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>Hansoh Pharmaceutical obtained clinical trial approval for HS10587 tablets for advanced solid tumors. CSPC Pharmaceutical got registration approval for Aprepitant Injection for the prevention of postoperative nausea and vomiting.</li>
<li>Chugai Pharmaceutical’s partner Roche has decided to discontinue the clinical development of GYM329 (emugrobart). Otsuka is acquiring the U.S.-based Transcend Therapeutics for an upfront payment of $700M.</li>
<li>Celltrion will invest KRW 1.2T to construct Plants 4 and 5 at its Songdo campus. Alteogen entered license agreement with Biogen for development of subcutaneous formulations of biologics utilizing ALT-B4.</li>
</ul>


Hansoh Pharmaceutical obtained clinical trial approval for HS10587 tablets for advanced solid tumors. CSPC Pharmaceutical got registration approval for Aprepitant Injection for the prevention of postoperative nausea and vomiting.
Chugai Pharmaceutical’s partner Roche has decided to discontinue the clinical development of GYM329 (emugrobart). Otsuka is acquiring the U.S.-based Transcend Therapeutics for an upfront payment of $700M.
Celltrion will invest KRW 1.2T to construct Plants 4 and 5 at its Songdo campus. Alteogen entered license agreement with Biogen for development of subcutaneous formulations of biologics utilizing ALT-B4.


APAC Healthcare Weekly (March 29) – Hansoh, CSPC, Chugai, Takeda, Otsuka, Celltrion, Alteogen

<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 entered outlicensing agreement with Sanofi for rovadicitinib for upfront payment of $135M. Antengene entered outlicensing agreement with UCB for ATG-201 for upfront and near-term milestone payment of $80M.</li>
<li>FDA accepted Takeda’s NDA for polycythemia vera drug rusfertide and granted Priority Review.  Sumitomo Pharma received conditional and time‑limited approval in Japan for the allogeneic cell product Amchepry.</li>
<li>FDA has cleared ABL Bio’s application for a Phase 1 clinical trial of ABL209. Glenmark Pharmaceuticals received FDA approval for generic Flovent with 180-day CGT exclusivity.</li>
</ul>


Sino Biopharmaceutical entered outlicensing agreement with Sanofi for rovadicitinib for upfront payment of $135M. Antengene entered outlicensing agreement with UCB for ATG-201 for upfront and near-term milestone payment of $80M.
FDA accepted Takeda’s NDA for polycythemia vera drug rusfertide and granted Priority Review.  Sumitomo Pharma received conditional and time‑limited approval in Japan for the allogeneic cell product Amchepry.
FDA has cleared ABL Bio’s application for a Phase 1 clinical trial of ABL209. Glenmark Pharmaceuticals received FDA approval for generic Flovent with 180-day CGT exclusivity.


APAC Healthcare Weekly (March 8) – Sino Bio, Antengene, Takeda, Sumitomo Pharma, ABL Bio, Glenmark

China

CSPC Pharmaceutical Group Limited is a prominent Chinese pharmaceutical company engaged in the research, development, manufacturing, and sale of pharmaceutical products, including innovative drugs and bulk drugs. Its key products include innovative drugs for nervous system diseases, oncology, anti-infectives, and cardiovascular diseases, as well as bulk products like vitamin C, antibiotics, and caffeine. The company was formally established in 1997 and is headquartered in Shijiazhuang, Hebei Province, China.

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CSPC Pharmaceutical (1093 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 (March 29) – Hansoh, CSPC, Chugai, Takeda, Otsuka, Celltrion, Alteogen

Hansoh got trial approval, while CSPC obtained new drug approval. Chugai’s partner is discontinuing development of emugrobart. Otsuka is acquiring...

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 8) – Sino Bio, Antengene, Takeda, Sumitomo Pharma, ABL Bio, Glenmark

Sino Bio and Anetengene stuck outlicensing deals with Sanofi and UCB, respectively. FDA accepted Takeda’s NDA for rusfertide. Sumitomo Pharma got...

Tina Banerjee

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