Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<ul>
<li>CSPC Pharmaceutical’s SYS6010 met primary endpoint in Phase 3 study as a monotherapy for NSCLC. Akeso’s ivonescimab demonstrates significant overall survival in Phase 3 trial for advanced biliary tract cancer.</li>
<li>Takeda Pharma secured FDA approval for Mimrylo (rusfertide) for the treatment of erythrocytosis in adults with polycythemia vera. Astellas Pharma initiates global Phase 3 study evaluating ASP2138 for gastric cancers.</li>
<li>Hanmi Pharm outlicenses obesity drug candidate HM1732 to Genentech for a total deal value of $2.3B. SK Biopharmaceuticals entered an agreement to in-license opakalim, an investigational antiseizure medication, from Biohaven.</li>
</ul>


CSPC Pharmaceutical’s SYS6010 met primary endpoint in Phase 3 study as a monotherapy for NSCLC. Akeso’s ivonescimab demonstrates significant overall survival in Phase 3 trial for advanced biliary tract cancer.
Takeda Pharma secured FDA approval for Mimrylo (rusfertide) for the treatment of erythrocytosis in adults with polycythemia vera. Astellas Pharma initiates global Phase 3 study evaluating ASP2138 for gastric cancers.
Hanmi Pharm outlicenses obesity drug candidate HM1732 to Genentech for a total deal value of $2.3B. SK Biopharmaceuticals entered an agreement to in-license opakalim, an investigational antiseizure medication, from Biohaven.


APAC Healthcare Weekly (August 30)– CSPC Pharma, Akeso, Takeda, Astellas, Hanmi Pharm, SK Biopharma

<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>Hengrui Pharmaceuticals’ trastuzumab rezetecan got third indication approval in China for colorectal cancer. CSPC Pharma and AstraZeneca entered JV contract for the construction of new-generation biologics manufacturing facility in China.</li>
<li>Takeda Pharmaceutical got FDA approval for Orzeyful for narcolepsy type 1. As a first-in-class orexin treatment, Orzeyful is the only medicine indicated in the U.S. to treat the disease holistically.</li>
<li>Otsuka announced new data from the Phase 3 trial demonstrating that Voyxact stabilizes kidney function decline. Alteogen signed an exclusive license agreement with a global pharmaceutical company for ALT-B4. </li>
</ul>


Hengrui Pharmaceuticals’ trastuzumab rezetecan got third indication approval in China for colorectal cancer. CSPC Pharma and AstraZeneca entered JV contract for the construction of new-generation biologics manufacturing facility in China.
Takeda Pharmaceutical got FDA approval for Orzeyful for narcolepsy type 1. As a first-in-class orexin treatment, Orzeyful is the only medicine indicated in the U.S. to treat the disease holistically.
Otsuka announced new data from the Phase 3 trial demonstrating that Voyxact stabilizes kidney function decline. Alteogen signed an exclusive license agreement with a global pharmaceutical company for ALT-B4. 


APAC Healthcare Weekly (August 9) – Hengrui, CSPC Pharma, Takeda Pharma, Otsuka, Alteogen

<ul>
<li>Jiangsu Hengrui received NMPA approval for camrelizumab as a first-line treatment of recurrent or metastatic cervical cancer. BeOne Medicines announced $300M expansion of its New Jersey manufacturing and R&amp;D center.</li>
<li>Takeda Pharmaceutical got China approval for Orzeyful as a treatment of narcolepsy type 1. Nippon Shinyaku outlicences NS-025 to Aquelys Therapeutics for the treatment of xerostomia associated with Sjögren’s disease.</li>
<li>Samsung Biologics is acquiring PolyPeptide, a leading global CDMO specializing in peptide-based API, for CHF1.46B. Celltrion has applied to the EMA for marketing authorization for its Cosentyx biosimilar candidate, CT-P55. </li>
</ul>


Jiangsu Hengrui received NMPA approval for camrelizumab as a first-line treatment of recurrent or metastatic cervical cancer. BeOne Medicines announced $300M expansion of its New Jersey manufacturing and R&amp;D center.
Takeda Pharmaceutical got China approval for Orzeyful as a treatment of narcolepsy type 1. Nippon Shinyaku outlicences NS-025 to Aquelys Therapeutics for the treatment of xerostomia associated with Sjögren’s disease.
Samsung Biologics is acquiring PolyPeptide, a leading global CDMO specializing in peptide-based API, for CHF1.46B. Celltrion has applied to the EMA for marketing authorization for its Cosentyx biosimilar candidate, CT-P55. 


