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>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>Innovent Biologics announced strategic global collaboration with Takeda for total deal value of $11.4B. Akeso announced that phase 3 trial evaluating ivonescimab versus tislelizumab in sq-NSCLC met primary endpoint.</li>
<li>Celltrion received FDA approval for two additional pediatric indications for Humira biosimilar, Yuflyma. Classys plans to acquire 77.5% stake in JL Health, South American energy-based aesthetic medical device distribution group. </li>
<li>Syngene plans to add a bioconjugation suite at its commercial biologics facility. Cipla and Eli Lilly agreed to distribute and promote tirzepatide in India under a second brand name, Yurpeak.</li>
</ul>


Innovent Biologics announced strategic global collaboration with Takeda for total deal value of $11.4B. Akeso announced that phase 3 trial evaluating ivonescimab versus tislelizumab in sq-NSCLC met primary endpoint.
Celltrion received FDA approval for two additional pediatric indications for Humira biosimilar, Yuflyma. Classys plans to acquire 77.5% stake in JL Health, South American energy-based aesthetic medical device distribution group. 
Syngene plans to add a bioconjugation suite at its commercial biologics facility. Cipla and Eli Lilly agreed to distribute and promote tirzepatide in India under a second brand name, Yurpeak.


APAC Healthcare Weekly (October 26) – Innovent, Akeso, Celltrion, Classys, Daiichi, Syngene, Cipla

<ul>
<li>Daiichi Sankyo’s indication expansion application for Enhertu has been accepted for review by FDA for certain types of breast cancers. Santen’s new drug application has been accepted in China.  </li>
<li>Hanmi Pharm entered into a global licensing agreement with Gilead Sciences granting Gilead the exclusive rights to develop and commercialize encequidar. Boryung is acquiring Sanofi’s cytotoxic anti-cancer drug Taxotere.</li>
<li>IHH Healthcare received SEBI approval for mandatory open offer for 26% stake in Fortis Healthcare. Lupin has launched Liraglutide prefilled pen, bioequivalent to Victoza, in the U.S.</li>
</ul>


Daiichi Sankyo’s indication expansion application for Enhertu has been accepted for review by FDA for certain types of breast cancers. Santen’s new drug application has been accepted in China.  
Hanmi Pharm entered into a global licensing agreement with Gilead Sciences granting Gilead the exclusive rights to develop and commercialize encequidar. Boryung is acquiring Sanofi’s cytotoxic anti-cancer drug Taxotere.
IHH Healthcare received SEBI approval for mandatory open offer for 26% stake in Fortis Healthcare. Lupin has launched Liraglutide prefilled pen, bioequivalent to Victoza, in the U.S.


APAC Healthcare Weekly (October 5) – Daiichi Sankyo, Santen, Hanmi Pharm, Boryung, IHH Health, Lupin

<ul>
<li>Terumo is acquiring OrganOx, a leading innovator in organ preservation devices. Eisai received FDA approval for once weekly Leqembi subcutaneous injection for maintenance dosing.</li>
<li>Chugai Pharmaceutical’s partner Eli Lilly announced positive topline results from the Phase 3 trial of oral GLP-1 drug candidate. Daiichi Sankyo received approval for Datroway in China.</li>
<li>Beigene announced positive topline results from a Phase 1/2 study of sonrotoclax in mantle cell lymphoma. Telix Pharmaceuticals received a Complete Response Letter from the FDA regarding Zircaix.</li>
</ul>


Terumo is acquiring OrganOx, a leading innovator in organ preservation devices. Eisai received FDA approval for once weekly Leqembi subcutaneous injection for maintenance dosing.
Chugai Pharmaceutical’s partner Eli Lilly announced positive topline results from the Phase 3 trial of oral GLP-1 drug candidate. Daiichi Sankyo received approval for Datroway in China.
Beigene announced positive topline results from a Phase 1/2 study of sonrotoclax in mantle cell lymphoma. Telix Pharmaceuticals received a Complete Response Letter from the FDA regarding Zircaix.


APAC Healthcare Weekly (Aug 31) – Terumo, Eisai, Chugai, Daiichi Sankyo, Beigene, Remegen, Telix

China

RemeGen is a China-based biopharmaceutical company dedicated to the discovery, development, production, and commercialization of innovative biological drugs. The company focuses on therapeutic antibody drugs, including antibody-drug conjugates (ADCs), antibody fusion proteins, monoclonal antibodies, and bispecific antibodies, for major diseases such as autoimmune disorders, oncology, and ophthalmology. Key products include Telitacicept (RC18) and Disitamab Vedotin (RC48). RemeGen was co-founded in 2008 and is headquartered in Yantai, Shandong Province, China.

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RemeGen (9995 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 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 (October 26) – Innovent, Akeso, Celltrion, Classys, Daiichi, Syngene, Cipla

Innovent Biologics announced collaboration with Takeda. FDA approves two additional indications for Celltrion's Humira biosimilar. Syngene is...

Tina Banerjee

APAC Healthcare Weekly (October 5) – Daiichi Sankyo, Santen, Hanmi Pharm, Boryung, IHH Health, Lupin

Daiichi Sankyo’s label expansion application for Enhertu has been accepted by FDA. Hanmi Pharm entered into global licensing agreement with Gilead...

Tina Banerjee

APAC Healthcare Weekly (Aug 31) – Terumo, Eisai, Chugai, Daiichi Sankyo, Beigene, Remegen, Telix

Terumo announced new acquisition. Eisai got FDA approval for Leqembi subcutaneous maintenance dosing. Chugai’s oral GLP-1 drug showed positive P3...

Tina Banerjee

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