Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<ul>
<li>Fosun Pharmaceutical initiated Phase 2 trial of FXS7553 for COPD in China. CSPC Pharma’s mpox mRNA vaccine candidate obtained clinical trial approval from the FDA.</li>
<li>Akeso secured NMPA approval for ivonescimab, in combination with chemotherapy, for the treatment of first-line squamous non-small cell lung cancer (sq-NSCLC). This indication marks ivonescimab’s third major approval.</li>
<li>Daiichi Sankyo’s Enhertu got China approval for the first-line treatment of breast cancer. Peptidream marked a milestone following the initiation of Phase 1 study for two radioligand therapies by Novartis.</li>
</ul>


Fosun Pharmaceutical initiated Phase 2 trial of FXS7553 for COPD in China. CSPC Pharma’s mpox mRNA vaccine candidate obtained clinical trial approval from the FDA.
Akeso secured NMPA approval for ivonescimab, in combination with chemotherapy, for the treatment of first-line squamous non-small cell lung cancer (sq-NSCLC). This indication marks ivonescimab’s third major approval.
Daiichi Sankyo’s Enhertu got China approval for the first-line treatment of breast cancer. Peptidream marked a milestone following the initiation of Phase 1 study for two radioligand therapies by Novartis.


APAC Healthcare Weekly (August 16) – Akeso, Fosun Pharma, CSPC Pharma, Daiichi Sankyo, Peptidream

<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>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

<ul>
<li>Simcere entered into license agreement with Vigonvita for new indications of Deuterated Remdesivir Hydrobromide. Kelun Biotech inked partnership with Crescent Biopharma to develop and commercialize oncology therapeutics, including novel combinations.</li>
<li>Samsung Biologics is acquiring land for third campus in Songdo, Icheon for KRW249B. SK Biopharmaceutical signed supply agreement with Eckert &amp; Ziegler for actinium-225 for the development of next-generation radiopharmaceutical.</li>
<li>Daiichi Sankyo won a court appeal for its long-running legal battle with Seagen. Biocon made settlement agreement with Amgen clearing commercialization path for its Denosumab biosimilars in Europe and RoW.</li>
</ul>


Simcere entered into license agreement with Vigonvita for new indications of Deuterated Remdesivir Hydrobromide. Kelun Biotech inked partnership with Crescent Biopharma to develop and commercialize oncology therapeutics, including novel combinations.
Samsung Biologics is acquiring land for third campus in Songdo, Icheon for KRW249B. SK Biopharmaceutical signed supply agreement with Eckert &amp; Ziegler for actinium-225 for the development of next-generation radiopharmaceutical.
Daiichi Sankyo won a court appeal for its long-running legal battle with Seagen. Biocon made settlement agreement with Amgen clearing commercialization path for its Denosumab biosimilars in Europe and RoW.


APAC Healthcare Weekly (December 7) – Simcere, Kelun Bio, Samsung Biologics, Daiichi Sankyo, Biocon

China

Genfleet Therapeutics is a biopharmaceutical company focused on developing innovative treatments for oncology, including various solid tumors, and autoimmune and inflammatory diseases. The company's pipeline includes products like GFH925 (fulzerasib) for advanced non-small cell lung cancer and GFH375, a KRAS G12C inhibitor. Genfleet Therapeutics was incorporated in 2017 and is headquartered in Shanghai, China.

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Genfleet Therapeutics (2595 HK)

APAC Healthcare Weekly (August 16) – Akeso, Fosun Pharma, CSPC Pharma, Daiichi Sankyo, Peptidream

Akeso’s ivonescimab and Daiichi Sankyo’s Enhertu got additional indications approvals in China. CSPC Pharma’s mpox mRNA vaccine candidate got FDA...

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 (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

APAC Healthcare Weekly (December 7) – Simcere, Kelun Bio, Samsung Biologics, Daiichi Sankyo, Biocon

Simcere stuck license pact with Vigonvita. Kelun Bio inked partnership with Crescent Biopharma. Samsung Biologics is acquiring land for third...

Tina Banerjee

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