APAC Healthcare Weekly (July 26) – Hengrui, BeOne, Takeda, Nippon Shinyaku, Samsung Bio, Celltrion

<ul>
<li>Sichuan Kelub Biotech’s sac-TMT in combination with Keytruda as a first-line treatment for PD-L1-negative non-squamous NSCL) met primary endpoint. NMPA accepted CSPC Pharma’s NDA for Trastuzumab Envedotin (HER2-targeted ADC).</li>
<li>InSilico Medicine announced a multi-target strategic alliance with Bora Pharmaceuticals. Eisai secured FDA approval for a once-weekly Leqembi subcutaneous autoinjector as an initiation dose for Alzheimer’s disease.</li>
<li>Celltrion obtained domestic approval for Phase 1 clinical trials for its Tremfya biosimilar candidate, CT-P68. Mesoblast achieved target of 300 patients treated in Phase 3 trial of rexlemestrocel-L for CLBP.</li>
</ul>


Sichuan Kelub Biotech’s sac-TMT in combination with Keytruda as a first-line treatment for PD-L1-negative non-squamous NSCL) met primary endpoint. NMPA accepted CSPC Pharma’s NDA for Trastuzumab Envedotin (HER2-targeted ADC).
InSilico Medicine announced a multi-target strategic alliance with Bora Pharmaceuticals. Eisai secured FDA approval for a once-weekly Leqembi subcutaneous autoinjector as an initiation dose for Alzheimer’s disease.
Celltrion obtained domestic approval for Phase 1 clinical trials for its Tremfya biosimilar candidate, CT-P68. Mesoblast achieved target of 300 patients treated in Phase 3 trial of rexlemestrocel-L for CLBP.


APAC Healthcare Weekly (July 19) – Kelun Bio, CSPC Pharma, Insilico, Eisai, Celltrion, Mesoblast

China

Shanghai Fosun Pharmaceutical (Group) Co., Ltd. is a pharmaceutical company. Through its subsidiaries, the Company manufactures genetic medicines, Chinese traditional medicines, diagnostic products, and medical instruments, provides technology, marketing, and advertising services, as well as invests in import and export trading.

Shanghai Fosun Pharmaceutical (Group) (600196 CH)

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Shanghai Fosun Pharmaceutical (Group) (600196 CH)

APAC Healthcare Weekly (August 30)– CSPC Pharma, Akeso, Takeda, Astellas, Hanmi Pharm, SK Biopharma

CSPC and Akeso announced positive results from their respective Phase 3 trials for cancer drug candidates. Takeda got FDA approval for blood cancer...

Tina Banerjee

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 (August 9) – Hengrui, CSPC Pharma, Takeda Pharma, Otsuka, Alteogen

Hengrui’s trastuzumab rezetecan got 3rd indication approval in China. CSPC and AstraZeneca form JV for biologics manufacturing facility in China....

Tina Banerjee

APAC Healthcare Weekly (July 26) – Hengrui, BeOne, Takeda, Nippon Shinyaku, Samsung Bio, Celltrion

Hengrui’s camrelizumab got indication expansion approval for cervical cancer. BeOne announced $300M expansion plan for US facility. Samsung...

Tina Banerjee

APAC Healthcare Weekly (July 19) – Kelun Bio, CSPC Pharma, Insilico, Eisai, Celltrion, Mesoblast

Kelun Biotech’s sac-TMT met primary endpoint in Phase 3 trial. FDA approves Eisai’s Leqembi Iqlik for Alzheimer’s starting therapy. Mesoblast met...

Tina Banerjee

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