC Healthcare Weekly (May 10) – Henlius Bio, Simcere, Olympus, Daewoong Pharma

<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

Japan

Shionogi & Company Ltd., is a pharmaceutical company. The Company develops prescription & over-the-counter drugs and diagnostics.

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Shionogi & Co (4507 JP)

APAC Healthcare Weekly (May 24)– Hansoh, Junshi Bio, Daiichi Sankyo, SanBio, Hanmi Pharm, Yuhan Corp

Hansoh’s HS-10504 tablets secured BTD in China. Junshi Bio secured 13th indication approval for toripalimab. Daiichi Sanyo’s Enhertu and Datroway...

Tina Banerjee

APAC Healthcare Weekly (May 10) – Henlius Bio, Simcere, Olympus, Daewoong Pharma

Henlius Bio and Simcere got trial approval for their respective ADC candidates in Japan and China, respectively. Olympus forges exclusive global...

Tina Banerjee

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

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